Challenging Realities of Today

Study start-up is commonly prone to delays due to the involvement of various stakeholders, technologies, and interdependent decisions. One decision that can greatly impact the success of a study is determining which sites to partner with. Unfortunately, the traditional feasibility process is inefficient and fragmented with multiple sites, sponsors, and CROs reaching out to the same investigators with the same questions.

In a study by the American Society of Clinical Oncology (ASCO), a clinical trial site receives a median of five feasibility questionnaires per month. Within those questionnaires, around 85% of questions are redundant across sponsors/CROs as well as within the same sponsor/CRO. According to recent research by the Tufts Center for the Study of Drug Development, an average of 200 hours are spent each month per investigative site completing feasibility assessments and site qualification visits for FDA regulated industry-funded clinical trials.

When combined with the known obstacles of physician retention and participant recruitment, the amount of time answering redundant questions would be better allocated to solving for participant recruitment challenges.

Best Practices for Site Feasibility

One of the primary difficulties in site feasibility is the consolidation of disparate data on sites. This includes information on past trials, site capabilities, and investigator profiles. To address this, it is essential to standardize data collection. By consolidating disparate data into a single, unified data source, organizations can ensure a comprehensive view of potential sites and facilitate informed decision-making. Additionally, utilizing a standardized question bank mapped to site and investigator profiles ensures 100% data reusability, reducing redundancy and ensuring consistency in data collection.

When standardized data is in play, an organization can begin to implement predictive analytics. Predictive analytics have a crucial role in site selection by effectively integrating back-end algorithms to structure the subjective opinions of key stakeholders and connecting key datapoints needed for decision making. Implementing these analytics allows for a data-driven approach, making the site selection process more objective and reliable. Integrating custom scoring of survey responses to support a uniform review of sites ensures that feedback from multiple stakeholders is built into the site scoring algorithm, removing subjective components from site selection. This objective approach helps identify sites with the highest potential for success.

However, regardless of the increase in data usage, analytics, and improvements in the site identification process, site feasibility still requires outreach to the sites to ensure that they are interested in participating in the clinical trial in question. During this phase of the site selection process, collaboration and communication are key components of an efficient site feasibility process. Using pre-configured surveys with standard questions and electronic confidential disclosure agreements (CDAs) help to streamline the process, making sites more likely to participate due to the emphasis on efficiency. Similarly, establishing tailored communication channels where the site is asked to validate the information we know about them, as opposed to re-answering the same questions, facilitates close collaboration between sponsors and sites, ensuring efficient interactions.

Focusing on improving the overall site experience builds stronger, long-term relationships with sites. This includes understanding the holistic view of site capabilities, interests, staff, and logistics, and doing more efficient outreach for future trials when you understand the core capabilities and interests of each individual site. When multiple stakeholders contribute to outreach, including medical science liaisons (MSLs) within the sponsor organization or a designated CRO, transparent and centralized reporting with clear and actionable interaction histories enhances transparency and accountability, while allowing a sponsor to see their entire investigator footprint throughout their organization.

Setting up for Success

Sponsors and CROs can streamline the site feasibility process by leveraging innovative approaches and best practices. Unlocking data and insights for more precise sites matched to a study reduces burden and creates faster response times from potential sites. WCG’s Total Feasibility solution can help sponsors and CROs address key challenges, enhance process efficiency, and build stronger relationships with sites. These best practices can serve as a valuable guide for organizations looking to improve their site feasibility process and achieve greater success in their clinical trials.

References:

1. ^{Recommendations to Streamline and Standardize Clinical Trial Site Feasibility Assessments: An ASCO Research Statement: https://ascopubs.org/doi/10.1200/OP.20.00821}
2. ^{Benchmarking the Investigative Site Qualification Process: https://www.appliedclinicaltrialsonline.com/view/benchmarking-the-investigative-site-qualification-process}

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The following Insight is a featured article from WCG’s 2025 Trends & Insights Report. If you would like to read more insights from this report, please click here.

Diversity in clinical trials is not just a matter of fairness— it is a scientific imperative. Historically, clinical studies have underrepresented certain populations, which has led to gaps in our understanding of how different groups respond to medical treatments. A 2020 FDA report showed that 75% of participants in clinical trials for new molecular entities were white, while only 11% were Hispanic or Latino, 8% were Black or African American, and 6% were Asian. But the disparities can often go beyond race, traced to gender, age, socio-economic representation, and even sexual orientation. This lack of diversity can result in disparities in health outcomes, as treatments may not be as effective or safe for all population segments.  

The FDA Guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies is expected to be released this year and represents a significant step forward in addressing these disparities. This guidance emphasizes the necessity of incorporating Diversity Action Plans (DAPs) in the planning and execution of clinical trials. By mandating that researchers proactively include participants from diverse backgrounds, the FDA aims to ensure that clinical trial results are more generalizable and applicable to the broader public.  

Moreover, participant engagement is expected to see significant improvements. With a focus on diversity, trial designs can be more inclusive, addressing potential barriers such as language, cultural sensitivities, and logistical challenges. Engaging community leaders and leveraging local resources can also enhance participation rates and retention. As sponsors look to understand the impacts their trials have on all types of diversity, there are dual-sided benefits, in that sponsor companies are educated on the public’s perception of clinical trials, specifically from diverse participants, and the public is educated more on the actual clinical trial process. By prioritizing the inclusion of diverse populations, educational initiatives can be tailored to raise awareness and understanding about the importance of clinical trial participation among underrepresented groups. This can lead to better engagement and trust in the medical research process.  

Site identification is another critical area where the FDA’s guidance will play a pivotal role. Identifying trial sites in areas that serve underrepresented populations will be imperative to enrolling more representative trial populations. This strategic approach can enhance the study findings’ relevance and foster equity in clinical research.  

The benefits of this guidance are profound. For the scientific community, it means more robust and reliable data, leading to better-informed decisions about the efficacy and safety of treatments across diverse populations. For public health, it translates to more personalized and effective healthcare interventions, ultimately contributing to reduced health disparities and improved outcomes for all. The upcoming finalization of the FDA Guidance on Diversity Action Plans is a crucial development that promises to enhance the inclusiveness and relevance of clinical trials. By fostering diversity, we move a tiny step closer to achieving equitable healthcare and advancing public health for everyone.  

Related Insights:

Diversity & Inclusion

FDA’s Path Toward Diversity in Clinical Trials: The DEPICT Act and Sponsor Responsibility

Whitepapers

The DEI Mandate: What’s on the Horizon and What’s Needed for IRB and Recruitment Processes (Part 1 of 2)

Videos

The DEI Mandate: How to Accelerate Diversity Initiatives with Data Analytics and Planning (Part 2 of 2)

Videos

The post The Importance of Diversity in Clinical Trials and the Impact of FDA Guidance appeared first on WCG.

On Oct. 15, 2024, WCG experts Matthew Staves and Cristin MacDonald presented the webinar, “Maximizing the Power of Central IRBs Prior to the FDA’s sIRB Mandate.” The panelists provided an overview of the impending sIRB mandate, discussed strategies for streamlining clinical trial processes to meet the new requirements, and shared how the role of site selection fits into the picture. Live questions submitted by the audience were addressed, summarized below. 

1. When the sIRB becomes mandatory, how will WCG work with local IRBs? Is there no role for local IRBs? 

2. If a study currently utilizes a central IRB and local IRBs, do sponsors need to switch to an sIRB model once the sIRB mandate is implemented? 

3. Under the sIRB mandate, how will “local language” requirements of universities be handled? Or will the central IRB’s informed consent form (ICF) be the template? 

4. How will this impact ongoing studies, especially if the ongoing study is using multiple IRBs? 

5. Will non-federally funded studies need to utilize an sIRB when this transition happens? Specifically, will sponsor-funded studies be required to use an sIRB? 

6. How do we expect the sIRB requirement to impact sites using their local IRBs? 

7. Will the sIRB requirement be for just US sites or will there be a global impact? 

8. Will sponsors have to choose one central IRB? Or can they have more than one for a study? We currently have two central IRBs for one study. 

9. Will sites that like to use a local IRB still be able to require their local IRB to review prior to central IRB submission? Will reliance agreements still be required? 

10. What might IRB review/approval look like under the new rule? Is the expectation that local IRBs and other central IRBs may still exist in a multi-center study and the chosen central IRB will liaise between the sponsor or those IRBs? Or will there only be two layers: the sponsor and one central IRB? 

11. How will the sIRB mandate affect reliance agreements when you have an IRB for oversight? Will reliance agreements still be required for sites with local IRBs? 

12. What happens if sites still have local IRBs? 

13. Currently, if the sponsor requires an sIRB, and the site agrees to use the sIRB, some sites still use their local IRB after the sIRB approval. Doesn’t this create duplicative work and cause delays in study timelines? 

14. Are there penalties in place for sites that do not comply with the mandate? 

Looking Ahead 

Preparing now for the sIRB mandate enables you to maximize the benefits of a central IRB and avoid last-minute adjustments to meet the upcoming requirements. Understanding the process of identifying the right sites is essential for the success of your studies. Take proactive steps today to elevate clinical trial efficiency. 

Have more questions? Connect with a WCG expert. 

The post The Upcoming sIRB Mandate and the Critical Role of Site Selection: Your Questions Answered  appeared first on WCG.

Published by the Journal for Clinical Studies, Volume 16 Issue 3, Oct. 23, 2024

Site selection is a crucial step in clinical research as it affects the quality, efficiency, and cost of the clinical trial. However, many challenges exist in the current site selection process, such as low investigator participation, poor recruitment performance, and lack of data-driven decision making. This article aims to highlight some of the key factors that need to be considered when selecting sites, and to provide suggestions on how to improve the process and leverage the potential of artificial intelligence (AI) and machine learning (ML) in the future.

Optimize your study planning, site identification, and selection processes based on robust data and insights with WCG ClinSphere™ Total Feasibility.

The post Site Selection in Clinical Trials: Current Challenges and Future Opportunities appeared first on WCG.

About the Webinar

The Food and Drug Administration’s (FDA) impending sIRB mandate will streamline processes by requiring multi-site studies to partner with one IRB reviewer. While the date is not set on when this mandate will go into effect, it is crucial to prepare your studies and processes now. Fortunately, in our recorded webinar, WCG’s experts share insights on how to best prepare for the sIRB mandate and the critical role of site selection. Understanding the process of identifying the right sites is essential for the success of your clinical trials. This webinar is most relevant to anyone conducting or managing multi-site research.

WCG’s expert panelists cover:

• An overview of the impending sIRB mandate.
• Strategies for streamlining clinical trial processes to meet the new requirements.
• The critical role of site selection, including best practices for identifying and preparing sites.
• Proactive steps to take now to ensure a smooth transition to an sIRB process.

WCG ClinSphere™ Total Feasibility

Optimize your study planning, site identification, and selection processes based on robust data and insights.

The post Maximizing the Power of Central IRBs Prior to the FDA’s sIRB Mandate appeared first on WCG.

The industry metrics paint a troubling picture of the current state of clinical trials recruitment and retention. With 37% of study sites not meeting their enrollment targets and 80% of studies failing to meet theirs, the industry faces a dire need for more effective strategies (source: 2024 WCG Data Intelligence).

Part of the problem can be attributed to the limited participation of investigators in clinical research and significant issues related to site staffing. Moreover, recruitment and retention difficulties are recognized as significant detractors, closely tied to a site’s resourcing levels. This not only disrupts timelines but can also inflate the cost of clinical trials substantially.

Tackling the Site Identification and Feasibility Process

The process of site identification and feasibility is traditionally data-driven, relying heavily on existing relationships, in-house data, and historical experiences. Yet, a more nuanced approach is needed, incorporating a variety of data sources and reevaluating assumptions continually. For example, factors like the competitive landscape and protocol requirements must be considered, as they significantly impact a site’s recruitment and enrollment capabilities.

These activities are often treated as “one and done,” when, in reality, data from both internal and external sources constantly evolves. Feasibility, recruitment, and retention strategies must remain adaptable on an ongoing basis to maximize efficiency and study success.

The Gap in Trust and Communication

A significant gap exists between sites and sponsors regarding trust in feasibility results. Many sites believe sponsors trust their feasibility responses, whereas a vast majority of sponsors showcase skepticism. This disconnect underscores the necessity for a dynamic approach to site identification and recruitment planning, continuously adapting to changes and reevaluating initial assumptions based on real-world challenges and situations.

Rethinking Recruitment and Retention

Recruitment and retention should be viewed as a universal process with interconnected stages: identification, enrollment, retention, and documentation. Effective site selection, requires a deep understanding of a site’s capability to navigate through these stages, considering both internal contributions and the need for external referrals. Understanding the capacity of sites to manage external referrals and their geographical suitability for community outreach or provider networking is crucial.

Resetting Expectations and Approaches

The industry must acknowledge the active nature of clinical trials and the inevitable changes and disruptions that occur. Open and clear communication channels between sites and sponsors, mutual trust, and a shared focus on trial and participant priorities are essential for navigating these changes effectively. By fostering a collaborative environment free from blame shifting, the industry can adapt more effectively to challenges in recruitment and retention, ensuring trials are completed safely, efficiently, and with integrity.

In conclusion, addressing feasibility, recruitment, and retention challenges in clinical trials requires a multifaceted approach, emphasizing flexibility, collaboration, and continuous reevaluation. By bridging the gap between sites and sponsors and adopting more dynamic strategies, the industry can move towards more effective and efficient clinical trial processes and successful outcomes.

Discover More

WCG Total Feasibility Solutions

Optimize your study planning, site identification, and selection processes based on robust data and insights.

learn more

WCG Recruitment & Retention Solutions

Simplify your recruitment and retention strategies to devote your attention to the science, your sites, and your participants.

learn more

The post Understanding the Complexities of Feasibility and Recruitment Strategies appeared first on WCG.

About the Webinar

Join us as we explore the competitive landscape of clinical trials and how feasibility and participant recruitment and retention play a pivotal role in the success of a study.

In this webinar, our experts discuss:

• Developing site selection and recruitment strategies that are not one-and-done and are continuously modified and updated over the course of a clinical trial.
• Leveraging data and insights to have a better projection of site enrollment.
• Instituting the best ways to have high-impact improvements on site selection and recruitment

Discover More

WCG Total Feasibility Solutions

Optimize your study planning, site identification, and selection processes based on robust data and insights.

learn more

WCG Recruitment & Retention Solutions

Simplify your recruitment and retention strategies to devote your attention to the science, your sites, and your participants.

learn more

The post Maximizing Trial Success Requires Evolving Feasibility and Recruitment Strategies appeared first on WCG.

“Quality by design” is prioritized in ICH E8(R1) (International Council for Harmonization General Considerations for Clinical Studies Guidance), calling for a comprehensive, stakeholder-inclusive approach to clinical trial design. These stakeholders include investigators and site staff, diverse patient populations, caregivers, and laboratory staff, among others.

This represents a significant change for many sponsor organizations. Historically, sponsors have handled protocol design and risk assessment in a silo. If sponsors do bring in an outside perspective, it’s usually a key opinion leader. The resulting protocols often will not work in any other environment than the one the key opinion leader is familiar with and understands. This mismatch leads to financial challenges and deviations from the protocol, which results in quality issues and increased costs.

Too often, sponsors view quality initiatives through the lens of overhead costs and it’s difficult to quantify the tangible benefits of quality. However, its absence can lead to significant financial and logistical setbacks which will increase cost and delay the project timeline.

As the industry grapples with complex and costly protocol amendments, inclusive stakeholder engagement not only ensures ICH E8(R1) compliance but also decreases the need for protocol amendments. Incorporating stakeholder input during the protocol design phase will pave the way for efficient, quality-focused, and culturally sensitive clinical trials.

The Problem with Amendments

Think of a clinical trial protocol as the foundation of a building. Amending the protocol means changing the foundation. That means knocking down everything above it to fix it and then rebuilding. It involves updating the lab manual and other documents, which comes at a cost. Then comes sending out the amended protocol to all the sites with the amended informed consent form, each of which requires a new IRB review. In addition, the sponsor must ensure that all stakeholders are trained on the new protocol amendment, affecting the cost and project timeline.

It’s frustrating and costly:

• According to a 2021 Tufts Center for the Study of Drug Development (CSDD) survey, 78% of phase II protocols and 69% of phase III protocols have at least one substantial protocol amendment. CSDD estimates that sponsors spend $7 to $8 billion annually to implement these amendments.¹
• In a more recent report, of 952 protocols assessed by Tufts CSDD between June and October 2022, three-quarters had at least one substantial amendment.²

Amendments create financial burdens and can compromise the quality of the research. One way to avoid unnecessary amendments is to spend more time at the outset thinking about the protocol and how to implement it, especially inclusion/exclusion criteria.

Examining Inclusion/Exclusion Criteria

Restrictive inclusion/exclusion criteria can eliminate an entire culture from participation. This limits a study’s breadth and applicability and can lead to incomplete or skewed data collection.

Consider a recent Alzheimer’s study protocol: It stated that participants could not have moved residences within three months, and they cannot move for the duration of the trial. Such rigid inclusion/exclusion criteria ignore cultural nuances. In many cultures, families share the care of their elders. A person may spend time with one adult child for a few weeks and then move to another relative’s home.

A study on sexual health unintentionally excluded a significant portion of the LGBTQ+ community due to a narrow and heteronormative definition of sexual activity.

From the sponsor or CRO’s perspective, neither protocol may appear restrictive, but they immediately reveal themselves in conversations with patients, caregivers, clinicians, and sites. It is imperative that sponsors begin to initiate these conversations.

Milestones that Matter

Sponsors and CROs often prioritize hitting key milestones, such as enrolling the first patient, over ensuring the quality of the protocol. Instead of planning for potential issues, problems are addressed after they arise in a retrospective manner, instead of an approach that prospectively mitigates issues. As a result, few trials finish on time. There’s a prevailing industry rush to hit early milestones, which overlooks the need for comprehensive feedback and quality assurance. This can lead to delays and additional costs down the line.

A quality-by-design approach builds in time on the front end to allow for stakeholder conversations and to identify and mitigate risks. Sponsors can shift attention from rushing to initiate the trial to focusing on developing a meticulously planned and executed trial that brings in various perspectives and leads to a successful project conclusion.

A Comprehensive, Independent Review

Reviewing a protocol from a 360-degree perspective can reduce uncertainty during study start-up, identify site readiness, flag potential obstacles to patient recruitment, and support a more robust approach to diversity, equity, and inclusion (DEI) planning. But such a review only succeeds if it’s both thorough and objective.

That’s why WCG provides a 360 Protocol Assessment to help sponsors ensure quality by design.

WCG’s subject matter experts in quality, operations, and DEI identify potential areas of risk in conjunction with its extensive network of investigators, sites, and patient advocacy groups. The assessment ensures sponsors hear from all key stakeholders. This equips them with the tools to identify and address key risks early in the trial’s planning phase, significantly reducing the need for protocol amendments.

As a neutral third party, WCG is free from external pressures and incentives related to deadlines or other external factors. When stakeholders that are close to the contractual terms of study also conduct protocol reviews, they tend to assess risk in terms of contract-related elements such as schedule and budget, rather than the nuances of scientific and project execution. Their rewards are connected to hitting milestones. This can result in a risk evaluation that’s more about logistical and contractual hurdles and less about the genuine challenges or risks inherent in the protocol. WCG enables a multi-lens review as your trusted partner.

For sponsors who want efficient, predictable, quality-focused trials that align with ICH E8(R1) guidelines, WCG’s 360 Protocol Assessment is crucial. Get comprehensive, unbiased insights from an unmatched network of experts and stakeholders. Let’s build protocols that work.

Connect with us to schedule a consultation today.

References

1. Getz, Ken. Doubling Down on Protocol Amendments and Deviations. www.pharmoutsourcing.com. March 1, 2022. https://www.pharmoutsourcing.com/Featured-Articles/584137-Doubling-Down-on-Protocol-Amendments-and-Deviations/

2. Protocol Amendments Continue to Increase, Report Shows. CenterWatch. March 6, 2023. https://www.centerwatch.com/articles/26488-protocol-amendments-continue-to-increase-report-shows

The post Establishing Protocol Quality by Design Through Stakeholder Collaboration appeared first on WCG.

About this episode:

In episode three of WCG Talks Trials, two WCG experts discuss key findings from the 2023 Avoca State of the Industry Report, which provides a 360-degree view on motivators and deterrents to clinical trial participation.

Listen in as we dive into feedback from perspectives across all clinical research stakeholders — sponsors, providers, sites, and patients — for valuable take-aways and insights into the trial experience.

Speakers:

• Crissy MacDonald, PhD, Vice President, Client Delivery, WCG Avoca
• Gina DiCindio, Associate Director, Industry and Client Research, WCG Avoca

Episode Transcript

Crissy MacDonald:

Hey everybody, I’m Crissy MacDonald, the Vice President of Client Delivery at WCG Avoca, and I am thrilled to be your host for today’s episode, discussing our report findings from the 360-degree assessment of the clinical trial industry. Before we dive in, I want to remind you to subscribe to this podcast and follow us on your favorite listening platforms like Apple Podcasts or Spotify, so you never miss an episode of WCG Talks Trials. I’m joined today by one of my colleagues and our research experts here at WCG, Gina DiCindio, who is the Associate Director of Industry and Client Research at WCG Avoca. Gina, thanks for joining me today and talking about our topic. But, before we get started, do you mind introducing yourself and telling people who you are and how long you’ve been around doing this research?

Gina DiCindio:

Sure. Thank you, Crissy. So, as mentioned, I am currently the Associate Director of Industry and Client Research at WCG Avoca. You might say that I’ve actually grown up with the company. I have over 16 years of experience in the life sciences industry, including 8 years of managing the delivery of large scale, multifaceted client relationship programs for pharma, biotech, CROs, and clinical service provider companies. I assist in survey design and presenting findings and themes and making recommendations to promote operational excellence to ensure quality relationship management and business growth. And then additionally, I provide project management support on various consulting projects related to inspection readiness, and most recently diversity, equity, and inclusion in clinical research.

Crissy MacDonald:

Thanks, Gina. Not to give it away, but that diversity, equity, and inclusion piece is going to come into play a little bit as we talk about our research today. But before we get into the nitty gritty there, can you give us a little bit of background, Gina, on this research and why we set forth for it?

Gina DiCindio:

Sure. So, for more than 20 years, WCG Avoca has surveyed industry executives to gain an understanding of key trends affecting outsourced clinical development, and industry leaders rely on our insights to strengthen relationships and enhance R&D, quality, and productivity. So, this annual report informs the industry about innovation in clinical development, intelligent approaches to trials, and sponsor and provider perceptions on managing risk, quality oversight, and more. So, past topics, for example, of the research that we’ve done have included innovation, diversity, quality oversight, outsourcing decisions, risk-based approaches, and with all of these research topics, we typically also touch on kind of a subcategory of related questions to gain insights and see what connections are there. So, for instance, when we researched diversity in clinical trial execution and participation, we asked about Decentralized Clinical Trials or DCT and we looked at how the use of DCT components in the clinical trials would impact the level of diversity in participants. So, it’s just one example.

Crissy MacDonald:

Yeah, and Gina, I think the crux of the research, and why we’ve done that is really listening to the highly discussed topics across the industry that are coming out as sort of concerns or pain points in the industry, and really doing that research to dive in and find out what exactly is the challenge. And ultimately, at the time it was for the consortium, the Avoca Quality Consortium to move forward with coming forth with some solutions; whether it’s documentation or trackers, or just having discussions to get it out in the open on what those regulatory expectations are, what people are seeing in the inspection readiness. That was the point of all of that research was to figure out what can we do as a collaborative to address some of these key challenges that were happening year on year. Is that right, Gina?

Gina DiCindio:

Right. It’s more like the industry buzz can be very informative. So, we’re always keeping our ears open and our eyes open and listening to see what people really need to know more about to make informed decisions.

Crissy MacDonald:

So, can you give us a little bit of insight of what was the industry buzz happening in 2022-2023, when this research was launched, that we were trying to dig into; what was the objective?

Gina DiCindio:

So, without patients, you can’t have clinical trials. So, we’re watching that, and most recently, our 2023 State of the Industry Report was released and this was a 360-degree assessment of the clinical trial industry. We wanted our research data to provide a 360-degree view of the current clinical research industry with perspectives from all stakeholders, meaning sponsors and providers, site staff, and patients, regardless of their experience with clinical trials; because we know that only about 3% of physicians participate in clinical research and less than 5% of cancer patients alone participate. So, what we know is pretty limited and based on feedback from this small portion of the pool. So, to improve and increase participation, we have to listen. Sponsors have to listen to everyone and have to develop protocols that meet the needs of even research-naïve patients and investigators. So, we wanted to hear from those who have and those who have not participated in clinical research. We were specifically looking to uncover the motivators and also the barriers or deterrents to clinical trial participation for these different stakeholders. So, if we need to expand that patient pool, we need to listen to everyone because without patients, there’s no trials. So, we felt it was valuable to determine what motivates people to participate and inform sponsors and sites, so that they’re putting their effort, their time and money in the right places. We also look to see what motivates sites and physicians to be part of clinical research and, what makes them avoid it on the other hand, what makes it challenging for them. So, sponsors can say, “Oh, okay, we didn’t realize that this was such a burden. Let’s see how we can make that easier for you or less time consuming, or make the protocol less complex, easier to understand and follow, maybe provide support for recruitment,” or whatever those unmet motivators are.

Crissy MacDonald:

So that’s a drastically different research plan than what WCG Avoca was previously doing, which was predominantly looking at industry trends across sponsors and providers. So, how did you go about obtaining this information when most of our contacts really are in the sponsor/provider space, or if they are investigators or patients, they’re very familiar with clinical research, not sort of naïve, per se.

Gina DiCindio:

Right, so that’s a very good point, and that presented somewhat of a challenge for us. As we’ve done in the past, we developed and distributed an approximately 20-minute online survey and we’ve done this every year, and we’ve always had a lot of, as you mentioned, connections and relationships that we were able to tap into for feedback. We ran into a bit of an issue with the fielding with regard to the patient population we reached. It was basically the same pitfall the industry tends to have. So, repeating the same approaches will yield the same results or same type of participants, whether it’s in a clinical trial or in this case, survey participants. So, we went about fielding for people to respond to the survey as we have always gone about it, and so we didn’t really have quite the diversity in patient respondents as we needed in order to conclude that this is how the general population feels about clinical trial participation. So, we realize this, and we course corrected and obtained input from approximately another 200 or so additional respondents that met specific key demographic and socioeconomic variables such as education level, income level, etc., resulting in patient survey data that was now more representative of the general population and provided insights into what motivates patients in the general population and what challenges and barriers they experience in order to provide these insights to sponsors and identify opportunities for improvements in the patient and site trial experience, so they can keep this feedback top of mind from start to finish in order to bridge those gaps and keep people of all types and sites motivated to participate in clinical trials and therefore expand and increase the involvement in clinical research.

Crissy MacDonald:

Yeah, it’s really interesting because I think that’s some of the key findings of the research itself. Not only do we, as an industry, have a tendency to repeat the same process, but we like to process-ize things and we like to process things in a very linear way. And I think some of the data that we see is that it’s not a, “We can’t do that linear one-size-fits-all approach.” We have to design trials in almost this very branchy, choose-your-own-adventure type of way to really meet patients and ultimately sites as well where they’re at. So, if we want to increase involvement, we have to recognize that not everyone is maybe highly educated, being treated at an academic center, that understands all the ins and outs of health literacy of what clinical trials are, that has access to all of those things, can take off work, all of that. And then we also have to recognize that sites aren’t all academic centers, and therefore they’re not resourced in that way from staff, from equipment, etc. And so, we have to be careful with what we’re doing to make sure that these trials are accessible across the board, and I think that’s a lot of what we saw in the research. I think what was most intriguing to me when you reported all of this out, Gina, is that when we looked at that patient population, it was something along the lines of 75% of respondents actually had no personal experience with clinical trials, and no personal experience wasn’t just that they themselves weren’t participating, it was that they didn’t participate and they didn’t have any friends or family who had participated in a clinical trial either. And so, when we talked to them, and asked them why, there was a lot of reasons and reasonable reasons why they were afraid basically to partake. There was a lot of fear of the unknown and then tangible concerns about the time commitment, the number of procedures, the types of procedures, etc., and high, high percentages. 86% had concerns about side effects or basically feeling worse than they did when they started the trial. I think it was 72% had concerns about time commitment. 80% were concerned about number of procedures. 83% were concerned about the type of procedures. Obviously, filling out a questionnaire is one thing, but asking them to do a biopsy or some surgical procedure, even blood draws, nobody likes to get a blood draw. And that’s concerning to them. But what I think was the most compelling is there was this very large volume, as we said, of people who have never participated. But then we looked at that smaller percentage of people that did participate. We actually asked them, “So, what was your experience like?” to really be able to compare for those who hadn’t, what are they concerned about? And for those who had, were those concerns real? And what we saw was that the experiences for people who had participated in clinical research were really generally pretty positive. So, 61% said they had no issues with feeling sick or unwell, they said their medical condition improved, they felt like it was a good experience, or they were just happy to be able to contribute to science. 72% of them said their expectations on the time commitment were spot on. 72% said the tests and procedures met their expectations, and then 80% of the people who participated in clinical trials noted that they like the health care professionals that they were working with, which is one of those things that we always think about in the industry as a concern; is that switching your health care provider to get clinical trial treatment is sometimes deemed a concern. And while it may be a concern on the start, we’re not seeing that necessarily on the back-end. But to me, the most important statistic of it all was when we asked them two key questions, was it worthwhile and would they participate again, we saw really affirmative responses. 85% said that they agreed that the time they spent participating in the clinical trial was worthwhile. And 90% said that they would definitely or probably participate in a clinical trial again in the future, which is really uncanny given our concern of finding participants. But the key is that we have to figure out how to leverage those experiences better. And we all know that as an industry, we’re not the best at reporting out outcomes, and those outcomes are often scientific in nature, but really being able to report back on some of these patient-reported outcomes and satisfaction of patients who participated in the trial are ultimately going to help get the word out on why clinical trials are beneficial, why people might want to be a part of it, and basically allow that positive word to spread. And we know that because when we look at how new participants are being attracted to clinical research, 45% of them say that a friend or a family member would be their most trusted resources for info on clinical trials. But even larger than that, 79% say their regular doctor or healthcare professional would be among the most trusted sources. So as an industry, if we’re looking to find more patients, we have to make sure that we’re doing a good job of educating their physicians on what’s out there as an opportunity. And that doesn’t mean necessarily forcing those physicians or trying to encourage those physicians to participate in clinical research. It just means giving them the words, the understanding, and some of this patient satisfaction information so that they can converse with their patients and say, “Hey, here’s something that you might want to consider if this standard of care isn’t meeting your needs right now,” and being able to equip them, I think, would make a drastic difference in what we’re seeing in ultimately being able to decrease that 75% number of patients who just aren’t familiar with clinical research at all. But I think when we look at patients, the other perspective and the other side of the coin that we talk about as sponsors is the sites, because they’re the closest to the patient. And we need to know how they feel about clinical research, sites, patient care locations, whatever, because again, 79% of patients are looking to their physician to tell them about whether they should participate in clinical research. So, we have to know how sites feel about their clinical trial experience to know whether they’re skewed as to whether they do or don’t want to promote clinical trial participation. And so, when we talk to site staff, generally, they agree that these trials are designed with patients in mind and that they would recommend them to a friend or family; 82% say that. And sites ultimately are participating for positive reasons. When we ask sites why they do participate, it’s predominantly altruistic rationale. They want to contribute to science, they want new and better treatments, they have curiosity in new treatments, and they want to stay up-to-date on those new treatments in their specialty area so that they can bring the best to the patients that they’re treating. And because of this, much like the patients, those sites that participate in clinical research, have a strong likelihood of participating again. Similar size as what we see in the patients, so 84% agree that the time they spend is worthwhile; 94% say they definitely or probably will participate again. But that being said, there are some components that aren’t always ideal. And these are some of the things that I think we need to look at from a sponsor standpoint to be able to increase the number of physicians who want to participate in clinical research, and really to be able to increase the number of physicians that are participating in clinical research, those that are investigators, having those conversations with their fellow physicians on why they would want to participate. Because when we talk about the experiences that aren’t ideal for sites, it’s things like startup, where only 31% of sites agree that budget negotiations is timely and efficient and that contracting process was timely and efficient. And these, these people are participating in clinical research, not because they want to be administrators, it’s because they want to bring the best to their patients. And so, they want to be doing patient care, not negotiating budgets and contracts. In the maintenance phase, only 38% of the sites agreed that the protocol is clear and easy to follow, and only 29% agreed that the study stayed on timeline. So, again, those are some key components that are making it more difficult for these sites to participate in clinical research. Which is inherently maybe moving them from that positive, “Yes, I absolutely want to do this,” to, “I don’t know if this is worth my time,” and certainly from what we know in the research field, if they’re not in that highly optimistic scale, that right end, that 9 that 10 of say, like an NPS score, then they’re not going to recommend their fellow physicians to participate in clinical research, or they’re not going to recommend their patients to participate in clinical research because there’s some negative perceptions that go along with that. And then when you get into the closeout piece, even though we know they’re not motivated by dollars, only 27% say that they’re compensated fairly and on time. And while they may not be motivated by dollars, they can’t take on business that’s inherently going to be a loss for them. But in general, the key thing here is that I think only a minority of these sites actually feel that their perspective is considered. So only 15% of sites strongly agree that clinical trials are designed with sites and staff in mind. And I think what’s key there is it comes back to, we’ve talked a lot in this industry about patient centricity and the importance of getting patient input on protocols prior to finalization to make sure that what is being put in there is meeting their needs. Not only in terms of, are the things too invasive that aren’t necessary? Is it too much time? All of that, but really looking at do the end points matter to them? Because they may not care about what their biomarker says if they feel better, so are we using the right end points that are patient-centric? And then I think when we look at the site piece, it’s also important to understand that all sites are different, just like all of our patients are different, and then in order to be patient-centric, we have to be site-centric. And we have to make sure that while we’re allowing those patients to have some insight and give us some knowledge as we’re designing those protocols, we also need that same support from sites, and diverse sites. So that community center, that academic institution, and that for-profit research center really just to be able to figure out how do we help you complete this protocol so that you can allow access to clinical research to the patients that you’re serving, and I think that’s one of the key components that this survey really highlighted to me was that there really is a need for more key stakeholder representation and sort of study design and overall strategy that sponsors are kind of putting out there. But with that, Gina, I want to ask you, as someone who’s involved in our diversity, equity, and inclusion consulting work here at WCG, I think this industry survey that we did really just quantified a lot of the discussions that we hear in our PABs, right? So, we conduct these Participant Advisory Boards for sponsors who are looking for feedback on their protocol or feedback on their recruitment materials, and I think what we hear from investigators who are treating these patients, from advocacy groups that are treating these patients, and from the patients themselves is a lot of those things that are just highlighting the not one-size-fits-all approach. Would you agree that that’s what we kind of consistently hear across the board?

Gina DiCindio:

Yes, absolutely. And it’s almost like at the root of every good relationship is good communication. And I think that there’s one thing that’s come out of the Participant Advisory Boards, and there’s that it’s not a one-size-fits-all; you have to make sure that, any of the communication that the site is putting out there, whether it’s for recruitment or explaining the protocol, it has to be at a level that’s understandable. And communication between sponsors and sites about the protocol, and, even if it’s budget negotiations, communication is a really important skill in all of this and making sure that you’re hitting all of the needs of all types of sites, all of the needs of all types of potential patients and that the communication is getting out there, even to educate our physicians that they’re clear on what research, clinical trials might involve, or what the commitment really is because everyone just bases it on the perceptions that they have. And it’s interesting when you have these participant advisory boards to hear the misconceptions, what some people have, they assume is really going to have to take place or what they’re really committing to compared to what is actually involved. So, it’s no surprise that those who have participated in a trial say, “Oh, I would do that again,” because I think they go in with expectations that it’s going to be, more difficult than it actually is in the end. So, kind of important to get that word out.

Crissy MacDonald:

Absolutely, absolutely. I mean, for me, the key takeaways that we had there is, from the sponsor and provider side, when we asked them how they felt, they all acknowledge and realize that they are burdening sites by strain on resources, the complexity that these trials bring, etc. And I think the implication and the ask and challenge that I would have to sponsors and providers is to really revisit how trials are designed. There’s always a discussion about quality by design, but even more so, it’s taking that time in the beginning to talk to the people that are really important; arguably, the most important to getting you those quality data points, because if they tell you, “I can’t get you this data point in a quality way,” because of such and such a reason, because A) patients aren’t going to want to have that biopsy done for an exploratory end point or because B) you want to set up a de novo site, but then you have to acknowledge that they don’t have the same equipment that’s there. And so maybe you don’t want to collect that data point, or you’re going to have to think about how you can provide them with what they might need. So really taking that time to get all of the key stakeholders involved and talk about the risks and challenges with that protocol design to try to fix them in advance. But I think in general, it’s again, talking to sponsors and providers to really evaluate how you’re staffing these trials and how you’re compensating for them; is it feasible to do this trial with one CRC, or do you need drastically more to be able to conduct it in a quality way? And then being able to provide those sites, which in turn is providing those patients the care that they need and deserve. Right?

Gina DiCindio:

Yeah, that time investment up front pays off in the long run and just has a positive trickling impact throughout the course of the study, and you’re not backtracking as much when you’re putting the time in up front like that.

Crissy MacDonald:

Absolutely yeah, so I think, the takeaway and what we saw here from the site’s perspective, as well as from what we see kind of across the board in our day-to-day work here at WCG is that we do have to elevate that site perspective almost as high as we elevate that patient perspective. And it means, not only speaking to key opinion leaders, but talking to, again, those community sites and talking to everyone at the site, anybody at that site, that’s going to be a key component of operationalizing it needs to be doing the review of that protocol to help these sponsors with their risk assessments. And then lastly, to me, the most important thing about patients and the key takeaway is that we really need to raise awareness and educate patients and we may need to educate patients through their most trusted resources, which is ultimately their physicians on what clinical research is. And the more transparent we can get as an industry of talking about these pros and cons of research, not only through the sort of legalese of an ICF, but really through more of these research type of experiences and capturing satisfaction of our patients as they’re participating and satisfaction of our sites as they’re participating in our clinical trials. We can be armed with some more subjective data to talk to them about, “Yes, here are the scientific risks, but here is what we see, people experience as we go through these trials,” just to educate them that, as Gina said, it’s not necessarily all a worst case scenario that they kind of envision in their mind based on what they see on social media or hear through news stories and whatnot, which may be a very, very small blip in the radar of what we’re doing as an industry. But to me, those are the key takeaways of our industry research and we’re about to embark on selecting our topic for this upcoming year, and we’re actually hoping that it can be as fruitful and interesting as this because I think what was most exciting about this research was really being able to quantify, like I said, some of those feelings that we see and pick up on across the industry, but really being able to kind of put them out there in a quantitative format for people to react to and point together to some of those disconnects. But with that, thanks again, Gina, for joining us today on the episode of WCG Talks Trials. Thanks to our listeners for tuning in. We hope you found this episode insightful and that you’ll join us on future episodes of WCG Talks Trials. To access the report we’ve mentioned during the podcast today, you can go to WCG’s website at wcgclinical.com. Thank you, again. Please look out for our upcoming industry research for the year, and we’ll be talking to you again soon. Bye bye for now.

Download the full 2023 Avoca State of the Industry Report for more findings and implications for sponsors, providers, site staff, and patients.

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