Revitalizing Research

We all know someone – a loved one, friend, or close acquaintance – who has struggled with a health condition that upended their life and changed their perception of “normal.” These individuals often endure great physical and/or mental pain daily.

Clinical trials offer a powerful approach; they can restore a sense of control to patients that may have previously felt unattainable. Not only can they provide a potential treatment, but equally important, they can be a source of hope. This is why clinical trial design needs to focus on the patient’s needs, and clinical trial execution must always center on the participant.

Clinical trial success begins with cultivating trust.

Cultivate Trust

Never underestimate the importance of public perception of clinical trials. It has a direct effect on people’s willingness to participate. Regulations, regulatory agencies, and institutional review boards ensure the safety and ethics of these trials, but they merely establish the baseline. It falls upon the sites and sponsors to cultivate trust among potential participants, who stand to benefit most from the treatments being developed.

The COVID-19 pandemic serves as an excellent case study for how to effectively build trust. One could argue that during the pandemic, the public had greater visibility into clinical trials than at any other time in recent history. Also, during this period, public opinion was sharply divided. On one hand, the rapid development of COVID-19 vaccines demonstrated the value of clinical research and drug development in response to public health threats. On the other hand, the circulation of misinformation, primarily through social media platforms, contributed to distrust of – and even active opposition to – clinical trials.

The clinical trial community has made significant advancements in patient engagement. Nevertheless, distrust persists, and those who would most benefit from clinical trials will suffer.

The 2023 WCG Avoca State of the Industry Report found that 75% of patient respondents had never participated in a clinical trial and didn’t know anyone who had. When the survey asked these research-naïve patients their opinion on “I believe clinical trials only benefit the pharmaceutical companies that run them,” 36% agreed, 36% disagreed, and 29% were neutral.

These findings underscore a clear need for the clinical research industry to prioritize patient education about clinical trials. Understanding the purpose, process, and results of these trials is crucial not only for the application of current treatments but also for addressing future diseases that lack effective standardized treatment options. Moreover, building trust through patient education can improve both recruitment and retention.

It begins with outreach.

Educate and Engage the Community

To cultivate trust and interest in clinical trials, community outreach and education are essential. Community engagement, which includes teaching patients what it means to be part of a clinical trial, is crucial to recruitment, enrollment, and retention.

The first step is to identify individuals and organizations with strong ties to the local community. These trust bearers could be local physicians and clinics, but they might also be places of worship, community support groups, social workers, or community centers. Understanding where potential participants spend their time – barber shops, local libraries, colleges, or festivals – is also key to effective engagement.

The next step is reaching out to them. By partnering with these trusted networks and individuals, sponsors can share information with the community through a trusted source. But it’s not just about getting in front of an audience, talking about a trial, and departing with the assumption that people will reach out if they are interested; it’s about building relationships. Consistent engagement is vital. It’s unlikely that a community leader will provide access to potentially vulnerable individuals after just one short informational meeting.

Advocating for clinical research is a long-term investment. But it is worth it. The more time a sponsor and/or site invests, the more likely they are to build meaningful, lasting connections.

Successful outreach often results from long-term relationship building and collaborative efforts. When implemented with sensitivity, these relationships not only aid in the success of the current study but also lay a foundation for participant enrollment in future studies.

Engagement is a conversation: It requires listening to patients and their support networks, not just talking to them.

Put Patients First

Patients live and breathe their condition every day. That’s why protocol development, including the schedule of events and study assessment selection, should always focus on the patient. Sites know their patients and the obstacles they face. Considering their firsthand knowledge and close interaction with study participants, sites should be recognized as subject matter experts on their patients.

Patients should be viewed as providing critical input that can help sponsors, clinical research organizations (CROs), and other stakeholders keep those obstacles top of mind when developing protocols.

Factors such as finding daycare, arranging transportation, and loss of work hours are all issues patients might consider before consenting to a clinical trial. Sometimes a stipend helps, but it may be inadequate to compensate a patient for wages lost. Or perhaps the individual lacks the means to arrange for an eight-hour on-site screening visit. In the 2023 WCG Avoca State of the Industry Report, 57% of the trial-naïve patients cited virtual visits as a motivation to participate in a clinical trial. In addition, 71% cited transportation or transportation reimbursement as a motivation, and 45% cited childcare or childcare reimbursement.

Offering transportation assistance, childcare, meals during longer visits, reimbursement for parking costs, and other tactics can also lessen the burden for the patient and make participation possible. Lessening the financial and logistical burden on the patient goes a long way toward turning patients into clinical research participants.

Keep in mind that the barriers and burdens often vary by patient population; site teams have the experience and expertise to help sponsors understand patient needs.

Leverage Site Expertise from the Start

Sites understand their patient populations and they have insights into what might deter patients from or motivate them to consider clinical trial participation.

Collaborating with sites on study design is one way to incorporate the patient perspective from the beginning. Site teams can help sponsors and CROs promptly identify and address protocol design issues. This is not a novel concept, but one that few sponsors and CROs have implemented.

Sponsors are missing a wealth of insight.

By integrating site expertise at the beginning of the protocol development process – and maintaining it throughout the trial – sponsors and CROs can learn about potential challenges to patient participation. For example, such collaboration allows for the creation of protocols and assessments that take into consideration the demands of patient-reported outcomes and the time intensity of patient assessments. This approach helps sponsors support patient convenience while still capturing the data they need to assess safety and efficacy to evaluate study endpoints.

Sponsors will be able to expedite enrollment because patients will see that the benefits of participation outweigh the burdens. The sites will have the opportunity to collaborate with the sponsor and vendors on trial design, helping them to feel more involved in the trial from the beginning. This, in turn, will increase enthusiasm for the trial and keep the study top of mind when speaking to potential participants.

Engage with the Site

Effective participant engagement begins with selecting the right sites. Only a small percentage of practicing physicians participate in clinical research. The most frequently cited figure is 3%, but even twice that would be inadequate.¹

Potentially more concerning, a 2021 analysis by the Tufts Center for the Study of Drug Development found that 66% of principal investigators leave clinical research after just one trial.²

Clearly, there is a pressing need for new investigators and sites.

To reach the right participant populations, sponsors need to encourage research-naïve practices and centers to consider clinical research. Not only will this broaden the base of principal investigators taking part in clinical studies, but it will also increase participant diversity.

Support Site Recruitment and Retention Efforts

Whether a site has years of clinical trial experience or is just starting its first trial, it will undoubtedly have valuable knowledge of the motivations of their patient demographic to participate in clinical research. So just as sponsors should consult sites on protocol design, they should solicit site input on developing recruitment and retention plans.

Experienced sites bring an abundance of knowledge in patient motivation and demographic-specific strategies. Research-naïve sites offer fresh perspectives and innovative approaches.

Both perspectives are invaluable. Integrating these diverse insights helps sponsors and sites develop effective recruitment and retention strategies. It also creates opportunities for sites to share best practices.

For example, sometimes sponsors ask their most senior research sites to support more novice ones as mentors or “site champions,” sharing their insights on a particular patient population and helping the smaller sites identify the most promising recruitment pathways.

Such an approach can boost the overall site engagement and morale. It also provides an opportunity for sponsors and CROs to identify and address any gaps, ensuring efficient site operation and goal achievement.

When sponsors invest in creating more collaborative platforms for discussions among sites, CROs and sponsors, they pave the way for success. This level of collaboration fosters better site engagement, boosts recruitment, supports more efficient study workflows from the start, and ultimately, accelerates research.

However, none of this happens if sites lack the support they need.

Bolster Site Capacity

Nearly half (48%) of respondents to the WCG 2023 Clinical Research Site Challenges Survey Report identified patient recruitment and enrollment as a top concern. This suggests sites and sponsors would benefit from proactively defining the requirements for recruitment and retention responsibilities on a study, creating the opportunity to identify capacity or operational gaps.

Most sponsors and CROs today understand that the success of their studies depends on the performance of their sites. But they may not fully appreciate how much sites are struggling with bandwidth issues. When sites lack the necessary overall team capacity to support a study, they may miss enrollment targets and important milestones.
Meanwhile, demand continues to outpace capacity. The number of clinical trials continues to grow exponentially, and they are increasingly complex.3 For example, Tufts Center for the Study of Drug Development noted a threefold rise in the number of data points collected in Phase III trials from 2013-2020.⁴

WCG’s 2023 Site Challenges Survey found that 51% of respondents work on more than 26 studies at any given time, and 21% manage more than 150 trials at once. This portfolio of studies is in addition to their regular patient care responsibilities. Further, 63% of respondents to the survey identified staffing and retention as their most significant concern. That should come as no surprise: Nationwide, for every experienced clinical research coordinator seeking work, there are seven jobs posted. For clinical research nurses, the ratio is 1:10 and, for regulatory affairs professionals, 1:35.⁵

These stats suggest that many sites lack the staffing capacities to fully dedicate team members to any one specific study. Instead, team members are likely juggling multiple studies, consistently shifting their priorities amongst varied complex projects.

Exacerbating the capacity issue, clinical trial protocols have become increasingly complex. For example, Phase II and III protocols average 263 procedures per patient, supporting approximately 20 endpoints.⁶ Many sites struggle to meet these escalating demands. For example, in the United States, more than 80% of clinical trials fail to achieve their enrollment targets, and 30% of study participants leave the trial.⁷

Sites need sponsor support. Research-naïve sites in particular may need experts to lean on while they get up and running. Working closely with sites allows sponsors to identify ways to help. Providing resources that allow for smooth and effective operations at sites will benefit the sponsor, site, and patients.

To Support Patients, Support Sites

Putting the patient’s perspective first is both the right thing to do and a smart strategy. It allows sites to recruit engaged participants, boosting enrollment and retention rates, and increasing the likelihood of a trial’s success.

Site expertise is essential.

By integrating site insights into trial design and execution and ensuring they have the resources they need, sponsors and CROs can help sites improve efficiency, accelerating research and getting new therapies in the hands of patients sooner.

References

1. “‘Trial-In-A-Box’ to help more practices take part in clinical trials.” American Medical Association. May 27, 2021. https://www.ama-assn.org/practice-management/digital/trial-box-help-more-practices-take-part-clinical-trials
2. Miessler, J. Unprecedented Decline in One-and-Done PI Rate Leads to Reversal of Turnover Trend. Jan. 10, 2022. CenterWatch.
https://www.centerwatch.com/articles/25915-unprecedented-decline-in-one-and-done-pi-rate-leads-to-reversal-of-turnover-trend
3. Freel SA, Snyder DC, Bastarache K, et al. Now is the time to fix the clinical research workforce crisis. Clinical Trials. 2023;20(5):457-462. https://doi.org/10.1177/17407745231177885
4. Passut C. Increasing protocol complexity requires adapting quality metrics tools. CenterWatch, 15 March 2021, https://www.centerwatch.com/articles/25462-increasing-protocol-complexity-requires-adapting-quality-metrics-tools
5. Freel SA, Snyder DC, Bastarache K, et al. Now is the time to fix the clinical research workforce crisis. Clinical Trials. 2023;20(5):457-462. https://doi.org/10.1177/17407745231177885
6. January/February 2022 Tufts CSDD Impact Report
7. Wandile PM. Patient Recruitment in Clinical Trials: Areas of Challenges and Success, a Practical Aspect at the Private Research Site. Journal of Biosciences and Medicines. 2023;11(10):103-113. https://doi.org/10.4236/jbm.2023.1110010

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