Patient recruitment is one of the most critical elements of a clinical trial. Without sufficient participation, studies will lack the power to demonstrate the statistical significance and efficacy of new treatments. Ultimately, poor patient enrollment will delay or prevent new therapies from reaching the market. Not only do such delays cost millions of dollars, but they also deprive patients of effective, potentially life-changing treatments.
Recruitment failures loom large across the industry, with 50 percent of trials delayed due to patient recruitment issues, according to a 2016 report in Pharmafile. Each day of delay costs an average of $600,000 but can go as high as $8 million a day for very complex studies. What’s more, once the trial is underway, up to 30 percent of recruited patients drop out.
Considering that it costs an average of $6,533 to recruit one patient and $19,533 to replace a patient who drops out, study sponsors are motivated to find solutions that optimize enrollment of the right patients from the beginning, and minimize patient dropout after enrollment.
Designing a Patient-Centered Protocol and Consent
Keeping the patient’s experience at the forefront of considerations can make patient recruitment, engagement, and retention more successful. Ideally, this begins the moment the team begins drafting the clinical trial protocol.
In a patient-centered approach, every aspect of the patient’s journey, from their first interaction with recruitment materials to the final assessment should be considered.
Chief among these is considering whether participating in the study will fit easily into a patient’s life, or whether it will become a burden. It’s easy to appreciate how traveling to and from a study site could be inconvenient, but that’s just one piece of the time demands that trials often place on patients.
The number of procedures performed in phase 3 clinical studies has increased 6 percent each year since 2003, often driven by the sheer number of clinical endpoints. Since 2013, the average number of endpoints has grown to 20 per study, while the average number of primary endpoints is only 1.6, according to a recent study by the Tufts Center for the Study of Drug Development (CSDD). When a study becomes this complex, it may be worth reevaluating the protocol to ensure it is truly measuring what matters – that is, collecting data that answers the primary research question — and not inconveniencing patients unnecessarily to collect supplementary information.
Overly restrictive or expansive inclusion/exclusion criteria are another frequent pain point. The average trial has 31 criteria patients must meet for inclusion. Understanding the critical criteria to define eligibility in the context of patient safety, regulatory requirements, and existing standards of care is key. It’s worth asking whether the pursuit of a “pure” sample is causing unnecessary delays or excluding patients who might benefit from the trial. Simplifying the inclusion/exclusion criteria not only helps resolve recruitment issues, but it can also reduce costs by more than 20 percent. Incorporating feedback from the patients for whom the treatment or device is intended can create greater transparency and trust between investigators and patients, and help patients feel more engaged in the study design.
Soliciting feedback from patients about other aspects of the study design — as well as from study coordinators and investigators — can help you achieve a more well-rounded perspective on what makes participation easier and what aspects complicate the experience. A patient advisory council can help illuminate these factors.
As you begin to view the patient as a colleague or collaborator it can help clarify which aspects of a clinical trial protocol are truly necessary versus which are extraneous. Patients will appreciate feeling that their insights, time, and contributions are valued and used efficiently, and will be more likely to remain engaged and enrolled.
A successful patient recruitment strategy is not just about ensuring the “right” patient is enrolled. The process also needs to support inclusivity and, of course, be time- and cost-efficient. The approach used to recruit patients is therefore critical to the success of patient enrollment campaigns.
A blueprint for how you will develop or leverage relationships with health care providers, advocacy groups, community organizations, and even trial-matching services is critical to ensure a rich source of patient referrals, particularly among diverse and underserved populations.
Prescreen and screen failure logs are becoming staple components of successful recruitment strategies. Together, they can alert study teams to trends that are keeping patients out of a study. Whether related to accessibility of the study, eligibility criteria or study design, these logs can serve as useful tools to highlight trends and enable staff to react quickly to address key barriers.
The innovative technology that powers Medable’s Digital & DCT screening tools can help study teams create a unified recruitment strategy by identifying trial-ready participants across a broad geographical area and supporting a streamlined screening process.
Diversity, Equity & Inclusion in Clinical Research
While recruitment is in part a numbers game, enrolling participants who are truly representative of the patient population is the bigger goal. Medical research is only meaningful if the trial population reflects the diversity of the population expected to use the medical product.
Historically, clinical trials have excluded people of color, women, the elderly, and children — despite the fact that many health conditions affect these groups disproportionately.
Even social determinants of health such as economic status, education and family size can influence outcomes, and these factors should be considered when aiming to enroll a truly representative patient population.
We can never be confident in the broad applicability of new treatments without studying how novel therapies affect people across a wide range of racial, ethnic, gender, age, and social differences,. Additionally, it’s critical we also work to ensure that all people have equal access to the potential benefits of participating in clinical trials.
Nothing has highlighted the disparities in health care and medical research more than the COVID-19 pandemic. People from the Black, Latin, and Pacific Islander communities, along with some homeless, incarcerated or otherwise institutionalized people, have been disproportionately affected by the disease, according to the MRCT Center of Brigham and Women’s Hospital and Harvard. In addition to experiencing more severe symptoms and greater mortality from COVID-19, some people in these groups are less likely to be vaccinated, according to the Centers for Disease Control.
The fact that some people will require additional reassurance to participate in clinical trials should not deter our efforts. Recruitment teams should acknowledge this and work to rebuild trust by developing partnerships within the community.
The FDA has issued guidance for increasing diversity in clinical trials. Sponsors, too, are increasingly recognizing the role they can play in engaging a greater diversity of people in clinical trials. Additionally, the DEPICT Act requires “Investigational New Drug (IND) and Investigational Device Exemption (IDE) applicants to: Report clinical trial enrollment targets by demographic subgroup, including age, race, ethnicity, and sex, and provide a rationale for those targets,” according to the bill’s language.
The Future of Patient Recruitment includes Digital
Electronic communication has vastly expanded our social networks and our professional lives, so it’s not surprising that digital marketing enables recruiters to reach patients in far greater numbers than traditional outreach efforts. As far back as 2013, the majority (53 percent) of people surveyed who were aware of clinical trials said they found out about them through the internet. In the nearly 10 years since then, digital connection has grown, particularly in the realm of social media, which is proving to be a powerful recruitment tool.
Recruiters who use social media must adhere to regulatory guidance, such as that distributed by FDA, NIH, and HHS when using such platforms. As long as companies are mindful of standard concepts like protecting data privacy, disclosing any necessary safety information, not promising specific results and obtaining IRB approval, leveraging digital communication opens up vast possibilities. And social media is hardly the only digital tool.
Recruiters can also leverage electronic health records and other digital platforms to identify patients who meet specific criteria for inclusion in a clinical trial. Currently, some pharmaceutical companies have created their own patient identification tools. In 2014, Novartis launched an app called “Clinical Trial Seek.” Apple made the development of such apps even simpler in 2015 when it released ResearchKit, and now large numbers of such apps are available for patients to download.
Medable can help streamline the process with solutions like TeleConsent, ePRO and TeleVisit. These allow you to recruit patients anywhere, using any device, with a flexible and modular technology platform. Even as the trial gets underway, these digital tools can make reporting symptoms and experiences fast and easy for patients.
The path toward better enrollment
Clinical trials are costly, and challenges in patient recruitment are among the primary causes of delays. Every day a trial is delayed increases the costs even more, and not just financially. Treatments that could improve the quality or quantity of life are held back, or only offered to a small subset of potentially eligible people. As an industry, we need to bring more effective treatments to the right patients, and we need to do it faster.
To accomplish this, we need to shorten research timelines, reduce costs and streamline patient recruitment. Patients are more likely to participate in a trial when it is designed with their experience in mind. Start with a patient-centered protocol, seek to include patients from diverse backgrounds, keep them engaged and empowered throughout the process, and make any necessary site visits convenient and accessible.