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Three Clinical Trial Recruitment Challenges and Strategies to Overcome Them
Patient participation is essential to the success of clinical trials, which are critical for advancing global health and improving patient outcomes. Patient recruitment and participation also tend to present major challenges as clinical trials struggle to enroll a sufficient number of participants. It has become a well known stat these days that 85% of all clinical trials fail to enroll enough patients. There is also an 80% delay in all clinical trials due to recruitment challenges. [1]
In this article we will discuss some of the challenges in clinical trial recruitment and provide several implementable solutions. Here they are at a glance:
Challenge 1: Traditional recruitment is constrained by the established patient population at research sites
Strategy: Increase the catchment area and access for patients who aren't seeing research doctors
Challenge 2: Structural barriers making it difficult or impossible for patients to join clinical trials
Strategy: Leverage technology to reduce logistical friction in clinical trials
Challenge 3: Patient reservations around participating in a clinical trial
Strategy: Design a patient-centric experience
Why are we talking about clinical trial recruitment challenges?
Clinical trial recruitment is a critical step in the process of getting a drug to market
Clinical trial recruitment is required for each of the four main phases of a clinical trial, and generally there is an increasing number of participants required for each phase. Yet, most clinical trials struggle to enroll enough patients. Did you know that about 10% of trials fail to enroll even one patient? [2] This is not a new problem, but it’s one that is still affecting clinical trials and requires innovative solutions.
Clinical trial recruitment in the US is a huge blocker to getting new drugs developed
Clinical trial recruitment challenges can’t be overlooked as they cause significant delays in research, and sometimes even lead to clinical trial termination. One study shows that a low accrual rate was the most frequently specified reason for termination for all terminated drug trials between 2010 to 2021, comprising ~25% of all terminated trials.[3]
Studies have also shown a gap between the willingness of patients to participate in trials and their actual participation rates. Currently, only 5% of eligible patients participate in clinical research, yet some studies show that ~72% of Americans say it's likely they would participate in a clinical trial if recommended by their doctor. [4,5] There is clearly great demand for new treatment options from both patient and research communities - clinicaltrials.gov, for example, has seen a 22x increase in organic traffic over the last seven years, according to Ahrefs data. And so we are living through an explosion of medical innovation, but the ways patients can participate are stuck in the past.
Three clinical trial recruitment challenges and strategies to overcome them
Challenge 1: Traditional recruitment is constrained by the established patient population at research sites
Only a limited number of doctors participate in clinical research
According to the Food and Drug Administration (FDA), only 3% of the nation’s physicians participate in clinical trial research that leads to new therapies. [6] Often these physicians are at top medical institutions or large academic health systems. This both limits the number of participants who become aware of clinical trials, and excludes large portions of the population.
Patients outside research sites have difficulty finding clinical trials
Patients who don’t have access to these institutions or physicians face difficulty finding clinical trials. People typically turn to browsing for clinical trials online and get lost in a rabbit hole of confusing information. People may turn to or get referred to check for trials on clinicaltrials.gov which is a clunky, government-run website that is confusing and hard to navigate.
Strategy: Increase the catchment area and access for patients who aren't seeing research doctors
Increasing the catchment area and access for patients who aren't seeing research doctors can help to address recruitment constraints by expanding the pool of potential participants for clinical trials.
Traditionally, recruitment was led by clinics or sites where the clinical research was being performed. This automatically limited recruitment to just a small subset of the population. Over the years, the market has evolved to include new recruitment approaches, many of which have been more and more focused on the patient. For e.g., social media campaigns can now be designed to share clinical trial info with a previously completely untapped part of the population.
The next step in increasing the catchment area is addressing patient accessibility, so that more of the population has access to clinical trial information. These types of solutions shift from outbound patient recruitment approaches to inbound approaches, where patients can find clinical trials themselves.
Here are a couple of tactical recruitment techniques that help increase the catchment area:
- Physician referral networks: Physician referral networks can be a powerful way to engage the community, increase your patient pool and increase diversity. Widen your reach by connecting with clinics in the community, especially those that are most likely to be specialized in the condition you seek for your clinical trial. Reaching out to local physicians in this way to increase knowledge about trials and provide an option for their patients can facilitate referrals.
- Inbound patient recruitment platforms: Create or use a platform that proactively attracts patients by providing resourceful information about available clinical trials. Power is an example of such a platform that allows patients to search for a clinical trial by filters like condition, location, and age, and shows clinical trial info in easy to understand ways.
Challenge 2: Structural barriers making it difficult or impossible for patients to join clinical trials
Study availability
Patients face numerous structural barriers that make it challenging to participate in clinical trials. Study availability is just one challenge that a patient might come across. If there is a study available, but not at the patient’s site, this would require travel which often is not a feasible solution for patients.
In a study performed by Columbia University Irving Medical Center, and the American Cancer Society Cancer Action Network (ACS CAN) for 13 studies spanning 15 years that involved over 8,800 patients, they found that 56% of patients didn't have a trial available at their institution. [7]
Getting to the site
If a study is available at a nearby site, traveling to the clinic site can also be a challenge for patients. For instance, 70% of potential participants typically live more than two hours from trial sites, and not all can commit to this travel and the associated financial burden. [8]
Strategy: Leverage technology to reduce logistical friction in clinical trials
This is another way of saying that we want to make it easier to conduct clinical trials by using digital tools and platforms to eliminate some of the barriers that come with traditional trial designs.
One way to do this is by incorporating components of decentralization or technologies that are aimed at making it easier for patients to participate in clinical trials.
Here are some ways to leverage technology to reduce friction:
- Digital patient recruitment: Use digital platforms to create awareness about the trial and search for volunteers online. Platforms like Power allow patients to search by location and allow sites to add distance from the site as a criteria so that patients can find clinical trials that are near them.
- Conduct pre-identification and eligibility criteria online: Conducting pre-screening activities online can help reduce both patient and site burden, and help remove another barrier for patients interested in enrolling by making it easier to do so.
- Leveraging digital tools to reduce the number of site visits required: Even though many trials won’t be suitable for a completely decentralized model, or may not be able to leverage a digital approach for all activities in the trial, nearly all trials can incorporate digital components. And incorporating these components can improve the patient experience, and make it less burdensome for patients. There are digital solutions for various components of clinical trials; some examples include leveraging tools like eConsent, eCOA, ePRO and many others!
Challenge 3: Patient reservations around participating in a trial
It's natural for patients to have concerns about participating in a clinical trial. Some of the most common worries include the safety and efficacy of the treatment being tested, potential side effects or risks, and the unknowns associated with being part of a research study.
Sponsors and researchers know that clinical trials are carefully designed and regulated to ensure that patient safety is the top priority. Before a trial can begin, it must go through a rigorous review process by regulatory authorities, including ethical review boards and institutional review boards, to ensure that it is ethical and scientifically sound.
In addition, clinical trials often have strict eligibility criteria to ensure that only patients who are likely to benefit from the treatment are included. Patients who do choose to participate in a clinical trial are closely monitored by trained medical professionals, and any potential side effects or adverse events are carefully tracked and reported. Patients need to be looped into this process.
Strategy: Design a patient-centric experience
Designing a patient-centric experience for clinical trials involves putting the needs and preferences of patients at the forefront of the trial design and conduct. Here are some steps to consider as it relates to improving patient recruitment:
Engage patients early: Involve patients in the trial design process from the outset to ensure that the study is designed with their needs in mind. This can be done through patient focus groups, surveys, or other forms of patient input.
Simplify the process: Streamline the trial process as much as possible to reduce the burden on patients. This can include offering online registration and scheduling, providing transportation and childcare support, and minimizing the number of in-person visits required. All of these things both minimize patient burden and patient worries since the process is clear.
Communicate clearly: Provide clear and concise information about the trial to patients, including what to expect during the trial, potential risks and benefits, and the roles and responsibilities of patients and researchers. Use plain language and visual aids to help patients understand the information.
By being transparent and addressing patient concerns, we can help to increase participation in clinical trials.
Improvements in patient recruitment in clinical trials can unlock immense value
Clinical trial recruitment and participation continue to pose significant challenges in medical research. These challenges cause delays in research and sometimes lead to clinical trial termination, ultimately affecting the drug development process. However, there are various strategies and solutions to address these challenges, and implementing them can make clinical trials more accessible to patients. Increasing the catchment area and access for patients who aren't seeing research doctors, leveraging technology to reduce logistical friction, and designing a patient-centric experience are all steps in the right direction. By addressing these challenges and implementing these strategies, the medical community can increase the diversity of clinical trial participants, improve patient outcomes, and accelerate the drug development process.