Clinical trials are a crucial step in developing and approving new medical treatments, but they can also be a major hurdle for researchers, academia, and biopharma companies. In fact, a significant number of clinical trials fail to meet their enrollment goals, leading to delays and increased costs. The impact, ultimately, hits all of us where it matters most: our collective health and well-being. Here are some particularly egregious statistics:
These stats demonstrate the significant impact that clinical trial failures can have on the development and availability of new medical treatments, as well as the costs and resources involved in bringing a new drug to market. With that as the backdrop, let’s explore the top 10 reasons why clinical trials fail to recruit enough participants—and what can be done to overcome these obstacles.
1. Lack of awareness and education about clinical trials
Many people are simply unaware that clinical trials are an option for them and may not understand the benefits of participating. This can be addressed through targeted education and awareness campaigns, as well as improved communication between healthcare providers and patients.
2. Fear and mistrust
Some people may be hesitant to participate in a clinical trial due to fears about the safety of the treatment or mistrust of the pharmaceutical industry. This can be overcome by providing clear, accurate information about the trial and its risks, as well as building trust with potential participants through a consistent “branded” experience based on principles of transparency and open communication.
3. Financial and logistical barriers
Participating in a clinical trial can be costly and logistically complex, which can make it difficult for some people to participate. Offering financial assistance or reimbursement for expenses and simplifying the enrollment and participation process will ease financial hesitation.
4. Difficulty reaching and engaging diverse populations
Many clinical trials struggle to recruit participants from diverse backgrounds, which can limit the generalizability of the results. This can be addressed by targeting recruitment efforts to specific communities and working with community leaders and organizations to build trust and understanding.
5. Time and travel constraints
Many people may not have the time or resources to travel to a clinical trial site. This can be overcome by advanced targeting tactics and, where possible, offering remote or virtual options for participation, such as telemedicine or home-based monitoring.
6. The limited reach of traditional recruitment methods
Traditional recruitment methods such as flyers and newspaper advertisements typically do not reach a wide enough audience to effectively recruit enough participants. This can be overcome by utilizing digital recruitment methods such as social media, search, and other online advertising channels to both expand reach and connect with more diverse audiences.
7. Complex eligibility criteria
Some clinical trials have very specific inclusion and exclusion criteria, which can make it difficult to find eligible participants. This can be addressed by rigorously pre-qualifying potential candidates (via the website and/or call center) and by relaxing the criteria, where possible.
8. Insufficient patient engagement
Inadequate patient engagement can lead to poor enrollment, retention, and lack of adherence, which can negatively impact the success of the trial. This can be overcome by involving patients in the design and execution of the trial, developing nurture programs for potential candidates that may not yet qualify, and providing ongoing support and education throughout the trial.\
9. Limited access to trial information
Some people may not be able to access information about clinical trials due to language barriers, digital comfort, or other factors. This can be addressed by providing information along the simple journey in multiple languages while reaching out to community organizations and leaders to help disseminate information.
10. Candidate drop-off in the last mile
While many potential trial candidates demonstrate interest and readiness to join a trial, clinical trial sites often have inadequate resources to efficiently process them. This can be addressed via an incentive program that rewards efficient candidate pull-through. From a workflow perspective, trials with an automated candidate alert mechanism (i.e., SMS and/or email) and a candidate status tracker are shown to enable faster follow-up and, therefore, greater overall enrollment.
Overall, recruiting enough participants for clinical trials is a complex and challenging task. By understanding and addressing the obstacles that can prevent people from participating, researchers and biopharma as an industry can improve the chances of success for their clinical trials.