Why Patients are Reluctant to Participate in Clinical Trials

Clinical trials are the cornerstone of medical advancement, providing the data needed to develop new treatments and improve existing ones. Despite their critical importance, patient participation in clinical trials remains low. Understanding the reasons behind this lack of participation is essential for healthcare providers, researchers, and policymakers who are all looking to improve recruitment and retention in these studies. For example, among patients considered for clinical research, about 1 in 7 candidates decline to participate in clinical research. This figure comes from the independent analysis conducted by BEKhealth, as we are seeking to help our industry determine the key factors contributing to patients’ hesitancy to participate in clinical trials. Over the course of this analysis, we uncovered several issues that contribute to low participation by patients, such as:

1. Lack of Awareness and Understanding

Many patients are simply unaware of clinical trials or do not understand what they entail. Medical jargon and complex study protocols can make research opportunities intimidating at best and unnavigable labyrinths at worst. Furthermore, most patients are not seriously considered nor informed by their healthcare providers about the availability of trials, or they may receive limited information that does not adequately explain the benefits and risks involved. As a validation of BEKhealth’s analysis, candidates who previously participated in a clinical research study, or know someone who has, were half as likely to decline a future study compared to candidates with no prior experience. This strongly suggests that candidates familiar with what to expect from clinical trial participation are much more inclined to take part.

2. Fear and Mistrust

Patients often harbor fears about the potential risks of participating in clinical trials. Concerns about side effects, receiving a placebo, or the experimental nature of treatments can be daunting. Historical instances of unethical research practices, such as the Tuskegee Syphilis Study, have also contributed to a deep-seated mistrust in the medical community, particularly among minority populations. According to the BEKhealth analysis, and somewhat surprisingly, patients across racial, ethnic, and gender backgrounds showed no difference in willingness to participate in research when controlling for confounders. What we did observe was that patients who did not disclose their racial, ethnic, and/or gender identity to their healthcare providers were twice as likely to decline to participate in a future study compared to candidates who did disclose those demographic characteristics. We hypothesize that this is indicative of patients that are less trusting with sharing their personal information.

3. Practical Barriers

Participation in clinical trials often requires significant time and commitment. Frequent visits to research sites, extensive paperwork, and potential long-term travel can be major deterrents, especially for patients with busy schedules, limited mobility, or financial constraints. Interestingly, and contrary to common wisdom, we observed that longer travel time and distance from the clinical trial site was not correlated with likelihood to decline research. This will warrant further analysis of potential confounders that offset a perceived travel burden such as travel assistance and compensation. In addition, we observed that the older a candidate was, the more likely they were to decline to participate in a future study. Candidates that were over 70 years old were three times more likely to decline to participate in research compared to younger candidates.

4. Perceived Lack of Personal Benefit

Some patients do not see a clear benefit to participating in a clinical trial, especially if they believe they might receive a placebo or if the treatment is unlikely to help their specific condition. The altruistic aspect of contributing to medical research may not be compelling enough for all individuals. Correlated with this, we observed that certain days of the month were associated with 2-3x higher likelihood of willingness to participate. Anecdotally, those particular days of the month seem likely to be associated with “payday” for individuals, suggesting that financial incentives are effective, but further analysis will be necessary to validate the causal relationship.

5. Socioeconomic and Cultural Factors

Socioeconomic status and cultural beliefs can significantly influence a patient’s decision to participate in clinical trials. Language barriers, lack of access to healthcare, and cultural beliefs about medicine and healthcare providers can all play a role.

Finding the Path Forward – Recommendations for Solutions:

In order to address patient concerns and overcome their reticence to participate in clinical research a number of solutions are warranted:

Awareness: Educational initiatives are crucial. Simplifying the language used in informational materials and study documents, providing comprehensive explanations, and training healthcare providers to discuss trials more effectively with patients can help bridge this knowledge gap. Additionally, taking care to deliver study messaging using the channels and most used and trusted among target patient populations is important. One-size-fits-all outreach strategies are rarely successful – research teams must invest in understanding their target patients better in order to craft more effective messaging and deliver it successfully.

Fear and Mistrust: Building trust and rapport is essential, especially as we all strive to conduct more inclusive and demographically diverse clinical trials. Transparency about the trial’s purpose, procedures, risks, and benefits, along with highlighting the ethical standards and regulatory oversight in place to protect participants, may alleviate some common patient fears. Engaging community leaders and using testimonials from past participants can also help build trust. Reinforcing messages about data privacy and participant confidentiality may be valuable amongst those types of candidates. Special consideration may also be necessary for institutions and companies affected by security breaches given the recent rise in targeted attacks in the healthcare industry.

Practical Barriers: Offering flexible scheduling, providing transportation assistance, and compensating participants for their time and travel can reduce the impact of these practical barriers. Additionally, utilizing study designs that make participation more convenient for patients (e.g., telemedicine for follow-ups when possible) can also make patients more comfortable enrolling in a study.

Perceived Lack of Benefit: Emphasizing the potential for personal benefit, such as access to cutting-edge treatments and closer monitoring of their condition, can be persuasive. Additionally, framing participation as a contribution to the greater good and a way to help future patients can appeal to a sense of altruism. 

Socioeconomic and Cultural: Culturally sensitive recruitment strategies and materials are must haves. Employing a diverse research staff, including translation services and translators, and partnering with community organizations can make trials more accessible and appealing to a broader range of patients.

Conclusion

Increasing patient participation in clinical trials requires a multifaceted approach that addresses each of the various reasons for reluctance. By improving awareness and understanding, building trust, reducing practical barriers, highlighting personal benefits, and considering socioeconomic and cultural factors, we can encourage more patients to take part in these vital studies. Ultimately, enhancing participation in clinical trials not only advances medical research but also paves the way for better healthcare outcomes for everyone. Utilizing software like the BEKhealth platform to proactively identify how best to engage different candidates can improve enrollment and reduce attrition.