Low patient recruitment in clinical trials is one of the biggest challenges that Sponsors, CROs, and Sites must overcome. Phase I through Phase III trials are, on average, 30% longer than planned due to patient recruitment issues and low patient retention. Fear and a lack of information are the big obstacles to greater success.1 New medicines and treatments for serious conditions are delayed in being brought to market because there are not enough people willing to participate in early medical research. This is the result of a lack of physician and patient awareness, and patient fear of being a “guinea pig” or of receiving a placebo. Increasing enrollment and retention rates is paramount for the future of clinical trials and healthcare advancements.
The Recruitment and Retention Hurdles that Researchers Face
Poor recruitment and retention results in delayed trials, high financial losses, and potentially skewed statistics. This results in a medical treatment not getting to the FDA approval process, not necessarily because it is harmful or unsafe, but because of too few participants to test it on to reach any solid conclusion. In general, at least 80% of pharmaceutical trials do not meet enrollment deadlines, which ultimately results in a $1.3 million loss for every day that the trial is delayed.2 Patient enrollment is cited as one of the most challenging aspects of clinical trials and it is one of the primary reasons that a clinical trial fails. These costly and time-consuming delays are found in all phases of clinical research and present themselves differently in each phase.
Each clinical trial phase has its own recruitment challenges. Phase I trials find it difficult to recruit healthy volunteers for the first stage of human testing. Often, the only obvious incentive for a healthy person to participate in an early phase trial is monetary, as many people do not understand and appreciate the immense impact that participation can have on medical advancements. Phase II and Phase III trials have similar recruitment issues but for different reasons. The challenge in later phase studies lies in the recruitment of sick patients. For example, oncology studies have a particularly difficult time recruiting cancer patients. According to multiple studies, only 3% of cancer patients participate in clinical research studies, stemming largely from a fear of receiving a placebo pill instead of the treatment being tested (a common misconception), and the fear of receiving a lower standard of care.
How Can Researchers Improve?
Patient recruitment and retention has long been a problem that clinical trials face, so how do we improve it? Here are some suggestions:
- Utilize the internet to inform patients. The first avenue for reaching subjects would be to utilize internet and social media marketing resources. Researchers should publish more materials that are geared toward patient recruitment, which not only provide information about clinical trials in general, but which also provide details on the study being conducted, and which make sure that standard misconceptions, like the use of placebos in cancer clinical trials and standards of patient care, are addressed and clarified.3
- Actively promote the benefits of clinical trial participation. This can be done through the marketing initiatives above, but there should also be a push to create short, engaging informational videos that are hosted online and distributed to physicians and patients to encourage participation. Participants need to better understand that by participating in clinical trials they can play a huge role in their own healthcare, receive care from expert physicians at first-rate medical facilities, receive a treatment that is not widely available, and contribute to medical advancements.4
- Increase physician awareness and cultivate collaboration. Currently, one of the major setbacks is lack of physician awareness about current clinical trials, which results in a lack of patient awareness. A survey conducted by Harris Interactive that interviewed over 5,500 cancer patients found that roughly 85% were completely unaware that they could participate in a clinical trial as part of their treatment plan.5 These numbers are shockingly high and solutions need to be implemented quickly in order to change this statistic. Sponsors, CROs, and Sites can increase physician awareness about the trials that are currently being conducted through collaboration and open communication between researchers, nurses, and physicians. Physicians and nurses could then pre-qualify their patients for trials for which they are eligible, and provide them with additional information about their options.
- Implement study retention strategies. Once patients are recruited, it is essential that they remain for the duration of the study. To maximize retention rates, sites should implement strategies like study specific websites for patients to have constant communication, information, and access to their physicians; educational support for patients and family members; and have regularly-scheduled appointments so that inconvenience never becomes an issue for the patient.
Without clinical trials, healthcare would be at a standstill. Growth in clinical trial participation will help change the future of medicine and has the potential to improve the lives of millions. It is imperative that strategies for patient recruitment in clinical trials be addressed, enhanced, and implemented immediately so that new treatments may be developed and utilized.
1 Drennan, KB. “Result Filters.” National Center for Biotechnology Information. U.S. National Library of Medicine, 22 Feb. 2002. Web. 13 Nov. 2015. http://www.ncbi.nlm.nih.gov/pubmed/11815229.
2 Sullivan, Jean. “Subject Recruitment and Retention: Barriers to Success.” Subject Recruitment and Retention: Barriers to Success. Applied Clinical Trials, 01 Apr. 2004. Web. 17 Nov. 2015. http://www.appliedclinicaltrialsonline.com/print/243254?page=full.
3 Cancer patients will never only receive a placebo. If a subject is not receiving the trial drug, they will be given a placebo along with the standard available treatment; and the standards of care that are given in clinical trials are the same or greater than what would otherwise be received.
4 Stubbs, John. “Qualitative Methods Improve Trial Recruitment.” Health Voices 325.7367 (2002): n. pag. Health Voices. Consumers Health Forum. Web.
Finn, Robert. “JNCI J Natl Cancer Inst.” Surveys Identify Barriers to Participation in Clinical Trials. Journal of the National Cancer Institute, 4 Oct. 2000. Web. 18 Nov. 2015. http://jnci.oxfordjournals.org/content/92/19/1556.
5 Finn, Robert. “JNCI J Natl Cancer Inst.” Surveys Identify Barriers to Participation in Clinical Trials. Journal of the National Cancer Institute, 4 Oct. 2000. Web. 18 Nov. 2015. http://jnci.oxfordjournals.org/content/92/19/1556.