In order to successfully run clinical trials, you will need to be able to successfully recruit subjects. It is critical to the success of your trial to implement strategies for subject recruitment and retention.
At the subject level, participation is voluntary based on informed consent. An essential element of the informed consent process is ensuring that subjects are provided with comprehensive information from appropriate investigational site staff about the clinical trial including its required procedures, risks and benefits of the procedures and/or investigational product, and what is required of participants in a clinical trial. It is on this basis that subjects will determine participation in a clinical trial. The provision of this information and addressing any resulting questions should serve to allay any fears and contradict any misinformation which may otherwise prevent an individual from participating.
Patients may be more likely to enroll in a clinical trial if they are very ill and there are no other suitable treatment options, whether due to unavailability of current effective treatments or lack of access to currently available treatments. Potential subjects are also more likely to engage in a clinical trial and demonstrate compliance since the number of study visits and types of assessments may be better than the standard of care for their conditions. Subjects who confirm as part of the informed consent process that they are able to fulfill the requirements of the clinical study should be enrolled. It is also indicated during this consent process that while there is a possibility that trial participation may not necessarily help a subject with his/her condition/disease, his/her participation will contribute to research that may help others with same.
Experienced clinical trial investigators who have active clinical practices in the respective therapeutic area(s) may be better able to discuss clinical trial options and educate interested patients. It should be noted that an investigational product to be studied in a clinical trial may be in competition with similar products in other trials or with similar drugs that are on the market, making subject enrollment more challenging. This said, clinical investigators need to be prepared to provide sufficient information to their patients to assist with their determination as to whether they will become clinical trial participants and if so, which clinical trial option is most suitable. Investigators will not keep very sick patients waiting to enroll in a potential clinical trial should more immediate and efficacious treatment options be available. Similarly, a significant barrier to enrollment is a placebo-controlled trial design, as a potential subject demonstrating significant and troubling symptoms may not be interested in participating if there is a probability that he/she will be receiving a placebo even for a limited period of time.
How to combat this, and other barriers? Education, understanding and management of expectations are key. Potential clinical research subjects are increasingly more engaged in their conditions and how to manage them. In addition, investigational sites should acknowledge that potential subjects often acquire awareness of potential new treatments under investigation through web-based search engines and social media. Therefore, individual medical context needs to be provided by treating physicians and/or investigators.
Once you’ve enrolled a subject, how do you retain them? Investigational site staff who can maintain a rapport with subjects for the duration of the clinical trial and who can make visit scheduling more convenient within the bounds of protocol requirements are more likely to successfully enroll and retain research subjects. It is possible that successfully enrolled clinical trial subjects may not see the trial through until completion, as the trial treatment has been efficacious for them. In these cases, subjects should be informed and routinely reminded that these visits are part of the trial design to continue to assess safety and efficacy even though in some cases, the treatment portion of the study may have ended. Retention is promoted through informative updates and reminders. If possible, minimization of investigational site staff turnover can contribute to subject retention by ensuring consistency and therefore, the confidence and comfort of clinical trial subjects thereby increasing the opportunity for continued and compliant participation.
