Why Patients Aren’t Joining Your Clinical Trial – Part 1

This is part 1 of a 2 part series on patient centricity in clinical trials. You can read part 2 here. Enrollment is the lifeblood of a clinical trial and is yet one of the most problematic issues. This blog explores the reasons why your patients may not enrolling and how they can be addressed. Background Most studies are initiated by a sponsor seeking out a clinical research organization (CRO) to handle recruitment. The CRO contacts potential study sites to ask if they may have patients who will qualify to be research subjects in the clinical trial. After that, there is sometimes little structured recruitment. Typically,  the CRO will reach out sites and ask them if they are treating patients who might qualify. In some cases, well-known or prestigious research sites (such as highly ranked university hospitals) may have qualifying patients. The sponsor would hope to get the more prestigious research sites on-board with the study. While they might have some patients who will qualify for the study, this recruitment model is not necessarily the best or only way to reach potential patients.    1. Define a recruitment strategy Sponsor clinical trial departments and clinicians routinely see marketing as a four letter word. However, once clinical trial recruitment fails, sites often request Sponsors for money for ad-hoc marketing advertisements. These advertisement plans are neither consistent nor necessarily effective. It is important that companies have a cohesive and consistent marketing plan that work together and produce consistent and planned efforts. 2. Identify patients Patients and caregivers routinely join patient support or advocacy groups to get information about their disease. These groups maintain a network of people with the disease state and help them stay informed and supported. Patient groups can help connect sponsors narrow down their recruitment efforts to patients with specific disease states.  While direct patient outreach is allowed and benefits patients when done correctly, inappropriate methods can expose companies to significant liabilities (as seen here and here). 3. Maintain patient trust through the secure maintenance of information For companies to begin engaging with patients, they must be prepared to maintain the security of patient information. Aside from the legal repercussions of improper disclosure of private health information, drug researchers are vying for patient trust. A patient may be reluctant to engage with organizations if they are not assured of the security of their information. Distributed ledger technologies (DLTs) such as Blockchain, help facilitate the appropriate sharing of information. Through Blockchain, sensitive information is transparent to certain approved people but is secure and protected when distributed improperly. Because it is both transparent and secure, Blockchain ensures data integrity and privacy and can be used to help build transparency and trust with patients.   4.   Spread awareness! Spreading awareness of a clinical trial can take many forms: Traditional Marketing