Multiple Efforts to Increase Recruitment of Subjects in Clinical Trials
[Posted on: Thursday, 14 April , 2016]

It is well known that the most challenging aspect of running a given clinical trial is finding patients to participate in it. The main reasons are negative public perception of clinical trial participation, poorly designed clinical protocols and lack of planning by the clinical trial managers. And regulators are trying to help change that. Last month, NIH and FDA jointly released a template for clinical trial protocols to help companies design better clinical trials that would encourage higher participation by investigators and patients. A few months ago, FDA and Duke University’s joint program, Clinical Trial Transformation Initiative (CTTI), made several recommendations to increase patient participation. Several programs have been launched recently to help connect patients with trials that they may be interested in. All these address various aspects of clinical trial recruitment. According to FDA, a clinical protocol should clearly state the purpose, risks and benefits of participating, along with defining the recruitment and retention strategies so participants can make an educated decision about the merits of enrolling in a given trial. Another recommendation is including simpler informed consent that provides the information most relevant to a patient in a simpler manner to aid their decision to participate in a clinical trial. The CTTI recommendations are broader in terms of their scope to increase patient engagement throughout the development of a new drug, connecting patient groups and sponsors, providing tools to evaluate recruitment programs. More than 40% of all clinical trials fail for lack of finding target number of subjects. Fewer than 10% of Americans participate in clinical trials; with some indications getting even fewer patients participate. Only about 3-5% of cancer patients participate in clinical trials. Recruitment efforts should form the focus of a clinical trial project plan. The recruitment plan should be multi-dimensional including patient engagement, education, and awareness. Access to patients is the key to recruitment. Identifying this, major healthcare providers with databases of patients are planning to use their patient databases for clinical trial recruitment. For example, Kaiser Permanente, with over 10 million members, uses electronic medical records to help its doctors quickly identify patients who are good candidates for trials. Kaiser also launched a website were its patient members can locate trials and get email updates for trials they may be interested in. Using its own doctors and medical centers to recruit Kaiser is able to recruit patients into trials at significantly higher rates. Other medical practices are starting to follow similar practices. These new practices coupled with traditional and non-traditional clinical trial promotion activities such as advertisement, social media campaigns, patient support group engagement and recruitment advisers should contribute to increased patient involvement in clinical trials. Participating in clinical trials is a mutually beneficial partnership between patients and sponsors and with 90% of the population not currently participating, there is a large prospect of growth in this area.