Clinical Trial Recruitment Planning: FDA and Others Provide Tips and Tools  
[Posted on: Thursday, May 26, 2016]

Challenges in recruiting patients are the most common reason for delays and increasing costs of clinical trials. This week the Clinical Trial Transformation Initiative (CTTI), a joint program between FDA, Duke University and industry representatives, announced recommendations for creating robust recruitment plans for clinical trials taking into consideration the most common challenges and potential solutions. CTTI also released a set of 4 tools to help with the recruitment planning. These recommendations are based on a survey of the most common reasons trials fail to recruit adequate number of participants and suggest actionable solutions. Recruitment plans should start early in the trial planning stage, involve all stakeholders, and continue throughout the life of the trial. Most trials do not start recruitment planning till the trial fails to meet its planned recruitment targets by which time the trial tries to play catch-up with escalated cost and excessive delays. The CTTI document presents a three-step recruitment plan. The first step in the recruitment plan takes place during trial design and protocol development. During the trial design, sponsors should collect opinions from all stakeholders such as patients, patient groups, investigators, sites, and key opinion leaders to identify the key factors that may impact recruitment such as relevant endpoints and outcomes, motivating factors for patients, measures to reduce burden of participation, realistic eligibility criteria, and reasonable data collection plans that include only data points necessary to ensure patient safety and answering the endpoints. The second step in the plan should address practical issues for trial execution such as site selection based on evidence-based feasibility analysis, realistic matrices and milestones to evaluate performance, budge and resource planning, training and monitoring. The third stage of recruitment plan should involve robust communication tools. These include communicating trial updates with the same stakeholders as used during the planning stage plus additional parties identified during steps 1 and 2. Messages tailored to specific patient groups should be publicized using creative material and suitable channels with appropriate budget and reasonable matrices to evaluate effectiveness of each message. The steps need to be repeated when the protocol is amended or new sites and population explored such as opening new sites in another country. These recommendations are logical and should not be a surprise to experienced clinical trial professionals. The recommendations emphasize the need to include patient perspectives in trial design and robust messaging to address awareness of a trial to potential patients. Less than 5% of patients participate in clinical trials hence there is a large scope of growth in recruitment rates for clinical trials. A good recruitment plan should understand that patients see trials as treatment options and enroll in studies that they can relate with. So recruitment plans should engage all stakeholders from doctors to patients, use valuable information reservoirs such as medical records and patient groups, and create integrated networks that enhance rapid recruitment with fewer sites. Recruitment specialists that can create, execute and improvise the plan are a necessary part of all clinical operation teams. The tools should be used by all clinical trial teams for all stage of clinical trials.