Clinical Trial Recruitment Planning: FDA and Others Provide Tips and Tools
5 July, 2016 Mukesh Kumar, Adjunct Assistant Professor, Clinical Research and Leadership at George Washington University
|Recruitment plans should start early
in the trial planning stage, involve
all stakeholders, and continue throughout
the life of the trial.
Challenges in recruiting patients are the most common reason for delays and increasing costs of clinical trials. This week (1) 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 four 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.
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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, budget and resource planning, training and monitoring.
The third stage of the 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 stages of clinical trials.
(1) May 26, 2016
This article first appeared in FDAMap. Reprinted with author's permission,
Dr. Mukesh Kumar is a Washington D.C.-based consultant in regulatory affairs and quality assurance for manufacturers and developers of pharma and biotech products. He is vice president of regulatory affairs and quality assurance for Amarex Clinical Research, a clinical research organization based in Germantown, Maryland, near Washington D.C. (www.amarexcro.com). He is also the founder and managing partner in Amarex BioVentures, an investment company specializing in FDA-regulated products. His key expertise is in FDA, EMA, and global regulations for healthcare products, clinical trials and multi-national project management. He has been involved in more than 100 multi-national clinical trials, has made hundreds of submissions to the U.S. FDA, EMA, and regulators in more than 20 countries. He has created and led numerous teams for development of pharmaceutical, biotech and medical device products all the way from early stage development to commercial markets. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe, South America and Asia. He has conducted hundreds of training workshops and has authored numerous peer reviewed high-impact articles on healthcare regulations. He authors a popular weekly newsletter on FDA-related issues read by more than 100,000 readers worldwide (www.fdamap.com). He is a frequent consultant to investment companies, government policy think tanks, social media enterprises, and international business corporations. He is a well-known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. He is a visiting professor at George Washington University, Washington DC, and Montgomery College, Maryland. Dr. Kumar holds a Ph.D. in Biochemistry.