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Patient recruitment is the process of finding patients suitable for clinical trials, enrolling them, and retaining them throughout the trial. This is a very time consuming and complex task, especially in the case of a large clinical trial with significant participant risks or very specific criteria for enrollment. Researchers may miss deadlines or fail to enroll enough patients, and this could jeopardize the trial's success. Many research organizations turn to third party patient recruitment specialists to get their trial participants.
In patient recruitment, it is necessary to develop a profile of the ideal patient and determine how to reach such patients. Clinical trials have very strict participant requirements to control for variables. Patients with comorbidities that might throw off results, for example, are not suitable. The recruiter also has to think about the location and time frame of the trial, as these could pose a problem for patient recruitment as well. Some consultants can make recommendations for trial design changes that might address recruitment issues, like moving the site of a trial to make it more accessible.
The recruiter reaches out to care providers, patient organizations, and other potential sources of patients who may be interested in the trial. It provides detailed information patients can review to see if they are eligible. The material encourages patients to apply, and the next step in recruitment is patient screening. New enrollees usually need medical testing as well as interviews and careful review to see if they are good fits for the trial. Once a patient is accepted, the retention process begins.
Clinical trial participation can be difficult, and a major part of patient recruitment involves taking steps to reduce the risk of losing patients partway through the trial. This can include everything from providing financial assistance so patients can cover the expense of a caregiver to making arrangements to collect data at locations and times that are more convenient for the patient. Trial researchers may travel to patient homes, for instance, rather than asking patients to travel to the trial site.
There are considerable ethical concerns to weigh in patient recruitment. The trial wants the best patients possible for the research, but it also must make sure all patients are fully informed and consenting. If patients do not have the right information they might drop out later in the trial or the researchers could be legally liable for ethics violations. Recruiters need to think about issues like laws that restrict medical advertising in the process of developing a plan to locate and enroll patients.