Recruitment

Patient Recruitment

Recruitment of clinical trial study participants involves careful consideration that the subjects meet the inclusion/exclusion criteria set forth in the protocol. In addition, the recruitment of certain patient populations may bias your study. For example, you may identify patients who have a favorable outcome to your product or may have less likelihood to have a favorable response or adverse effect. For example, African Americans respond poorly to the blood pressure effects of beta-blockers, so a comparison of a new antihypertensive with these drugs in such patients would show favorable efficacy outcomes.

The choice of a patient population for your clinical studies covers a wide range of possibilities, such as etiology, disease state, age, gender, concomitant diseases, and medications. Therefore, the measures of efficacy and safety are directly related to the restrictions placed on patient eligibility.

Certain restrictions in the protocol or the disease state being studied may cause study enrollment issues, such as a delay in patient recruitment and completion of the study.

Other issues that can affect patient recruitment are the amount of compensation for the study, length of the study, the amount of in-clinic visits, patient privacy issues, and the chances of getting a placebo.

It is important to recruit patients who are able to read and understand the informed consent and their requirements in the study. They must understand how to fill out all the trial-related documentation, such as questionnaires.