Subject Selection

Abstract

Identification and successful enrollment of subjects in your clinical trial are obviously essential for its success. This process might, at face value, seem easy, but it is often unexpectedly more challenging than you anticipate. For this reason, dedicate significant time and energy to planning this component of your trial design. The subjects targeted for any study are, such as the endpoints and interventions, initially defined by your primary research question. The group will then be further refined by the specific inclusion and exclusion criteria defined in your recruitment plan. The more liberal the criteria used, the larger but more varied the resulting population will be. The more stringent, the smaller and more narrow the cohort. Finally, develop your informed consent process and, in the end, make allowances for that fact that many perfectly eligible subjects will decline consent and enrollment. Taking all this into account from the beginning will translate into reasonable recruitment forecasting for your trial and avoid enrollment difficulties.