Not Yet Recruiting Clinical Trials

In the earliest stages of a clinical trial, participants are not yet being recruited or enrolled. Although patients are not yet being enrolled or contacted at this point, a research participant goal is likely being established and documented to ensure the best possible results. During this process, designers of the trial protocol account for the number of recruited volunteers who will fail pre-trial screenings and not make it into the pool of participants.

Furthermore, during this stage it is expected that others will drop out of the study prematurely due to various factors, including consent withdrawal, poor compliance of protocol, and even adverse events which call for study withdrawal. Therefore, those designing the study must designate a number larger of recruited volunteers than the study will finally end with. During each stage of a trial, these trial designers anticipate a given number of recruits to drop out, which is why pre-recruitment planning is essential.

The Society of Clinical Research Associates, Inc.