Feasibility assessment is a critical step in conducting a successful clinical trial. Selecting the right site can be beneficial for both the sponsor and the clinical site. In addition, it can provide an opportunity for many patients to be enrolled in a study that may change their life. Therefore, the sponsors and CROs should spend sufficient effort on site assessment to select the appropriate sites. The feasibility questionnaire is the tool that ensures the right sites are selected for a clinical study. However, sometimes answering a feasibility questionnaire is not enough and the sites that have accurate databases and evidence are the ones that can facilitate the process of site selection. The following are some pieces of evidence that the sites can provide to stand out to sponsors and show that they have the feasibility to conduct the clinical study.
Network
The clinical sites that have access to local network referrals or patient communities have more chance of enrolling patients in trials. Also, having a network can help some newer research sites which do not have a long record of experience. In some studies, dedicating some budget for advertisements on radio, social media, or newspaper is valuable to attract the right patients to the study.
Recruitment plan
A site that has the potential patient population but doesn’t follow a specific recruitment plan will not be able to meet the recruitments goals. Presenting the documentation from other study enrollments to the sponsor demonstrates the site’s capability to meet the recruitment goals.
Patient population
The size of the database used to identify patients for any particular study will affect patient enrollment. Therefore, sites with more physicians usually have larger numbers of patients available.
Other active studies at the site
The sponsor should always be aware of any other competing studies at the site. If the principal investigator is participating in several studies within similar enrollment criteria, that could affect the recruitment goals.
Full cooperation and timely responses
Fast response from sites is critical for sponsors to hit the milestones on time. A site with full cooperation and timely responses will speed up timelines.
The sponsor considers several factors in site selection. During the assessment, some important questions are what is the main clinical site’s patient population, how the sites identify eligible patients, how many patients are seen by the physician regularly, and whether the potential investigator is participating in any competing studies. Determining site feasibility is an essential step during the study start-up process and worth the upfront time and effort in order to shorten the overall clinical trial timeline.