With thorough site feasibility processes, sponsors can increase speed to first patient in and maximize enrollment potential.
According to Pharma Intelligence Informa, two-thirds of all clinical trial sites are unable to meet enrollment goals. Half of all sites recruit one or zero patients.
Even for trials that are able to meet recruitment goals, 86% experience delays, with actual enrollment timelines typically 2x their planned estimates (averaging 8 months to initiate a trial from site identification to first patient in).
These are daunting numbers. What can a sponsor do to minimize the risk of delays, enrollment failures, and sunk costs?
Selecting the Right Sites: Best Site Feasibility Practices
A well-planned study with properly selected sites can decrease costs and speed up the study timeline.
Poor enrollment can lead to the need to seek out and bring in new investigators, drawing out timelines. It may also require an adjustment to eligibility criteria, and protocol amendments may move a study several steps back.
At the very least, underperforming sites add extra opportunity costs.
At the worst, a study’s target enrollment may never be reached, and your entire program may be compromised.
During the site selection process, sponsors/CROs should consider the following (uncomprehensive) list:
- Assessing general site feasibility questions
- Are there any regulatory red flags?
- Does the site have the right resources (equipment, staff, etc.) to allow the trial to be successful?
- Assessing epidemiology and patient population
- Is the site located in an area with a high incidence of the disease of interest?
- Does the site have access to the targeted patient population?
- Assessing historical performance site-by-site
- Does the site have successful experience within clinical research?
- Does the site have efficient regulatory, contract, and budgetary processes?
- Does the site have successful experience within the study’s therapeutic area?
- Does the site have a history of meeting enrollment goals?
- Assessing experience of investigators and site staff
- Does the PI/site staff have experience within the study’s therapeutic area/indication?
- Does site staff have the bandwidth to take on more studies?
- Does the investigator have a vested interest in the condition? Is it an area of focus for their practice, or are they recognized as an expert?
