Medicine advances when people volunteer to participate in clinical trials, yet many clinical trial sites fail to enroll a single patient, resulting in wasted time, money and resources in bringing new treatments to market. In fact, studies have shown that approximately half of all clinical research sites enroll one or no patients in their studies, a trend dubbed “zero enrollment.” At a recent national industry conference (Drug Information Association), I presented strategies that investigator sites can employ to limit the number of failed research sites due to zero enrollment, and to improve site efficiency and communication of quality data between sponsors and investigator sites.Consequences of zero enrollment can be devastating to the investigator site, the sponsor, and ultimately to those who would benefit from new, approved drug therapies and treatments. For the investigator site, failure to enroll a single patient results in uncompensated labor costs, wasted time and resources, and a tarnished reputation with the sponsor. For the sponsor, zero enrollment at a site causes the study to fall behind schedule, resulting in a substantial financial loss. Studies show that sponsors lose up to $8 million each day a drug is delayed from market.
Successful clinical trials often hinge on a few best practices. Investigator sites can set themselves on a path to success by adopting these strategies:
Think before you act. One reason why sites fail to enroll patients is that, too often, sites are selected based on where the investigators are located rather than where the patients are. Once a trial site has been fully activated by a sponsor, an inordinate amount of time and money can be wasted trying unsuccessfully to recruit patients where there are none. Investigator sites can improve efficiency by conducting a thorough feasibility of their available patients by searching their active database study before accepting a protocol.
Make the right decisions early in the process. A well-designed feasibility assessment can bring critical factors to the forefront and help an investigator site know when to accept or reject a protocol. Read and dissect a protocol in depth before you agree to get involved. Evaluate if your site is capable and has access to perform required procedures and that the Investigator agrees with the clinical requirements of the study design.
Put the work in on the front end. If a site does accept a clinical study, provide a standard work-flow, identify protocol barriers, and set realistic projections.
Track and measure performance. Investigator sites must track and measure the study’s performance and plan to make critical adjustments along the way. Select metrics that are meaningful to the sponsor and that can be improved upon, and use the data to improve decision-making, alter staff ratios, and communicate with sponsors. Metrics to consider tracking may include: planned verse actual enrollment; enrollment rate; retention of subjects; number of queries; query resolution time; screen failure rate; percentage of evaluable subjects; and start-up time.
Be transparent. Two-way, ongoing communication between the research sponsor and the investigative site is critical to the success of any clinical trial. Provide a high level of transparency into your study performance metric to get a quick dash-board view that is easily interpreted.
Sites that dedicate time up front on feasibility assessments will yield rewards on the back end. By creating site metrics to measure performance and allowing results to guide the improvement of inefficiencies, investigator sites will avoid the pitfalls of zero enrollment, build lasting partnerships with study sponsors, and make a positive contribution to the advancement of medicine.
