Guest Expert Louis Pavia: Clinical trial accrual--turning a 'vicious cycle' into a 'virtuous' one!
Please welcome our guest expert, Mr. Louis Pavia, Chairman of the Development Committe for the Education Network to Advance Cancer Clinical Trials (ENACCT). You won't want to miss the new 3-part series on AccrualNet that details the 7 strategic questions that sites must answer to improve accrual.
The Clinical trial accrual process is failing patients, researchers and clinicians. Too many trials fail to reach their primary end point on schedule if at all and too many sites are enrolling so few patients that we are squandering the limited resources of sites and sponsors. While there are many aspects of the research process that can be improved, clinical trial sites have a role and opportunity to improve their own performance.
The best sites are accruing patients at 3-5 times the rate of the average comparable site. We have seen, for example, a small hospital treating just 300 new cancer patients a year in a minority community identify the opportunity and implement improvements to their screening and patient engagement processes that increased their accrual rate for interventional trials to 10% per year. Similarly, a Mid-west university affiliated cancer hospital focused on the clinical trials accrual culture and patient engagement to double their accrual rate. Another health system in southern California identified gaps in the skills of their staff and introduced training programs that enhanced accrual. While sites are under tremendous pressure just to meet the clinical and management requirements of their existing clinical trials program, like the shoemaker whose kids have no shoes, it is important to step back and assess the entire clinical trials ecosystem to identify bottlenecks and constraints and systematically improve processes and procedures to maximize your potential.
ENACCT has developed a process and tools to help guide a site through a comprehensive self assessment process to systematically evaluate the 7 critical dimensions of the accrual process and identify areas to focus improvement efforts. Click HERE to review a three part series that 1) describes the rationale and the opportunity, 2) defines the metrics that can be used to analyze your portfolio, protocols, and processes and 3) focuses on the types of problems that may be identified and strategies to resolve them.