Study Start-Up Times: One Site's Analysis of the Process, the Problem, and the Plan to Shorten Times
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Some of the greatest technological advances in medicine have come from clinical trials. These trials provide cutting edge technology to patients suffering from acute and chronic illnesses. Getting these trials started expeditiously saves money, time, and more importantly benefits patients in need of relief. Unfortunately, many trials do not get started as quickly as the industry and institutions had planned. Very few publications address delayed study startups. The author’s institution conducted a retrospective analysis of ten clinical studies (5 drug and 5 device) at their local institution to determine where the delays were in the study startup process. Utilizing 7 metric cycle times developed in 2010 at the Clinical Trials Transformation Initiative, time points were collected and analyzed. Most of delays came from the IRB process as well as budgeting and contracting. Once the study startup delays were identified, a plan for the author’s institution was developed to reduce those times.