Not getting lost in translational science: A tool for navigating the pre-implementation phase of multi-site pharmacological clinical trials.

The compelling need to improve the efficiency of multi-site pharmacological clinical trials has received increasing attention and a number of challenges needing to be addressed have been delineated. This paper discusses one of the challenges, how to avoid a lengthy pre-implementation phase, and proposes the strategy of using a Pre-implementation Timeline “Calculator” developed in working with the National Drug Abuse Treatment Clinical Trials Network. The Calculator is a Microsoft Excel worksheet designed to assist investigators in planning for, and completing, the pre-implementation phase of multi-site pharmacological clinical trials in a timely manner. Preliminary data are presented comparing the pre-implementation phase length of pharmacological trials that did (n=3) and did not (n=4) use the Calculator. The amount of time taken to complete the stage between having a sponsor-approved protocol and the initiation of recruitment at a study site averaged nine months for the Calculator trials compared to 15 months for the Non-Calculator trials. The period between the Investigators’ meeting and the initiation of recruitment at a study site averaged two months for the Calculator trials compared to five months for the Non-Calculator trials. An estimate of the site staffing costs associated with the later time frame was calculated for a hypothetical trial conducted at 10 sites. The results revealed that the extra three months were associated with a cost of $388,000.

Conclusions: The Calculator is a free, easily implemented, tool that may provide significant benefits in reducing the time and financial resources required to complete the pre-implementation phase of multi-site pharmacological clinical trials; thus, its more wide-spread use in multi-site pharmacological clinical trials seems warranted.