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Should we plan for the unplanned? Managing undesirable but unavoidable protocol amendments in clinical trials.

Primary: Sarah J. Finlayson
Author(s): Sarah J. Finlayson Alpana Ghadge Wendy Hague
University of Sydney University of Sydney University of Sydney

SCT Annual Meeting 2018

Background: Protocol amendments in clinical research are common, and are associated with significant time and economic costs. Approximately 55% of amendments are unavoidable, for reasons including new safety data and changes in standard of care1. While some data exist on approval timelines for pharma-sponsored studies, limited data exist for investigator-initiated studies. We present the approval timelines for the most recent of 3 protocol amendments in the investigator-initiated Australian Placental Transfusion Study. Methods: The amendment was finalized on July 1st, 2016. Dates of release to site and lead ethics submission were collected from Sponsor records, while approval date was taken from the final approval letter. All other dates were by site report. All 25 APTS sites were included. Sites under a lead ethics committee were grouped, unless sites required subsequent institutional approval – in which case, they were grouped only when measuring ethics times. Results: Median time to approval was 89 days, however the range was very large (13-256d). Approval times for Australian sites were considerably shorter than for international sites (45d vs. 119d). Site time accounted for the greatest proportion of approval time, followed by ethics, other institutional approval, and Sponsor time. There was a strong relationship between approval time and the level of central resourcing required, as measured by site prompts (R2=0.93). Results were also collected for internal approval timelines, different approval models and methods of site contact. Discussion: Approval timelines were lengthy, and delays were associated with increased central resourcing. Co-location of the coordinating center may explain the shorter approval times for Australian sites. Given the impact of site time, early additional coordinating resources (possibly targeted at international sites lacking a local coordinating centre) may provide an opportunity to reduce approval timelines. Protocol amendments delay studies, and result in a loss of enthusiasm at site. To minimize amendments and their impacts, investigators should ensure appropriate planning and feasibility assessments are completed prior to study commencement. References: 1. Getz K. Acknowledging cycle time impact from protocol amendments. Applied Clinical Trials 2016; 25(4): 16-17

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