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Abstract
The Protocol-in-a-Day (PIAD) workshop was developed to support junior faculty and residents with clinical trial protocol design, with the main goal of providing initial feedback during development to reduce time for review and approval from institutional oversight committees. Our objectives are to mentor and educate participants and to evaluate the time to institutional approval by oversight committees. PIAD provided concurrent educational feedback on 6 key elements of trial design. These included: (1) regulatory aspects; (2) institutional scientific review committee (SRC) and institutional review board (IRB); (3) clinical research and data coordination (including nursing); (4) statistics; (5) correlatives including imaging, biospecimens, and health services research/patient-reported outcomes; and (6) operations. The average number of days from submission to IRB approval or study activation for PIAD protocols was compared to other protocols submitted between January 2018 - January 2022 within the Division of Radiation Oncology. Participants were also given a 15-question survey to assess their perspective of the impact of the workshop. A total of 25 protocols went through the PIAD workshop between January 2018-January 2022. Of the 25 protocols, 7 (28%) were excluded from this study due to not being submitted possibly after participants benefited from education on the limitations of their design. Eighteen protocols were included in our final analyses. These protocols included phase II (n = 11), phase 1 (n = 5), and phase III (n = 2). At the time of this report, all protocols (n = 18) have received IRB approval and have been activated. Protocol elements that could impact study activation included protocols requiring investigational new drug (IND) approval (n = 8) and multicenter studies (n = 1). Analyzing the time of submission to request for activation showed a decrease in time for protocols that went through PIAD vs those that did not [PIAD protocols, 254 days vs All other protocols, 262 days]. Likewise, those who attended PIAD had a lower average time from submission to IRB Approval [ PIAD protocols, 40 days vs All other protocols, 59 days]. All participants (100%) of the PIAD workshop responded that the educational program "improved the overall quality of the study design." The most commonly cited changes were protocol language (n = 17), statistics (n = 15), consent language (n = 8), and study design (n = 8). Aspects participants identified as the most educational included mentorship from regulatory, clinical research finance, and IRB review. PIAD from participant surveys provided high educational value in the areas of improving trial quality, language and statistical design. When analyzing the average time, from 'submission to IRB initial approval' and 'submission to activation', PIAD protocols had a shorter time for approval, and thus suggests PIAD is effective in improving the overall design of protocols.
Published Version
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