Sponsor Perspectives on the Impact of the COVID-19 Pandemic on Interventional Cancer Clinical Trial Protocols and Data Quality.

PURPOSE: The onset of the COVID-19 pandemic created major disruptions in the conduct of cancer clinical trials. In response, regulators and sponsors allowed modifications to traditional trial processes to enable clinical research and care to continue. We systematically evaluated how these mitigation strategies affected data quality and overall trial conduct. METHODS: This study used surveys and live interviews. Forty-one major industry and National Cancer Institute Network groups (sponsors) overseeing anticancer treatment trials open in the United States from January 2015 to May 2022 were invited to participate. Descriptive statistics were used for survey data summaries. Key themes from interviews were identified. RESULTS: Twenty sponsors (48.8%; 15 industry and five Network groups) completed the survey; 11/20 (55.0%) participated in interviews. Sponsors predominantly (n = 12; 60.0%) reported large (≥11 trials) portfolios of phase II and/or phase III trials. The proportion of sponsors reporting a moderate (9) or substantial (8) increase in protocol deviations in the initial pandemic wave versus the pre-pandemic period was 89.5% (17/19); the proportion reporting a substantial increased dropped from 42.1% (n = 8/19) in the initial wave to 15.8% (n = 3/19) thereafter. The most commonly adopted mitigation strategies were remote distribution of oral anticancer therapies (70.0%), remote adverse event monitoring (65.0%), and remote consenting (65.0%). Most respondents (15/18; 83.3%) reported that the pandemic had minimal (n = 14) or no impact (n = 1) on overall data integrity. CONCLUSION: Despite nearly all sponsors observing a temporary increase in protocol deviations, most reported the pandemic had minimal/no impact on overall data integrity. The COVID-19 pandemic accelerated an emerging trend toward greater flexibility in trial conduct, with potential benefits of reduced burden on trial participants and sites and improved patient access to research.

21 Code of Federal Regulations Part 11-Compliant Digital Signature Solution for Cancer Clinical Trials: A Single-Institution Feasibility Study.

PURPOSE: Inefficiencies in the clinical trial infrastructure result in protracted trial completion timelines, physician-investigator turnover, and a shrinking skilled labor force and present obstacles to research participation. Taken together, these barriers hinder scientific progress. Technological solutions to improve clinical trial efficiency have emerged, yet adoption remains slow because of concerns with cost, regulatory compliance, and implementation. METHODS: A prospective pilot study that compared regulatory-compliant digital and traditional wet ink paper signatures was conducted over a 6.5-month period in a hospital-based health system. Staff time and effort, error rate, costs, and time to completion were measured. Wilcoxon rank sum tests were used to compare staff time and time to completion. A value analysis was conducted. A survey was administered to measure user satisfaction. RESULTS: There where 96 participants (47 digital, 49 paper), 132 studies included (31 digital, 101 paper), and 265 documents processed (156 digital, 109 paper). A moderate reduction in staff time required to prepare documents for signature was observed (P < .0001). Error rates were reported in 5.1% of digital and 2.8% of paper documents, but this difference was not significant. Discrepancies requiring revisions included incomplete mandatory fields, inaccurate information submitted, and technical issues. A value analysis demonstrated a 19% labor savings with the use of digital signatures. Survey response rate was 57.4% (n = 27). Most participants (85.2%) preferred digital signatures. The time to complete documents was faster with digital signatures compared with paper (P = .0241). CONCLUSION: The use of digital signatures resulted in a decrease in document completion time and regulatory burden as represented by staff hours. Additional cost and time savings and information liquidity could be realized by integrating digital signatures and electronic document management systems.