Recommendations to Streamline and Standardize Clinical Trial Site Feasibility Assessments: An ASCO Research Statement. Issue 1 (20th January 2021)

• Record Type: Journal Article
• Authors: Kurbegov, Dax; Hurley, Patricia; Waterhouse, David M.; Robert, Nicholas J.; Nowakowski, Grzegorz S.; Thompson, Michael A.; Bruinooge, Suanna S.; Schilsky, Richard L.; Byatt, Leslie; Dempsey, Kandie; Dawson, Casey; Hofacker, Janie; Liu, Jane; MacDougall, A. Kate; Kim, Edward S.
• Is Part Of: JCO oncology practice. Volume 17:Issue 1(2021)
• Page Start: 41
• Page End: 51
• Publication Date: 2021-01-20
• Subjects: Oncology -- Periodicals; Medical Oncology; Neoplasms; Oncology; Periodicals; 616.994
• DOI: 10.1200/OP.20.00821
• Languages: English
• ISSNs: 2688-1527

Abstract

Abstract : PURPOSE: Feasibility assessments (FAs) are important to establish site capabilities to conduct clinical trials and their suitability for specific trials. However, current FA methods used by biotechnology and pharmaceutical (biotech-pharma) trial sponsors and contract research organizations (CROs) are costly, inefficient, unnecessarily burdensome, and resource intensive. These methods delay trial start-up, act as a barrier to site participation, and ultimately reduce timely patient access to clinical trials and novel treatments. METHODS: An ASCO Task Force was convened to assess the specific burdens and challenges with FAs and to develop recommendations to improve their efficiencies and effectiveness. Stakeholders (including trial sites, biotech-pharma sponsors, and CROs) provided insights into challenges and offered solutions through two surveys and an in-person meeting. The Task Force used the feedback to formulate consensus recommendations to improve FAs for oncology clinical trials. RESULTS: Three key recommendations were identified for application across all biotech-pharma sponsored trials: (1) implement a streamlined and uniform FA process across trials and sponsors; (2) minimize and standardize questions; and (3) leverage technology to centralize FAs, facilitate communications, and reduce redundancies. CONCLUSION: There is an urgency to improve the current FA process, which is costly, inconsistent, inefficient, labor intensive, and of uncertain effectiveness. All stakeholders stand to benefit from implementing these recommendations, which aim to minimize burdens and ensure that more trial sites and patients have timely access to oncology clinical trials. To have meaningful impact, adoption and consistent execution of these recommendations across all trials, sponsors, CROs, and sites are essential.