Creating and Implementing a Principal Investigator Tool Kit for Enhancing Accrual to Late Phase Clinical Trials: Development and Usability Study

• DOI: 10.2196/38514
• Publication Date: 2022-08-25T13:15:32Z
• Authors: Kristin A Higgins; Alexandra Thomas; Nancy Soto; Rebecca Paulus; Thomas J George; Thomas B Julian; Sharon Hartson Stine; Merry Jennifer Ma...; Maria Werner-Wasik
• Keywords: social media tools; PI toolkit; social media; 610; 03 medical and health sciences; 0302 clinical medicine; 616; clinical trial accrual; study; Other Medicine and Health Sciences; development; RC254-282; accrual; principal investigator; Original Paper; Neoplasms. Tumors. Oncology. Including cancer and carcinogens; clinical trial; tool; 3. Good health; oncology; community; activation; patient; investigators; planning; resources; engagement

Accrual to oncology clinical trials remains a challenge, particularly during the COVID-19 pandemic. For late phase funded by National Cancer Institute, development of these research protocols is resource-intensive process; however, mechanisms optimize patient accrual after trial activation are underdeveloped across Clinical Trial Network (NCTN). Low can lead premature closure and ultimately delay availability new, potentially life-saving therapies in oncology.The purpose this study formally create an easily implemented tool kit resources for investigators within NCTN, specifically NRG Oncology cooperative group, order accrual.NRG sought develop use at specific time points lifetime trials. The tools clearly described involve facilitation engagement principal investigator with scientific advocate community planning, activation, periods. Social media also leveraged enhance such engagement. (PI) was created 2019 thereafter piloted Oncology/Alliance NRG-LU005 II or III small-cell lung cancer. PI developed Protocol Operations Management committee tested NRG/Alliance LU005 randomized NCTN.NRG has seen robust enrollment, currently 127% projected accrual. Importantly, many elements already being used ongoing trials, 56% active using least one element all in-development offered resource. This underscores feasibility potential benefits deploying moving forward.While be challenging, been shown augment low-cost implementable fashion. It could widely consistently deployed NCTN improve trials.ClinicalTrials.gov NCT03811002; https://clinicaltrials.gov/ct2/show/NCT03811002.