Creating and Implementing a Principal Investigator Tool Kit for Enhancing Accrual to Late Phase Clinical Trials: Development and Usability Study.
Kristin A Higgins, Alexandra Thomas, Nancy Soto, Rebecca Paulus, Thomas J George, Thomas B Julian, Sharon Hartson Stine, Merry Jennifer Markham, Maria Werner-Wasik
Author Information
Kristin A Higgins: Winship Cancer Institute, Emory University, Atlanta, GA, United States. ORCID
Alexandra Thomas: Atrium Wake Forest Baptist Comprehensive Cancer Center, Wake Forest University, Winston-Salem, NC, United States. ORCID
Nancy Soto: NRG Oncology Operations Center, American College of Radiology, Philadelphia, PA, United States. ORCID
Rebecca Paulus: NRG Oncology Statistics and Data Management Center, American College of Radiology, Philadelphia, PA, United States. ORCID
Thomas J George: University of Florida College of Medicine, Gainesville, FL, United States. ORCID
Thomas B Julian: Allegheny Health Network Cancer Institute, Allegheny General Hospital, Pittsburgh, PA, United States. ORCID
Sharon Hartson Stine: NRG Operations Center, American College of Radiology, Philadelphia, PA, United States. ORCID
Merry Jennifer Markham: University of Florida College of Medicine, Gainesville, FL, United States. ORCID
Maria Werner-Wasik: Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, United States. ORCID
BACKGROUND: Accrual to oncology clinical trials remains a challenge, particularly during the COVID-19 pandemic. For late phase clinical trials funded by the National Cancer Institute, the development of these research protocols is a resource-intensive process; however, mechanisms to optimize patient accrual after trial activation are underdeveloped across the National Clinical Trial Network (NCTN). Low patient accrual can lead to the premature closure of clinical trials and can ultimately delay the availability of new, potentially life-saving therapies in oncology. OBJECTIVE: The purpose of this study is to formally create an easily implemented tool kit of resources for investigators of oncology clinical trials within the NCTN, specifically the NRG Oncology cooperative group, in order to optimize patient accrual. METHODS: NRG Oncology sought to formally develop a tool kit of resources to use at specific time points during the lifetime of NRG Oncology clinical trials. The tools are clearly described and involve the facilitation of engagement of the study principal investigator with the scientific and patient advocate community during the planning, activation, and accrual periods. Social media tools are also leveraged to enhance such engagement. The principal investigator (PI) tool kit was created in 2019 and thereafter piloted with the NRG Oncology/Alliance NRG-LU005 phase II or III trial in small-cell lung cancer. The PI tool kit was developed by the NRG Oncology Protocol Operations Management committee and was tested with the NRG/Alliance LU005 randomized trial within the NCTN. RESULTS: NRG Oncology/Alliance NRG-LU005 has seen robust enrollment, currently 127% of the projected accrual. Importantly, many of the tool kit elements are already being used in ongoing NRG Oncology trials, with 56% of active NRG trials using at least one element of the PI tool kit and all in-development trials offered the resource. This underscores the feasibility and potential benefits of deploying the PI tool kit across all NRG Oncology trials moving forward. CONCLUSIONS: While clinical trial accrual can be challenging, the PI tool kit has been shown to augment accrual in a low-cost and easily implementable fashion. It could be widely and consistently deployed across the NCTN to improve accrual in oncology clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT03811002; https://clinicaltrials.gov/ct2/show/NCT03811002.
