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

Abstract

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://ichgcp.net/clinical-trials-registry/NCT03811002.

Keywords: PI toolkit; accrual; activation; clinical trial; clinical trial accrual; community; development; engagement; investigators; oncology; patient; planning; principal investigator; resources; social media; social media tools; study; tool.

Conflict of interest statement

Conflicts of Interest: TJG has grants or contracts through his institution from Bristol-Myers Squibb, Merck, AstraZeneca/MedImmune, Lilly, Bayer, Incyte, Tesaro/GSK, Ipsen, Seattle Genetics, and Genentech, as well as consulting fees from Tempus. SHS is an employee of the American College of Radiology, a grant awardee of the National Cancer Institute (NCI), and a sub-awardee of the Radiation Therapy Oncology Group (RTOG) Foundation (under NRG Oncology grant). KAH has grants or contracts from RefleXion Medical and Jazz Pharmaceuticals; consulting fees from AstraZeneca, RefleXion Medical, and Janssen Pharmaceuticals; and leadership or fiduciary role in other board, society, committee, or advocacy group (paid or unpaid) such as AstraZeneca, RefleXion, and the NRG Oncology Board of Directors. TBJ has a leadership or fiduciary role in other board, society, committee, or advocacy group (paid or unpaid) such as Chair of NRG Communications Committee. RP has grants or contracts from entities such as NCI (Grant # U10CA180822; NRG Oncology Statistics and Data Management Center). AT has grants or contracts from entities such as Sanofi (research paid to institutions) and Syndax (research paid to institution). She also has support for attending meetings or travel from Genentech (meals to discuss federal grant); participates in a Data Safety Monitoring Board or Advisory Board form BeyondSpring Pharmaceuticals and Lilly (Advisory Board); and has stock or stock options from Pfizer, Johnson and Johnson, Gilead, and Bristol Myers Squibb. MWW has grants or contracts from NRG Oncology; has leadership or fiduciary role in other board, society, committee, or advocacy group; is Chair of Protocol Operations Management Committee of NRG Oncology (not paid); is member at RTOG Foundation Board of Directors; and has other financial or nonfinancial interests such as principal investigator for NRG Oncology at Thomas Jefferson University, Philadelphia, PA. MJM, SHS, and NS have no conflicts of interest to declare.

©Kristin A Higgins, Alexandra Thomas, Nancy Soto, Rebecca Paulus, Thomas J George, Thomas B Julian, Sharon Hartson Stine, Merry Jennifer Markham, Maria Werner-Wasik. Originally published in JMIR Cancer (https://cancer.jmir.org), 25.08.2022.

Figures

Figure 1

Accrual pace of NRG/Alliance LU005 (top panel) relative to other NRG Oncology lung cancer phase II or III trials (bottom panel).