JMIR Publications

ABSTRACT

Background:

Background:

Accrual to oncology clinical trials remains a challenge, particularly in the era of the COVID 19 pandemic.

Objective:

Objective:

The purpose of this study was to formally create a toolkit of resources for investigators of NRG Oncology clinical trials to easily implement in order to optimize patient accrual.

Methods:

Methods:

NRG Oncology sought to formally develop a toolkit of resources to use at specific time points during the lifetime of NRG trials. The tools are clearly described and involve facilitation of engagement of the study principal investigator with the scientific and advocate community during the planning, activation, and accrual periods. Social media tools are also leveraged to enhance such engagement. The Principal Investigator toolkit was created in 2019 and thereafter piloted with the NRG Oncology/Alliance NRG-LU005 phase II/III trial in small cell lung cancer. The PI toolkit was developed by the NRG Oncology Protocol Operations Management committee and was tested with the NRG/Alliance LU-005 randomized trial within the National Clinical Trial Network (NCTN).

Results:

Results:

NRG Oncology/Alliance NRG-LU005 has seen robust enrollment, currently 127% of projected accrual. Importantly, many of the toolkit elements are already being utilized in ongoing NRG Oncology trials, with 56% of active NRG trials utilizing at least one element of the PI toolkit and all trials in development offered the resource. This underscores the feasibility and potential benefits of deploying the PI toolkit across all NRG Oncology trials moving forward.

Conclusions:

Conclusions:

While clinical trial accrual can be challenging, the Principal Investigator toolkit has been shown to augment accrual in a low-cost and easily implementable fashion. It could be widely and consistently deployed across the NCTN. Clinical Trial: Trial Registration: ClinicalTrials.gov Identifier: NCT03811002.