Background: The VA Connecticut Healthcare System Cancer Center developed and implemented a standardized pre-screening process and infrastructure to help identify patients for clinical trials and increase enrollment. Participation rate of cancer patients in clinical trials in the US is low, and the rate of enrollment of veterans with cancer into clinical trials is even lower than in the non-VA population. We hypothesized that a standardized process to prospectively identify potential patients for available clinical trials would increase enrollment of veteran cancer patients.
Methods: Our process uses the Research Electronic Data Capture (REDCap) system to pre-screen patients for clinical trials and to create a registry of potential research subjects. Patients are initially identified through multiple resources (clinic lists, tumor boards, cancer registry), and a standardized medical chart review is used to manually populate customized data fields in REDCap. Limited data fields are entered on all cancer patients, and more detailed information including stage, previous treatments and comorbidities is captured in patients for which we have active clinical trials. Providers are alerted prior to clinic when a potential research subject is scheduled, and have the opportunity to confirm eligibility, review the protocol, and set aside adequate time in clinic to discuss the study with the patient. The pre-screening protocol is approved by our IRB.
Reasults: From March 2017 through March 2019, research coordinators pre-screened and entered 4,959 unique patients into REDCap and identified 1,282 potential participants for trials. Of these, 756 patients met study specific criteria. Of those who were approached, 439 patients consented and proceeded with study specific screening procedures. We also routinely use our REDCap™ database to help estimate the likelihood of meeting enrollment targets when considering new clinical trials. Our clinical trials enrollment numbers have increased from 66 in 2016 to 238 in 2018, and the number of open trials has increased from 16 to 26 during this period.
Conclusion: An IRB-approved prescreening protocol which utilizes a data capturing system such as REDCap can help increase cancer clinical trials enrollment. Next steps will be to expand this concept across VA sites and to automate portions of data capture.
