Bolstering the complex study start-up process at NCI cancer centers using technology

Dinesh Pal Mudaranthakam; Sam Pepper; Alexander Alsup; Tara Lin; Natalie Streeter; Jeffrey Thompson; Byron Gajewski; Matthew S Mayo; Qamar Khan

doi:10.1016/j.conctc.2022.101050

Bolstering the complex study start-up process at NCI cancer centers using technology

Contemp Clin Trials Commun. 2022 Nov 30:30:101050. doi: 10.1016/j.conctc.2022.101050. eCollection 2022 Dec.

Authors

Dinesh Pal Mudaranthakam^{1

2}, Sam Pepper^{1

2}, Alexander Alsup^{1

2}, Tara Lin², Natalie Streeter², Jeffrey Thompson^{1

2}, Byron Gajewski^{1

2}, Matthew S Mayo^{1

2}, Qamar Khan²

Affiliations

¹ Department of Biostatistics & Data Science, University of Kansas Medical Center, Mail Stop 1026, 3901 Rainbow Blvd., Kansas City, KS, 66160, USA.
² The University of Kansas Cancer Center, University of Kansas Medical Center, 3901 Rainbow Blvd, Kansas City, KS, 66160, USA.

Abstract

Background: The study startup process for interventional clinical trials is a complex process that involves the efforts of many different teams. Each team is responsible for their startup checklist in which they verify that the necessary tasks are done before a study can move on to the next team. This regulatory process provides quality assurance and is vital for ensuring patient safety [10]. However, without having this startup process centralized and optimized, study approval can take longer than necessary as time is lost when it passes through many different hands.

Objective: This manuscript highlights the process and the systems that were developed at The University of Kansas Comprehensive Cancer Center regarding the study startup process. To facilitate this process the regulatory management, site development, cancer center administration, and the Biostatistics & Informatics Shared Resources (BISR) teams came together to build a platform aimed at streamlining the startup process and providing a transparent view of where a study is in the startup process.

Process: Ensuring the guidelines are clearly articulated for the review criteria of each of the three review boards, i.e., Disease Working Group (DWG), Executive Resourcing Committee (ERC), and Protocol Review and Monitoring Committee (PRMC) along with a system that can track every step and its history throughout the review process.

Results: Well-defined processes and tracking methodologies have allowed the operations teams to track each study closely and ensure the 90-day and 120-day deadlines are met, this allows the operational team to dynamically prioritize their work daily. It also provides Principal investigators a transparent view of where their study stands within the study startup process and allows them to prepare for the next steps accordingly.

Conclusion/future work: The current process and technology deployment has been a significant improvement to expedite the review process and minimize study startup delays. There are still a few opportunities to fine-tune the study startup process; an example of which includes automatically informing the operational managers or the study teams to act upon deadlines regarding study review rather than the current manual communication process which involves them looking it up in the system which can add delays.

Keywords: Cancer; Oncology; Study start-up; Trial.