Improving the efficiency of clinical trials by standardizing processes for Investigator Initiated Trials

Contemporary Clinical Trials Communications

卷:18

Lauren Clark¹  Devin C. Koestler²  Milind A. Phadnis²  Jeffrey Thompson²  John Keighley³  Ron Krebill³  Byron J. Gajewski⁴  Dinesh Pal Mudaranthakam⁴  Jo A. Wick⁴  Matthew S. Mayo⁴ 

[1] Corresponding author. Department of Biostatistics and Data Science, University of Kansas Medical Center, 3901 Rainbow Blvd. Kansas City, KS, 66103, USA.;

[2] Data Science, University of Kansas Medical Center, Mail Stop 1026, 3901 Rainbow Blvd., Kansas City, KS, 66160, USA;

[3] University of Kansas Cancer Center, University of Kansas Medical Center, 3901 Rainbow Blvd., Kansas City, KS, 66160, USA;

[4] Department of Biostatistics &

关键词: Clinical trial execution;    Trial optimization;    Data driven approach;    Investigator initiated trial;   

DOI  :  

来源: DOAJ

【 摘 要 】

1. Abstract: Early phase clinical trials are the first step in testing new medications and therapeutics developed by clinical and biomedical investigators. These trials aim to find a safe dose of a newly targeted drug (phase I) or find out more about the side effects and early signals of treatment efficacy (phase II). In a research institute, many biomedical investigators in oncology are encouraged to initiate such trials early in their careers as part of developing their research portfolio. These investigator-initiated trials (IITs) are funded internally by the University of Kansas Cancer Center or partially funded by pharmaceutical companies. As financial, administrative, and practical considerations play an essential role in the successful completion of IITs, it is imperative to efficiently allocate resources to plan, design, and execute these studies within the allotted time. This manuscript describes monitoring tools and processes to improve the efficiency, cost-effectivness, and reliability of IITs. The contributions of this team to processes such as: participant recruitment, feasibility analysis, clinical trial design, accrual monitoring, data management, interim analysis support, and final analysis and reporting are described in detail. This manuscript elucidates how, through the aid of technology and dedicated personnel support, the efficiency of IIT-related processes can be improved. Early results of these initiatives look promising, and the Biostatistics and Informatics team intends to continue fostering innovative methodologies to enhance cancer research by improving the efficiency of IITs.

【 授权许可】

Unknown