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. 2020 May 27:18:100579.
doi: 10.1016/j.conctc.2020.100579. eCollection 2020 Jun.

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

Dinesh Pal Mudaranthakam  1   2 , Milind A Phadnis  1   2 , Ron Krebill  1 , Lauren Clark  1 , Jo A Wick  1 , Jeffrey Thompson  1   2 , John Keighley  1 , Byron J Gajewski  1   2 , Devin C Koestler  1   2 , Matthew S Mayo  1   2
Affiliations

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

Dinesh Pal Mudaranthakam et al. Contemp Clin Trials Commun. .

Erratum in

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.

Keywords: Clinical trial execution; Data driven approach; Investigator initiated trial; Trial optimization.

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Figures

Fig. 1
Fig. 1
Investigator Initiated Trial workflow within BISR.
Fig. 2
Fig. 2
IITs conducted at the KU Cancer Center between 2012 till 2018.
See this image and copyright information in PMC

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