Abstract
Background
Despite the fact that unaddressed delays in clinical trial operation could severely compromise the overall effort invested, there seems to be a lack of concerted effort in reforming such delays. This study evaluated the composite effect of initiatives in reforming trial operation efficiency.
Methods
A high-volume academic medical center in Korea has implemented various initiatives to improve the trial operation efficiency by expediting times from institutional review board (IRB) submission to approval, from IRB submission to trial open for subject enrollment, and from trial open to first patient-in. The initiatives include implementation of the protocol preliminary review, parallel processing of the clinical trial agreement review in line with the protocol submission to the IRB, and involvement of project manager for operational risk management. Times from IRB submission to approval, from IRB submission to trial open, and from trial open to first patient-in before and after implementation of initiatives were compared.
Results
The median time required in IRB approval was meaningfully shorter in the postinitiative group (19 vs 14 days; P <.001). The median times from IRB submission to trial open for subject enrollment and from trial open to first patient-in were reduced significantly in the postinitiative group (trial open: 25 vs 18 days, P <.001; first patient-in: 111.5 vs 100 days, P =.014).
Conclusions
The initiatives were effective in reforming trial operational efficiency. Additional studies to address the cause of operational delay and modifiable factors influencing subject enrollment are needed to further improve operational efficiency.
Similar content being viewed by others
References
Abrams JS, Mooney MM, Zwiebel JA, et al. Implementation of timeline reforms speeds initiation of National Cancer Institute-sponsored trials. J Natl Cancer Inst. 2013;105:954–959.
Cheng SK, Dietrich MS, Dilts DM. A sense of urgency: evaluating the link between clinical trial development time and the accrual performance of Cancer Therapy Evaluation Program (NCI-CTEP) sponsored studies. Clin Cancer Res. 2010;16:5557–5563.
Getz KA, Wenger J, Campo RA, Seguine ES, Kaitin KI. Assessing the impact of protocol design changes on clinical trial performance. Am J Ther. 2008;15:450–457.
Dilts DM, Sandler AB. Invisible barriers to clinical trials: the impact of structural, infrastructural, and procedural barriers to opening oncology clinical trials. J Clin Oncol. 2006;24:4545–4552.
CenterWatch Investigative Global Site Survey. 2011.
Dilts DM, Sandler AB, Cheng SK, et al. Steps and time to process clinical trials at the Cancer Therapy Evaluation Program. J Clin Oncol. 2009;27:1761–1766.
Choi YJ, Jeon HJ, Kim S, et al. A trial activation initiative to accelerate trial opening in an academic medical center. Therapeutic Innovation & Regulatory Science. 2015;49:234–238.
Glickman SW, McHutchison JG, Peterson ED, et al. Ethical and scientific implications of the globalization of clinical research. N Engl J Med. 2009;360:816–823.
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Choi, Y.J., Kim, Kp., Park, S. et al. Process Innovation Improves Trial Operation Efficiency. Ther Innov Regul Sci 50, 510–514 (2016). https://doi.org/10.1177/2168479016634148
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1177/2168479016634148