Abstract
Object To collect a scientific basis for improving the quality and success rate of drugclinic al trials by analyzing the reasons for the suspension or termination of clinical trials in China and abroad.
Method Drug Clinical Trials Registration and Information Disclosure Platform (chinadrugtrials.org.cn) and ClinicalTrials.gov (www.clinicaltrials.gov) were searched from August 1,2007 to August 1, 2017. Searches were conducted using the status “suspended” or“terminated”.
Result From August 1, 2007 to August 1, 2017, the drug clinical trials of total items of which 6.30% were suspended/terminated prematurely. In the main type, by comparing the cause on Chinese and foreign clinical trials to suspend/early termination type, the results show that the two groups are similar distribution. By comparing the causes of
subtypes, the most common reason for the termination of clinical trials abroad is the difficulty of recruiting subjects. The most common cause of suspension of domestic clinical trials is the decision of the sponsor.
Conclusion About 59.09% of the clinical trials were due to nothing to do with the test data to suspend or early termination. While reasons are corrected, we can take the initiative to minimize the probability of clinical trials to be suspended.
Keywords
Full Text:
References
Hay M, Thomas DW, Craighead JL, Economides C, Rosenthal J.Clinical development success rates for investigational drugs. Nat Biotechnol. 2014;32:40–51.
Gul RB, Ali PA. Clinical trials: the challenge of recruitment and retention of participants. J Clin Nurs. 2010;19:227–233.
Osann K, Wenzel L, Dogan A, Hsieh S, Chase DM, Sappington S, et al. Recruitment and retention results for a population-based cervical cancer biobehavioral clinical trial. Gynecol Oncol. 2011;121:558–564.
Cooley ME, Sarna L, Brown JK, Williams RD, Chernecky C, Padilla G, et al. Challenges of recruitment and retention in multisite clinical research. Cancer Nurs. 2003;26:376–384.
China Food and Drug Administration. Drug Clinical Trial Quality Management Practices [EB/OL].2003-08-06. http://www.sda.gov.cn/WS01/CL0053/24473.html
Cui L, Lin LV, Dai ZL, Zeng HP. Several problems about drug management in drug clinical trial process. China Pharmacy.2010;21:820.
ICH harmonised tripartite guideline: guideline for good clinical practice. 8. Essential documents for the conduct of a clinical trial. J Postgrad Med. 2001;47:264–267.
Qing-Yan BU, Xiong NN, Zou JD, Jiang M, Liu F. CRF development from the standpoint of clinical data management. Chinese Journal of New Drugs. 2007;16:339–343.
Davis JR, Nolan VP, Woodcock J, Estabrook RW. Assuring data quality and validity in clinical trials for regulatory decision making: workshop report. Washington (DC): National Academies Press (US); 1999:45.
China Food and Drug Administration. Announcement of the State Food and Drug Administration on Carrying Out Self examination and Verification of Drug Clinical Trial Data (No. 117
of 2015) [EB/OL].2015-07-22. http://www.sda.gov.cn/WS01/
CL0087/124800.html
China Food and Drug Administration. Announcement of the State Food and Drug Administration on Issuing Key Points for Field Clinical Checks on Drugs (No. 228 of 2015) [EB/OL].2015-11-10. http://www.sda.gov.cn/WS01/CL0087/134440.html
Hinshaw SP, Hoagwood K, Jensen PS, Kratochvil C, Bickman L, Clarke G, et al. AACAP 2001 research forum: challenges and recommendations regarding recruitment and retention of participants in research investigations. J Am Acad Child Adolesc Psychiatry. 2004;43:1037–1045.
Fletcher B, Gheorghe A, Moore D, Wilson S, Damery S. Improving the recruitment activity of clinicians in randomised controlled trials: a systematic review. BMJ Open. 2012;2:e000496.
Sully BG, Julious SA, Nicholl J. A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies. Trials. 2013;14:166.
Sheiner LB. Learning versus confirming in clinical drug development. Clin Pharmacol Ther. 1997;61:275–291.
Refbacks
- There are currently no refbacks.
Copyright (c) 2018 Journal of Pharmaceutical and Biomedical Sciences
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.