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Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource

BMJ 2018; 362 doi: https://doi.org/10.1136/bmj.k3218 (Published 12 September 2018) Cite this as: BMJ 2018;362:k3218

Re: Compliance with requirement to report results on the EU Clinical Trials Register: cohort study and web resource

This is an interesting article bringing up the issues of posting results on the clinical trial registry. As a part of the system it is encouraging to see that about 50 percent of the registrants among the company trials are put on the trials register (EUCTR). This provides access to all sections of the society scientific and general public - the very purpose of the transparency in the conduct of clinical trials. Nevertheless the results disclosure on the clinical trial registry platform continues to be a great challenge.

The Clinical Trial Registry India (CTRI), a primary register of WHO in India which is run by ICMR, has signed an agreement with WHO on the disclosure of trial results where it has funded trials (1,2). It intends to capture the detailed results including the design through a pre-designed format. Presently it is capturing the results under a summary section, an open ended data set point of CTRI (3). Here also it is observed that most of the results posted are from the companies which are conducting regulatory trials and very limited compliance is seen among other research and academic trials. Intense efforts are made through reminders on email but not to the expected success.

It must be remembered that most of the clinical trial registries are facilitator bodies and do not have any regulatory powers so is India’s CTRI. In order to promote encourage finally enforce results disclosure on registry platform the regulatory body of that country needs to come out with an order to make results disclosure mandatory. In India the registration of the trial was made mandatory by Drug Controller General of India (DCGI) for the regulatory trials (4). The other academic and trials from the research bodies got a boost through the mandate of editors of various journals in India and also International Committee of Medical Journals and Editors (ICJME) (5, 6). As a result India has more than 15500 trials registered on CTRI to date. In the venture of promoting results disclosure, again ICJME can play a major role. They can further put a caveat for the publication if the trial is “results disclosure compliant”. The standard modality of course can be worked out. We are sure that as the researcher gets convinced about relevance and importance of posting of results they would volunteer to come out without any compulsion.

References
1. http://www.ctri.nic.in/
2. Joint Statement on Public Disclosure of Results from Clinical Trials. Available from: http://www.alltrials.net/wp-content/uploads/2017/05/18-May-2017-joint-st.... [accessed on Jan 03 2019].
3. Pandey A, Aggarwal A, Maulik M, Gupta J, Juneja A. Challenges in Administering a Clinical Trials Registry: Lessons from the Clinical Trials Registry-India. Pharmaceutical Medicine 2013; 27 (2): 83-93
4. Mandatory registration of human clinical trials from June https://www.livemint.com/Home-Page/LMWzOePxnrahx6SDyWEckL/Mandatory-regi...
5. Satyanarayana K, Sharma A, Parikh P, et al. Statement on publishing clinical trials in Indian biomedical journals. Indian J Ophthalmol. 2008;56(3):177-8.
6. International Committee of Medical Journal Editors (ICMJE). Recommendations for the conduct, reporting, editing, and publication of scholarly work in medical journals. 2015. http://www.icmje.org/recommendations/. Accessed Jan 03, 2019.

Competing interests: No competing interests

04 January 2019
Atul Juneja
Scientist
Tulsi Adhikari, M. Vishnu Vardhana Rao
ICMR-National Institute of Medical Statistics
ICMR-NIMS Ansari Nagar, New Delhi-110029