Journal of Postgraduate Medicine
 Open access journal indexed with Index Medicus & ISI's SCI  
Users online: 43308  
Home | Subscribe | Feedback | Login 
About Latest Articles Back-Issues Article Submission Resources Sections Etcetera Contact
 
  NAVIGATE Here 
  Search
 
 :: Next article
 :: Previous article 
 :: Table of Contents
  
 RESOURCE Links
 ::  Similar in PUBMED
 ::  Search Pubmed for
 ::  Search in Google Scholar for
 ::  Article in PDF (73 KB)
 ::  Citation Manager
 ::  Access Statistics
 ::  Reader Comments
 ::  Email Alert *
 ::  Add to My List *
* Registration required (free) 

  IN THIS Article
 ::  The Way Forward
 ::  Possible Impact
 ::  JPGM Commitment
 ::  References
 ::  Article Tables

 Article Access Statistics
    Viewed5220    
    Printed109    
    Emailed1    
    PDF Downloaded495    
    Comments [Add]    

Recommend this journal


 


 
EDITORIAL
Year : 2008  |  Volume : 54  |  Issue : 1  |  Page : 1-3

Clinical Trial Registry - India (CTR-I): A meaningful initiative. How to take it forward?


Journal of Postgraduate Medicine, Department of Pediatrics, Seth GS Medical College and KEM Hospital, Parel, Mumbai - 400 012, India

Correspondence Address:
S B Bavdekar
9, A2 Worli Seaside CHS, Pujari Nagar, KAG Khan Road, Worli, Mumbai-400 018
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0022-3859.39180

Rights and Permissions




How to cite this article:
Bavdekar S B. Clinical Trial Registry - India (CTR-I): A meaningful initiative. How to take it forward?. J Postgrad Med 2008;54:1-3

How to cite this URL:
Bavdekar S B. Clinical Trial Registry - India (CTR-I): A meaningful initiative. How to take it forward?. J Postgrad Med [serial online] 2008 [cited 2019 Nov 20];54:1-3. Available from: http://www.jpgmonline.com/text.asp?2008/54/1/1/39180


Volunteers agree to participate in clinical trials with a sense of selflessness and trust. They assume that information generated in the clinical trial that they participate in, will help in the advancement of medical knowledge, improvement in therapeutic options and making the healthcare systems better. However, for a variety of reasons, many trials and trial results remain out of bounds for other stakeholders in biomedical research, which include other researchers, research participants, patients, doctors, regulators and insurance companies. Investigators' and editors' inclination to publish only those trials that have proved the new intervention to be better than standard therapy is one of the reasons for several trials with so-called 'negative results' remaining unpublished. There have been instances where some pharmaceutical companies have at times chosen not to report certain observations made during clinical trials to the regulators for various considerations, including commercial ones. This tendency has caused a great deal of upheaval in the medical fraternity and patients' rights groups. Such non-revelation of information leads to marketing of the drug without these aspects being mentioned as a cautionary note. [1],[2],[3],[4],[5] The doctors, therefore, prescribe the drug without being aware of the complete picture. Although the drug may eventually get withdrawn when the side-effects become evident during the post-marketing phase; this generally happens only after several individuals have got exposed to or suffered from the drug's side-effects.

Concealing such information is ethically abhorrent. It underlines the need for taking steps to ensure that sponsors and investigators do not conceal the existence of trials and do not keep uncomfortable observations in a clinical trial under wraps. Arguments in favor of clinical trial registration are rooted in both bioethics and science. [6] By making trial methods and results public, the investigators can be seen to fulfill the pledge they make to research participants to contribute to medical knowledge. In the absence of a formal consensus on international norms and standards for reporting of study results, at present, [7] the initiative is limited to registration of clinical trials. Even this partial step has a great potential in providing global access to information, reducing unnecessary duplication of research efforts and wasteful squandering of resources, decreasing the potential for patient harm and enabling monitoring of the way research is conducted. It could enhance the reliability of evidence on which healthcare-related decisions are based. It could also assure the public that research is conducted in an ethical and transparent manner and for the benefit of mankind. The step could help boost public confidence in research activities and improve trial participation. As information regarding fellow researchers becomes available, opportunities for building collaborations and improving research designs could multiply. [6],[8] Thus, trial registration would help raise the overall scientific and ethical quality of research.

In the absence of a law mandating such registration, the International Committee of Medical Journal Editors (ICMJE) took the first step towards ensuring greater transparency in reporting clinical trials. [9] The ICMJE averred that for a trial to be reported in the member journals, it should have been registered in an openly accessible registry. It prescribed certain criteria for a registry to be eligible and also described the certain minimum information regarding the trial that should be available. [9] Over the years, several other journals and the pharmaceutical industry have endorsed the ICMJE initiative [1],[6],[10],[11],[12],[13] and this step has been successful in demonstrating a large increase in the number of clinical trial registrations. [14],[15]

The National Institute of Medical Statistics (NIMS), Indian Council of Medical Research (ICMR) has set up a clinical trial registry called the Clinical Trial Registry- India (CTR-I) in 2007. This effort has been funded by the Department of Science and Technology (DST). The World Health Organization has provided financial and technical support for its establishment. The registration is voluntary and free of charge. The CTR-I encourages all clinical trials conducted in India to be prospectively registered before enrollment of trial participants is initiated. It also allows for registration of trials conducted in other countries in the region. Registration mandates disclosing details of 20 items deemed mandatory by the WHO International Clinical Trial Registry Platform (ICTRP) dataset. The CTR-I also requires disclosure of certain additional information such as clearance from ethics committees and regulatory agencies [Table - 1]. The CTR-I meets the ICMJE requirements and is recognized as a primary register by the WHO for its International Clinical Trials Registry Platform (ICTRP). The CTR-I contributes data to the WHO search portal.


 :: The Way Forward Top


Now that an easily accessible registry with a mandate to register clinical trials in India has been established, editors of Indian biomedical journals have decided to take this initiative forward. A Policy Statement is being formulated. The Indian biomedical journals and their editorial boards after having averred to wholeheartedly support the initiative of trial registration should take steps that would strengthen the initiative and encourage investigators and sponsors to register their clinical trials. They should:

  • Collaborate with professional organizations and the Indian Council of Medical Research to inform researchers, members of the institutional ethics committees and other members of scientific community regarding issues related to clinical trial registry and motivate them to register trials in CTR-I or other registries compatible with the WHO criteria.
  • Engage other editors of Indian biomedical journals and encourage them to join the initiative.
  • Appeal to other stakeholders including ethics committees, the pharmaceutical industry, governmental and non-governmental funding agencies to act in a manner that would encourage and motivate investigators to register their trials.



 :: Possible Impact Top


In India, most clinical trials are sponsor-initiated and are supported by grants from the pharmaceutical industry. Many of these trials get reported in journals published abroad. It is possible that many multi-centric international clinical trials sponsored by multinational companies are already being registered with other registries, since the sponsors would like to publish the trials in reputed international journals that may be endorsing ICMJE guidelines. Hence, trials undertaken by the Indian pharmaceutical industry and those that are undertaken by postgraduate students as a part of their dissertation work would get registered with CTR-I. Many trials done as a part of dissertation work are carried out as preliminary studies without enough attention being paid to determination of adequate sample size, appropriate study design or other protocol-related issues. As many of these issues will be required to be decided apriori at the time of registration, these young scientists would be required to pay greater attention to these details resulting in better quality research being conducted in the country. Trial registration would generate information about Indian researchers and the kind of clinical trials conducted on Indian soil. As stated earlier, it might avoid waste of resources as funding agencies would become aware of research work that is already in progress. In addition, Indian researchers would be able to collaborate with other researchers doing similar work in the country. It is feared that for various reasons, many research studies in India are carried out without the requisite ethical clearance. If this intervention is used in collaboration with the ethics committees, it would ensure greater compliance with the requirement of ethics committee approval. This could lead to greater adherence to the principles of ethics in conduct of clinical trials. [18],[19]

There is a flip side to registration as well. Clinicians in India find it difficult to conduct clinical trials due to various factors; one of them being the proportion of time that they have to devote to patient care. They will be expected to commit additional time for complying with the requirements of registering clinical trials. However, considering the advantages of better scientific and ethical research, this would result in time well spent. There could be an impact on medical journals as well. Editors will have to face a situation where they would be required to desist publishing a well-designed well-conducted trial on an important health issue just because it has not been registered. Many researchers may loathe the idea of registering trials for the fear of bureaucratic hurdles and would rather choose to select a journal not insisting on trial registration. As a consequence, it is feared, that many small journals may find it difficult to sustain if fewer research articles are submitted to them. [20] Although there may be some substance in these apprehensions, we do not feel that insisting on registration would have a significant adverse effect on Indian journals. In any case, the greater public good should take precedence.

It is possible that over the next few months a consensus might evolve regarding providing results of clinical trials in public domain. When this happens, individual patients and support groups will have access to individual trial results. They will have to appreciate that usually observations made in a single trial do not bring about a change in medical practice. [6] In addition, the media will have to report these results responsibly and without sensationalization to ensure that patients do not clamor for unproven therapies and treating doctors are not forced to use an intervention that has not been convincingly proved to be safe and efficacious.


 :: JPGM Commitment Top


Enhancing knowledge, improving preventive and curative strategies and finding better healthcare delivery systems are the basic aims of conducting clinical research. Registering clinical trials is not a panacea for all the ills related to selective reporting of data, concealing information generated during clinical trials or duplicate publications; it is nevertheless an important step that could help build and boost public confidence in the way clinical research is conducted by assuring greater transparency and allowing public scrutiny. We also hope that registering clinical trials will ensure that data from such trials will be reported with greater transparency and utmost honesty. JPGM endorses the initiative taken by the ICMR in establishing CTR-I. JPGM would like to assure the public, in general, and the scientific community, in particular, that it would collaborate with other Indian biomedical journals and with other stakeholders in clinical research for taking steps that would encourage investigators to register their clinical trials.

 
 :: References Top

1.European Federation of Pharmaceutical Industries and Associations. Joint position on the disclosure of clinical trial information via clinical trial registries and databases. January 2005.  Back to cited text no. 1    
2.Whittington CJ, Kendall T, Fonagy P, Cottrel D, Cotgrove A, Boddington E. Selective Serotonin reuptake inhibitors in childhood depression: Systematic review of published versus unpublished data [review]. Lancet 2004;363:1341-5.  Back to cited text no. 2    
3.Roth D, Boyle E, Beer D, Malik A, deBruvn J. Depressing research. Lancet 2004;363:2087.  Back to cited text no. 3    
4.Topol EJ. Failing the public health: Rofecoxib, merck and the FDA. N Engl J Med 2004;351:1707-9.  Back to cited text no. 4  [PUBMED]  [FULLTEXT]
5.Topol EJ. Arthritis medicines and cardiovascular events: "House of coxibs". JAMA 2005;293:366-8.  Back to cited text no. 5  [PUBMED]  
6.Stone JH, Lockshin MD, Katz PP, Yelin EH. New Journal policy regarding registration of clinical trials. Arthritis Rheum 2005;53:484-7.  Back to cited text no. 6    
7.World Health Organization. International Clinical Trials Registry. Results reporting. Available from: http://www.who.int/ictrp/results. [Last accessed on 2007 Dec 23].  Back to cited text no. 7    
8.Krleza-Jeric K, Chan AW, Dickersin K, Sim I, Grimshaw J, Gluud C; the Ottawa Group. Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). BMJ 2005;330:956-8.  Back to cited text no. 8    
9.De Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al . Clinical trial registration: A statement from the international committee of medical journal editors. N Engl J Med 2004;351:1250-1.  Back to cited text no. 9    
10.Abbasi K. Compulsory registration of clinical trials will be a requirement before submission to the BMJ from July 2005. BMJ 2004;329:637-8.  Back to cited text no. 10  [PUBMED]  [FULLTEXT]
11.AVRO statement on Registering Clinical Trials. Investig Ophthalmol Visual Sci 2006;47:1-2  Back to cited text no. 11    
12.Couser W, Drueke T, Halloran P, Kasiske B, Klahr S, Morris P. Trial registry policy: Common editorial statement: A uniform clinical trial registration policy for journals of kidney diseases, dialysis and transplantation. Nephrol Dial Transplant 2005;20:691.  Back to cited text no. 12    
13.Bland KI, Rikkers LF, Lillemoe KD, Balch CM, Edmunds LH, Murie J, et al . Consensus statement on mandatory registration of clinical trials. Ann Surg 2007;245:505.  Back to cited text no. 13    
14.Zarin DA, Tse T, Ide NC. Trial Registration at ClinicalTrials.gov between May and October 2005. N Engl J Med 2005;26:2279-87.  Back to cited text no. 14    
15.Laine C, Horton R, DeAngelis CD, Drazen JM, Frizelle FA, Godlee F, et al . Clinical trial registration: Looking back and moving ahead. CMAJ 2007;177:57-8.  Back to cited text no. 15  [PUBMED]  [FULLTEXT]
16.Clinical Trials Registry- India. CTRI Bull 2007;1:1-4.  Back to cited text no. 16    
17.CTRI Datasheet and Description. Clinical Trial Registry- India. Available from: http://www.ctri.in/Clinicaltrials/CTRI_Dataset_and_Description.pdf. [Last accessed on 2007 Dec 23].  Back to cited text no. 17    
18.Khopkar U, Pande S. Registration and reporting of clinical trials. Indian J Dermatol Venereol Leprol 2008;74:2-4.  Back to cited text no. 18  [PUBMED]  [FULLTEXT]
19.Gitanjali B. ICMJE statement on compulsory clinical trial registration: Should Indian journals follow suit? Indian J Pharmacol 2005;37:207-8.  Back to cited text no. 19    
20.Habibzadeh F. Impact of mandatory registration of clinical trials on small medical journals: Scenario on emerging bias. CMAJ 2006;47:181-2.  Back to cited text no. 20    



 
 
    Tables

  [Table - 1]



 

Top
Print this article  Email this article
Previous article Next article
Online since 12th February '04
2004 - Journal of Postgraduate Medicine
Official Publication of the Staff Society of the Seth GS Medical College and KEM Hospital, Mumbai, India
Published by Wolters Kluwer - Medknow