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Indian Journal of Dermatology, Venereology and Leprology, Vol. 74, No. 1, January-February, 2008, pp. 2-4 Editorial Registration and reporting of clinical trials Khopkar Uday, Pande Sushil Department of Dermatology, Seth GS Medical College and Kind Edward Memorial Hospital, Mumbai Code Number: dv08002 Clinical trials form an integral part of the drug discovery process worldwide. However, registration of clinical trials is not restricted to drug interventions. A clinical trial is defined as "any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes." [1] Interventions include not only drugs but also cells and other biological products, surgical procedures, radiologic procedures, devices, behavioral treatments, process-of-care changes, preventive care, etc. A set of guidelines are already in place in India for the ethical conduct of studies to safeguard the interests of patients or volunteers participating in the study. However, there is a need to promote knowledge and awareness of regulatory laws and the more recent phenomenon of registration of clinical trials in India. Inadequate and Selective Reporting Currently, apart from a few academic clinical trials sponsored by government bodies or NGOs, the majority of clinical trials conducted in India are sponsored, randomized controlled trials. Most of the major hospitals are equipped with appropriately constituted Institutional Ethics Committees (IEC) and Review Boards (IRB). However, the results of clinical trials or their information are not adequately disseminated in many instances. Only selected or positive results might get published which are at risk of being doubted as being biased. Often in such cases, valuable scientific efforts are wasted without yielding desired outcomes. As reports of clinical trials form an important source of information for practitioners, researchers, academicians and the public, it is the moral, ethical and scientific responsibility of researchers to report the results. The so called ′discreetness′ of clinical trials defeats the very purpose of scientific research and principles of evidence-based medicine. It may distort the evidence required for making correct clinical decisions. Besides, it deprives trial participants, the general public and fellow researchers of their right to information. It commonly results in duplication of efforts and wastage of vital resources. Clinical Trial Registratiion In order to make clinical data and reports available to all, an online clinical registry has been initiated by the Indian Council of Medical Research (ICMR) for the registration of any interventional trial to ensure the following goals: [2]
CTRI will create a database of prospective clinical trials in India after their registration. The data and reports of these clinical trials and their status will be available to the public and professionals free of cost after formal registration on their website www.ctri.in Currently, the registration of clinical trials is only voluntary and not mandatory. With increased awareness about this initiative and wide acceptance of the purpose of CT registration, it is likely that it may become mandatory in the future for initiation of clinical trials in India. It has been affirmed that CT registration should be done before the actual enrollment of study subjects in the trial. The principal investigator or sponsor should share the responsibility of CT registration. In the case of multicentric studies, the lead investigator or sponsor should ensure that the CT is registered. For the registration of a CT, it is essential to declare 20 items relevant to the CT as determined by the International Clinical Trial Registration Platform (ICTRP) of the World Health Organization (ICRTP-WHO). For registration with the CTRI, additional items related to the EC or IRB′s permission and that of Director Controller General of India (DCGI) are included. At the end of a successful registration, each CT is assigned a unique WHO identification number called the Unique Trial Reference Number (UTRN) [Table - 1]. Registration of Nonsponsored Clinical Trials It is widely perceived that the registration requirement for clinical trials refers only to sponsored trials. However, current guidelines for the registration of clinical trials do not make any distinction between sponsored and nonsponsored trials. Enforcement of registration for nonsponsored studies also offers the same advantages as for sponsored trials. Hence, as of today, it is recommended that all clinical trials, sponsored or nonsponsored, be registered at the time of inception. This includes a large number of interventional clinical studies that are conducted in medical colleges as part of postgraduate dissertations. It is particularly important for these to be registered as many of these are duplicated studies and not reporting them leads to wastage of resources.Publication of Clinical Trials Although the CTRI is a recent phenomenon, similar registries have been in existence in other countries for some time. As such pretrial registration ensures the authenticity of a clinical trial, medical journal editors prefer a registered clinical trial over an unregistered one. Therefore, registration before the initiation of a trial is a prerequisite for publishing clinical trial data in many medical journals.Member journals of the International Committee of Medical Journal Editors (ICMJE) declared in a common editorial published in 2004, that their journals will not publish the results of any clinical trial that began recruitment after 1 st July 2005 if it was not registered with an authorized registry at the time of inception of the trial. [3] Studies on pharmacokinetics or major toxicity ( e.g , phase I trials) have been exempted by ICMJE guidelines to ensure protection of original ideas. [4] However, it is mandatory for all the pharma sponsors to make public all their findings within a given framework of time as a part of their responsibility to the public at large. Thus, clinical trial registration offers unique advantages to researchers in terms of the smooth publication of results in international and national journals. Apart from this, it encourages researchers to engage in more meaningful and scientifically and ethically sound clinical research. Needless to say, it will build up public confidence in the conduct and authenticity of clinical trials. Currently, most Indian journals do not enforce the registration for clinical trial reports that are submitted to them for publication. However, with the recent launch of the CTRI website, it may soon become inevitable for them to enforce the registration at the time of inception of a study. References
Copyright 2008 - Indian Journal of Dermatology, Venereology and Leprology The following images related to this document are available:Photo images[dv08002t1.jpg] |
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