There is a need for strong regulatory mechanism to supervise, review and restrict clinical trials and that should be transparent. The regulator should insist on obtaining well-informed consent from the families or persons on whom the clinical tests are intended to be conducted.
No transparency in clinical trials
There is a need to generate interest among the medical researchers and make them aware towards using these guidelines. The Clinical Trials Registry encourages the registration of all clinical trials conducted in India before the enrolment of the first participant. “The registry is meant to bring transparency to clinical trials conducted in India” explains Kapoor, who is all too aware of the shortcomings of current trial publication practices, including a tendency to publish trial results only when they are positive.
“Trials done earlier where the drug has not been found to be effective are sometimes not publicized,” she says, adding that information about failures should also be put in a publicly searchable database. Working together with the Indian Journal of Medical Research, the Clinical Trial Registry also brought together the editors of 12 Indian biomedical journals at the beginning of the year to develop policy covering the publication of clinical trials.
The editors issued a statement urging all those conducting and/or planning to conduct clinical trials involving human subjects to register their trials in the Clinical Trials Registry or any other primary clinical trial register. From January 2010, these journals will consider publication of a trial started in or after June 2008 only if it has been previously registered.
Bulletin of the World Health Organization of August 2008 reported: “Dr Chandra Gulhati, editor of the Monthly Index of Medical Specialities, for example, would like to see more teeth in the clinical registration process in the country.” “The first step should be the Drugs Controller General of India making it obligatory for all trials to be registered on the Clinical Trials Registry site before permission is granted to conduct them,” Gulhati says. “The failure to do so should carry a penalty. In addition, while registering trials, the composition of hospital ethics committees, which approved the trial, should be disclosed.”
Gulhati is particularly concerned about ethics committees lacking independence. “Fewer than 40 Ethics Committees in India are properly constituted and functioning, which means that the safety of the subjects of clinical trials is on the back burner,” he says, adding that it is also worrying that there is no legal requirement for investigators or members of the Ethics Committees to declare a conflict of interest. He considers this a particularly serious problem given the increasing number of hospitals now owned by drug companies.
“Clinical trials at such hospitals should carry a statement of disclosure about the relationship,” Gulhati says in a past issue of Bulletin of the World Health Organizations. Using animals in clinical trials raise several ethical issues relating to PETA and might provoke RTI requests, which need to be answered.
If clinical trials extend to human beings, it involves more serious issues and transparency at every stage should be made mandatory. The Indian Council of Medical Research brought out the 'Policy Statement on Ethical Considerations involved in Research on Human Subjects' in 1980 and revised these guidelines in 2000 as the 'Ethical guidelines for Biomedical Research on Human Subjects'.
This was revised in 2005. Some of the points in the international guidelines for biomedical research on human participants, which have relevance to international collaborative research initiatives, have been included in this version. General policy statements says: Such research is CONDUCTED under conditions that no person or persons become a mere means for the betterment of others and that human beings who are subject to any medical research or scientific experimentation are dealt with Statement of General Principles in Biomedical Research Involving Human Participants in a manner conducive to and consistent with their dignity and well-being, under conditions of professional fair treatment and transparency; and after ensuring that the participant is placed at no greater risk other than such risk commensurate with the well-being of the participant in question in the light of the object to the achieved. Principles of voluntariness, informed consent and community agreement, principles of accountability and transparency were incorporated (Bulletin of the World Health Organizations).
M S Valiathan, Chairman, Central Ethics Committee on Human Research, ICMR, New Delhi, stated: “India is being projected as a global hub for clinical trials and the number of corporate hospitals with state-of-the-art facilities is growing, visits by foreign specialists using newer techniques or devices is increasing….. Due to globalization rapid techniques of diagnosis and therapy are now available through R&D.
The advances in the area of genetics, genomics and molecular biology have grown by leaps and bounds with the resultant need to rein in these advances with sufficient safeguards to protect the rights and welfare of human participants subjected to biomedical research.
Globally international agencies have been bringing out guidelines for researchers in their countries with relevance to developing countries. Considering the recent advances in the field of Assisted Reproductive Technologies, separate guidelines have been brought out by the Indian Council of Medical Research as "National Guidelines for Accreditation, Supervision and Regulation of ART Clinics in India"(2005)”.
A separate document has been made for regulating the medical devices under Indian Medical Devices Regulatory Authority (IMDRA). The guidelines for the important biotechnology areas like stem cell research and stored tissue including DNA banking have been added in the revision of guidelines in 2005.
The revision has taken into consideration the changing dimensions of ethical issues in the context of new technologies and evolving universal guidelines and revised the existing chapters on Clinical trials, Organ Transplantation, Human Genetics, Epidemiology and Assisted Reproductive Technologies.
If the Ministry of Health passes the legislation, a Biomedical Research Authority will be set up under Ethical Review Procedures as per the proposed Bill on Biomedical Research on Human Participants (Promotion and Regulation) which would require that all IECs register with this Authority. It will also evaluate and monitor functioning of the IECs, and develop mechanisms for enforcing accountability and transparency by the institutions.
Medical devices is a flourishing business in India, which can convert the corporate hospitals to extortionists and patients gullible victims, unless there is strong regulatory with compulsory disclosures at regular intervals. We are seeing the scandals involving implantation of stents and similar other medical devices at high cost than the original value.
Author Amir Maroof Khan concluded that: Comprehensive and transparent reporting makes research credible, reproducible and help reduce research wastage. Standardized guidelines give directions towards achieving this objective. More and more specialized biomedical research reporting guidelines are being developed which can serve the varied interests of the medical researchers to make research transparent.
There is a need to generate interest among the medical researchers and make them aware towards using these guidelines. The public health-related information referred above, has to be in public domain, and should be given on request otherwise. Transparency can prevent corruption in public health schemes and save the lives.