Telangana Director of Medical Education issues important measures on clinical trials

Hyderabad: Clinical trials for drugs are legal across the world to increase scientific knowledge and improve health care. However, it should only be done after following stringent norms framed by regulatory authorities with total transparency, said Dr K Ramesh Reddy, Director of Medical Education(DME), on Sunday.

Given recent reports about alleged clinical trials in various government hospitals, the Telangana Director of Medical Education shared an official statement on essential measures taken by the government for patients’ safety during clinical trials.

While issuing a clarification on alleged clinical trials in Nilofuer Hospital, he said, “Only healthy patients, who come forward voluntarily, are included in trials. It is mandatory to conduct enquiries in case of complaints. Same was done in the case of Niloufer Hospital. This is a preventive step for volunteers’ safety. Additionally, individual doctors should not defame institutes for their egos and cause disrepute to the institutes. Disciplinary action will be taken against anyone violating this, as per CCA rules. Any grievance should be addressed to the head of an institution or the Director according to specific guidelines.”

All you need to know about the necessary measures taken by the government for patient safety during clinical trials:

• The norms for clinical trials in India are prescribed by ICMR and Central Clinical Trials Registry (CCTR) should be maintained with all the details. National Ethical Guidelines for Biomedical and Health Research is followed in cases involving human participants. An ethics committee should assess inherent benefits and risks; ensure a favourable balance of benefits and risks; evaluate plans for minimising the risk and discomfort, and decide on the merit of the research before approving it.
• For all biomedical and health research involving human participants, it is the primary responsibility of the researcher to obtain written, informed consent of the prospective participant or legally acceptable/authorised representative (LAR). If a participant or LAR is illiterate, a literate impartial witness should also be present during the informed consent process.
• Ethical committees are entrusted with the initial review of research proposals before their initiation, and also have a continuing responsibility to regularly monitor the approved research to ensure ethical compliance during the conduct of research.
• A few clinical trials are conducted by some departments in Government Hospitals by unit Chief after taking all necessary legal permissions.
• Participants are enrolled voluntarily to take part in the trial. The Principal Investigator has to follow legal procedures. Only legally permitted clinical trials are conducted in government hospitals. General patients are not included in clinical trials.
• All institutional ethics committees are instructed to check documents of trials permitted by them within one week. Any trial not following protocols should be stopped as per ICMR rules. Data and safety monitoring Boards will be established in each institute.

Clinical trials in Niloufer Hospital are allowed by the institutional ethics committee of Osmania Medical College, and they have all necessary permissions. The three-member committee will check all documents to ascertain whether all safety measures were followed. The general public need not panic as any of these drugs is used on regular patients. Only standard drugs procured by TSMSIDC are supplied. These drugs follow all safety measures.