Tuesday, 16 June 2009

New guidelines issued: Registration must for human clinical trials in India

Syed Akbar
Hyderabad, June 15: The Central government's new guidelines on compulsory registration of clinical trials involving human beings came into force on Monday.

From now onwards all clinical trials involving human subjects will have to be invariably registered with the Central drug control authorities. The move comes in the wake of reports of gross misuse of clinical trials. Hyderabad, which has of late emerged as the pharma hub of India, virtually leads the country in terms of drug research. There have been instances of deaths of human subjects involved in
laboratory trials of new drugs.

Registration of clinical trial has to be made in ICMR Clinical Trial Registry at www.ctri.in

However, the new guidelines will be applicable to all new clinical trials that will be taken up after June 15. Pharma and research institutions, who want to involve research on human subjects, will have to register themselves with the Clinical Trial Registry controlled by the Indian Council of Medical Research. Those failing to register will be prosecuted, according to a Government of India Gazette notification.

Meanwhile, the State Human Rights Commission has posted for hearing on June 22 the human trial death case involving GVK Bio. The SHRC has issued notices to the State Drug Control Administration. Now that the new guidelines have come into effect, the State Drug department wants to wash its hands off the responsibility in the GVK Bio case.

According to sources, the State Drug department will plead with the SHRC that the Central government be made a party to the GVK Bio clinical trial death case.

State Drug Control Administration director-general RP Meena welcomed the new guidelines and demanded that the State body too be given powers under the new legislation. "We do not have the power of licencing and thus no power of regulation. We will request the Central government to give us equal powers on par with the Central drug authority," he said.

Several multinational pharma companies have been outsourcing clinical research trials to India and the Central government has put the market at around Rs 1500 crore. The new regulations will rein in the erring pharma firms which do not follow the established ethical guidelines where human subjects are involved.

R Uday Bhaskar, general secretary of All India Drug Controllers' Federation, said the government should come out with stringent punishment for those misusing the trials. "Unless we have severe penal provisions, we cannot curb malpractice," he warned.

All About the Clinical Trial Registry

Clinical trials hold enormous potential for benefiting patients, improving therapeutic regimens and ensuring advancement in medical practice that is evidence based. However, the data and reports of various trials are often difficult to find and in some cases do not even exist as many trials abandoned or are not published due to "negative" or equivocal results.

However, this tendency for availability of only selective information from the myriad clinical trials conducted is not commensurate with the practice of "evidence-based medicine". Today, world over, a need has been felt on the imperative for transparency, accountability and accessibility in order to re-establish public trust in clinical trial data. And this would be feasible only if all clinical trials conducted are registered in a centralized clinical trials registry.

Hence, a registry for clinical trials has been set up by the ICMR's National Institute of Medical Statistics (NIMS) and anybody who wishes to conduct a clinical trial in the country would have to declare not only the twenty items of the Trial Registration Data Set as required by the WHO's ICTRP, but also a few more items relevant to the Indian scenario such as Ethics committee Approval Status, Regulatory Clearance by the DCGI, etc, before the enrolment of the first patient.

Thus, the Registry will collect information on all prospective clinical trials to be undertaken in India and make this information available to the public. The Indian Registry is planned to be a freely available and searchable Primary register. To register a study, trialists will submit information including the basic data required by the ICTRP and will receive a WHO assigned unique identification number. In addition, CTRI will encourage trialists to include subsequent protocol amendments and give regular updates on the status of trial.

Thus, setting up a Clinical Trials Registry would ensure that all clinical trials conducted in India are publicly declared and identifiable and a minimum set of information of all clinical trials is freely available to physicians, health researchers, academicians, pharmaceutical industries as well as the common man.


The mission of the Clinical Trials Registry-India (CTRI) is to encourage all clinical trials conducted in India to be prospectively registered before the enrolment of the first participant and to disclose details of the 20 mandatory items of the WHO International Clinical Trials Registry Platform (ICTRP) dataset. In this manner the CTRI hopes to become a WHO ICTRP ICMJE compliant Primary Register for India.

While registration is voluntary, only trials that disclose details of the 20 mandatory items of the WHO/ ICMJE dataset will receive a full registration number that satisfies WHO/ICMJE requirements. While 20 item dataset comprise the majority of the items required for a full registration number, a few additional items are required for registration in the ICTRP, particularly items describing clearance from ethics committees and regulatory agencies.

The vision of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the 20-item WHO ICTRP dataset, as well all items of the CTRI dataset. While this register is meant primarily for trials conducted in India, the CTRI will also accept registration of trials conducted in other countries in the region.

Trials registered in CTRI will be monitored to ensure increasing voluntary disclosure of all items in the register. These items have been selected in order to:

Improve transparency and accountability: By disclosing all required details of the protocol of trials, public confidence in clinical trials is likely to be enhanced.
Improve the internal validity of trials:

Empirical research has shown that some aspect of the methods of the trial are particularly important to produce reliable results by minimizing biases, confounders and the effects of chance or coincidence. These include the method of random sequence generation, adequate concealment of allocation of participants to interventions, adequate blinding of participants, investigators and outcome assessors, and inclusion of all participants' results.

The CTRI hopes that these items, though not mandatory at present, will be disclosed by all registrants, as incorporating such elements at the protocol stage is likely to increase the internal validity of the trial and also increase the chances of publication in a high impact journal that endorses the ICMJE requirement of reporting trials in accordance with the CONSORT statement.

Conform to accepted ethical standards: The Indian Council of Medical Research through its Bio-ethics initiative has developed ethical guidelines for the conduct of trials and for ethics committees.

Clearance by local ethics committees is mandatory for all clinical trials and the CTRI hopes that making disclosure of ethical clearance a mandatory field for registration, it will lead to better links with the ICMR's bio-ethics initiative.
Lead to reporting of all relevant results of all clinical trials in India and the region: The WHO ICTRP is also working towards full reporting of all relevant results from clinical trials and the CTRI will work with the WHO ICTRP to ensure reporting of results of all trials registered with the CTRI.

1 comment:

Hapi said...

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