ICMR to implement UN agency’s standards on clinical trials

In news:

India’s apex medical research body along with other leading groups will adopt UN health agency’s recommendations to register and publicly disclose results of all clinical trials they fund or support.

* The Indian Council of Medical Research and the other leading groups* agreed to develop and implement policies within the next 12 months that require all trials they fund, co-fund, sponsor or support to be registered in a publicly-available registry.

(*the Norwegian Research Council, the UK Medical Research Council, Medecins Sans Frontieres and Epicentre, the Coalition for Epidemic Preparedness Innovations, Institut Pasteur, the Bill & Melinda Gates Foundation and the Wellcome Trust)

* All results will be disclosed within specified time frames on the registry or by publication in a scientific journal.

* The agreement will mean the ethical principles described in both statements will now be enforced in thousands of trials every year.

* Most of these trials and their results will be accessible via WHO’s International Clinical Trials Registry Platform, a unique global database of clinical trials that compiles data from 17 registries around the world.

Importance:

India is set to grab clinical trials business valued at approximately US$ 1 billion by 2010, up from US$ 200 million last year, making the subcontinent one of the world’s preferred destinations for clinical trials.

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.

Clinical trials:

Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices,dietary supplements, and medical devices) and known interventions that warrant further study and comparison.

Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial – their approval does not mean that the therapy is ‘safe’ or effective, only that the trial may be conducted.

Depending on product type and development stage, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical study design aims to ensure the scientific validity and reproducibility of the results.

Only 10 percent of all drugs started in human clinical trials become an approved drug.

The Declaration of Helsinki (DoH) in Finland is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics. It is not a legally binding instrument under the international law, but instead draws its authority from the degree to which it has been codified in, or influenced, national or regional legislation and regulations.

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