Friday, 3 August 2012

CDSCO office has released the draft guidance related to Clinical Trials for feedback purpose

Dear All,

CDSCO office has released the draft guidance related to Clinical Trials for feedback purpose.

Please provide your comments and suggestions regarding these draft documents as the feedback needs to be submitted within 30 days of publication, to CDSCO, FDA Bhavan Kotla Road, New Delhi 110002

Draft Notification G.S.R.572(E) Regarding Inspection of Clinical Trial

Draft Notification G.S.R.573(E) Regarding Registration of Ethics Committee

Draft Guidance for calculation of compensation to be paid in case of clinical trial related injury or death

Wednesday, 1 August 2012

No reason to fear clinical trials

M. D. Nair
Hindu Business Line

It is wrong to argue that Indians are being used as guinea pigs in clinical trials.
The Supreme Court’s recent directives to the Government to deal with illegal clinical trials are timely and relevant, both for the development of medicine and the welfare of subjects participating in such trials.
Clinical research is an essential component of drug discovery and development, and cannot be substituted by any other credible method of validation of an experimental drug. Clinical trials are studies conducted in human volunteers (healthy or sick) to better prevent or treat diseases and determine whether the new treatment is both safe and effective.
Such trials are approved by the regulatory agency of the Government and undertaken only after there is adequate evidence from animal experiments for their safety and efficacy.
It is clear that medical research should continue as a cornerstone for making new drugs available for diseases for which no drugs are available, or when the available ones are not effective or safe.
Advances in drug research have substantially contributed to increase in life expectancy and a better quality of life. Over 90 per cent of the drugs available today have been discovered and developed by research-based pharmaceutical companies in U.S., Western Europe and Japan, even though much of the basic work which led to the discovery process may have been carried out in academic institutions.
Issues of concern in the conduct of human trials are: rights and privileges of the participants, their informed consent, assessment of the risk-to-benefit ratios, and ethical issues connected with the use of unknown drugs.


One of the first realisations that clinical research needs to be regulated came in the wake of a tragedy which killed over 100 people in the US, who consumed sulphanilamide elixir. This led to the Food & Drugs Act in the US in 1938.
The Nuremburg trials in 1947, when over 20 Nazi doctors were tried for unethical and immoral human experimentation, led to the Nuremburg Code for human experimentation in 1948.
The biggest tragedy in the history of medicine occurred in 1960 when over 10,000 children were born with malformed limbs (thalidomide babies) around the world as a consequence of their mothers taking the sedative thalidomide during the first trimester of their pregnancy.
That led to stringent controls on clinical trials as stipulated under the Kefauver-Harris amendment to the U.S. Drugs law. Over the years the laws have become more stringent with respect to clinical trials, and in 1990 the international Conference On Harmonisation of Clinical Trials (ICH) laid down strict Guidelines for Good Clinical Practice (GCP).
The Helsinki Declaration of 1964 provides the guiding principles for conducting biomedical research on humans. Article 11.3 of the Declaration mandates that all patients, whether in an active treatment group or control group should receive the best possible therapy, although it allows the use of a placebo when no such treatment exists.
Article 11.6 stipulates that research in patients is justified only if it is of potential value to the patient in the best judgment of the investigator and the Ethics Committee. (The Ethics Committee is a statutory body consisting of members of the public.) The Declaration also requires investigators to obtain subjects' freely given and non-coerced informed consent, in writing.
It forbids payment to the patients by way of incentives to participate. These well-laid out procedures are today the best possible safeguards against drug-related harm to patients.

Deficiencies In Trials

In spite of available guidelines, several deficiencies still plague clinical research.
Some of these are: whether of results of animal studies is relevant to human beings; human errors in planning and execution of the trials per se; fraudulent informed consent and even deliberate fraud on the part of the stake holders.
To ensure that clinical trials are carried out in a fair, ethical and transparent manner around the world, all sponsors of trials are required to register their trials in an International Clinical Trials Platform (ICTRP) set up under US Public Law 110-85 and managed by the National Institute Of Health. Voluntary and informed consent from every subject undergoing trials is mandatory.
In India, the medical profession, the drug manufacturers and the regulatory agencies have accepted international mandatory regulations as well as ethical standards embodied in the Hippocrates Oath, Helsinki Declaration and the ICH.
According to the international registry of clinical trials, the data bank maintained by the NIH in U.S. (clinical, around 129,599 trials are being carried out in 179 countries.
An Indian registry was set up under the aegis of WHO and the Indian Council of Medical Research (ICMR) in 2008 and registration of all trials was made mandatory from June 15 of 2009. At the last count, the number of clinical trials in India was 2010, representing only 1.6 per cent of the global trials.
At the same time China accounts for over 8 per cent, substantially higher than India. The fear that there is an avalanche of trials moving to India and risking our population is thus unfounded. India is by no means a preferred hub for clinical trials.
It is also a fact that the largest number of clinical trials in India are Phase III trials, which are multi-centric world-wide trials on well tested drugs with a common protocol, and hence risks are minimal.

Opportunity for India

Clinicians in India have a great opportunity to train themelves in this discipline, particularly at a time when several research organisations and pharmaceutical companies are developing skills in drug discovery and development.
The future of Indian capability in drug disovery will depend on our expertise in clinical research. In addition, for the many diseases which are endemic to India, such as tuberculosis, malaria, dengue, leptospirosis, chikungunya, and parasitic diseases, clinical trials can be carried out only where patients are available, and India offers major advantages.
The oft-repeated accusation that Indians are being used as ‘guinea pigs’ is baseless. Rules for ethical and high quality clinical research are laid out under Schedule Y of the Indian Drugs And Cosmetics Act, which is the ultimate authority for the registration, monitoring and approval of clinical trials.
Any attempt to bypass well-laid-out systems in the registration, monitoring and control of clinical trials should be dealt with utmost severity.
At the same time, properly conducted trials meeting highest quality standards should be encouraged for the sake of global medical progress.
(The author is a Chennai-based consultant to healthcare industry.)
(This article was published on August 1, 2012)

Business Line : Opinion : No reason to fear clinical trials

Business Line : Opinion : No reason to fear clinical trials