Clinical Trials is “a prospective biomedical or behavioural study of human subjects that is designed to answer specific questions about biomedical or behavioural interventions. (Vaccines, drugs, treatments, devices or new ways of using known drugs, treatments or devices)”

Modern Clinical Trials are conducted in 4 different phases to prove the safety and efficacy of the new drug. In Phases I to III, the new drug or treatment is tested on a small group of people and then in larger groups of people to evaluate the safety, efficacy to determine safe dosage range, side effects and compared to commonly used treatments.

In phase IV, studies are done after the drug/treatment has been marketed to gather information on the drug’s effects on various populations and any side effects associated with long term use.

The major reasons for failure of Clinical Trials are insufficient efficacy, safety concerns, and  sometimes lack of funding.

Market size of Clinical Research

The World market for Clinical research is estimated roughly at USD 60 to 65 billion. 70% of this is in U.S. followed by U.K. Asia is now a preferred destination for the conduct of Global Clinical Trials.

India is a major preferred destination due to the availability of large ethnic patient population, highly educated work force, a wide spectrum of diseases, lower operational costs, English speaking population and favourable Economic and Intellectual Property environment and regulations.

Controversy in India’s Clinical Trial Industry

Clinical Trials in India was at its peak in 2010 with about 500 approved clinical trials. The number dropped to 325 in 2011 and 262 last year.

The plunge in approved trials came after the Government of India responded to an outcry over the number of deaths recorded in the trials and adopted new rules to force trial sponsors to pay more compensation and required independent Ethics Committees to monitor the trials. ‘Safety of Indian subjects comes first’ was the essence of the new rules.

To compound the problem, The Supreme Court of India, on a PIL filed by the NGO – Swasthya Adhikar Manch, opined that no clinical trial should be allowed for new drugs till a mechanism is put in place to monitor and protect the lives of trial subjects on whom the drugs are tested.

Further the Supreme Court has asked the Centre not to allow Clinical Trials for untested medicines. Meanwhile, the Prof. Ranjit Roy Choudhury Expert Committee constituted by the Union Health Ministry to formulate policy and Guidelines for approval of new drugs, clinical trials and banning of drugs has submitted its recommendations in July 2013, which says :-

• Clinical trials can only be carried out at centres which have been accredited for such purpose.
• Ethics committee of the Institute must also be accredited.
• For any adverse effect (AE) or serious adverse effect (SAE), the Sponsor Investigator is responsible.
• No compensation needs to be paid for therapeutic inefficiency, since the very purpose of clinical trials is to determine safety and efficacy of given drug, vaccine, or device.
• Whereas, the Industry is happy about the recommendation about the compensation, the NGO’s and others are up in arms about it. The Industry is unhappy about the recommendation regarding the accreditation of Centers for clinical trials and the Ethics committee.

India, considered as the most favored destination for conducting clinical trials is almost losing ground mainly because of complicated regulatory policies, contradictory norms by government agencies..

But with the Supreme Court of India’s verdict that the government must video record clinical trials of five new drugs, has made it difficult for multinational companies to dodge accountability if the testing of their patented drug reacts negatively.

Recently, 162 trials approved by DCGI (Drug Controller General of India) were stalled following orders from the Supreme Court which subsequently proved to be a major setback for foreign pharma companies that are into drug development.

Early this year, the government of India set up an Expert Committee with Professor Ranjit Roy Choudhury, National Professor of Pharmacology and Adviser to Department of Health, as Chairman to formulate policies, guidelines and standard operating procedures for approval of new drugs, clinical trials, ethics committee and for banning of drugs already in the market.

The Committee’s report submitted a couple of months ago recommended major changes in the structure of conducting clinical trials. The fact is, clinical trial as a subject lacks public awareness. People in general are not aware of what a clinical trial is all about. The media mentions about clinical trials when some negative aspects pertaining to trials occur. What it mentions or exposes is not always a true picture but a report that is not verified or authenticated.

Steps required to create the awareness

• This can start with the family physician to his patients on individual level.
• Media has to take the lead – for this Media has to take the initiative in spreading the benefits and importance of clinical trials.
• Professional bodies, associations like ISCR (Indian Society for Clinical research), ACRO (Association of Contract Research Organizations) can conduct workshops, seminars etc.
• Pharma companies can take the lead through media campaigns in the interest of public welfare.
• Introduction of Clinical Trial and Research at academic level

Amniocentesis

It Is A Diagnostic Technique To Check For Genetic Abnormalities In Unborn Babies. The test involves taking a sample of the amniotic fluid which surrounds the growing baby inside the womb. It is usually done about the 16th week of pregnancy as by this stage

This fluid contains cells from the developing baby. Chemical and microscopic examinations of these cells can provide invaluable information revealing the presence or absence of genetic disorders which cannot be detected otherwise.

The chromosome analysis of the cells in the amniotic fluid can also reveal the sex of the baby.