The Hindu Business Line : Drug trial is a three-legged stool

WHEN one news headline reads, `Cop accused of bribery by witness in drug trial', and another announces, `Fertility drug trial bears joyful fruit', it is obvious that the phrase `drug trial' is yet to settle down. For starters, the former is about narcotics drugs and psychotropic substances, and the latter is also known as clinical trial or drug testing.

Clinical trial is "a rigorously controlled test of a new drug or a new invasive medical device on human subjects," explains www.thefreedictionary.com. The Web site www.clinicaltrials.gov explains clinical trial or clinical research as "a research study in human volunteers to answer specific health questions". The rationale is that carefully conducted clinical trials are the fastest and safest way to find treatments that work.

While interventional trials determine whether experimental treatments are safe and effective under controlled environments, observational trials address health issues in large groups of people in their natural environment, explains the portal.

There are also other trials such as treatment trials to test "experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy"; prevention trials that look for "better ways to prevent disease in people who have never had the disease or to prevent a disease from returning"; diagnostic trials aimed at finding "better tests or procedures for diagnosing a particular disease or condition"; screening trials on "the best way to detect certain diseases or health conditions"; and quality of life trials a.k.a. supportive care trials that aim at "ways to improve comfort and the quality of life for individuals with a chronic illness".

The September 2003 issue of the FDA Consumer magazine, available on www.fda.gov, the Web site of the US Food and Drug Administration, has an FAQ on what happens in clinical trials. Phase-I trials use about 20 to 80 healthy volunteers to try "to determine dosing, document how a drug is metabolised and excreted, and identify acute side effects".

In phase-II, participants numbering 100 to 300 with the disease or condition that the product potentially could treat are the volunteers.

If the new or improved drug passes this phase, there is a phase-III where it is tested on about 1,000 to 3,000 people to check its effectiveness and monitor side effects. At times, the drug moves on to a phase-IV after product approval, "to find out more about the treatment's long-term risks, benefits, and optimal use, or to test the product in different populations of people, such as children."

India too has laws governing introduction of new drugs, as for example the Drugs and Cosmetics Act and Rules. Form 44 is the format of `application for grant of permission to import or manufacture a new drug or to undertake clinical trial' and it speaks of `human/clinical pharmacology' as phase-I, `exploratory clinical trials' as phase II, and `confirmatory clinical trials including published review articles' as phase-III.

With the Union Minister of State for Science and Technology, Mr Kapil Sibal, urging global drug companies to invest in India and develop drugs here, the need for a foolproof regime governing clinical trials is high.

A posting dated June 17 on www.domainb.com by Venkatachari Jagannathan speaks of a recent claim by GlasxoSmithKline Consumer Healthcare that a `clinically proven' study found that children who drank Horlicks were taller, stronger and sharper than the non-Horlicks drinkers.

When asked if the company had the permission of the Drug Controller of India to conduct the clinical study, the response, one learns, was in the negative, on the reasoning that such studies did not require permissions.

Currently, most drug trials are designed to be randomised, double-blind, and placebo-controlled, explains www.en.wikipedia.org. "This means that each study subject is randomly assigned to receive one of the treatments, which might be the placebo. Neither the subjects nor scientists involved in the study know which study treatment is being administered to any given subject; and, in particular, none of those involved in the study know which subjects are being administered a placebo." According to the CII (Confederation of Indian Industry), the clinical trial industry in India is worth $100 million, and it is registering an annual growth rate of 20 per cent. Before the end of the first decade of this century, the value is set exceed $1 billion.

Less than a year ago, Kotak Securities had estimated the global outsourcing opportunity in pharmaceuticals at $24 billion, which will double by 2007.

`Indian Guinea Pigs for Sale: Outsourcing Clinical Trials,' by Sandhya Srinivasan on www.indiaresource.org makes an interesting read. "A huge population with a diversity of diseases that are untreated — yes, that is the `India Advantage' identified by Igate Clinical Research International, (www.igatecorp.com), commenting that India represents a largely untapped resource for clinical trials. Besides the fact that the ill in India are largely `drug naïve' (read `untreated'), the company also lists high enrolment rates, good patient compliance/retention, `competitive costs', and an `increasingly accommodating regulatory environment' as the other benefits of conducting clinical research in India," writes Sandhya.

An interesting sidelight to the trials in India is that Singapore stands to gain from a boom in clinical trial shipments. A recent report on www.channelnewsasia.com informs that some 70 per cent of clinical samples from Asia are sent to Singapore for testing before being shipped to laboratories in the US. "Companies like the express and logistics provider, TNT, are already cashing in on the opportunities... Clinical shipments between the US and Asia ex-Japan are worth about $30 million a year."

The trial of a case is a three-legged stool, said Warren E. Burger. "A judge and two advocates." A drug or a clinical trial is similarly three-legged, one may say, with the company, market and volunteers as the different limbs, though unequally strong, especially when trials are tolerated as norms to be fulfilled before a drug can hit the shelves and rake in money.

ZeroBase@TheHindu.co.in

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