Clinical trials are mandatory to evaluate the safety and efficacy of medicines. A drug is ready to be marketed only after it undergoes three phases of assessment on humans. More than 90-95 percent of the clinical trials are done on drugs, but trials are also conducted for surgical procedures, medical devices and other therapies.

Clinical trials are largely conducted in the US, United Kingdom and Western European countries. The areas are mainly cardiovascular diseases, infectious diseases, oncology, respiratory disorders, dermatology and vaccines.

Phase I studies are conducted on healthy volunteers to evaluate a drug's absorption, metabolism and excretion. Phase II is performed on patients with mild to moderate disease and Phase III trials are multi-centric with a large number of patients to evaluate the safety and efficacy of the drug in comparison with standard treatment [or placebo]. If this data is accepted by the regulatory authorities, then a marketing license is granted to the pharmaceutical or biotechnology company to manufacture the drug. Phase IV studies or post-marketing surveillance are done largely by pharmaceutical companies to obtain commer-cial data as well as to identify rare side effects.

India has so far conducted small phase III trials in a few hospitals with relatively smaller [compared to large trials in the west] to fulfil the regulatory requirements. The situation is rapidly changing. Both scientific as well as commercial reasons are bringing in large phase III trials in to India.

Agencies like the World Health Organisation (WHO), United States Federal Drug Agency (US-FDA) and European Regulatory Authorities and scientists around the world are interested in data on the effects in different ethnic groups especially from developing countries. India and a few other developing countries are fast becoming favourable locations for conducting trials. The reasons being, the availability of a vast patient pool, excellent doctors and hospitals apart from relatively low salaries for research staff and competitive costs of investigations. The challenge is to organise and train personnel to conduct such projects that are extremely complex.

The Division of Clinical Trials headed by Prof Prem Pais, St. Johns Medical College Hospital is currently conducting the CREATE Study which is already the largest clinical trail in South Asia. This is an international multi centric trial in acute myocardial infarction study from Canada whose principal investigator is Prof. Salim Yusuf. The trial is ongoing in 69 hospitals in India and has recruited over 4,400 patients with a target of 8,000 for the country. There are three other clinical trials in stroke, unstable angina and perioperative ischemia that will start shortly.

In India, the Drugs Controller General of India (DCGI) and the Ministry of Health and Family Welfare are doing their best to help simplify the regulatory requirements to facilitate the conduct trials in a similar scale as is being done in the west. This means companies and academic institutions can conduct the study adhering to international guidelines and submit the report to the regulatory authorities in a relatively shorter duration.

In the last few months, the regulatory authorities have clarified and simplified the processes. Also clear guidelines are now available on how the Indian government wants the clinical trials to be carried out. Apart from following international guidelines, emphasis is primarily to ensure the safety of patients in India to the same extent as being done in the West.

Another issue looked into by the DCGI is the easier import of clinical trial samples. While there is a drastic cut in customs duty, there is also a proposal for zero duty, which was announced in April 2003.

This certainly augurs well for clinical researchers in India. We should soon be able to conduct several large-scale clinical trials that will make a global impact.

-- The author is Coordinator, Clinical Trials Division, Institute of Population Health and Clinical Research, Assistant Professor, Department of Pharmacology, St. John's National Academy of Health Sciences, Bangalore