Sunday, November 26, 2006


Clinical trials for MNCs conducted in India


Gauri Kamath

India is an attractive destination for drug trials — mainly due to the fast recruitment of a large number of patients, which shortens the trial process and saves companies a lot of money. It also adds to the richness of data since the drug is tried on different ethnic groups. However, conducting trials in an emerging market like India is not that simple. Try this.

Last week, Swiss drug maker Roche said it would conduct phase 3 trials of its rheumatoid arthritis (RA) drug Mabthera in India. It has been allowed one and a half years to hire 50 patients by its parent company, which is conducting the trials globally. Considering that India has 7 million RA patients, finding subjects should be quick and easy.

However, in this case, it could well use the time. Patients have to answer seven detailed questionnaires in writing without any help. This requires them to be sufficiently literate, which is not always the case in India, says Percy Sanjana, medical advisor, Roche. International regulators like the USFDA and EMEA have fixed this protocol for all rheumatology trials. This is because RA is a debilitating condition. So improvement in the quality of life is an important outcome. However, a trial using Mabthera on cancer patients (the drug was first approved for non-Hodgkin’s lymphoma) had no such issues. “There were just one or two questionnaires and it would not have much importance in the overall outcome of the trial,” he says.

The inclusion criteria are also stringent. For instance, a patient has to be diagnosed as suffering from RA at least six months earlier. In India, where the availability of case histories and other documents is poor, this evidence is often not available. Goes to show, Indian companies — sponsors and clinical research outfits — will do well to not be swayed by the numbers alone.

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