Saturday, 14 July 2012

Clinical trials get bad press for nothing: Experts
Experts said bad publicity is a major factor in discouraging the government from granting approval to new human clinical trials. 

From a share of 2 per cent of clinical trials conducted world over, India's current share has dropped to 1.5 per cent.

“It is slated to go down further within months as no new trials are being launched,” said Dr Krathish Bopanna, president, Indian Society for Clinical Research (ISCR).

He was speaking at a workshop on the clinical research industry organised by ISCR.

According to the June 2012 data on the US administration website, of the  128,726 clinical trials in 178 countries, just 1,961 studies or 1.5 per cent are being done in India.

As many as 62,436 studies (49 per cent) are being carried out in the US,  6,765 (5.2 per cent) in the United Kingdom and 3,027 (2.3 per cent) in China.

Approval takes long

“There are two reasons for the decline. Indian authorities take a long time in granting approval for the trial. On an average, the timeline for the Drug Controller General of India for approval is nine months which is very high,” said Dr Shamsher Dwivedee, senior consultant, Vidyasagar Institute of Mental Health and Neuro-Sciences (VIMHANS).

“Also, recently there have been numerous media reports regarding deaths during clinical trials. The DGCI is scared of bad publicity,” he added.

In other Asian countries like Taiwan, Philippines and Singapore, the approval time is three months.
South Korea, which is becoming a hub of clinical trials, has a timeline of between three and six months.

Media affect

Talking about the adverse coverage  clinical trials get in the media, experts at the workshop said the issue should be looked at in a proper perspective.

“All cancer patients who participate in a study are registered as dead after the study is over because we have to calculate their survival time after administering the drugs and procedures. That should not be reported as deaths in a clinical trial,” said Dr Arun D Bhatt, executive committee member, ISCR.

‘Trials safe’

Dr Shoibal Mukherjee, chief medical officer, Quintiles, said patients in clinical trials are safer because they go through a more thorough scrutiny than the rest.

"In a particular trial on vaccines, 10 died per 1,000 infants, while the infant mortality rate in India is 47," he argued.

Dr Dwivedee said the gap between  policy and its implementation has to be reduced in the country.

The laws and regulations are strong, but due to enforcement deficits, the trials are being discredited. 

New Delhi, Jul 13, 2012, DHNS 

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