India’s booming clinical trials business is under scrutiny, following a story in a UK newspaper that set off a flurry of media and regulatory attention.
The Times of London reported last week that as many as 49 infants have died during clinical trials at the government-owned All-India Institute of Medical Sciences (AIIMS). The infants were among 4,142 infants who participated in clinical trials since January 2006, including 2,728 infants who were less than a year old. The Uday Foundation for Congenital Defects and Rare Blood Groups, a non-profit group, exposed the deaths after receiving information about the trials through a freedom-of-information request.
After the deaths came to light, AIIMS launched an internal inquiry into the deaths at the request of India’s Health Minister, but the Uday Foundation is calling for an external investigation after a report emerged saying that two of the pharmaceuticals tested on infants last year had not previously been studied in patients under 18 years of age.
AIIMS maintains that many of the infants, some of whom received placebos, were seriously ill before entering into the study. The infants’ mortality rate was 1.2%, significantly lower than the mortality rate for all patients treated in Indian hospitals (forecasted to be between 3.2% and 5%).
“The cause of these deaths is under investigation and until a report is produced, one cannot say whether the infants died due to the clinical studies or whether they were really seriously ill,” said Rashna Cama, head of clinical operations at the Institute of Clinical Research, a provider of clinical research education and training in India.
In the past few years, India has become one of the top locations for outsourced clinical trials, largely because of the availability of trial participants and the reduced cost of conducting the trials (Indian trials reportedly cost up to 60% less than trials in developed countries).
Although the industry has seen impressive growth, critics have questioned the country’s ability to appropriately staff testing facilities and monitor safety. Regulatory growth has been slow, Cama acknowledged, and the industry has been dogged by recruitment problems for qualified investigators.
“There is a dearth of GCP [Good Clinical Practice]-trained investigators. The few hundred GCP-trained investigators are working to full capacity; hence, new investigators are needed to handle the increase in clinical trials coming into India,” Cama said.
Before the deaths were reported, India was already in the process of introducing regulations for ethic committees and institutional review boards, but some Indian congressmen have called for India to stop all clinical trials until the investigation is complete.
The infants’ deaths will not likely influence large global sponsors who outsource their trials to India, Cama predicted, but the media attention around the deaths could reduce patient participation in general.
“The infant deaths being harped on continuously by the media would ultimately affect the number of patients signing up for clinical trials, which means increasingly difficult recruitment,” Cama said. “One rarely hears the media talk about the benefits of participating in a clinical trial. This is needed to offset the skepticism associated with clinical trials.”