Better Bonding Between U.S., Indian Regulators Can Ensure Good Quality Of Data From India's Clinical Trial Sites, Say Experts

MUMBAI - Select Indian clinical research organizations have called for greater collaboration between drug regulators in India and the U.S. to increase confidence about the quality and reliability of clinical trial data being increasingly generated at scores of Indian sites.

Executives from a few large CROs spoke to PharmAsia News following the recently released 50-page report by the U.S. Department of Health and Human Services titled "Challenges To FDA's Ability To Monitor And Inspect Foreign Clinical Trials."

With the primary objective of determining the extent to which sponsors submit data from foreign clinical trials for marketing applications in the U.S., along with U.S. FDA's ability to monitor and inspect those foreign trials, the study found that in 2008 sponsors relied heavily on foreign data. As much as 80 percent of approved marketing applications for drugs and biologics had data from trials outside the U.S. and more than half of the clinical trial subjects and sites were located outside the U.S.

The study revealed that FDA had inspected clinical investigators at less than 1 percent of foreign sites. Total marketing applications submitted in 2008 showed that India had 384 subjects at 49 sites. Other countries, such as Germany and France, included a few thousand subjects in clinical trials.

Kiran Marthak, director of Veeda clinical research and a veteran in the Indian industry, reasoned that the HHS concerns about FDA's monitoring ability was reasonable due to the sensitivity of the subject. But he also said it would be virtually impossible to allocate the budget and manpower necessary to inspect every trial site in the world. "It boils down to the sponsors and the CROs to arrive at protocols that adhere to the best practices taking into account the welfare of the subject and the required scientific data," he said.

In the recent past, Veeda CR has undergone six surprise audits by FDA, without receiving any FDA-483 observations. Marthak said the agency is trying to include as many checks as it can with its limited resources. Indian inspectors being trained by FDA will handle inspections in due course and provide better scrutiny of sites and subjects, he opined.

The Drug Controller General of India has made the registration of clinical trials mandatory since last year and it is hoped by industry experts that once that is implemented, every site can be easily tracked. However, Arun Bhatt, chief executive at ClinInvent - another large CRO - said that while electronic registration is a positive move, it may have limited impact if the data is not properly recorded. "Many times some of the other vital information is missing, which reflects poorly on the industry," he said.

"At times people claim propriety over trial data and refuse to fill in the requisite fields," Bhatt said, putting the onus on the sponsors and the need for better systems to implement the laws for clinical trials in India.

Bhatt estimated that India has 1,000-1,200 active trial sites, 60 percent of which are involved in Phase III trials, and 20-30 percent in Phase II studies. Remaining trials specialize in handling Phase I or safety studies for new drugs. In all, India may have at least 300 organizations involved in conducting clinical trials.

Against that backdrop, and the fast growth in other sectors of the Indian pharma industry, it will be increasingly tough for FDA to scrutinize trials in India. "At best, there could be greater sampling of sites but 100 percent supervision is largely impossible," Bhatt said, noting that roughly 70,000 global trials are conducted simultaneously.

- Vikas Dandekar ([email protected])