New Wave Of Clinical Trials May Throw Indian Regulators Off Balance - DIA Conference

MUMBAI - India's ability to handle a growing number of clinical trial applications has reached a tipping point as ethics committees, regulators and other stakeholders struggle to meet demand which is expected to double in 2008, industry officials said.

India's drug control office projects that so far in 2008 as many as 420 clinical trial applications are under review from 210 in 2007, Sadhana Joglekar, vice president of medical and clinical research at GlaxoSmithKline said during a panel discussion at the Drug Information Agency's first Indian Annual Regulatory Conference on April 28 in Mumbai.

"The drug controller staff vouches for the fact that the volume of work they do has gone up significantly in the past year while staff and resources are stretched," Joglekar said.

She said that 61 companies, more than 100 CROs and 80 hospitals are involved in Phase I -IV clinical trials that, while only a miniscule fraction of the global total dominated by the U.S., has shown no signs of slowing down. She said of the 655 trials underway in India, the majority are in Phase II and III while 32 are in Phase I and 63 are in Phase IV.

That compares to more than 39,500 clinical trials worldwide from Phase I-IV, Joglekar said.

In addition to more trials, the workload for reviews is increasing and "early-phase studies are of particular concern," as new questions arise, said Urmilla Thatte, professor of clinical pharmacology at Mumbai's Nair Hospital and is also active in ethics committee monitoring efforts.

She noted that ethics committees are grappling with developing clearer models for informed consent practices and struggling with the issue of compensation and after care, particularly for poorer patients.

"Getting medicine free in a clinical trial can be seen as indecent," Thatte said. 'We need to make sure that patients are not doing trials because they get medicines free."

India's potentially large patient pool, modern hospitals and well-trained doctors are strong magnets for research efforts into diabetes, cancer, heart diseases and illnesses such as TB and HIV/AIDs widely prevalent in the country, said Vasudeo Ginde, president and managing director of CRO iGate in Mumbai.

"More companies are coming to India now and it's threatening to explode."

"The system has changed since it began picking up in 1994 and is more conducive and more structured," Ginde said. "So far, it has just matched what's required. But if India is to make significant growth, capacity has to grow."

Mohandas K. Mallath, a doctor and academic dean at the Tata Memorial Centre in Mumbai, said that India stands to gain access to lower cost and better medicines over the longer-term by expanding clinical research, but noted that many civil society groups oppose the research, fearing it exploits people.

Thatte said that while costs have come down for some medicines in India as research has expanded and company's market new generic versions for less, the more rarefied and expensive cancer drugs under clinical trials bring up major issues for ethics committees.

"Informed consent in these cases may require recording the process or having ethics committee people on hand. There has to be a clear idea that you are offering a patient continued access if a drug works and a subsidy for the poor. These are real issues that have to be addressed."

She also said the procedures for the committees needs to be streamlined with guidelines that would most probably come from a committee formed by the Indian Council for Medical Research.

"Ethics committee work doesn't pay, but is in great demand. Some investigators however see us as a roadblock and not part of the process. So investigators too should be trained in ethics."

She said this antagonism has lead to "ethics committee shopping" in India and raised concerns that an investigator turned down by one committee may approach another without informing of the previous denial and could put uneducated or "professional" patients at risk.

Ginde said fears that uneducated or poor Indian patients are being used as "guinea pigs" in clinical trials was overblown as "free medicines, diagnostics happens all over the world. The question is how can we do it better? I have proposed we use biometric scans of all patients at clinical trials and have a transparent database. That means the regulator has to be involved to record patient sites. It's a collective responsibility."

To avoid the guinea pig perception, industry insiders have stressed the importance of conducting studies only in countries where companies intend to make the drug available (Also see "Negative Perceptions of Clinical Trials In India Persist – Clinical Trials Panel" - Scrip, 6 Apr, 2008.).

- Ed Lane ([email protected])