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Outsourcing Clinical Trials Gaining Popularity

The skyrocketing cost of drug development over the past decade, coupled with stiff competition for limited numbers of potential trial participants, has compelled pharmaceutical and biotechnology companies to seek more cost effective ways of conducting clinical research. This quest has led to outsourcing clinical trials to developing countries where large numbers of qualified patient volunteers await, the cost of doing business is far cheaper, and new therapeutics can be brought to market faster.

The cold, hard facts are that:

Clinical trials conducted in the U.S. typically cost about $150 million, 60% more than in India, according to a study by Rabo Bank.^[1]
Recruitment time can be halved, a significant advantage to sponsors seeking hundreds, and in some cases thousands, of clinical trial participants.^[1]
India's billion-plus population offers tremendous genetic diversity, and a large patient population that has never received drug treatment, simplifying patient enrollment and trial management.^[1]
Whereas Western patients are often wary of participating in clinical trials, many in India are eager to enroll in order to gain access to free medical care and tests, as well as drugs they could not otherwise afford.^[1]
China, too, is becoming an increasingly popular site for clinical trials, with sponsors drawn by its “potentially lucrative market for new drugs, which some estimate will be worth $50 billion in five years.” ^[3]
“In the first half of 2003, applications for clinical trials soared 420 percent over the year before to almost 2,500,” according to China's Department of Drug Registration. Demand is so great that dozens of hospitals are being added to the 165 already permitted to conduct human clinical trials.^[3]

Dangers inherent in outsourcing clinical trials to developing countries:

Review boards that oversee trials in developing countries often don't include ethicists and “favor the interests of doctors and hospitals,” says Li Benfu, president of the Chinese Medical Ethics Association.^[3]
Rapid growth in new trials may be overwhelming regulators in China.^[3]
Poor practices, an underfunded medical system, poor enforcement of regulations and widespread poverty “threaten to erode trust between China's sick and dying and its medical establishment, and undermine confidence in the medical data that drug companies collect in China.”^[3]
Because foreign trial participants have cultural, nutritional, and economic differences from the average American participant, precautions must be taken to avoid skewing clinical trial results. One such example is the requirement that one-third of the participants in any given clinical trial must come from the U.S. and/or Europe.

Ethical concerns abound

As clinical trials expand overseas, ethics are a growing concern, with debate focused on the possible exploitation and coercion of trial volunteers. As a result, “drugs might be approved for use in the United States on the basis of studies that don't meet U.S. standards,” says Peter Lurie, Deputy Director of the Public Citizen’s Health Research Group, a consumer advocacy group based in Washington DC.^[7]

The FDA is considering the adoption of less restrictive rules for clinical research conducted outside the U.S. These changes would:

Allow the use of placebos in clinical trials to “assess the effectiveness of a drug, even when there is a known effective treatment for the condition.”
Eliminate the requirement that clinical trial participants be given the best available treatment for their condition after the trial has ended. This is popular with drug companies who “don’t want to be saddled with responsibility to patients after studies are done,” said Lurie.
Exempt overseas trials from adherence to the Declaration of Helsinki, a code of medical ethics created by 82 national medical associations, to protect trial participants.
Require overseas trials need only comply with “good clinical practices,” which is much weaker regarding patient protections.

“The Declaration of Helsinki is the standard-bearer for international research ethics and enjoys particular respect in the developing world,” Lurie said. “It would be tragic if the US tendency to arrogantly flout international laws claimed the declaration as another victim, even as the President touts the universalism of human rights.”[4]

Despite everything, for India, the potential benefits of clinical research are far greater than its hazards, says Rajesh Jain, Managing Director of drug maker Panacea Biotec Ltd. “It brings in the best in industry practices in clinical research for the benefit of our population's health-care needs while exposing the medical community to global processes and standards.”^[1]

Sources:

[1] http://www.atimes.com/atimes/South_Asia/FG23Df03.html; India's clinical trials and tribulations By Indrajit Basu; Asia Times online, July 23, 2004

[2] Drug Companies Cut Costs With Foreign Clinical Trials By SARITHA RAI The New York Times, February 24, 2005.

[3] Meds And Miracles: China's medical system is straining to accommodate a flood of Western firms testing new medicines. By Craig Simons Newsweek International ,April 11/18 issue

[4] http://www.news-medical.net/?id=8698; US tendency to arrogantly flout international ethical practice for patient trials abroad; Pharmaceutical News; Published: Monday, 28-Mar-2005

[5] FDA Considers Changes For Offshore Drug Trials; Wall Street Journal, March 28, 2005

[6] FDA Seeks Weaker Ethics Rules for Medical Trials, Critics Claim, March 24, 2005