According to numerous sources, pharmaceutical companies have outsourced trials to CROs and foreign countries largely due to economic pressures, time-consuming regulatory burdens in the United States, legal entanglements, and low or absent participation by treatment-naive American patients.
According to the ACRO, globalized trials can reduce development time by more than half.
“By gaining access to a global population of 7 billion rather than a U.S. population of 312 million, patient recruitment is vastly accelerated, leading to a cost savings in addition to drugs being made available to patients sooner,” Lewis says.
In a 2008 article in Harvard Business Review, GlaxoSmithKline CEO Jean-Pierre Garnier said that, “discovering and developing a new medicine takes at least 12 years, and the average cost is now more than $1 billion,” compared with less than $100 million almost two decades ago.5 “By switching 50% of its trials from high-cost places such as the United States and Western Europe to low-cost places such as India and South America, a mid-size pharmaceutical company with 60,000 patients in clinical trials could save $600 million annually.”
Ethics of International Trials
Jeremy Sugarman, MD, MPH, Harvey M. Meyerhoff Professor of Bioethics and Medicine at the Johns Hopkins Berman Institute of Bioethics in Baltimore, notes that, “having studies conducted in international locations is not necessarily a bad thing. It depends upon a variety of factors, including the quality of the site and the quality of the investigators doing the research, regardless of the location.”
Unfortunately, many of the foreign sites that got into the clinical trial business weren’t prepared, according to Dr. Schulman. “We moved into these markets very aggressively, and then the clinical research standards evolved. We’re not training physicians or regulatory people to get them up to speed before we do the research,” he says. “What we should do is share the clinical risk. If some country is not the niche market for the product, it shouldn’t have a disproportional burden of research on investigational products.”
Among the ethical considerations are disparities in education, economic and social status, and healthcare systems that may jeopardize the rights of research participants, according to a July 21, 2009 news release from ACRO.6
“Unfortunately, international research comes under almost constant attack, most often by those who make grand conclusions about ethics and quality based on a few anecdotes,” said Doug Peddicord, ACRO executive director, in April 2011.7
Still, concerns about the ethics of international clinical trials are not unfounded. Testing drugs on people in low-income countries incurs more risks than previously discovered, according to a report by the Centre for Research on Multinational Corporations in collaboration with the Latin American organization Salud y Fármacos and the Indian Center for Studies in Ethics and Rights.8 The report referenced “trade-offs between speed and costs of the clinical trial managed by CROs on the one hand, and the ethical quality of these trials on the other. The suggestion is that sponsors expect CROs to conduct the trial as quickly as possible, which might put pressure on the CROs to be lax on the ethics (e.g., by circumventing informed consent procedures, not reporting adverse events, etc.).”