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Members of the Association of Clinical Research Organizations (ACRO) have seen their clinical trials activity in India decrease more than 60 percent since 2010 as a result of a “confusing, inconsistent and arbitrary” regulatory environment, ACRO’s Vice President of Public Affairs, John Lewis, testified before the United States International Trade Commission. The USITC hearing was held last week in Washington, DC.
ACRO’s John Lewis preparing to testify before U.S. International Trade Commission (Photo: Business Wire)
“To be clear, ACRO members are committed to conducting safe, ethical, high-quality clinical research across the globe. But to do that, researchers and research companies must depend upon a regulatory framework that is reasonable and rooted in science, not politics,” Lewis testified.
ACRO members have been operating in India since 1999 and have invested more than $100 million in the country building out a research infrastructure, training thousands of employees and establishing approximately two dozen facilities around the country. ACRO member companies have conducted an estimated two-thirds of all industry-sponsored clinical trials in India. In 2010, there were 256 industry-sponsored trials being conducted in India, according to clinicaltrials.gov, but this number fell to 86 by last year.
“In reality, research can be relocated to more hospitable countries to mitigate the direct economic damage,” Lewis continued. “The real loss is to the global research environment that is critical to the efficient development of new treatments and therapies for patients in need, in the U.S., in India and around the world.”
About ACRO
The Association of Clinical Research Organizations (ACRO) represents companies that provide a variety of specialized services that support the development of new pharmaceuticals, biologics and medical devices. The association provides an active voice for the CRO industry globally. Through its member companies, ACRO helps improve the quality, efficiency and safety of biomedical research. ACRO member companies employ approximately 100,000 professionals worldwide and annually conduct more than 11,000 clinical trials involving nearly two million participants in 115 countries. For more information, please visit www.acrohealth.org. Twitter @acrohealth. YouTube @ACROHealthChannel.
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CONTACT
Association of Clinical Research Organizations (ACRO)
John
Lewis, 202-464-9340
jlewis@acrohealth.org
