Wednesday, January 12, 2011

UK Proposes a New Clinical Trials Agency to Improve its Global Standing in Clinical Research

by Adam Clark, Ph.D.,Director of Scientific and Federal Affairs at FasterCures

Fewer patients in clinical trials, increasing costs and time for drug development, and a “one-size fits all approach” to drug approval – are among the standard descriptors of the challenges facing clinical research in the U.S. However a new report by the Academy of Medical Sciences, A New Pathway for the Regulation and Governance of Health Research, points to these as barriers to medical progress in the U.K. as well.

The report details that in just four years the U.K.’s global share of patients involved in clinical trials fell by over half to under 3 percent. And, it will be even lower as pharmaceutical companies cited expectations to continue to reduce the number of trials due to the complex regulatory environment. With disparate agencies and bodies needed to approve numerous steps in the clinical trials process, it takes well over a year and a half to move from applying for a trial to enrolling the first patient – a process that does not weigh in favor of benefiting individuals, the public health, or the economy.

To revamp the system and enhance U.K.’s prominence in clinical research, the report calls the British government to establish a new Health Research Agency (HRA) to streamline the governance and approval across all aspects of a clinical trial and to have a single system for ethical approvals. The proposed HRA would embed research as a core activity within the National Health Service and increase public involvement and patient participation in clinical trials. They propose to establish “safe havens” to identify patients who match for clinical trials and offer the option of an investigational drug. Additionally, the HRA would implement appropriate measures that balance the benefit:risk ratio based on patients needs.

From across the pond, members of the 112th Congress and policy-makers should pay close attention to these recommendations and steps the U.K. may take to streamline and improve its clinical trials regulatory environment. For the U.S. to maintain its global leadership in medical innovation, we must step up to the task of ensuring our clinical research system is able to deliver the best possible outcomes for every patient. Maximizing the return on our nation’s investment in both basic scientific discovery and improved health care delivery hinges on a modernized approach to clinical research.

As the challenges are shared, the solutions may be even more so. When nations compete to improve its global standing in clinical research, patients win.

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