ACRO Pushes Global Trials Language in PDUFA
June 5, 2012
Dear Chairman Harkin, Chairman Upton, Ranking Member Enzi and Ranking Member Waxman:
The Association of Clinical Research Organizations (ACRO) commends you and thanks you for your thoughtful and timely consideration of the reauthorization of the Prescription Drug User Fee Act (PDUFA).
ACRO represents the world’s leading clinical research organizations and each year our members conduct in excess of 11,000 clinical trials involving nearly two million participants in 115 countries. Our members contributed to the development of all of the top 20 selling prescription drugs in the world and the vast majority of new drugs and biologics approved for use each year globally.
As you work to reconcile S 3187 and HR 5651, we strongly encourage you to adopt Section of 1126 of the Senate bill “Optimizing Global Clinical Trials.”
Diseases know no boundaries and the pharmaceutical, biotech and medical device industries are complex enterprises that must compete on a global basis. To a large extent, CROs have become the infrastructure supporting the development of new drugs, biologics and devices so we have a shared interest in ensuring that research is conducted to the highest standards of quality and ethics wherever it takes place, whether in India or Indiana.
With access to the global population to conduct clinical trials, the development of new medical products can be accelerated dramatically. For example, if all Phase III clinical trials for new cancer treatments were conducted only in the United States, it would take nearly six years to recruit enough patients. But by conducting these trials globally, this time can be reduced to less than two years. The bottom line is, cancer patients can access new treatments four years sooner if both U.S. and “foreign” data is used to support approval.
Some raise concerns about the quality of foreign data, or about the ethical standards for research outside of the established markets of the U.S., Western Europe and Japan. To confront these issues, ACRO has conducted research into the quality and ethics of global research. Our first study, soon to be published in the peer-reviewed DIA Journal, found no statistically significant differences in data quality among or between countries or “mature” and “developing” regions. Stated differently, the FDA can expect data from Asia or Latin America to be of the same quality as data from the U.S. or Europe.
A second ACRO study is evaluating potential differences in protocol adherence and safety reporting in the conduct of clinical trials in the U.S. and around the world. Again, preliminary results of this study show no statistically significant variances that are attributable to geography.
Just as the FDA’s approval of a new medical product must be driven by sound data, so too must the policy decision to accept foreign clinical trial data. To date, we have seen no convincing evidence that clinical research conducted outside the U.S. is of lesser quality or adheres to a lesser standard of patient protections. In fact, the evidence is to the contrary.
We would be remiss if we did not also comment on the “accelerated approval” provisions contained in both the House and Senate bills. ACRO strongly supports efforts to bring new therapies to patients sooner, without compromising safety or evidence of efficacy. We note that the both bills encourage the FDA to make efforts to improve not only accelerated approval but also accelerated development. We believe that an examination of the FDA’s efforts in this regard, by way of a Government Accountability Office report or other means, should evaluate the success of the agency’s efforts both to approve medical products faster as well as efforts to support the faster development of new medical products.
Thank you for your consideration. We would be happy to discuss these issues with you in more detail at your convenience.
Douglas Peddicord, Ph.D.