ACRO Testifies Before FDA on Clinical Trial Modernization

 April 23, 2012 - WASHINGTON, DC – The Association of Clinical Research Organizations (ACRO) today provided the FDA with a number of suggestions to improve the drug development process, highlighted by a call to appoint a Chief Innovation Officer within the agency. ACRO's recommendations were included in testimony presented by Executive Director Doug Peddicord, Ph.D., at a public hearing titled "Modernizing the Regulation of Clinical Trials and Approaches to Good Clinical Practice."

"The current drug development paradigm is unacceptable and unsustainable because too much time and too much money is spent producing too few new products," said Peddicord. "CROs have a history of embracing innovative ideas, like electronic data capture and globalization, and stand willing and ready to work with sponsors and regulators to reduce the time and cost of drug development."

Peddicord expressed concern about the slow progress that has been made since the release of the FDA's "Critical Path" whitepaper in 2004. He noted that while some FDA-supported efforts, such as the C-Path Institute and the Clinical Data Interchange Standards Consortium (CDISC) have had success developing tools to advance drug development, other efforts have fallen short. Notably, Peddicord singled-out the Clinical Trials Transformation Initiative (CTTI).

"While CTTI is well-intentioned, it has not taken on projects that have the potential to be 'transformative'," said Peddicord. "Every effort at innovation that the FDA supports, directly or

through the funding of public-private collaborations, should be measured against three objectives: does it make the drug development process faster, cheaper or more productive."

ACRO made several specific recommendations for the FDA to consider, including the appointment of a Chief Innovation Officer at the agency with broad authority to approve novel approaches to clinical trials. Several other organizations, led by the Biotechnology Industry Organization (BIO), have expressed support for this concept and it is expected to be included in the Prescription Drug User Fee Act reauthorization (PDUFA) later this year.

ACRO also recommended:

Incorporating more modern regulatory science into clinical trial design so that a sponsor can potentially generate the data necessary for product approval with fewer subjects;
Simplifying the informed consent process so that the information provided to potential participants is more intelligible and meaningful;
Testing, across therapeutic areas, the use of a single, central IRB on a country level to improve the quality of independent review;
Approaches to risk-based oversight of sites/investigators by sponsors, including statistical and other sampling, remote and other technology-enabled monitoring;
Expanding regulatory cooperation and information sharing for multi-regional clinical trials to limit or eliminate duplicative audits, examinations and reviews.
"ACRO's recommendations are by no means exhaustive but rather represent a starting point for the FDA to address widely-acknowledged areas of inefficiency," said Peddicord. "But the agency must encourage and reward innovation because without proper assurances no organization will be willing to undertake the serious financial or operational risks associated with an unpredictable regulatory environment."

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 75,000 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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