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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
Clinical research organizations see reform in clinical-trial process, including the establishment of chief innovation officer at FDA.
The Association of Clinical Research Organizations (ACRO) testified before Congress last month to provide 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, PhD, 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, in a ACRO Apr. 20, 2012, press release. “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). The CTTI, which was launched by FDA, oversees specific projects to identify existing issues related to current practice, design models for improvement, and test new models and compare them to the existing system in an effort to modernize the clinical-trial process.
“While CTTI is well-intentioned, it has not taken on projects that have the potential to be ‘transformative’,” said Peddicord, in the release. “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, have expressed support for this concept and it is expected to be included in the Prescription Drug User Fee Act reauthorization later this year, according to the ACRO release.
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 institutional review board 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 multiregional 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.”