Collaborative initiative to develop standards for clinical research sites underway
Posted March 12, 2013 by Mary Tobin
Meyerson and Blumenfeld leading effort
Alliance for Clinical Research Excellence and Safety (ACRES) President, Greg Koski, former director of the Office for Human Research Protections (OHRP) at the U.S. Department of Health and Human Services, announced a major step forward in efforts to re-shape the world of clinical research through a collaborative systems approach that leverages the expertise and resources of stakeholders world-wide.
ACRES’ Site Accreditation Standards Initiative (SASI), inaugurated in December of 2012, has teamed up with industry leaders Linda Meyerson and Tracy Blumenfeld who will serve as Co-Chairs of the SASI Steering Committee. SASI brings together prominent representatives from the multi-sector biomedical research community to promote formal standards for accreditation of clinical research sites worldwide.
With more than 250,000 research sites around the globe, numbers that are rapidly growing outside of the traditional bases in North America and Europe, the development of such standards represents a critical step toward creating a global system to enhance safety, quality, ethics and efficiency in clinical trials and health research.
Meyerson recently retired as the chief operating officer at Icon CR, a Philadelphia-based pharmaceutical services company where she was responsible for handling clinical operations, conducting clinical trial programs, and analyzing data that support clinical development and clinical study. She was formerly the vice president for global clinical operations at GlaxoSmithKline.
Tracy Harmon Blumenfeld is the co-founder, president and CEO of RapidTrials, a leader in improving the efficiency of clinical trials. For the past decade, RapidTrials has been at the forefront of aiding sponsors in selecting, assessing, and managing sites, with an end result of significantly faster enrollment and more efficient, high-quality trial execution.
“The research site is a critical element of a clinical trial. Despite this vital role in the research process, no uniform standards exist to define the requirements of sites or distinguish levels of quality among sites. SASI is a collaboration of global leaders in clinical research to define site standards so that we can enhance safety, quality and efficiency of drug development”, says Blumenfeld.
Over the next two years, SASI working groups, representing all key stakeholder groups, will develop and pilot test standards in at least four areas: facilities, professional personnel, information technology and quality management. Standards will provide the foundation for globally recognized, third-party accreditation of research sites that will ensure industry-wide inter-operability and efficiency, while driving standardization, safety and quality in clinical trial conduct worldwide through a global network system.
Meyerson notes, “It’s all about quality–while cost and time matter in clinical trials, ultimately success depends on quality, and site excellence is a hallmark of quality. With quality sites everyone wins, sponsors, clinicians, regulators and most importantly, patients.”
Through its alliance-based approach, ACRES seeks to integrate its efforts with complementary activities being conducted by like-minded organizations, including The Multi-Regional Clinical Trials Center at Harvard (MRCT), the Metrics Champion Consortium (MCC), the Association of Clinical Research Professionals (ACRP), the Health Improvement Institute (HII), PharmaTrain, the Consortium of Academic Programs in Clinical Research (CoAPCR), and Model Agreements & Guidelines International (MAGI) among others.
“To be successful, this initiative must be collaborative and informed by the wisdom and needs of the sites themselves”, says Koski. ” In addition to the sites, there are many stakeholders in the clinical research process, not the least of which is the public, and all will benefit. Standards and accreditation are proven methods for building public trust by ensuring quality and enhancing safety, while driving standardization and efficiency. Accreditation also affords an opportunity for sites to demonstrate their commitment to quality and safety. This initiative is greatly needed and long overdue.”
Leveraging global expertise to create a connected world of clinical research that is safer, better, faster
ACRES is a private, non-profit, multi-sector organization aligning ethical principles and good business practices to address critical challenges facing the drug and device development in a socially responsible manner.
ACRES is working together with stakeholders and like-minded organizations world-wide to develop site-accreditation standards, launch safety and quality initiatives, and to build a global technology network to support the clinical research system and its oversight. Through standardization of policies and procedures, regulatory simplification, professionalism and information technology, the ACRES system will enhance safety, quality and efficiency while reducing the cost and time required to responsibly deliver new medical products and better health to the people of the world.