NEJM: Accreditation of Clinical Research Sites — Moving Forward


Accreditation of Clinical Research Sites — Moving Forward

NEJM 27 June 2018

  • Greg Koski, Ph.D., M.D., Larry Kennedy, Ph.D., Mary F. Tobin, Ph.D. and Matthew Whalen, Ph.D.

Accreditation is used in many fields, including education, travel, construction, and health care. When implemented correctly, it improves quality, performance, and safety, while signaling to the public that an accredited entity is committed to an agreed-on set of values. Key to its effectiveness is broad acceptance of the standards on which it’s based and a robust process for ensuring that accredited entities conform to them.

In clinical medical research, high-performing research sites are essential for the effective and efficient conduct of trials, but currently only a fraction of active sites would qualify as high-performing. There are a variety of potential solutions, including greater professionalism and voluntary accreditation.

Citing the many challenges facing the clinical trials endeavor and recognizing the lack of a reliable framework and method for assessing and ensuring research quality, Johnston et al. recently called for voluntary accreditation of clinical research sites to accelerate the dissemination of standards and processes and to accelerate development of therapeutic products.1 Can the various players in the biomedical research-and-development ecosystem come together to implement accreditation that will be embraced by everyone involved as responsive to concerns about the operations and quality of research sites?

We submit that the answer is yes. In fact, approximately 6 years ago, an initiative to design a system of site accreditation was begun as part of a larger collaboration that aims to transform the clinical research process through the application of systems thinking — that is, seeing this complex endeavor as integrated sets of components (people, processes, and technologies) that are connected and interoperable, working together as a whole to achieve synergy.2 Implicit in this initiative’s conception was an understanding that an accreditation system must recognize and reward a site’s commitment to high quality and performance and that sites and trial sponsors would have to be compensated somehow for the burden of achieving such accreditation. Today, this initiative is coming to fruition, and we believe that it will soon provide the essential elements of an effective program for accreditation of clinical research sites.

The initiative followed a consensus approach [to continue reading the article please go to NEJM for full text]

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