Developing a New Set of Standards for Clinical Research Site Accreditation

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By knowing which sites are high-performing, sponsors could spend less time devoting resources to verifying these locations and spend more money on the clinical trials.
By knowing which sites are high-performing, sponsors could spend less time devoting resources to verifying these locations and spend more money on the clinical trials.

The medical research field is undertaking a challenging question: Can groups with such different viewpoints come together to agree on a set of standards for the accreditation process of clinical research sites?

Greg Koski, PhD, MD, and colleagues, from the nonprofit organization Alliance for Clinical Research Excellence and Safety, in Cambridge, Massachusetts, authors of a study published in the New England Journal of Medicine,1 believe it possible and that there is incentive to do so.

"High-performing research sites are essential for the effective and efficient conduct of trials," the authors wrote, "[b]ut currently only a fraction of active sites would qualify as high-performing."

By knowing which sites are high-performing, sponsors could spend less time devoting resources to verifying these locations and spend more money on the clinical trials.

The authors  have been working for the last 2 years alongside a variety of organizations to create a set of standards for accreditation. The standards, adapted from a paper penned by S. Clairborne Johnston, MD, PhD, dean of Dell Medical School at The University of Texas, Austin, and colleagues, were published by the National Academy of Medicine2 and are presented as follows:

Principles for Developing Standards

INDEPENDENCE

  • Maintain standard development as an independent activity
  • Collaborate, harmonize, and integrate to avoid duplication
  • Establish a management team
  • Use standards experts for writing

TRANSPARENCY

  • Disclose and manage potential conflicts of interest
  • Publish methods and publicize ways in which to participate in the development of standards
  • Create an open process for stakeholders and the public to review draft standards

EFFECTIVENESS

  • Organize separate domain work groups
    • Stakeholders nominate small group of experts to draft standards
    • Standards are based on public comments from stakeholders
  • Use a common template to describe standards
  • Work virtually to expand participation
  • Develop methods to assess the value of standards to the research ecosystem

The group's quality standards can be requested for review here.

According to these findings and additional research, a pilot program is set for early 2019.

References

  1. Koski G, Kennedy L, Tobin MF, Whalen M. Accreditation of clinical research sites — moving forward [published online June 27, 2018]. N Engl J Med. doi:10.1056/NEJMp1806934
  2. Johnston SC, Lewis-Hall F, Bajpai A, et al. It's time to harmonize clinical trial site standards [published online October 9, 2017]. NAM Perspectives. doi:10.31478/201710b

 

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