Clinical Trial Site Standards Harmonization
The Clinical Trial Site Standards Harmonization Action Collaborative is an ad hoc activity associated with the Forum on Drug Discovery, Development, and Translation at the National Academies of Sciences, Engineering, and Medicine (the National Academies). Any products and activities do not necessarily represent the views of any one organization, the Collaborative, the Forum, or the National Academies and have not been subjected to the review procedures of, nor are they a report or product of, the National Academies.
Since sponsoring a workshop series on issues relating to the U.S. national clinical trials enterprise from 2009 to 2011, the Forum on Drug Discovery, Development, and Translation (Forum) continues to devote time and attention to issues around clinical trials. Mobilized in 2012, the Clinical Trial Site Standards Harmonization Action Collaborative (Collaborative) is an ad hoc activity associated with the Forum that provides a venue for joint and collaborative activities among participants to accelerate progress in the improvement of our national clinical trials infrastructure. To date, the Collaborative has drawn together a group of diverse stakeholders for three in-person meetings (December 2012, August 2013, and March 2014) as well as working group projects between meetings. Participants come from multiple sectors and disciplines associated with the conduct of clinical trials.
The cost and duration of clinical trials have escalated dramatically in the past 20 years, hampering introduction of new therapies and driving recruitment to developing countries, raising questions about generalizability, data quality, and participant protections. Although some sites in the U.S. are extremely efficient in launching new trials and in identifying participants, many still suffer from long delays in contracting and IRB approvals, and enrollment targets are frequently missed. Protections of research participants are variably applied, with processes for consent and adherence to Good Clinical Practice (GCP) suboptimal at some sites, and standards for training and site-level preparedness are variable. Furthermore, resistance to systems-based improvements, such as deferral to a central institutional review board (IRB) or use of master contracts, has been difficult to overcome at many institutions. The consequences are borne by the National Institutes of Health (NIH), foundations, and industry alike, with the ultimate impact on the public.
Some Collaborative participants are currently preparing a Discussion Paper to be made available by the National Academy of Medicine (NAM), which will summarize their perspectives on the concept of clinical trial site accreditation as well as a framework and principles for developing site standards.
In addition, some Collaborative participants have undertaken a project to collect, analyze, and assess how research sponsors’ baseline site standards could be harmonized. Part of this project involves analysis of clinical trial site standards (e.g., site selection and monitoring checklists) from a small group of research sponsors. The analysis will identify standards that are the same among research sponsors, not the same but may be equivalent, or clearly different or only used by some stakeholders. The next phase of the project will foster an examination of these standards to inform the development of a baseline set of clinical trial site standards that could be considered for broad application by research sponsors.