Shedding light on data monitoring committee charters on ClinicalTrials.gov

Dear Editor,

We read with interest the commentary by DeMets et al., ¹ which advocates for public access to data monitoring committee (DMC) charters and considers ClinicalTrials.gov to be “the most logical place to make DMC charters public because it is the established archive for structured and searchable trial information.” We concur that making DMC charters more accessible would increase transparency while potentially benefiting the clinical trial enterprise. In response to the authors’ proposal, aimed to “enhance the credibility of the trial and ultimately improve the quality of DMC charters,” we would like to clarify that ClinicalTrials.gov already permits optional linking to DMC charters, as described below, and announce a plan to facilitate linking to and searching for DMC charters on ClinicalTrials.gov as part of our ongoing, multiyear modernization effort. ²

ClinicalTrials.gov, operated and maintained by the National Library of Medicine (NLM), already permits sponsors and investigators to provide links from study records to DMC charters posted on other websites or presented within publications (e.g. Supplemental file 2 of publication PMC8899655, provided in NCT04797013v.3). To enable easier search and retrieval of study records that link to DMC charters, as suggested in the commentary, ClinicalTrials.gov plans to update an existing optional data element to allow for unambiguous labeling of sponsor-submitted links to DMC charters. This approach is consistent with the suggestions made by members of the NLM Board of Regents Public Service Working Group on ClinicalTrials.gov Modernization. ³

Specifically, by 2025, ClinicalTrials.gov plans to provide:

• A “DMC Charter” option for the structured Available IPD/Information Type registration data element in the Protocol Section of the study record.

• Instructions for data submitters for how to designate links to DMC charters in the Protocol Registration and Results System or PRS.

• Guidelines for ClinicalTrials.gov users for searching for records displaying links to DMC charters on ClinicalTrials.gov, using its application programming interface.

At that time, we would call on the commentary authors and members of the Society for Clinical Trials and other professional associations to actively engage with the community to educate them about this new, dedicated DMC charter linking capability on ClinicalTrials.gov and promote its use. We are pleased to have the opportunity to shed additional light on DMC charters on ClinicalTrials.gov, and we look forward to further enhancing clinical trial transparency.