A systematic review of Federal Drug Administration Docket for community consultation and public disclosure in exception from informed consent trials

Abstract

Background: Exception from informed consent imposes community consultation and public disclosure requirements on clinical investigation in critically ill and injured patients. In 2011, the Food and Drug Administration instructed sponsors to submit publically disclosed information to the Food and Drug Administration Docket, but to date there has been no comprehensive analysis of available data. We summarized the community consultation and public disclosure practices of exception from informed consent trials published on the Food and Drug Administration Docket in order to better understand the breadth of common practices that exists among acute care clinical research.

Methods: We performed quantitative and qualitative analysis of Docket FDA-1995-S-0036 from its initiation until June 2017 in order to summarize existing practices. We developed a 4-point scoring system to categorize public disclosure and community consultation based on inclusion of key components such as a detailed plan, schedule of events conducted, results, and materials uploaded.

Results: The 177 docket submissions represented 34 trials. Material related to public disclosure accounted for 49% of pages, community consultation 45%, and 6% other. The median Docket Review Content Score for public disclosure was 3 (mean: 2.5, range: 0-4) and 2 (mean: 2.1, range: 0-4) for community consultation materials.

Conclusion: The public information contained in the Docket varies broadly by trial and content. Additionally, as evidenced by the wide range of the Docket Review Content Score, submission guidelines are not followed uniformly. Given the apparent uncertainty about what should be submitted, and the need for best practice recommendations, it is valuable to categorize and summarize existing community consultation and public disclosure content.

Keywords: Exception from informed consent; acute care research; community consultation; public disclosure.

Figure 1. Pages of Public Disclosure and Community Consultation Documentation on Docket

Thirty-four trials reported in the docket shown by reported start date. Bubble size is proportional to the number of pages submitted that are related directly toward community consultation or public disclosure (as opposed to general trial materials such as Institutional Review Board correspondence or study protocols).

Figure 2. Examples of Templates Used for Community Consultation and Public Disclosure

Examples of Neurological Emergency Treatment Trials Network community consultation and public disclosure materials.