Toward Greater Transparency and Rigor

Transcription

1 Toward Greater Transparency and Rigor TRANSPARENCY: ClinicalTrials.gov registration and results reporting The Center for Clinical & Translational Science

2 Toward Greater Transparency and Rigor TRANSPARENCY: ClinicalTrials.gov registration and results reporting The Center for Clinical & Translational Science

3 History of Clinical Trials.gov Pending Changes Why it is important Changes and challenges

4 Sept 16,2016 new requirements Goal increase transparency and compliance Two new sets of requirements: DHHS Notice of Final Rule Clinical Trial Registration and Results Information Submission regulation at 42 CFR Part 11 Implement by Jan 18,2017 NIH - NOT-OD NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information NIH expands DHHS requirements

5 DHHS requirements: ClinicalTrials.gov reporting Clarifies the statutory language Provides objective, structured criteria for evaluating whether a study is an applicable clinical trial (ACT). Clarifies that for purposes of the final rule, all multi-group studies and all single-group interventional studies with pre-specified outcome measures are considered controlled Clarifies distinction between secondary and other pre-specified outcome measures Expands transparency beyond the basic statutory (initial) requirements Requires submission of results information for ACTs of unapproved products Requires submission of baseline information on race or ethnic group, if collected during the clinical trial, and other characteristics associated with primary outcome measures Defines required levels of specification for outcome measures Requires submission of information about adverse-event timeframe and collection method, as well as all-cause mortality Requires submission of full protocol and statistical analysis plan (if not in protocol) at the same time as submission of results information Provides a list of potential legal consequences for non-compliance. Other issues Records will be posted within a specified time frame, may be posted without complete review by ClinicalTrials.gov with a disclaimer as to accuracy

6 Which protocols must be posted on CT.gov Applicable device clinical trials Pediatric postmarket surveillance of a device product as required by FDA A clinical trial with 1 or more arms that meets all of the following Study type is interventional Purpose of the trail is other than feasibility The trial studies an FDA regulated device product One or more of the following applies: At least 1 or more facilities conducting the study in the US Device produced and/or exported from the US Device has an IDE number

7 Which protocols must be posted on CT.gov (CON T) Applicable drug clinical trials Clinical trial with 1 or more arms meeting one of the following conditions Interventional Study phase other than phase I FDA-regulated product At least one or more of the following One facility in the US Drug product (including a biologic product) under investigation that is produced in the US and exported Has an IND number

8 NIH requirements: ClinicalTrials.gov reporting All clinical trials supported in total or in part by NIH must be posted Penalties: lack of compliance could result in Monetary fines Loss of funding PI and or institution being unable to obtain future funding from the NIH

9 What the Federal Registry says about penalties: (DHHS) Subpart E Potential legal consequences of Non-Compliance Civil and Criminal Judicial actions (section 301(jj) Failure to comply with the Final Rule Monetary fines (section 303(f)(3)) Penalty of not more than $10,000 for all violations in a single proceeding Not more than $10,000 per day after first 30 days Loss of funding(secion402(j)(5)(3)) DHHS will require certification that all ACTs have been registered/results reported If not: remaining funding for a grant or future grant may not be released (DHHS director may allow the grantee 30 days to correct non-compliance)

10 Challenges Increased registration and results reporting More scrutiny needed at the local site Institutional and investigator responsibility Posting entire protocol at end of study will confirm accuracy of study description and of outcome measures. Writing endpoints appropriately before the study starts is critical.

11 More to come Information is still being released about implementation of the new ClinicalTrials.gov requirements. We will keep you updated as we learn more over the next few weeks. Implement: 18 January 2017

12 Questions? th Ave. S UAB Campus - PCAMS Thank you to our Partners! The Center for Clinical & Translational Science ccts@uab.edu