FDA Commissioner Scott Gottlieb and his top aides are encouraging drug sponsors to continue providing a study drug that may have provided a benefit to especially needy clinical trial patients, after the study ends and before the new treatment is officially approved. (CenterWatch)
Can Flatiron succeed in changing the clinical trial model?
Flatiron Health, a small tech company acquired by Roche, is trying to use real-world data from patient electronic medical records to replace more traditional clinical trial data. One of their major goals is to use data from health records to mimic a control group. However, FDA is not fully on board with the prospect of replacing control groups. (STAT)
New FDA proposal could relax informed consent requirements
A new proposal from the FDA would allow institutional review boards (IRBs) to amend or waive entirely informed consent where the intervention under investigation poses no more than minimal risk to participants. The FDA expects to withdraw related 2017 guidance, should the proposed rule become final. (Clinical Oncology News)
FDA publishes framework on real-world data (RWD) and real world evidence (RWE)
The U.S. FDA has published a new framework discussing how the agency will use real-world data (RWD) and real world evidence (RWE) to help companies win new indications for approved drugs and biologics, expand labeling, and satisfy post-approval study requirements. The impetus for the creation of this framework is the 21st Century Cures Act, which directed FDA to build an RWE program. (Regulatory Focus)
FDA is sued over failure to enforce clinical trial reporting requirements
A New York University faculty member and a former U.S. Food and Drug Administration official have filed a lawsuit against the FDA saying that the Final Rule creates requirements for registering clinical trials and reporting their results, but it does not go far enough. It does not comply with the Food and Drug Administration Amendments Act insofar as it exempts certain trials from the Act’s registration and reporting requirements, and the government does not post noncompliance notices on ClinicalTrials.gov. (LAW360)
Will the FDA update the IND pathway?
The U.S. FDA has initiated a review of its Investigational New Drug (IND) application process whereby researchers are permitted to begin clinical trials in humans. Depending on the results of this review, the IND application process may be changed, especially if the study uncovers widespread safety concerns. (Modern Healthcare)
FDA will issue policies targeting “quality control” activities in clinical trials
The U.S. Food and Drug Administration (FDA) will soon be issuing specific policies aimed at reducing the burdens associated with the conduct of clinical trials. These policies could target “quality control” activities in clinical trials, which, according to FDA Commissioner Scott Gottlieb, aren’t necessary in a digital age and add unnecessary workload and cost. (acrp.net)
Watchdog files lawsuit against FDA to revamp informed consent, citing 150 deaths
The lawsuit cites more than 150 alleged clinical trial-related deaths since 2014 with plaintiffs calling on the FDA to update current informed consent regulations. (outsourcing-pharma.com)
FDA proposes changes in informed consent guidelines
The U.S. Food and Drug Administration (FDA) proposed changes that would allow institutional review boards (IRBs) to waive or alter requirements for obtaining informed consent for clinical trials involving minimal risk to participants. Under current FDA regulations, exceptions for obtaining informed consent can only be made in life-threatening situations or when conditions for emergency research are met. (Regulatory Focus)
FDA seeks feedback on surrogate endpoints
The U.S. Food and Drug Administration is seeking feedback on a table of surrogate endpoints the agency is developing that may be appropriate for use as primary efficacy clinical trial endpoints for drug or biologic approvals. A critic of this list says that it is done at a high level with little detail, and proposes an alternative. The FDA is welcoming comments concerning the utility of the table. (Regulatory Focus)