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)
Should we be bringing drugs to market quickly?
Disease-free survival is a “surrogate end point”, a measure of a drug’s efficacy that can be used as an alternative to overall survival when testing new treatments. Researchers analyze how long the drug prevents the disease from returning or how long a tumor is prevented from growing, thereby accelerating trials and bringing drugs to market more quickly than if using overall survival as the endpoint. (RACONTEUR)
FDA knocks clinical studies of depression drug
On November 2, a panel of outside experts will review evidence for an experimental drug for depression, ALKS-5461, from Alkermes, and debate whether the FDA should approve the drug in 2019. The FDA is critical of the data Alkermes has accrued, the trial design it used, and whether the drug will be safe for patients to take. (Xconomy Boston)
Minnesota hospital doses emergency patients without informed consent
The U.S. Food and Drug Administration (FDA) has cited the Hennepin County Medical Center in Minnesota over its institutional review board’s (IRB) oversight of clinical trials including one case involving dosing emergency patients with ketamine without the patients’ consent. Public Citizen called on the FDA to suspend the hospital’s IRB until they took corrective steps to ensure adequate protections for research subjects going forward. (Regulatory Focus)
FDA wants sponsors to use patient-reported outcomes in phase 3 trials
Patient-reported outcomes (PROs) can enhance drug development, but the integration of PRO measures as end points in phase 3 clinical trials has been slow. The FDA held a two-day workshop to gather input on a series of drug development documents they are developing to provide guidance to stakeholders on collecting information on patient experiences to inform product development. (ajmc.com)
FDA seeks comments on changes to Adverse Events reporting forms
The FDA is planning to make changes to the forms used by health professionals, drugmakers, and hospitals to report adverse events, and has put out a call for comments on these proposed revisions. The FDA would like feedback on whether the information is perceived as necessary, and ways to minimize the burden of the collection of information on respondents. (Regulatory Focus)
FDA will hold public meeting on Inclusion and Exclusion criteria in clinical trials
On April 16, 2018, the FDA will hold a public meeting on “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” The purpose of the meeting is to bring the stakeholder community together to discuss topics related to eligibility criteria in clinical trials and their impact on patient access to investigational drugs. The meeting will be held at the National Press Club in Washington DC, and there will also be a live webcast for those unable to attend in person. Register at https://healthpolicy.duke.edu/events/evaluating-inclusion-and-exclusion-criteria-clinical-trials (Federal Register)