2021 Update
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Authors of a new study published in JAMA Internal Medicine research found that just one-fifth of confirmatory trials for cancer drug indications approved via FDA’s accelerated approval pathway demonstrated improvements in overall survival (OS). Although improvement in surrogate measures may be acceptable for accelerated approval, confirmatory trials should verify the clinical benefits in terms of overall survival (OS) or quality of life. (Regulatory Focus)
The U.S. FDA is implementing policies to eliminate health disparities in clinical trials, research, and treatments of chronic, debilitating diseases. The agency published guidance on the collection of race and ethnicity data in clinical trials, and recently created a Minorities in Clinical Trials Initiative to increase patients’ understanding of the benefits of clinical research. (Health IT Analytics)
In 1997 the U.S. Food and Drug Administration Modernization Act stipulated that the FDA may consider data from just one clinical investigation to approve a new drug. Of 59 novel drugs approved in 2018, 42% (25) were approved on the basis of only one trial. A large proportion of the drugs relying on only one trial were new orphan and cancer drugs. (Regulatory Focus)
Novartis was recently inspected and cited with an Official Action Indicated (OAI) as part of their new drug application for their recently approved multiple sclerosis drug Mayzent (siponimod). In one study protocol, blinding was not adequately maintained, and study personnel were given inappropriate access to the database, raising questions as to whether inappropriate access to information led to bias. (Regulatory Focus)
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)
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)
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)
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)
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)
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)