-
Informed Consent Forms (ICF) for clinical trials are required to communicate the essential details of a trial to prospective participants including the procedures, the risks of using the investigational product (IP) or device, and actions the participant would be expected to take during the trial (i.e., filling out questionaries, coming in for routine visits, etc.). As clinical trials continue to evolve and become increasingly complex, ICFs must accurately explain these complexities as they can lead to confusion for the intended audience.
-
The US Food and Drug Administration (FDA) published guidance on “Use of Data Monitoring Committees in Clinical Trials” in February 2024 which, once finalized, will take precedent over the FDA’s previous guide on the subject from 2006. The guidance clarifies data monitoring committees’ (DMC) relevance and importance in clinical trial oversight, and how to determine when utilizing a DMC is practical for certain clinical trials.
-
On October 20, 2023, the FDA issued an investigator warning letter to Maria W. Greenwald, M.D.. The inspection was part of the FDA's Bioresearch Monitoring Program, aimed at assessing research conduct to safeguard the rights, safety, and well-being of human subjects. The investigation was conducted for several clinical studies, and there were multiple instances where the site failed to comply with investigational plans.
-
On September 18, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence to provide further detail on the accepted types of confirmatory evidence used to support the results of one adequate and well-controlled clinical investigation.
-
On September 6, 2023 the US Food and Drug Administration (FDA) issued a bulletin announcing three new draft guidances regarding the FDA’s Center for Devices and Radiological Health’s (CDRH) 510(k) premarket submission program to verify that the medical device to be marketed is substantially equivalent to a legally marketed device as medical devices continue to become more complex and innovative.
-
On March 21, 2024 the Centre for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) issued a warning letter to the New York State Psychiatric Institute (NYSPI) institutional review board (IRB). The FDA’s inspection resulted in six major observations, all of which occurred during convened IRB meetings.
-
On October 20, 2023, the FDA issued an investigator warning letter to Maria W. Greenwald, M.D.. The inspection was part of the FDA's Bioresearch Monitoring Program, aimed at assessing research conduct to safeguard the rights, safety, and well-being of human subjects. The investigation was conducted for several clinical studies, and there were multiple instances where the site failed to comply with investigational plans.
-
On August 8, 2023, the U.S. Food and Drug Administration (FDA) issued an investigator Warning Letter to Angela M. Stupi, M.D.. There were multiple deficiencies noted at Dr. Stupi’s clinical site. The site enrolled participants who were ineligible per protocol and did not follow the requirements for administering the investigation product.
-
In a recent investigator warning letter issued by the US Food and Drug Administration (FDA), an investigator was cited for failing to ensure an Institutional Review Board (IRB) that complies with the applicable regulatory requirements in 21 CFR 56 was overseeing their clinical trial. During the time where IRB approval for the protocol lapsed, the site continued to enroll and administer investigational products to study participants under that protocol. The investigator’s response to the FDA was inadequate because they explained that they did not need to report any adverse events during that timeframe.