-
On April 15th, 2024 the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) announced the establishment of the CDER Center for Clinical Trial Innovation (C3TI). Clinical trial design and conduct must be held to rigorous standards and policies in order to safeguard the well-being of trial participants and the public. These standards and policies are outlined within the ICH E8(R1) Guideline: General Considerations for Clinical Studies.
-
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On September 18, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence to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.
-
SAM Sather, MS, BSN, CCRC, CCRA, Vice President of Clinical Pathways, LLC, will be speaking at the Association of Clinical Research Professionals (ACRP) New York Metropolitan Chapter’s symposium. Chapter members can receive 6.5 contact hours, and they are available for purchase for others.
-
SAM Sather, MS, BSN, CCRC, CCRA, Vice President of Clinical Pathways, LLC, will be speaking at the Association of Clinical Research Professionals (ACRP) Research Triangle Park (RTP) Chapter’s first regional conference. SAM will present on October 4th. Subject matter experts will cover key issues impacting clinical trials, and the conference provides networking opportunities and 12.0 ACRP continuing education credits are available.
-
The U.S. Food and Drug Administration (FDA) released a final guidance, “Humanitarian Device Exemption (HDE) Program.” The guidance is in alignment with requirements from the 21st Century Cures Act and amendments to the Federal Food, Drug, and Cosmetic Act by the FDA Reauthorization Act of 2017 (FDARA).
-
In life, the purchase of a new car, or house, invokes feelings of excitement, potential value and sustainability. Being new is positive thing, with infinite possibility.
Whereas, in the clinical research industry, a new/inexperienced employee may invoke feelings of unease, and the investment of critical time and resources without prospective return. Wonderful possibility is not anticipated, rather, ability is questioned. This doubt forces the choice of experience over potential, on what is comfortable/predictable (such as the requisite two years of CRA experience for an entry level CRA position) over the unknown.
-
Male breast cancer is rare, but nonetheless as deadly as for women when at the same stage of progression. Men have been traditionally excluded from breast cancer clinical trials, so any treatment for them has been developed with data from women subjects. This results in fewer FDA approved treatment options for men with breast cancer.