Guest User
Improving Clinical Trial Patient’s ...

04/09/2024

-

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.

Guest User
FDA Issues Updated Draft Guidance on Use of ...

04/02/2024

-

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.

Amanda Dzengeleski
FDA Issues Warning Letter for Clinical ...

01/03/2024

-

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.

Amanda Dzengeleski
FDA Releases New Draft Guidance on Confirmatory ...

09/27/2023

-

On September 18, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence to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.

Jennifer Lawyer
FDA Releases 3 New Draft Guidances Regarding ...

09/13/2023

-

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.

Guidance on Adaptive Design for Clinical Trials Released for Comments!

12/04/2019

-

The Food and Drug Administration (FDA) released a final guidance “Adaptive Designs for Clinical Trials of Drugs and Biologics” for comments. An adaptive designed clinical trial means that during the trial, the design can be changed based on an interim analysis of the data collected from subjects already enrolled. This means that the trial design could be altered during enrollment to increase the type of subjects that are more likely to benefit or reduce those who may be at greater risk for adverse effect. This could reduce the time needed to determine if the investigational product is safe and effective and reduce risks to subjects. The final guidance clarifies principles for the design, conduct, and reporting of adaptive clinical trials for evaluation of safety and effectiveness of drugs and biologics and is part of FDA’s modernization efforts.

Clinical Safety Data Management eLearning Course Now Available for Purchase!

11/21/2019

-

What is ICH E2A? ICH E2A provides guidance on how to handle expedited safety reporting and includes important definitions and standards. Following harmonized standards and procedures for safety reporting on investigational products ensures Good Clinical Practice (GCP).

Critical Thinking and Artificial Intelligence

11/14/2019

-

In the ever-evolving world of increasing automation, computers and artificial intelligence are taking over jobs that humans use to do. Self-driving cars and home assistant devices may be helpful, but humans are still necessary for their critical thinking skills that artificial intelligence cannot replace.

FDA Framework for Use of Real-World Evidence

11/05/2019

-

The U.S. Food and Drug Administration (FDA) released a Framework in December 2018 for the use of real-world evidence, which is not routinely collected during the course of a clinical trial. Under the 21st Century Cures Act, the FDA was to establish a program to evaluate the use of real-world evidence to help support a new indication for an approved drug or to satisfy post approval requirements. RWE evidence has been used by the FDA for some time to monitor drug safety, but its use to determine effectiveness has been limited.