Clinical Research Management Briefing – February 5, 2018
During Tuesday’s State of the Union, President Trump voiced support for ‘right to try’ legislation that would allow terminally ill patients to have access to experimental treatments.
STAT, January 30
The National Institutes of Health (NIH) broadens policy to include people of all ages for clinical research studies in applications due on or after January 25, 2019.
National Institutes of Health, January 24
Nine companies participating in the U.S. Food and Drug Administration's (FDA) software pre-certification program for medical devices provide feedback during early stages of the pilot program.
Regulatory Affairs Professionals Society, January 30
Financial and Operations
The NIH is awarding $190 million in grants for research that brings CRISPR gene editing closer to clinical trials in the U.S.
Gizmodo, January 24
After years of research and perseverance, several biopharma companies believe they have found a safe way to relieve pain with nerve growth factor (NGF) treatments.
STAT, January 31
A new animal study suggests that the high doses of gene-carrying viruses used in such treatments may not always be as safe as the human clinical trials indicated.
Science, January 31
By creating a patient-centric clinical trial experience that reduces the barriers facing participants, research institutions can increase participation and bring medical advances to the public sooner.
Watch the fourth in a series of complimentary webinars on how to operationalize the revised Common Rule.