Few Alzheimer’s patients qualify for Lecanemab
Inclusion and exclusion criteria whittle down the pool of eligible treatment candidates....
16 August, 2023
Clinical Trials
FDA issues final guidance on obtaining informed consent in drug and device clinical trials
The US Food and Drug Administration (FDA) recently announced it has finalized guidance to help institutional review boards (IRBs), clinical investigators, and sponsors comply with informed consent regulations for clinical investigations....
15 August, 2023
Part of a cancer cure? Wisconsin doctor discusses growth of nuclear medicine
UW–Madison's Dr. Steve Cho discusses the rise of nuclear medicine, including why there's been a rapid increase in research and clinical trials that involve nuclear pharmaceuticals....
15 August, 2023
FDA draft guidance focuses on postapproval trial diversity data
Sponsors can employ several postmarketing strategies to beef up safety and efficacy data on populations that were under-represented in initial clinical trials of drugs and biologics, according to new draft guidance issued by the US Food and Drug Administration (FDA)....
14 August, 2023
AI’s potential to improve clinical operations, trial matching
With the rise of generative AI models like ChatGPT, there come questions of how this technology can be used in industry, especially in healthcare....
11 August, 2023
PIs recognize need for greater diversity in trials, feel frustrated by limitations
Principal investigators recognize the need for greater diversity among participants in the clinical trials they run but are frustrated that the inclusion/exclusion criteria handed to them by sponsors often don't match the real-life situations of the average patient in their practice with the condition of...
09 August, 2023
Psilocybin reduces anorexia symptoms in first-of-its-kind trial
A recent phase one study investigating the effects of psilocybin-assisted therapy in treatment for anorexia nervosa has yielded promising results....
02 August, 2023
After 70 years, family of Henrietta Lacks settles with Big Pharma
The Lacks family reached a settlement with Thermo Fisher 70 years after Henrietta Lacks' cells, which continue to be used for health research, were taken without her consent at Johns Hopkins Hospital....
02 August, 2023
Universal flu vaccine candidate shows promise in mid-stage trial
An investigational vaccine appears promising as a universal flu shot that could protect against multiple strains, regardless of annual mutations....
02 August, 2023
‘Voice of the clinical research professional’ heard in comments submitted to FDA on DCTs
In their combined feedback to the FDA, ACRP members and volunteers weighed in on a variety of concerns they had over vague language and possible misconceptions about DCTs in the draft guidance....
01 August, 2023