Faster drug approvals by FDA raise concerns about transparency and beneficence in clinical trials
Are faster drug approvals by the FDA hurting the public's overall perception of clinical research?...
30 August, 2023
Clinical Research
Psychedelic drug trial guidance: Commenters see vital role for psychotherapy
Commenters on the FDA's guidance on clinical investigations and drug development programs for psychedelic drugs raised concerns about decoupling drug administration from psychotherapy support, the proposed credentials for lead safety monitors and the agency’s characterization of the abuse potential of psychedelic drugs....
29 August, 2023
UW–Madison joins state consortium to bolster Wisconsin’s lead in biohealth
UW–Madison has joined a statewide consortium, mobilizing its experience and expertise as a collaborative powerhouse in bioscience and technology to help bolster Wisconsin’s leadership in personalized medicine and biohealth technology....
28 August, 2023
Where are all the Arabs? And how a U.S. Census change could improve clinical trial diversity
Arabs are are often categorized as white in clinical research. Grouping individuals from diverse genetic backgrounds under a single racial category can be problematic in clinical research....
25 August, 2023
UW Carbone marks 50 years of cancer innovation
Since 1973, UW Carbone has remained at the forefront of life-saving discoveries as Wisconsin’s only National Cancer Institute (NCI)-designated comprehensive cancer center....
23 August, 2023
New approach shows hydrogen can be combined with electricity to make pharmaceutical drugs
Working with scientists at the pharmaceutical maker Merck & Co. Inc., UW–Madison chemists and engineers sought to develop a more sustainable method to manufacture ingredients needed to make many types of drugs....
21 August, 2023
How To Design A Clinical Trial Protocol With Patient And FDA Collaboration
n a recent Clinical Leader Live! episode hosted by Life Science Leader Chief Editor Ben Comer, clinical trial experts Mitchell Katz, SVP, global clinical operations at Kyowa Kirin; Jessica Powell, VP, clinical operations at Alto Neuroscience; and Michael Krams, chief quantitative medicine officer at Exscientia,...
18 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FDA draft guidance focuses on postapproval trial diversity data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