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data on populations that were under-represented in initial clinical trials of drugs and biologics, according to new draft guidance issued by the US Food and Drug Administration (FDA)....
With the rise of generative AI models like ChatGPT, there come questions of how this technology can be used in industry, especially in healthcare....
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...
Thanks to machine learning algorithms, short pieces of DNA floating in the bloodstream of cancer patients can help doctors diagnose specific types of cancer and choose the most effective treatment for a patient. ...
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weighed in on a variety of concerns they had over vague language and possible misconceptions about DCTs in the draft guidance....
Following the release of some initial reactions to the draft guidance in May, volunteer members of ACRP’s DCT Think Tank Regulatory Working Group and other subject matter experts, including the ACRP Content Committee and ACRP Fellows, took a closer look at how FDA worded its...
Medical collaborations at UW–Madison, like the Comprehensive Diabetes Center, have the promise of tackling an often-deadly disease affecting an estimated 34.2 million Americans and exacting an annual health care cost of $3.9 billion in Wisconsin alone....
Clinical trial recruitment and retention could be boosted by physicians integrating clinical trials into their private community practices to make clinical research a natural extension of the routine care they provide their patients....
A knowledgeable and compassionate team of nurses helps cancer patients at the UW Health | Carbone Cancer Center learn about and connect to clinical trials that may provide another avenue for treatment....
The agency proposes significant revisions to oversight programs for drugs and medical products....
