Rethinking Clinical Trials

JANUARY 17, 2024

The first drug that used the new process was Remdesivir in May 2020. The committee worked with communications specialists who partnered with palliative care providers and others to draft FAQs and other communication guidance for clinician teams who were having conversations about drug allocations with patients and families.

Clinical Trials 182

Clinical Trials Clinical Trials Antibody Trials 182

Rethinking Clinical Trials

JULY 27, 2022

ACTIV-6 is testing medication doses approved by the FDA for other purposes, i.e., repurposed drugs. Given the history with other repurposed drugs, I was concerned people would not want to take Ivermectin. This was one of the reasons we gave people options about which drugs they were willing to take. Susanna Naggie, MD, MHS.

Trials 182

Trials Pharmacy Medicine Clinical Trials 182

Rethinking Clinical Trials

FEBRUARY 7, 2024

Winckler, RPh, Esq Chief Executive Officer Reagan-Udall Foundation for the FDA Slides Keywords U.S. Food and Drug Administration, FDA, Misinformation, Communication, Health Information Key Points U.S.             Speaker Susan C.

Regulation 162

Regulation Production Clinical Trials Clinical Trials 162

Rethinking Clinical Trials

OCTOBER 26, 2023

There is now a cure for Hepatitis C, but many people are not able to access it. point of care diagnostic tests, provide broad access to curative Hepatitis C medications with a national subscription model, with Medicare co-pay assistance and commercial insurance coverage. Rates are the highest among 20-39-year-olds.

Clinical Research 147

Clinical Research Clinical Trials Clinical Trials Research 147

Rethinking Clinical Trials

JULY 6, 2023

Over the past several years, a variety of factors have accelerated the need for decentralized trials, including the push to make trials more accessible, the increased speed of science, the possibility of environmentally conscious trials, and the need to be flexible in a rapidly changing world.

Trials 130

Trials Clinical Trials Clinical Trials Licensing 130

Rethinking Clinical Trials

FEBRUARY 28, 2024

But there are concerns to developing DCTs including lack of standardization and validation, regulatory and ethical uncertainties, engagement vs. coercion, data security and privacy issues, technological literacy and access, resistance to change and adoption, and lack of “safe” sharing. Balance with not adding barriers for participation.

Clinical Trials 147

Clinical Trials Clinical Trials Trials Clinical Research 147

Rethinking Clinical Trials

AUGUST 28, 2023

 Speakers Prof Sir Martin Landray, FMedSci Professor of Medicine & Epidemiology University of Oxford Chief Executive, Protas Khair ElZarrad, PhD, MPH Director, Office of Medical Policy Center for Drug Evaluation and Research (CDER) U.S. While E6(R3) provides a foundation for GCP expectations, guidelines alone are not adequate.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130