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. Winckler, RPh, Esq) appeared first on Rethinking Clinical Trials.

Regulation 152

Regulation Production Clinical Trials Clinical Trials 152

Rethinking Clinical Trials

JULY 6, 2023

There has been a growing sense of hesitancy about whether regulators will remain equally receptive to these decentralized methods when the pandemic recedes. The Food and Drug Administration (FDA) issued a draft guidance in May 2023 that provided guidance about the conduct of decentralized clinical trials.

Trials 130

Trials Clinical Trials Clinical Trials Licensing 130

Rethinking Clinical Trials

AUGUST 28, 2023

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. Time, cost and failure to recruit trial participants are significant barriers that must be addressed. The guidance should not remove the need to think.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130

Rethinking Clinical Trials

AUGUST 28, 2023

Food and Drug Administration (FDA) Slides Keywords Pragmatic trials; Research; Guidance, Regulatory, Data Governance Key Points The clinical trial enterprise needs modernization. Time, cost and failure to recruit trial participants are significant barriers that must be addressed. The guidance should not remove the need to think.

Clinical Trials 130

Clinical Trials Clinical Trials Trials Development 130