keyword drug-safety 
Rethinking Clinical Trials
JULY 27, 2022
ACTIV-6 is testing medication doses approved by the FDA for other purposes, i.e., repurposed drugs. There were no safety concerns or differences in hospitalization or death. No safety concerns were identified. Given the history with other repurposed drugs, I was concerned people would not want to take Ivermectin.
Rethinking Clinical Trials
FEBRUARY 14, 2024
Both drugs have a well-established safety profile and would be a good fit for a pragmatic design. The VA IRB determined DCP was a minimal risk study, with less restrictive eligibility criteria and EHR-based safety and outcome monitoring. DCP aimed to recruit 13,500 patients across the U.S.
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Rethinking Clinical Trials
FEBRUARY 28, 2024
Was there complete ascertainment of primary and secondary safety data? Getting study drug and other study materials into the hands of a participant requires distribution via mail or courier, breaking the traditional chain of custody. Did participants receive the assigned treatment and did they stay on the treatment?
Rethinking Clinical Trials
JULY 6, 2023
The Food and Drug Administration (FDA) issued a draft guidance in May 2023 that provided guidance about the conduct of decentralized clinical trials. Additional considerations are needed for the data management plan, monitoring plan, safety plan, task log, and case report forms in the FDA draft guidance.
Rethinking Clinical Trials
DECEMBER 20, 2023
Yet enrollment of ethnic minorities in NIH clinical trials and for trials studying approved devices and drugs remains low. Globally cardiovascular disease (CVD) prevalence had decreased between 1990 and 2010, but it has slightly increased since 2010.
Rethinking Clinical Trials
JUNE 7, 2023
The primary endpoint was composite of valve thrombosis or valve-related thromboembolism, and the primary safety endpoint was major bleeding. The drugs were administered open label and all patients were given a low dose of aspirin. The trial took place at 64 sites, and randomized 863 patients.
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.
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