On May 22, 2018, the US Food and Drug Administration (FDA) issued draft guidance for drug makers on maximal usage trials for the purpose of adding a topical active ingredient to an over-the-counter (OTC) drug monograph. A maximal usage trial is a pharmacokinetic (PK)...
According to industry experts, the current research model is failing many people, but more specifically those who live in a mobile world. As of now, clinical trials take years to recruit. For example, oncology trials are only able to recruit half a patient per site...
Three factors could vastly transform the clinical research industry as we know it. The three factors include: the patient engagement movement, rich data and analytics, and the learning health system model, reported CenterWatch.1 Ken Getz, an industry veteran spoke at...
Clinical trials create opportunities for patients to access groundbreaking, and potentially lifesaving, cancer treatments before they reach the market. However, clinical trial participation continues to be an issue, with only 5% of cancer patients participating in...
A team of researchers from the University of Birmingham and the University of Sydney developed new international guidelines for the inclusion of patient-reported outcomes in clinical trial protocols. The SPIRIT-PRO protocol checklist, which was recently published in...
The US Food and Drug Administration (FDA) recently made two announcements indicating a commitment to addressing questions about the clinical trial process for clinical trial stakeholders, The National Law Review reports. FDA announced two actions in late January that...
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