According to an expert, the rise in the number of protocol amendments occurring before the first patient has even received the first dose reflects a failure in planning trial design. Amending a protocol often involves making the study more complex, which impacts study costs and participant satisfaction. (CenterWatch)
Participants in failed Alzheimer’s trials react
Biogen and Eisai recently stopped two phase 3 trials of the Alzheimer’s treatment aducanumab after 36 months due to lack of efficacy. The 3,200 people in the trials and their families reacted with a sense of hopelessness and resign, particularly as there is no other treatment or clinical trial option for them. (STAT)
Recently Published Book: Clinical trials and the African person
This book explores ethical issues with clinical trials. When clinical trials, much of which are conceived in the Global North, involve other cultures, particularly Africa- in the Global South, where many of the trials are often offshored to, there is a need to apply some additional considerations, because the significance of the person in the African setting differs from the Western perspective. (blog of the APA)
Cost of pivotal clinical trials varies around the globe
Little is known about how trial site costs vary around the world. In this sample, most patients (60%) and sites (57%) enrolled were outside of North America. In Africa, Central Europe, Middle East, and Latin America, the cost per site was about 50% of the cost per site in North America. (PubMed)
Gottlieb encourages drug sponsors to provide expanded access
FDA Commissioner Scott Gottlieb and his top aides are encouraging drug sponsors to continue providing a study drug that may have provided a benefit to especially needy clinical trial patients, after the study ends and before the new treatment is officially approved. (CenterWatch)
Contributed article. The importance of a holistic perspective in investigator selection
A successful business collaboration is rooted in respect, transparency, and a big picture perspective. When these characteristics accompany the creation of a partnership, they ensure the sustainability of the relationship. This philosophy is integral to investigator selection activities. As a new CRA, I was ruffled when a site I evaluated, Read more
Guest interview. Leveraging artificial intelligence to manage clinical trials
Leveraging artificial intelligence to manage clinical trials An interview with Kim Walpole, Co-Founder and CEO of Trials.ai. Conducted by Tatsiana Vertak Tatsiana: What does Trials.ai do? Kim: At Trials.ai we are on a mission to get treatments to patients faster by optimizing clinical trial protocols for speed and success. We Read more
Insider Tip: 8 Steps to Follow When Building Your Next Clinical Trial Website
1. Make the language reader-friendly. 2. Create the website for your target audience. 3. Provide relevant and informative details about the trial. And more. (Clinical Site Services)
Solving pharma’s ‘big text’ problem with NLP
There are about 27m articles in PubMed and 280,000 studies on ClinicalTrials.gov – so how does the industry begin to make sense of all this data? (outsourcing-pharma.com)
The false positive rate of published clinical research findings could be 35%
It has been suggested that medical research is facing a “replication crisis.” This article shows that, by using simple mathematics, it is possible to predict that, using a significance level of 0.05, up to 35% of published clinical research findings may be false. One solution to reducing the high false positive rate is to raise the bar of significance from 5% to 0.5%. (castor)
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