Intercept Pharmaceuticals’ reported that their experimental medicine to treat nonalcoholic steatohepatitis (NASH) achieved its primary goal in a Phase 3 trial, giving it a shot at becoming the first drug to treat the condition. NASH is a chronic disease in which fat accumulates in the liver; patients in the advanced stages of NASH present with cirrhosis and may require a liver transplant in order to survive. (STAT)
Clinical trials a theme at J.P. Morgan Healthcare Conference
The annual J.P. Morgan Healthcare Conference, a health care investment symposium, was held January 7-10, 2019 in San Francisco, with over 9,000 attendees. Numerous sessions discussed inefficiencies in clinical trials and how we can innovate to facilitate research and drug development without placing an undue burden on patients by trial participation requirements. (Healio Gastroenterology)
Join us at the Clinical Trials Congress in San Diego March 3-5
Do you want to meet with senior executives from big pharma, emerging biotech, academia, CROs, technology innovators, regulators, patient groups and hospitals? Network with 700+ attendees and learn how to streamline your clinical trials? The Clinical Trials Congress is part of the Festival of Biologics USA which includes 4 co-located Read more
Using sound and light: a new way to perform drug-based studies?
www.scienceandtechnologyresearchnews.com
An international team has developed an innovative new way to hold samples using sound while they are gently imaged using light. The normal way to immobilize an object would be to use a gel, but introducing drugs to the sample could be slow and unpredictable using this method. Using sound and light is a new way to perform drug-based studies. (Science & Technology Research News)
Drug sponge could minimize side effects of cancer treatment
Catheters are used today to deliver drugs directly to tumors, but half of the drug can still escape to the rest of the body, causing side effects. Doctors treating liver cancer worked with chemical engineers to design an absorbent polymer-coated device that can be temporarily placed in the vein coming out of the liver to absorb unused chemotherapy drugs, potentially lowering the risk of side effects. (Science Daily)
Boehringer, IBM to test blockchain technology in clinical trials
Boeringer Ingelheim Ltd and IBM Canada plan to explore the use of blockchain technology in clinical trials. This marks the first time that blockchain technology will be used in a clinical trial setting in Canada. The alliance aims to improve the quality of clinical trial processes and record keeping. (Contract Pharma)
Randomized clinical trials with run-in periods: a threat to validity?
Run-in periods are occasionally used in randomized clinical trials to exclude patients after inclusion, but before randomization. During a run-in period, all patients receive the same treatment– for example, a placebo, the experimental drug, or observation only. A recent analysis of published trials found that 5% reported a run-in period, which could affect study validity if a large number of patients are excluded. (Dovepress)
Are remote clinical trials cheaper?
We shouldn’t think of remote clinical trials as something that will decrease costs in and of themselves, simply because remote clinical trials should cost less. One of the biggest driver of cost savings when conducting remote clinical trials is the reduction in the number of investigator sites. Investment in developing a technology platform will be one of the biggest costs. (Clinical Leader)
CRAs are at risk of work-related mental health disorders
Clinical research associate (CRA) turnover has long been a challenging issue in the clinical research industry. This article, based on a survey of 700 CRAs, is the first of a four-part series that will investigate the disillusionment that CRAs today experience with their role, why they do, and what we can do about it. (Clinical Leader)
13 famous clinical trial failures of 2018
Most drug trials fail, and failure is expensive. This is a list of 13 failed clinical trials of drug candidates in 2018 that also touched off a variety of consequences that included termination of development programs, losses in the millions, layoffs, and more. Five of the 13 failed drug candidates were for Alzheimer’s treatments. (Genetic Engineering & Biotechnology News)
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