New FDA Guidance: The Least Burdensome Provisions
This guidance document replaces the Center for Devices and Radiological Health (CDRH)’s 2002 Least Burdensome Guidance. It defines “least burdensome” to be the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time. (fda.gov)
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)
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)
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)
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)
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)
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)
Using sound and light: a new way to perform drug-based studies?
 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)
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