In 2018, President Trump signed a federal Right to Try Act into law, allowing dying patients access to experimental treatments. Although there is an as-yet-unapproved treatment for Amyotrophic Lateral Sclerosis (ALS) currently in Phase 3 trials, ALS patients have to date not been able to access this treatment under Right to Try. (STATNews)
Only 10% of those harmed in clinical trials in India receive compensation
Since 2005, nearly 17,000 clinical drug trials were conducted in India. It is estimated that nearly 5,000 people lost their lives in clinical trials in India, and hundreds developed serious side effects, but only 10% of those affected received compensation. (Pharmafile)
Australia plans to implement GCP inspection program
Clinical trials in Australia are initiated based on approval of a Human Research Ethics Committee, not Australia’s Therapeutic Goods Administration (TGA), and TGA also lacks a routine inspection program to check whether clinical trials are complying with good clinical practice (GCP). TGA is now planning a GCP inspection pilot program as a stepping stone to a permanent, routine GCP inspection program. (Regulatory Focus)
China overhauling its clinical trial and drug processes
Clinical trial sponsors have long found a disconnect between the country’s potential and reality as a research location. Recently, however, Chinese authorities have been overhauling its clinical trial and drug processes, which now make it possible to get drugs approved in China using data generated overseas, and improved the process for sponsors that run trials in the country. (PMLIVE)
Veterans Administration mandated to conduct clinical trials on marijuana
House lawmakers introduced a bill last week that would mandate research into the potential therapeutic use of cannabis for conditions that commonly afflict veterans, such as chronic pain and post-traumatic stress disorder. While similar legislation filed during the last Congress said that the VA may conduct and support research relating to cannabis, this version stipulates that the VA “shall” carry out clinical trials on marijuana. (Marijuana Moment)
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Why do Phase 3 trials fail?
Drug development is marked by high attrition rates, and the third phase is the most critical. A recent commentary reviewed high profile cases of failed drugs to identify the sources of late-stage failure, and classified the causes of drug failure into avoidable and unavoidable errors. Avoidable errors arise from a lack of scientific rigour, while unavoidable errors arise due to a deficiency in scientific knowledge. (Medical News Bulletin)
Trial in China of high-tech headband raises privacy concerns
The Massachusetts-based startup BrainCo has partnered with a Chinese school for a trial of its high-tech headband to monitor the brains of schoolchildren in class to make sure they are concentrating. The Focus 1 headband uses electroencephalograph (EEG) sensors to detect brain activity when the wearer is engaged in a task. The devices were worn by 10,000 schoolchildren aged 10-17 during a recent 21-day trial in China. (DailyMail.com)
Cancer vaccine is first drug given under “right-to-try” legislation
In November 2018, a cancer vaccine being developed by Epitopoietic Research Corp. became the first drug to be given to a U.S. patient under new “right-to-try” legislation that gives terminally ill patients access to experimental drugs. The right-to-try law dictates that any compound used in this way must have successfully completed Phase 1 safety testing and be under the FDA’s ongoing approval process. (FierceBiotech)
Should FDA’s trial review include economic criteria?
The U.S. FDA’s formal evaluation process for medical devices looks at safety and efficacy prior to market clearance. Should economic considerations be added as part of the FDA review? Authors of this editorial claim that you can’t gain a complete picture of the comparative performance of a procedure by focusing on health outcomes alone; you also need to examine costs in relation to the outcomes to show cost-effectiveness. (DIAC)
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