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)
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)
The EMA’s 5 goals: Fostering innovative trial design, exploiting AI, and other recommendations
The EMA recently outlined five strategic goals with a focus on fostering clinical trial innovation, optimizing capabilities in modeling and simulation, as well as exploiting AI and investing in special populations, among other objectives. (Outsourcing-pharma.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)
FDA publishes framework on real-world data (RWD) and real world evidence (RWE)
The U.S. FDA has published a new framework discussing how the agency will use real-world data (RWD) and real world evidence (RWE) to help companies win new indications for approved drugs and biologics, expand labeling, and satisfy post-approval study requirements. The impetus for the creation of this framework is the 21st Century Cures Act, which directed FDA to build an RWE program. (Regulatory Focus)
Watchdog files lawsuit against FDA to revamp informed consent, citing 150 deaths
The lawsuit cites more than 150 alleged clinical trial-related deaths since 2014 with plaintiffs calling on the FDA to update current informed consent regulations. (outsourcing-pharma.com)
FDA proposes changes in informed consent guidelines
The U.S. Food and Drug Administration (FDA) proposed changes that would allow institutional review boards (IRBs) to waive or alter requirements for obtaining informed consent for clinical trials involving minimal risk to participants. Under current FDA regulations, exceptions for obtaining informed consent can only be made in life-threatening situations or when conditions for emergency research are met. (Regulatory Focus)
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