In a recent study, only one-third of the cancer trials that were the basis of FDA approvals in 2016 were found to demonstrate a “substantial clinical benefit” according to the European Society of Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). Under the terms of this scale, for a drug to be considered to have a substantial clinical benefit, it not only has to be efficacious, but also has to include information on patient quality of life and postmarketing data. (Cancer Therapy Advisor)
A special session at a recent TCT (Transcatheter Cardiovascular Therapeutics) meeting addressed the question of how to design clinical trials in interventional cardiovascular medicine in an era where new therapies offer incremental gains. The pitfalls of using composite endpoints in studies were discussed in the context of the ISCHEMIA trial, which added additional “soft” endpoints late in the design phase. The program session also discussed the feasibility of sham-controlled trials for medical devices. (tctMD)
The clinical development services provider Phesi is looking to patent its method and system for developing clinical trial protocols – which enables faster patient enrollment and study completion, says CEO.
On April 20th, 2018, Tanya Verstak interviewed Guy Iannuzzi regarding his company Mentus and the development of biotechnology in San Diego as well as Biocom. About the interviee: Guy and Mentus market entrepreneurial and technology based companies and products. Their success is enabled by creative solutions driven by customer-centric strategic Read more
Interview with Guy Iannuzzi, Part 1: An industry voice for ACRP regarding the importance of clinical research certification
On April 20th, 2018, Tanya Verstak interviewed Guy Iannuzzi regarding his role as a trustee for the ACRP from an industry perspective regarding the need for clinical research certification. About the interviee: Guy and Mentus market entrepreneurial and technology based companies and products. Their success is enabled by creative solutions Read more
Clinical trials that explore the repurposing of drugs for off-label uses are common, but without a commitment to rigorously testing the hypotheses generated by these exploratory trials, drugs used off-label are costly and may be ineffective. Ethics committees should devise measures that encourage coupling of exploratory testing with confirmatory trials. (British Medical Journal)
Mitsubishi Tanabe Pharma and Hitachi have become the latest example of pharma and tech companies coming together and using artificial intelligence (AI) to improve the drug development process. Hitachi has developed AI technology for automated information search and collection, which has shortened by 70% Mitsubishi’s time spent collecting information from medical papers and other sources in designing clinical trials. (pharmaphorum)
The FDA is allowing the approval of novel drugs based on pivotal trials using surrogate markers of the disease as primary endpoints, but new research highlights potential problems with this approach. In those drugs/indications where there were postapproval trials using the same surrogate marker as a trial endpoint, treatment effects were higher in the pivotal than the postapproval trials.
In an editorial in the New England Journal of Medicine, two medical device experts posit that real-world evidence (RWE) is most useful in the postmarket setting, where our current systems are inadequate for ensuring the safety and performance of medical devices. However, using RWE for initial marketing decisions for medical devices carries significant risk, as RWE analyses are observational in nature and don’t control for treatment selection bias. (Regulatory Focus)
The FDA will hold a public meeting on March 20 to discuss the use of complex innovative designs (CID) in clinical trials of drugs and biological products to inform regulatory decision making. The meeting is intended to help the FDA develop a guidance document on CID, as required by the 21st Century Cures Act, and develop a CID pilot program. To register for this meeting, visit: https://complexinnovativedesigns.eventbrite.com/ (Regulatory Focus)