Given the advances being made in cancer treatments, it’s time to move beyond the maximum tolerated dose (MTD) to dose-optimization trials for targeted therapies, the U.S. FDA said in a new draft guidance.
Clinical trials in China are growing up in much the same way the R&D enterprise in China has grown up. They are evolving and becoming more sophisticated, reflecting the maturation of the R&D environment around them.
It was a year of turmoil in Europe as Russia’s invasion of Ukraine and the fall-out from the COVID-19 pandemic shaped the fortunes of the life sciences industry in 2022. After years of tension, Russia’s attempt to annex Ukraine on Feb. 24 caused outrage and disruption and was unanimously opposed on humanitarian grounds by the life sciences and pharma industry.
Europe is losing its innovative edge in biopharma, especially when it comes to advanced therapy medicinal products, including tissue, gene and cell therapies used to prevent, treat and cure rare conditions and some cancers.
Reflecting statutory and regulatory requirements added over the past five years, the U.S. FDA is issuing a revised draft question-and-answer (Q&A) guidance on expanded access to investigational drugs. One of several guidances recently issued, the 40-page draft incorporates requirements from the 21st Century Cures Act and the 2017 FDA Reauthorization Act that took effect after the current final Q&A guidance was updated in 2017. It also answers new questions sponsors have raised over the past few years.
It’s a time of economic crisis and political upheaval in the U.K. But, according to the country’s pharma trade body, there’s another looming problem of access to clinical trials in the country, which is becoming less and less attractive as a place to conduct life sciences research.
Endpoint solutions company Clario Inc. has published a roadmap on how artificial intelligence (AI) can be used to improve the experience of patients participating in decentralized clinical trials (DCTs).
In recent years, ethicists have executed a 180-degree shift on including children in clinical trials testing drugs, biologics and medical devices, moving from the idea that it was unethical to include youngsters in trials to an understanding that such inclusion may be the best way of protecting them.
Australia’s Therapeutic Goods Administration (TGA) is proposing that devices be subject to good clinical practices (GCP) inspections, and it is proposing two approaches to achieve that goal.
The U.S. FDA’s formation of the Digital Health Center of Excellence was heralded as a key enabler of digital health technologies, but the news hasn’t necessarily had the expected effect. The agency’s December 2021 draft guidance on the use of digital health technologies to assist in the conduct of clinical trials is still in regulatory drydock.
