Clinical Trials
A working group of EU regulators has developed a comprehensive repository of fee requirements relating to the Clinical Trials Regulation to help sponsors navigate the diverse demands of member states in the European Economic Area.
The MHRA’s new scientific dialog program will offer drug developers “closed-door meetings” that will offer “confidential, commercially sensitive discussion” with its staff to help them “refine” their real-world evidence generation strategies.
The UK’s “world-first” tailored regulatory framework for point of care manufacturing is set to enter into force this summer.
In new draft guidance, the US FDA recommends sponsors carefully weigh the circumstances for requiring tissue biopsies for clinical trial subjects and emphasizes the need to limit them in pediatric studies.
The US Food and Drug Administration updated obesity drug development draft guidance for the first time in almost 20 years and although a lot has changed in the field, the FDA’s fundamental expectations to support approval did not.
The draft guidance clarifies that sex and gender are not interchangeable, but could be vulnerable in the Trump Administration as Republicans have argued against transgender medical care and that sex and gender must be congruent.
Final guidance on communicating scientific information on unapproved uses (SIUU) allows firm-generated presentations to be based on sources other than reprints, but says communications based on nonscientific content are not protected from enforcement.
An artificial intelligence-based pathology tool for metabolic dysfunction-associated steatohepatitis shows promise for a drug development landscape that is said to be “fraught with trials that have shown borderline results or outright failures based on liver histology.”
Clinical trial sponsors should strive to strike a balance between privacy and transparency at the very beginning of a trial to be successful, advises Certara’s Honz Slipka.
Two transparency experts share best practices for writing clinical study reports to protect patient privacy.
EU regulators have approved a strategy to streamline the submission and approval of studies that involve the simultaneous investigation of a medicinal product, an IVD, and/or a medical device. The strategy involves rolling out seven cross-sector projects over the next few years.
The Equitable Breakthroughs in Medicine Development initiative, funded with a PhRMA grant, provides sites in historically under-represented communities with support to conduct clinical research. In an interview, EQBMED’s Tesheia Johnson Harris talks about the local sites selected, therapeutic areas for research, and learnings to date.
Staburo’s Kathi Künnemann examined the utility of artificial intelligence in developing plain language summaries for clinical trials results.
Robert Temple, the US FDA’s most experienced drug regulator, is currently serving an emeritus role at the agency. The immediate impact of his departure will be mostly symbolic, but still unsettling.
EU legislators must be “mindful” that any changes made to the EU orphan medicines framework and its incentive structure will impact drugmakers and patients for the next two decades, says Soraya Bekkali, head of Europe, Canada, and international at Alexion.
Himal Thakur said the required long-term safety study can replicate a clinical trial, which is not the intent.
The landscape for primary biliary cholangitis or cirrhosis, PBC, is set to change if Intercept withdraws Ocaliva, which received its fourth safety alert from the US FDA and lost conditional marketing authorization in EU. Pink Sheet studies data from Citeline’s Pharmaprojects and separately Evaluate Pharma to reveal a promising clinical trials landscape and a sizeable market
Incorporating pragmatic and decentralized approaches into postapproval studies presents less risk for data collection and reliability than in the premarket setting, an expert panel said at a Friends of Cancer Research meeting.
The Center for Real-World Evidence Innovation will promote consistency across the FDA drug center’s many initiatives while addressing regulatory and scientific barriers to real-world evidence in regulatory decisions.
Speedier approval of clinical trials, flexibility towards new technologies, faster access to new drugs and lingering regulatory barriers to decentralized trials are among the challenges South Korea is facing in becoming a global trial hot spot.