Clinical Trials
In this first of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet how the use of alternatives to animal testing in drug development is gaining traction and discusses the challenges that exist.
A survey asks FDA staff to disclose whether DEI policies caused discrimination or resulted in disciplinary action against career employees over the past five years, but uses a web form that the general public also can access.
Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.
A draft international guideline on using adaptive trial designs says sponsors should provide a clear rationale for using such designs to address the potential ‘tension’ between the confirmatory nature of late-stage trials and the flexibility introduced by mid-trial adaptations.
Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.
HHS and its agencies violated the law by swiftly implementing “sweeping and poorly thought-through directives that ordered the bulk removal of healthcare resources,” including FDA draft guidances on diversity action plans and sex differences in clinical trials, a federal court said.
Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.
Sponsors should investigate signals of possible fraud in a manner that does not raise alarms or else evidence might disappear, UK and US regulators said.
Swiss health care products agency Swissmedic will launch a pilot in July to fast track clinical trial applications, which the agency claims will place Switzerland at the forefront compared to other European countries.
Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.
Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.
The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.
As the EU tests the feasibility of a radical “all-in-one” procedure for reviewing applications to conduct combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.
The former CDER director said she tells sponsors not to conduct an FDA-recommended study design or randomized trial if it will not work.
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
The UK government is making it easier for millions of people to participate in clinical trials and is boosting transparency around how studies are delivered across the National Health Service.
The European Medicines Agency expects the International Council for Harmonization’s new guideline will help address the critical lack of data on the use of medicinal products in pregnant and breastfeeding populations.
Highlights from Day Three of the BIO International Convention include the realities of MFN pricing, AstraZeneca's R&D plans for obesity, the need for resources for the FDA's rare disease hub and reactions to the Commissioner's National Priority Review Voucher program.
The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
The EU is testing a groundbreaking “all-in-one” process for reviewing requests to conduct combined drug and diagnostic trials via a single application for coordinated assessment.