Clinical Trials
Industry representatives raised several concerns about an FDA proposal to charge additional fees to sponsors not conducting Phase I trials in the US, including that the idea could increase the burden of drug development overall.
The UK’s medicines regulator reports promising outcomes from a pilot scheme testing streamlined processes for reviewing low-risk substantial modifications to ongoing clinical trials.
Experts said the impact of the planned approval standard changes are difficult to assess given the potential for flexibility outlined in the JAMA article, as the FDA again eschews guidance and public comment in making new policy.
The EU is finetuning a new coordinated procedure to streamline the evaluation of multinational clinical trials and address persistent delays and inconsistencies in approval timelines under the Clinical Trials Regulation.
The FDA proposed conditions for eliminating six-month animal studies in mAb development and gave examples when shorter-duration studies could be eliminated.
The growing use of non-clinical biomarkers in clinical trials of drugs for Parkinson’s disease has led the European Medicines Agency to propose changes to its guideline to clarify their role in patient enrollment for both targeted and non-targeted treatments.
The Association of the British Pharmaceutical Industry said 2024 marks the fourth consecutive year of declining patient recruitment in UK industry trials, calling it the most concerning trend despite a surge in trial initiations.
New approach methodologies are increasingly shaping the future of medicine development by making drug testing less reliant on animals.
Portugal has made permanent a pilot aimed at cutting review timelines for certain clinical trial applications.
The FDA wants to charge a yearly fee after an IND is filed for firms that do not conduct Phase I clinical studies in the US as part of its proposal to encourage more domestic development.
Postmarket optimization studies for cancer drugs can strengthen clinical trust in cancer medicines, which in turn results in therapies being used more often, a researcher says.
Integrating patient choice in clinical trials is a compelling vision, but achieving it at scale requires balancing flexibility with regulatory compliance, operational feasibility, and data integrity.
Decentralizing clinical research demands rethinking accountability and logistics to prevent gaps that could compromise safety and trial integrity.
France is set to pilot a new fast-track process that could more than halve the timeline for authorizing certain clinical trial applications.
Europe’s RADIAL study comparing fully decentralized, hybrid and conventional trial approaches reveals why online recruitment is not simple.
Sponsors and CROs planning commercial trials in the UK can now use a standardized template to confirm NHS site selection and start study setup activities in parallel with formal contracting and regulatory approvals.
Incentives are “probably the only solution” to encouraging companies to optimize cancer drugs, but this will require funding and systemic changes, the chair of the European Medicines Agency’s oncology working party says.
While the upcoming EU Biotech Act presents an opportunity to simplify the regulatory landscape for clinical trials, improving the current Clinical Trials Regulation remains the immediate priority.
The orphan drug share of US FDA’s 2025 novel approvals is holding steady, with examples of approvals based on a single trial with confirmatory evidence from UCB, Precigen, Jazz Pharmaceuticals and Stealth Biotherapeutics
A cluster of CRLs for rare disease applications based on one trial plus confirmatory evidence may represent a shift away from the regulatory flexibility that had come to characterize ultra-rare drug development