Clinical Trials
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
AI is moving from blue-sky potential to specific applications in drug development, streamlining pharmacovigilance and clinical trial design, but strong governance remains essential to ensure transparency and reliability.
Upfront planning is critical to navigating a change in the standard of care while a randomized registrational trial is underway. Sponsors must also be mindful to what patients and clinicians will consider an acceptable comparator arm, a new white paper states.
US FDA’s rejection of Biohaven’s troriluzole is a huge disappointment for patients with SCA and the company. But it is also a notable example of how communication strategies are changing now that FDA is making its ‘complete response’ letters public.
Regulatory reliance processes for drug registration and clinical trial application approvals in Brazil have not met their “full potential,” says Brazil’s medicines regulator.
Pharmaceutical companies will be expected to phase out certain animal tests in the drug development process under a UK roadmap aimed at pivoting towards using alternative models, such as organ-on-a-chip systems and artificial intelligence.
The US FDA’s oncology team is emphasizing a methodical approach to developing novel endpoints like MRD or ctDNA and that community buy-in is important, not just regulatory standards.