The UK government hopes a new independent review can help find ways to halt a steep decline in the number of commercial clinical trials being conducted in the country.
UK Launches Inquiry Into Its Clinical Trials Problems After Pharma Outcry
Ex-Health Minister To Report Back In Spring
Stung by criticism from the AstraZeneca and GSK CEOs, the UK government has launched an independent review into commercial clinical trials in the hopes of reversing a steep decline.
More from Clinical Trials
• By
While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.
• By
Payers and health technology assessment bodies in the Netherlands, Germany and Italy are either unwilling to use real-world data in assessments or cannot due to their existing frameworks, say representatives from Gilead Sciences and Autolus Therapeutics.
• By
The Clinical Trials Regulation was “supposed to harmonize” requirements in the EU, but instead it is giving some countries the chance to get ahead by offering faster approval timelines, notes Telethon’s head of regulatory affairs.
• By
Companies have until 17 March to respond to an EU consultation on a new strategy that will seek to simplify the regulatory framework and make it easier for innovative small and medium-sized enterprises to “access the capital they need” to scale up in the bloc.
More from R&D
• By
Companies have until 17 March to respond to an EU consultation on a new strategy that will seek to simplify the regulatory framework and make it easier for innovative small and medium-sized enterprises to “access the capital they need” to scale up in the bloc.
• By
Experts argue that current guidelines on attributing responsibilities in clinical trials point in the right direction but lack the specificity to address the diffusion of responsibilities caused by the use of AI systems in decentralized studies.
• By
Trial sponsors in Germany should start preparing negotiation strategies to tackle difficult discussions with trial sites over standardized clauses.