The UK government has revealed plans to give patients more of a say in how clinical trials are designed and managed. It is also planning to update current its Good Clinical Practice principles to make sure they are “flexible and can be applied to a broad range of clinical trials.”
UK Regulator Calls For More Patient Involvement In Trial Design
More Flexible Rules On GCP And IMPs Are Planned
UK plans for a flexible and streamlined clinical trial regulatory regime are now out for consultation, covering areas such as investigational medicinal products, greater patient involvement in trial design, and lighter-touch oversight of low-intervention trials.
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Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.
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Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.
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Manufacturers are engaging the European Commission and individual countries to allocate more health care spending to innovative medicines and align prices more closely to those in the US.
Non-Submissions To UK HTA Body Could Increase Unless Commercial Environment Improves, Warns Industry
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Finding ways to lower the rebates paid by the pharmaceutical industry to the UK government and fostering partnerships to make the UK a more attractive launch market could help reduce the number of terminated technology appraisals conducted by NICE, the health technology appraisal institute, says the UK pharmaceutical industry.
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Swiss authorities have introduced temporary measures that will make it easier for health care professionals to import medicines that are either not authorized or not available in Switzerland, which will particularly benefit pediatric drugs, in light of ongoing shortages.
• By
Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.
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With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.