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STAT+: European regulators take steps to bolster clinical trial transparency
In a boost for greater clinical trial transparency, the European Medicines Agency (EMA) is taking what consumer advocacy groups are calling unexpectedly “rapid action” to ensure that study results are made public as required by law.
The move comes after a recent analysis found results for less than half of the studies registered in a key European database were reported within the required time frame and complete results were fully reported for only 42%. The researchers contended that overall compliance with legal reporting requirements was weak and regulatory oversight is lacking.
This was the first analysis to examine the Clinical Trial Information System (CTIS) that was created in 2022 as part of an effort to enhance transparency across the European Union and the European Economic Area. The registry contains more than 8,400 mid- and late-stage trials and, in the coming months and years, sponsors will be legally required to make results public.
In a boost for greater clinical trial transparency, the European Medicines Agency (EMA) is taking what consumer advocacy groups are calling unexpectedly “rapid action” to ensure that study results are made public as required by law.
The move comes after a recent analysis found results for less than half of the studies registered in a key European database were reported within the required time frame and complete results were fully reported for only 42%. The researchers contended that overall compliance with legal reporting requirements was weak and regulatory oversight is lacking.
This was the first analysis to examine the Clinical Trial Information System (CTIS) that was created in 2022 as part of an effort to enhance transparency across the European Union and the European Economic Area. The registry contains more than 8,400 mid- and late-stage trials and, in the coming months and years, sponsors will be legally required to make results public.
Uncategorized
Biologics push CMOs/CDMOs to expand sterile fill-finish and prefilled syringe capacity
Biologics push CMOs/CDMOs to expand sterile fill-finish and prefilled syringe capacity
As biologics, biosimilars and GLP-1s drive demand for sterile drug products, CMOs and CDMOs are investing in fill-finish, lyophilization, inspection and packaging capacity to keep pace with a dynamic injectable market. Read More
The FDA’s new investigational new drug pilot program—one part of HHS’s broader clinical trial modernization initiatives—has lofty goals to expedite first-in-human trials of novel drugs, but experts say it won’t tip the scales much on its own.
The Phase 3 failure of AstraZeneca and Ionis Pharmaceuticals’ antisense therapy in transthyretin amyloid cardiomyopathy last month left the space reeling—and readjusting. BioSpace looks at five contenders and where they currently stand.
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