FDA's push to encourage development of new antibiotics requires getting past data integrity issues in the class. The agency's workshop on antibacterial clinical trials revealed a range of efforts aimed at better Good Clinical Practices compliance - and those efforts can just as easily be applied to other drug classes
By Laura Helbling
The push to encourage antibiotic drug development includes finding a cure for data integrity issues that have plagued the class...
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The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
The whole contract research organization industry is being impacted by the current volatility in the pharmaceutical industry.
The UK government has acknowledged that sponsors of clinical trials for rare diseases face challenges around patient recruitment and trial design, which will be addressed in its clinical trials reform, a lawyer says.
Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.
