FDA Oncology Trial Guidance Targets Eligibility Barriers
FDA oncology clinical trial guidance targets restrictive eligibility criteria, covering performance status, washout periods, medications, and laboratory values.
“The pharma industry is beginning to look at biological age as a surrogate endpoint to improve clinical trials."
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FDA oncology clinical trial guidance targets restrictive eligibility criteria, covering performance status, washout periods, medications, and laboratory values.
EHR patient recruitment could improve clinical trial matching, but workflow integration, data quality, interoperability, and AI validation remain key challenges.
Revised FDA draft guidance for generic peptide products updates expectations for ANDAs, impurities, structure, immune response, and biological activity.
Ethical obligations in decentralised clinical trials extend beyond consent and privacy. Sponsors must protect safety, scientific validity, equity, and oversight.
Adaptive clinical trials can improve efficiency, reduce patient burden, and support faster development through structured, evidence-based flexibility.
Learn how AI in pharmaceutical GMP manufacturing is improving quality, data integrity, predictive maintenance, and regulatory compliance in modern drug production.
Patient and public involvement in clinical trials improves study design. Learn why better reporting is essential for transparent, patient-centred research.
A recent systematic review reveals incredible detail about informed consent in clinical trials, participant understanding, and trial quality. Find out now.
Learn how optimised clinical trial data collection improves data quality, reduces protocol and patient burden, and supports smarter clinical development.
The FAST-EU Pilot aims to accelerate multinational clinical trials through faster coordinated assessments, supporting Europe’s 2030 clinical research ambitions.
One pivotal trial for FDA approval could accelerate drug development, reshape clinical trial strategy, and change the pharmaceutical regulatory landscape.
The new European Life Sciences Strategy aims to accelerate pharmaceutical innovation through investment, regulatory reform, biotechnology, and AI capabilities.