Pharma and biotech sponsors are increasingly following the FDA’s lead in using real-world data (RWD) and real-world evidence (RWE) in clinical trials, according to a new survey asking about the most valuable resources for clinical trials.
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When faced with an FDA inspection, sponsors, CROs and sites must be ready to present trial master files (TMF) that are up to date and give a comprehensive account of the study. And the most efficient way to ensure they are is to maintain a constant state of inspection readiness with a regular TMF review schedule.
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The FDA has published draft guidance outlining an ethical framework for involving children in clinical trials of drugs and devices, as well as trial design considerations.
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Sponsors, CROs and sites themselves agree that delayed site payments are still a significant issue in clinical research — so significant that they identified it as the most important activity to address in a recent survey.
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Pfizer’s minority fellowship program is discriminatory toward Whites and Asians, claims the nonprofit Do No Harm, a group of healthcare professionals, policymakers and patients dedicated to protecting healthcare from discriminatory ideology.
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