Within the clinical trials industry, there is a growing consensus about the value of evidence-based research – that is, research that more carefully and methodically takes into account past studies on the same topic – as a way of more efficiently building clinical consensus around particular therapies and to fight what some see as rampant waste and redundancy in research.
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In clinical research, appropriate use of biostatistics is crucial to a successful trial. Biostatistical methods determine the appropriate size and type of study population, underpin the entire statistical analysis plan (SAP) applied throughout the trial and play a key role in ensuring the integrity and quality of data generated during the study. This helps ensure that PIs and other key research staff draw the right conclusions about an investigative treatment’s performance based on the evidence provided.
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The FDA has offered its latest recommendations for sponsors of drugs being developed to treat or prevent COVID-19, issuing another straight-to-final guidance on clinical trials that supplants the agency’s prior direction on the subject.
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As 2023 drew to a close, the FDA issued several final guidances, including documents on collecting trial data with digital health technologies, developing rare disease drugs and biologics, and using real-world data sources, as well as a new draft guidance on clinical trial master protocols.
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A Detroit, Mich.-based principal investigator’s (PI) failure to renew IRB approval during a trial and adhere to the required treatment phases in a trial’s investigational plan has netted an FDA warning letter.
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