The call for diversity in clinical trial participants reached a crescendo last year with the emergence of the COVID-19 pandemic and the killing of George Floyd. The US Food and Drug Administration sped up the tempo when it issued guidance specifying what companies can do to boost enrollment of people of color. But some stakeholders are concerned that it may not be enough to get sponsors to modify their practices.
Clinical Trial Diversity: We Must ‘Turn This Moment Into A Movement’
Pfizer and Genentech execs describe steps they’ve taken to increase diversity in clinical trials from moving trial sites into new neighborhoods to modifying protocols and holding others accountable for diversity.
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Newly published insights from a series of European Medicines Agency workshops can guide drug developers in designing development plans that meet the needs of both regulators and health technology assessment bodies.
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The new global GCP guideline, ICH E6(R3), enables researchers and clinical trial administrators to tailor their documentation processes, but also opens the door for more scrutiny during GCP inspections.
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The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.
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As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.
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As Indian CROs are bracing for new registration mandates, an expert panel at the IGBA’s 3rd Bioequivalence conference discusses the implications of non-compliance in bioequivalence studies.
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Experts working in the advanced therapy space say the US has less strict criteria for regulatory pathways for cell and gene therapies than the EU, particularly for products in early development.
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Japan adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.