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Medable perspective: Key takeaways of recent FDA DCT Draft Guidance
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Population Representation: Everyone Must Play a Part

Perspectives
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Perspectives

Gender equity relies on health equity

6 min

By Sanskriti (“Sans”) Thakur, CGO. As we celebrate Women’s History Month this March, the world takes a moment to recognise women’s accomplishments, while also highlighting the inequity that remains. When it comes to women’s health, those inequities are stark. And a contributing factor is the lack of women in clinical trials. When population representation falls short, medicines are less safe and effective. Measures such as the US Congress’s proposed DIVERSE Trials Act are helping drive equitable representation, but that’s just the beginning.

Perspectives

ACRP: Unique Considerations for Patient Retention in Decentralized Clinical Trials

6 min

By Ingrid Oakley-Girvan, PhD, SVP, Value and Strategy. As decentralized clinical trials (DCTs) become more prevalent, particularly in the wake of the pandemic, their lower burden approach can make participation more attractive for some. Yet the vexing issue of retaining participants throughout the course of a trial will continue to be problematic without a thoughtful approach to keep them engaged. A three-phase model of engagement, based on proven science and intelligently informed by utilizing data, can make important inroads into solving this long-standing challenge.

vaccine
Perspectives

ACRP: With a Reinvigorated Focus on Vaccine Research, Why Are We Still Using Dated Approaches?

6 min

By Musaddiq Khan, VP DCT Solutions. The pace of development for new medicines has traditionally been slow and burdened with lengthy enrollment, conduct, and analysis timelines. However, COVID-19 was a catalyst to adopt novel approaches to drug development that have harnessed technology to create new, accelerated processes for conducting clinical trials. Technology-enabled hybrid and decentralized clinical trials (DCTs) are now moving from the periphery into starring roles across many areas of research—with a notable exception.

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