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Back to basics: How the FDA's diversity requirements impact clinical trial treatments
The FDA is taking steps to ensure that clinical trials are more representative of the diverse populations they aim to serve. This comes after the industry and the FDA's long-term recognition that clinical trials have often excluded underrepresented groups, leading to health disparities across the United States and the world.
The Future of decentralized clinical trials: Opportunities and adaptations for Medable
Traditionally, clinical trials have relied heavily on centralized sites and face-to-face interactions between researchers and participants. However, the limitations of this model have become increasingly apparent, especially during the COVID-19 pandemic, which prompted an unprecedented emergence of decentralized clinical trials (DCTs), whose characteristics of remote patient engagement, virtual assessments, and mobile health technologies allowed the healthcare industry to continue drug development (albeit at a slower pace). As the healthcare landscape continues to evolve, DCTs are emerging as a vital component of the clinical research ecosystem. By leveraging technology and data to streamline processes and the need to enroll a greater diverse patient population, DCTs promise enhanced patient engagement, improved data quality, and accelerated study timelines. As with everything in life, nothing is always that simple. In this blog, we will explore the future of decentralized clinical trials and look at the challenges faced by sponsors, sites, and patients when planning, implementing, and running a DCT. We will also discuss how Medable is continuously adapting its platform and software capabilities to reduce risks and provide solutions that allow the benefits of DCTs listed above to be fully realized.
Bringing empathy into the digital environment
Learn best practices to incorporate empathy and human interaction in the digital environment with attentive listening, building relationships with sites, promoting clinical trial technology implementation, and learning from other industries that have successfully transitioned to digital.