Decentralized Clinical Trials
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.
Meet patients where they are with consent information
The cornerstone of access to any clinical research project is the informed consent process–the decision of a participant to join a study based upon full and complete sharing of information about what the study will require, the risks of participation, and the voluntary nature of that participation.
This isn’t simply the participant’s signature on a paper or electronic form. According to governmental organizations like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), that signature is only part of the process. Of perhaps even greater importance is the provision of information to the patient accompanied by a discussion of the study and a chance to have questions answered, so that the decision can truly be considered “informed.”
How to bring patients into the product journey
Technology today has given patients unparalleled access to information and influence over their health care. As a result, many clinical trial sponsors now recognize the importance of taking a “patient centric” approach to clinical trials. That means designing a treatment, clinical trial, or other health solution centered around the patient, and includes getting feedback from patients, caregivers, families, and advocacy groups every step of the way.
In other words, it means treating patients as informed stakeholders whose participation is key to a successful trial and product following marketing authorization. Engaging patients and truly bringing them into the product journey has the power to transform the future of research and medicine. Read on to understand what patients expect from clinical trials today, and how to engage them throughout the product journey.
White paper: The foundations of decentralized clinical trials
Understand the benefits of web-enabled research tools and how they work.
White paper: The building blocks of DCT. How to create a seamless experience across eConsent, eCOA and more
Combining multiple market solutions at the site level can result in a negative experience due to different processes, login credentials, and redundant training. A unified DCT platform that works seamlessly with other core clinical systems to streamline workflows and simplify key trial processes.
Podcast: How do you ensure clinical trial access for all?
Medable CEO Michelle Longmire joins Beyond the Molecule Podcast to discuss how the industry can expand clinical trial access to all populations.
Back to Basics: Remote patient monitoring
Remote patient monitoring programs and technologies are becoming increasingly popular, backed by growing clinical evidence showing numerous benefits to patients and providers. While remote patient monitoring (RPM) isn’t new, it’s evolving quickly due to the regulatory push to expand access to care during the COVID-19 pandemic. Coupled with the fact that the digital health market is poised to more than double by 2026, providers and patients have a greater ability to track vitals between visits, and both centralized and decentralized clinical trials rely on remote data collection now more than ever. While there is tremendous potential upside, some barriers and risks are inherent in this digital process. Human-centered design and strategic implementation can ensure that RPM in clinical trials is both beneficial and cost effective.