Decentralized Clinical Trials

DIA 2022 provided four days worth of content spanning over 13 talk tracks and hundreds of speakers with three major takeaways.

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Explore ways to improve the consenting communication process using clear language and the latest technology.

Get the basics on ClinROs, why they are important, the industry governance around them, and how their electronic versions can benefit clinical trials.

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Colin Miller is Co-Founder and CEO at The Bracken Group, a life science consultancy providing high-level expert support in imaging, regulatory, due-diligence, and more.  A scientist by education, Colin has written more than 70 peer-reviewed scientific and medical publications, published 3 books, and holds 3 patents.

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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.”

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Clinical trials are essential for the development of new medical treatments and devices. However, enrolling patients in clinical trials is one of the most challenging aspects of conducting these studies. This is especially true when it comes to recruiting a diverse and representative patient population.

We sat down with Rosamund Round, VP, Patient Innovation Center and Decentralized Trials at Parexel, about the challenge of improving diversity in clinical trials and what Parexel is doing to meet it.

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.

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Understand the benefits of web-enabled research tools and how they work.

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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.

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Medable CEO Michelle Longmire joins Beyond the Molecule Podcast to discuss how the industry can expand clinical trial access to all populations.

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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.

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