Decentralized Trial Technology Insights

1. Not What I Expected From A Vendor Conference 9/12/2024

   Dan Schell recounts some of his key takeaways after attending the Veeva R&D Quality Summit in Boston in September 2024. Some of the topics discussed include DCTs, eCOA, and the need to simplify tech integration at sites. 

2. Can DCTs Be Both Patient Centric And Financially Efficient For Sites? 9/22/2023

   While DCTs have the potential to provide more convenience and improved access for patients, the anticipated cost savings touted for these trials have yet to materialize fully at the site level. In fact, the opposite has occurred in some instances.

3. Advancing Rare Disease Research With Patient Registries 6/16/2023

   In this Q&A, “Rare dad” Harsha Rajasimha, Ph.D. of IndoUSrare discusses the current state of rare disease research and explains how patient registries can help propel drug development for rare disease therapies. 

4. Clinical Trial Diversity, Flexibility Championed By The Food And Drug Omnibus Reform Act 5/23/2023

   The Food and Drug Omnibus Reform Act, signed into law by President Biden on Dec. 29, 2022, includes provisions intended to modernize clinical trials and are broadly divided into two categories: encouraging the enrollment of diverse populations and facilitating novel clinical trial designs.

5. Understanding Data Collection And Management In Decentralized Clinical Trials (DCTs) 5/18/2023

   When it comes to wading into the muddy waters of a DCT, it's important to specify the risks up front and determine how decentralization is appropriate for each protocol. From a data collection and management standpoint, there is plenty to consider in terms of data flow management through multiple sources and systems.

6. FDA Releases Draft Guidance On Decentralized Clinical Trials 5/18/2023

   The FDA has released a new draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices. Check out the key takeaways related to remote trial visits, digital health technologies, and more. The public comment period ends August 1, 2023.

7. Why Developing A Metrics-Driven Culture Is A Clinical Operations Must-Do 4/14/2023

   The number of systems used to support the conduct of clinical trials has increased and the amount of data used to monitor our portfolio, studies, and processes has soared. While there is still value in using traditional dashboards and reports, the use of advanced analytics and RWD/E is enabling us to ask more sophisticated questions to be more predictive — what will happen — and prescriptive — how to make it happen.

8. AI And Healthcare Disparities: Driving A Wedge Or Closing The Gap? 3/31/2023

   The enthusiasm for the role of AI in upgrading global health and care provision is justified, provided we understand that the path to success is just as much about communication and collaborative development as it is about the raw potential of the technology itself. Because realizing this technological potential requires us to consider the role of people and processes in an integrated approach.

9. Sites Look To Unravel The Tech Tangle Of DCTs 2/28/2023

   Decentralized clinical trials and all their elements are touted as flexible options for patients. But what about the sites carrying them out? Jimmy Bechtel of the Society for Clinical Research Sites (SCRS) says sites are looking for clarity and consistency when it comes to the tech being thrust upon them by sponsors and CROs.

10. Faster, Easier, and More Anxiety-Inducing: Are DHTs Harming Patients' Mental Health? 2/2/2023

    Digital health technology (DHT) filled the communication gap created by physical distance during the pandemic, but have we created more space between participant and provider as we increasingly introduce and rely upon technology?