Clinical Trial Technology Editorial

  1. How Blockchain Can Empower Patients And Improve Clinical Trials 8/4/2023

    Blockchain is far bigger than cryptocurrency. It's a data encryption technology that can not only strengthen existing clinical systems, but also (and most importantly) empower patients by giving them more control and ownership of their clinical data.

  2. New Advancement Toward The First Primary Endpoint Qualification Of A Digital Endpoint For Duchenne 4/27/2023

    Current methods for assessing ambulatory function in patients with Duchenne muscular dystrophy do not fully reflect how they experience DMD in their daily lives. Now, researchers have developed a new endpoint measured by a wearable device that records a patient's fastest spontaneous strides outside the clinic. What's more, it could become the first-ever digital primary endpoint approved by regulators.

  3. 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.

  4. The CDISC Open Rules Engine (CORE): Open-Source Software For Clinical Trials 3/29/2023

    Open-source software development, widely used across most industries globally, has recently been gaining ground in clinical research. Discover how CDISC's Open Rule Engine (CORE) can make sharing standardized data sets easier and improve your workflow.

  5. Consistent And Clear Terminology, Best Practices Needed To Scale Sensor-Based DHTs 3/24/2023

    Sensor-based digital health technologies (DHTs) have been increasingly adopted in clinical research, clinical care, and everyday life, but a lack of clarity regarding usability best practices means that not all of these tools can be successfully implemented at scale.

  6. New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices 2/15/2023

    The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.

  7. How BMS Uses AI To Improve Study Design And Reduce Costs 1/19/2023

    In 2022, Bristol Myers Squibb (BMS) announced plans to work with AI developer Owkin to design and optimize cardiovascular drug trials. The partnership will allow BMS to use machine learning to enhance clinical trial design and execution.

  8. DTRA Looks At The Future Of Decentralized Trials 1/3/2023

    In November 2022, the Decentralized Trials & Research Alliance (DTRA) held its annual meeting in Boston. The meeting was a chance for members of the Alliance to come together to discuss the progress that has been made and what the future holds for the emerging technology.

  9. How One Pharma Company Is Embracing Digital Technologies 12/21/2022

    The increased demand for hybrid and decentralized approaches to clinical trials has increased the use of digital devices and other tools that will make studies more patient centric. Sanofi is one of the companies leading the way in getting devices into the hands of patients.

  10. The Future Of TransCelerate: Clinical Trial Modernization 12/19/2022

    In January 2023, Janice Chang will take over as the head of industry consortia non-profit organization TransCelerate. Chang has been involved with TransCelerate since it was just a concept, and notes the time spent in the group since its launch has been an amazing journey.