Featured Editorial

  1. 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.

  2. 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.

  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. Unlocking The Potential Of RWD: Validating Prevalence Estimates For Rare Diseases 3/27/2023

    Real-world data (RWD) has proven to be valuable in studying rare diseases. Incorporating RWD has led to the identification of previously undetected cases and the monitoring of treatment outcomes. However, challenges such as the lack of standardized data collection and analysis methods still exist. To replicate successes, researchers should collaborate to establish standardized protocols, thereby advancing our understanding of rare diseases and improve patient outcomes.

  6. 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.

  7. TMF Reference Model Affiliation With CDISC Could Improve TMF Interoperability 3/20/2023

    There is a growing desire within the clinical trials industry for better data integration — not just to help regulators, but also to help sponsors manage trials more effectively. The recent affiliation of the TMF Reference Model with the Clinical Data Interchange Standards Consortium (CDISC) may become key to making this possible.

  8. Dispelling 4 Common Myths Of Data Quality Governance 3/9/2023

    Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.

  9. Are Baseline Measurements Reliable? How RWD Can Help 3/6/2023

    Baseline measurements presume to establish physiological and/or metabolic status before introduction of test drug(s). But what if they aren't truly reflective for a particular patient? Introducing real-world data (RWD) might be the answer for improved accuracy.

  10. 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.