Real-World Data / Real-Word Evidence Insights

11. 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.

12. 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.

13. 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.

14. The 5Vs Of Collecting Clinical Data 1/26/2023

    Not all data is created equal. Our data strategies need to be commensurate with the risks, complexity, and value of the data collected. If the true value of data is to be realized, it must be collected and captured in accordance with the five “V” dimensions: volume, variety, velocity, veracity, and value.

15. 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.

16. Two Straightforward Ways To Improve DE&I In Clinical Trials 12/27/2022

    We don’t have to wait for federal guidance, additional DHT, or new innovations. We have the tools to begin to address the lack of trust and limited data and incorporate them into diversity plans for clinical trials today. Here's how.

17. Best Practices For Evaluating The Relevance And Quality Of RWD 12/20/2022

    Data scientists from Merck's Real-World Data Analytics and Innovation team share how they applied the Use-case specific Relevance and Quality Assessment (UReQA), a fit-for-purpose RWD quality framework, to assess and select high-quality and relevant data for RWE studies.

18. AstraZeneca Hopes To Advance Oncology RWE 12/6/2022

    AstraZeneca is an emerging leader in the chronic lymphocytic leukemia space. It now hopes to develop treatments so patients can avoid chemotherapy, with the hope those therapies will prolong survival in patients while also producing a better quality of life.

19. RWE & Advanced Diagnostics Propel Better Patient Outcomes 10/28/2022

    Notable diagnostic advancements in data science and the scientific community’s ability to use analytic tools are playing an essential role in improving patient outcomes.

20. FDA Releases Final Guidance On RWD/RWE Submissions For Drugs & Biologics 10/20/2022

    The guidance describes the approach sponsors should use to identify if and how real-world data (RWD) and real-world evidence (RWE) are incorporated into their regulatory submissions. The FDA notes that this guidance specifically applies to INDs, NDAs, and BLAs that contain RWD and RWE.