Real-World Data / Real-Word Evidence Insights

1. Is Double Programming Really Required For Validation? 3/10/2025

   Double programming has been the gold standard for validation, but technological advancements and improved sponsor oversight of CRO deliverables have introduced more efficient and reliable alternatives.

2. Meaningful Industry Change Means Balancing Tech And Human Touch 5/6/2024

   Technology and AI/ML are advancing at an unprecedented pace, and we must not lose sight of our industry's core: human-to-human interaction.

3. Embracing Hybrid Trial Design — How, When, & Why To Use It 6/28/2023

   Global Clinical Sciences & Operations Innovation Lead Lewis Millen talks about UCB’s approach to hybrid trial design, how and when it chooses to implement remote and virtual elements, and why a hybrid trial is beneficial to both the sponsor and the patient.

4. Using RWD For Rapid Signal Assessment: Current Gaps And Opportunities 6/23/2023

   One of the chief benefits of applying RWD for rapid signal assessment is that it can provide a more accurate view of outcomes that should be expected within a given clinical scenario. However, before RWD’s maximum potential for rapid signal assessment can be reached, the industry must overcome some sizable challenges. Amgen's Vaishali Patadia explains.

5. Safety-centric Monitoring: Measuring Safety Data In A Consistent And Standardized Manner 6/19/2023

   Today, we have access to more data than ever before, and in an ever-advancing technological landscape, it is increasingly important to adopt a safety-centric monitoring approach that ensures we can measure safety data in real time and in a standardized manner across the industry. The challenge now is how to extract and leverage the quality data from the large volume that we have access to.

6. 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. 

7. How Do You Determine If RWE Is A Good Fit For Your Org? Ask (And Answer) The Right Questions 6/5/2023

   Real world evidence (RWE) is being heralded as a way to enrich our clinical data and lower the barriers to reimbursement. It also carries the potential of reducing the patient burden and lowering the cost of clinical data acquisition. But before getting to the point where we can reap the promises of RWE, we face a number of challenges as an industry. 

8. 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.

9. Patient-Powered AI Is Driving Science And Innovation Forward 5/17/2023

   Drug discovery is a game of information: If we understand disease well, we know where to intervene and how to design a molecule to target the disease. AI can be used to integrate the patient experience and voice into solutions, further enhancing their relevance. 

10. Speed Up, Collect More, And Reach Further: Using RWD To Optimize Your Clinical Trials 5/10/2023

    The benefits of real-world data (RWD) have been so promising, the FDA now recognizes RWD — and corresponding real-world evidence (RWE) — as valid tools for monitoring the safety of products post-market and, in some cases, for making regulatory approval decisions. At Freenome, we first integrated the use of RWD during a clinical study launched in 2022 for the early detection of multiple cancers. Along the way, we’ve discovered several benefits RWD can bring to any clinical research program.