Real-World Data / Real-Word Evidence Insights

41. 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.

42. 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.

43. 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.

44. 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.

45. 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.

46. 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.

47. 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.

48. How To Take Full Advantage Of RWD Without Jeopardizing Privacy Laws 9/26/2022

    Biopharma companies need personally identifiable information to aggregate and analyze valuable real-world data. However, in many countries, these details are protected by data privacy laws. The EU's EHDS regulation helps clarify the situation in Europe, but other regulatory authorities will also need to clarify and articulate their positions.

49. Using RWE In Clinical Trials: Challenges & Opportunities 9/19/2022

    What are real-world data (RWD) and real-world evidence (RWE), and how can we overcome the challenges of integrating them into clinical trials to produce better outcomes?

50. Walgreens Is Ready To Re-Envision Recruitment, DCTs, And RWE 9/12/2022

    Since becoming CEO of Walgreens Boots Alliance (WBA) in March 2021, Rosalind Brewer has been focused on healthcare and what the company could do to help its patients. WBA refers to the integrated healthcare, pharmacy, and retail store that currently serves millions of customers and patients every day. This past June, the company launched its clinical trial business.