Real-World Data / Real-Word Evidence Insights
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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.
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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.
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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.
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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.
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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.
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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.
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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?
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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.
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Digital Solutions, Technology, And Patient Care Top Life Science Trends
9/6/2022
Technology company Within3 has produced a paper on the six top trends that are going to impact the pharmaceutical space. It’s no surprise that technology solutions were one of the trends making the list, but also included were factors such as patients, cyber threats, and a growing global marketplace.
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Combining Data Science & RWE For Better Clinical Outcomes For Immunological Diseases
8/15/2022
As we continue to better understand immune-mediated inflammatory diseases, Janssen is applying machine learning and artificial intelligence to real-world data to generate real-world evidence (RWE). This RWE gives us a deeper awareness of patient needs, gaps in current treatment options, and a vision toward new areas of research.