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Real-world evidence and regulatory decision-making: A round-up of readings on progress to date, and what’s to come
In recent years, the U.S. Food and Drug Administration (FDA) and other global regulatory ...
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Lessons from four recent FDA decisions in infectious disease
The use of real-world evidence (RWE) has proven pivotal to research in infectious ...
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The Cures Act’s second act: Six ways to ensure Congress doubles down on its boldest bet
In the article below, originally published in Morning Consult, Carolyn Magill, CEO of ...
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How to generate insights on COVID-19 interventions with real-world data: Three learnings from the COVID-19 Therapeutics Evidence Accelerator
The COVID-19 Evidence Accelerator, organized by the Reagan-Udall Foundation for the FDA ...
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What’s ahead for the use of RWE by regulators and HTAs? Q&A with Dr. Lucinda Orsini, Associate Chief Science Officer of ISPOR
Lucinda Orsini, D.P.M., M.P.H., has decades of experience working with biopharma, ...
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Financing innovative therapies in the era of COVID-19: The collaborative work ahead
Much discussion surrounds how our society will pay for curative and high cost therapies, ...
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The case for regulator-HTA collaboration on RWE methodology standards
Regulatory and health technology assessment (HTA) bodies have announced their commitment ...
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Trends and predictions for RWE: Perspectives from Dr. Sean Hennessy, pharmacist and pharmacoepidemiologist
Sean Hennessy, Pharm.D., Ph.D., is a pharmacist and pharmacoepidemiologist who feels he ...
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Q&A with Dr. Nicolle Gatto: Leveraging external comparators for drug development and COVID-19 research
Nicolle Gatto, Ph.D., is the Senior Vice President of Scientific Research at Aetion, ...
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The causal revolution in observational research: Breaking the causality taboo
As interest in real-world evidence (RWE) increases, the conversation often focuses on the ...
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How can biopharma use oncology real-world data to support clinical development? Q&A with Viraj Narayanan, VP of Life Sciences, COTA
In oncology, real-world data (RWD) has emerged as an important tool to support clinical ...
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COVID-19: The critical role of real-world evidence made real
In the article below, originally published in HLTH Matters, Carolyn Magill, CEO of ...
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FDA vaccine approval and common self-controlled study designs for vaccine safety testing
Across the United States, a patchwork of communities have begun to lift the stay-at-home ...
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HTAs and RWE: Current use, predicted trends, and next steps for biopharma
In recent years, technological advances have both expanded the amount and availability of ...
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Priorities for modernizing ClinicalTrials.gov: Five ideas to facilitate transparency in observational research
ClinicalTrials.gov (CT.gov) is the largest public clinical registry and results database ...
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Real-world evidence and COVID-19: Empower rapid, reliable, data science-driven decisions
The COVID-19 pandemic has triggered intense and widespread action among the biopharma ...
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The surge in RWE supported FDA approvals: A look at three FDA decisions
The U.S. Food and Drug Administration (FDA) is approving more drugs with the help of ...
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Optimizing pharma organizational design for effective use of real-world evidence
Across the pharma product lifecycle, factors like the regulatory environment and business ...
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How RWE can inform cancer care: Q&A with Dr. Deb Schrag, oncologist and observational researcher
Real-world evidence (RWE) has emerged as a useful tool for industry and regulators in ...
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How can you leverage RWE to help advance your organization’s goals? Q&A with Dr. Yin Ho
Trained as an emergency medicine physician, Yin Ho, M.D., M.B.A., stepped out of the ...
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How to plan for evidence generation in a time of uncertainty
Much of my time lately has been dedicated to contemplating the magnitude of COVID-19’s ...
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COVID-19: Recommended readings and resources from Aetion scientists
Over the past few weeks, we’ve been adjusting to the many changes and uncertainties ...
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Making the business case for RWE: Julie Schiffman’s advice for biopharma on leveraging data to drive impact
How can teams within biopharma ensure their real-world evidence (RWE) studies make the ...
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Psychiatrist and health care CEO Dr. Gary Gottlieb: Treating the patient as a whole person
With his previous professional experience ranging from CEO of Massachusetts-based ...