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November 4, 2024: Update to Living Textbook Offers Tips for Developing a Compelling PCORI Grant Application

Rethinking Clinical Trials

The NIH and the Patient-Centered Outcomes Research Institute (PCORI) are major funders of pragmatic clinical trials embedded in healthcare systems. An existing chapter of the Living Textbook of Pragmatic Clinical Trials provided guidance on how to Develop a Compelling Grant Application for the NIH.

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Eisai and National Cancer Center partner for tazemetostat clinical research

Pharmaceutical Technology

Eisai and the National Cancer Center have signed an agreement to partner on investigator-initiated clinical research for the anti-cancer agent, tazemetostat (Tazverik Tablets 200 mg), based on the Patient-Proposed Healthcare Services system.

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Why prospective real-world studies hold so much promise for clinical research

Bio Pharma Dive

PrwS studies can reach beyond the limitations of today’s RWE studies and expand the role of RWD across the entire drug development cycle.

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The State of Pediatric Clinical Research: An Interview with Paidion CEO Barry Mangum, PharmD, FCP

Camargo

Barry Mangum talks the importance of pediatric research, its evolution over the years, and the obstacles and opportunities that the industry faces as it moves forward. How long have you been in pediatric clinical research, and how did you enter the field? We used drugs we developed in adults off-label in children.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? This new guidance will clearly impact the clinical research field, but how? Learning Objectives: Dose-response curves and patient treatment: How do pharmacologic and toxicologic principles apply to the dosing of drugs in clinical development?

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Mitigating FEAR in Clinical Research Innovation: ‘Face Everything And Rise’ Together!

ACRP blog

Change management is an overarching theme in innovation, with a need to mitigate and resolve barriers to change due to low institutional and personal risk tolerance, says David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, at the FDA Center for Drug Evaluation and Research (CDER).

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Eisai and Washington University to develop neurodegenerative disease therapies

Pharmaceutical Technology

Eisai has entered a comprehensive research partnership agreement with Washington University School of Medicine in St Louis, US, to develop potential new therapies for neurodegenerative ailments. Under the deal, the parties intend to develop treatments for diseases including Alzheimer’s and Parkinson’s.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management.