The US Food and Drug Administration's Real-World Evidence Framework: A Commitment for Engagement and Transparency on Real-World Evidence

Mitigating Limited Data Challenges to Improve Artificial Intelligence Integration in Rare Disease Drug Development.

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Leveraging Artificial Intelligence in Drug and Biological Product Development: An FDA and Clinical Trial Transformation Initiative Workshop Report.

NEJM AI·2025

Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants: A Randomized Clinical Trial.

JAMA network open·2022

Advancing an agile regulatory ecosystem to respond to the rapid development of innovative technologies.

Clinical and translational science·2022

Leveraging the Capabilities of the FDA's Sentinel System To Improve Kidney Care.

Journal of the American Society of Nephrology : JASN·2020

Recommendations for data monitoring committees from the Clinical Trials Transformation Initiative.

Clinical trials (London, England)·2017

Model-based clinical pharmacology profiling of subcutaneous nivolumab in renal cell carcinoma: Bridging to alternative dosing regimens and indications.

Clinical pharmacology and therapeutics·2026

Trust, but Verify: Translating Dosing Evidence to Understudied Populations in Low- and Middle-Income Countries.

Clinical pharmacology and therapeutics·2026

From Biological Mechanisms to Causal Inference: Quantitative Systems Pharmacology and Causal Frameworks in Drug Development.

Clinical pharmacology and therapeutics·2026

The Hidden Cost of QTc Assessment: A Quantitative Weight of Evidence Framework to Eliminate Structural False Positives and Restore the Lost Opportunity Cost of Abandoned Medicines.

Clinical pharmacology and therapeutics·2026

Creatinine-Cystatin C Discrepancy and Renal Transporter Polymorphisms in Japanese Patients with Breast Cancer Receiving Abemaciclib.

Clinical pharmacology and therapeutics·2026

Probabilistic Risk-Benefit Profile of Ticagrelor Monotherapy After Short Dual Antiplatelet Therapy: A Bayesian Analysis of the ULTIMATE-DAPT Trial.

Clinical pharmacology and therapeutics·2026

Policy Standards for Healthy Built Environments: A Systematic Review of Health Impact Assessments and Nonrandomized Evaluations of Implemented Policies.

Journal of urban health : bulletin of the New York Academy of Medicine·2026

A research agenda for making evidence useful, usable and used in policymaking.

Nature human behaviour·2026

Perceived Social Connectedness and Substance Use among Adolescents and Young Adults in North Carolina.

Prevention science : the official journal of the Society for Prevention Research·2026

Reconciling fragmented sectors of health research regulation: toward an ecosystem of processual regulation.

Humanities & social sciences communications·2026

Historical Changes and Cross-Country Comparisons of Long-Term Care Policy: A New Resource.

Journal of long-term care·2026

The role of lived and living experience in evidence-based decision-making in suicide prevention.

Health promotion international·2026

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