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Publication Project: RWE

White Paper | Considerations for Leveraging Real-World Endpoints in Oncology Drug Development

2024 Scientific Report

White Paper | 2024 Annual Meeting | Pragmatism in Postmarket Trials

Peer Review | Evaluation of Real-World Tumor Response Derived From Electronic Health Record Data Sources: A Feasibility Analysis in Patients With Metastatic Non–Small Cell Lung Cancer Treated With Chemotherapy

Public Comment | Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases

Public Comment | Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices

Public Comment | Cancer Clinical Trial Eligibility Criteria: Minimum Age Considerations for Inclusion of Pediatric Patients

2023 Scientific Report

Peer Review | Real-world Overall Survival Using Oncology Electronic Health Record Data: Friends of Cancer Research Pilot

Randomized controlled trials (RCTs) evaluate the safety and efficacy of medical products in specific patient populations under rigorously controlled conditions. While adherence to structured protocols, use of restrictive eligibility criteria, and patient randomization maximize the internal validity of RCT results, eligibility and protocol-directed care may reduce the relevancy of study results for broader patient populations…

Peer Review | The Friends of Cancer Research Real-World Data Collaboration Pilot 2.0: Methodological Recommendations from Oncology Case Studies

The 21st Century Cures Act was enacted in 2016, to evaluate the health policy goals of trial design modernization and use of real-world evidence (RWE) creating numerous synergistic efforts.1 These efforts aim to further understand ways in which RWE may complement or supplement randomized controlled trial data for regulatory purposes.2–6 Evaluating applied examples of real-world data (RWD)…