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Use of Real‐World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018–2019
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Use of Real‐World Data and Evidence in Drug Development of Medicinal Products Centrally Authorized in Europe in 2018–2019 (2021)Use of Real‐World Data and Evidence in Dr…Understanding Use of Real‐World Data and Real‐World Evidence to Support Regulatory Decisions on Medical Product Effectiveness (2021)Understanding Use of Real‐Wor…Use of Real-World Evidence to Support FDA Approval of Oncology Drugs (2020)Use of Real-World Evidence to…Use of Real-world Data for New Drug Applications and Line Extensions (2020)Use of Real-world Data for Ne…Examining the Use of Real‐World Evidence in the Regulatory Process (2019)Examining the Use of Real‐Wor…Real world data: an opportunity to supplement existing evidence for the use of long-established medicines in health care decision making (2018)Real world data: an opportuni…Characteristics and follow‐up of postmarketing studies of conditionally authorized medicines in the EU (2016)Characteristics and follow‐up…Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs (2012)Quantum of Effectiveness Evid…Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma (2008)Approvals of drugs with uncertain benefit–risk profiles in Europe (2015)From adaptive licensing to adaptive pathways: Delivering a flexible life‐span approach to bring new drugs to patients (2015)“Adaptive pathways” to drug authorisation: adapting to industry? (2016)Which clinical studies provide the best evidence? (2000)Hierarchy of evidence: a framework for ranking evidence evaluating healthcare interventions (2002)Using Real-World Data for Coverage and Payment Decisions: The ISPOR Real-World Data Task Force Report (2007)Assessing the efficacy‐effectiveness gap for cancer therapies: A comparison of overall survival and toxicity between clinical trial and population‐based, real‐world data for contemporary parenteral cancer therapeutics (2020)Current challenges for assessing the long-term clinical benefit of cancer immunotherapy: a multi-stakeholder perspective (2020)Developing a framework to incorporate real-world evidence in cancer drug funding decisions: the Canadian Real-world Evidence for Value of Cancer Drugs (CanREValue) collaboration (2020)The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies (2007)The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for Reporting Observational Studies (2007)The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) Statement (2015)Enhancing the quality and efficiency of regulatory science literature reviews through innovation and collaboration with library and information science experts (2024)Motivación de los empleados: un poderoso modelo nuevo (2008)Use of External Comparators for Health Technology Assessment Submissions Based on Single-Arm Trials (2021)Contribution of Real‐World Evidence in European Medicines Agency's Regulatory Decision Making (2022)Market withdrawal of new molecular entities approved in the United States from 1980 to 2009 (2011)Current landscape of innovative drug development and regulatory support in China (2025)Data Quality–Driven Improvement in Health Care: Systematic Literature Review (2024)
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References

  • 2018Real world data: an opportunity to supplement existing evidence for the use of long-established medicines in health care decision making237 cited
  • 2019Examining the Use of Real‐World Evidence in the Regulatory Process166 cited
  • 2020Use of Real-World Evidence to Support FDA Approval of Oncology Drugs121 cited
  • 2020Use of Real-world Data for New Drug Applications and Line Extensions83 cited
  • 2021Understanding Use of Real‐World Data and Real‐World Evidence to Support Regulatory Decisions on Medical Product Effectiveness62 cited
  • 2016Characteristics and follow‐up of postmarketing studies of conditionally authorized medicines in the EU55 cited
  • 2012Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs54 cited

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