Cargando…

A Structured Preapproval and Postapproval Comparative Study Design Framework to Generate Valid and Transparent Real‐World Evidence for Regulatory Decisions

Real‐world evidence provides important information about the effects of medicines in routine clinical practice. To engender trust that evidence generated for regulatory purposes is sufficiently valid, transparency in the reasoning that underlies study design decisions is critical. Building on existi...

Descripción completa

Detalles Bibliográficos
Autores principales:	Gatto, Nicolle M., Reynolds, Robert F., Campbell, Ulka B.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2019
Materias:	Reviews
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6771466/ https://www.ncbi.nlm.nih.gov/pubmed/31025311 http://dx.doi.org/10.1002/cpt.1480

Ejemplares similares

Characteristics of Preapproval and Postapproval Studies of Vaccines Granted Accelerated Approval by the US Food and Drug Administration
por: Egilman, Alexander, et al.
Publicado: (2021)

Best practices in designing preapproval information engagements for US health care decision makers
por: Dodda, Sai, et al.
Publicado: (2023)

Author's response to Poole, C. Commentary: How Many Are Affected? A Real Limit of Epidemiology
por: Gatto, Nicolle M, et al.
Publicado: (2010)

Transferability of real-world data across borders for regulatory and health technology assessment decision-making
por: Jaksa, Ashley, et al.
Publicado: (2022)

The Structured Process to Identify Fit‐For‐Purpose Data: A Data Feasibility Assessment Framework
por: Gatto, Nicolle M., et al.
Publicado: (2021)

The progress of postapproval clinical studies on Sabin IPV
por: Shi, Li, et al.
Publicado: (2021)

Redundant causation from a sufficient cause perspective
por: Gatto, Nicolle M, et al.
Publicado: (2010)

Distributional interaction: Interpretational problems when using incidence odds ratios to assess interaction
por: Campbell, Ulka B, et al.
Publicado: (2005)

Extending the sufficient component cause model to describe the Stable Unit Treatment Value Assumption (SUTVA)
por: Schwartz, Sharon, et al.
Publicado: (2012)

Strengthening postapproval oversight in research ethics committees: Challenges and solutions
por: Shetty, Yashashri Chandrakant, et al.
Publicado: (2023)

Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval
por: Wallach, Joshua D., et al.
Publicado: (2021)

Leadless pacemaker implant in patients with pre‐existing infections: Results from the Micra postapproval registry
por: El‐Chami, Mikhael F., et al.
Publicado: (2019)

Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review
por: Pease, Alison M, et al.
Publicado: (2017)

DuraSeal Exact Is a Safe Adjunctive Treatment for Durotomy in Spine: Postapproval Study
por: Kim, Kee D., et al.
Publicado: (2018)

Postapproval trials versus patient registries: comparability of advanced melanoma patients with brain metastases
por: Ismail, Rawa K., et al.
Publicado: (2020)

Getting Interdisciplinary Teams into the Field: Institutional Review Board Preapproval and Multi‐Institution Authorization Agreements for Rapid Response Disaster Research
por: Peek, Lori, et al.
Publicado: (2021)

Role of CTSA institutes and academic medical centers in facilitating preapproval access to investigational agents and devices during the COVID-19 pandemic
por: Gravelin, Misty, et al.
Publicado: (2021)

Availability of comparative real-world evidence research in Medicare patients: implications for Centers for Medicare and Medicaid Services drug price negotiations
por: Jaksa, Ashley, et al.
Publicado: (2023)

Real-world evidence for regulatory decision-making: updated guidance from around the world
por: Burns, Leah, et al.
Publicado: (2023)

A System Framework for Personalized and Transparent Data-Driven Decisions
por: Oppold, Sarah, et al.
Publicado: (2020)

Where Can Patients Obtain Information on the Preapproval Access Pathway to Investigational Treatment in Japan? A Survey of Patient Advocacy Organizations’ Websites
por: Nakada, Haruka, et al.
Publicado: (2019)

Comparison of survival outcomes after CyberKnife(®) radiotherapy in Taiwan using preapproved insurance-based reimbursement versus out-of-pocket expenditure
por: Hsu, Ya-Hui, et al.
Publicado: (2022)

Advancing a Framework for Regulatory Use of Real-World Evidence: When Real Is Reliable
por: Dreyer, Nancy A.
Publicado: (2018)

Six‐month outcomes in postapproval HeartMate3 patients: A single‐center US experience
por: Bansal, Aditya, et al.
Publicado: (2022)

Transparent, abrasion-insensitive superhydrophobic coatings for real-world applications
por: Helmer, Dorothea, et al.
Publicado: (2017)

Real‐World Data for Regulatory Decision Making: Challenges and Possible Solutions for Europe
por: Cave, Alison, et al.
Publicado: (2019)

Contribution of Real‐World Evidence in European Medicines Agency's Regulatory Decision Making
por: Bakker, Elisabeth, et al.
Publicado: (2022)

Postapproval clinical experience in the treatment of Dupuytren’s contracture with collagenase clostridium histolyticum (CCH): the first 1,000 days
por: Schulze, Scott M., et al.
Publicado: (2014)

Prescriber Compliance With Liver Monitoring Guidelines for Pazopanib in the Postapproval Setting: Results From a Distributed Research Network
por: Shantakumar, Sumitra, et al.
Publicado: (2019)

Patient burden and clinical advances associated with postapproval monotherapy cancer drug trials: a retrospective cohort study
por: Carlisle, Benjamin Gregory, et al.
Publicado: (2020)

Validation of a transparent decision model to rate drug interactions
por: Far, Elmira, et al.
Publicado: (2012)

Real World-Evidence for Regulatory Use Decision Aid: An Interactive Tool To Inform Clinical Development and Regulatory Strategies
por: Burns, Leah, et al.
Publicado: (2022)

Results of the combined U.S. multicenter postapproval study of the Nit‐Occlud PDA device for percutaneous closure of patent ductus arteriosus
por: Kobayashi, Daisuke, et al.
Publicado: (2018)

Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments
por: Skydel, Joshua J., et al.
Publicado: (2019)

Process of drug registration in Israel: the correlation between the number of discussions within the Ministry of Health and postapproval variations by EMA and/or FDA
por: Hiayev, Stephany, et al.
Publicado: (2023)

Real‐world evidence to support regulatory decision‐making for medicines: Considerations for external control arms
por: Burcu, Mehmet, et al.
Publicado: (2020)

Use of Real-World Evidence for Drug Regulatory Decisions in China: Current Status and Future Directions
por: Li, Pei, et al.
Publicado: (2023)

Reproducibility and Transparency by Design
por: Petyuk, Vladislav A., et al.
Publicado: (2019)

The Current Landscape and Emerging Applications for Real‐World Data in Diagnostics and Clinical Decision Support and its Impact on Regulatory Decision Making
por: Baumfeld Andre, Elodie, et al.
Publicado: (2022)

Analysis of US Food and Drug Administration Breast Implant Postapproval Studies Finding an Increased Risk of Diseases and Cancer: Why the Conclusions Are Unreliable
por: Swanson, Eric
Publicado: (2019)

Cannot write session to /tmp/vufind_sessions/sess_njv84rtd98675cutqseq9n2u47