Real-world Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application Approvals from 2015-2020
This study aimed to analyze attributes of real-world studies in FDA's decision-making and characteristics of full versus accelerated approvals through a systematic review of oncology product approvals. Oncology approvals from 2015-2020 were reviewed from FDA.gov. Applications were screened for inclusion of RWE, and variables related to regulatory designations of the application, pivotal clinical trial, and real-world studies were extracted. FDA feedback was reviewed to identify takeaways and best practices for adequate RWE. Among 133 original and 573 supplemental approvals for oncology, 11 and 2, respectively, included RWE...
Source: Clinical Cancer Research - October 20, 2021 Category: Cancer & Oncology Authors: Bhakti Arondekar Mei Sheng Duh Rachel H Bhak Maral DerSarkissian Lynn Huynh Kelsey Wang John Wojciehowski Melody Wu Bryon Wornson Alexander Niyazov George D Demetri Source Type: research
Real-world Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application Approvals from 2015-2020
This study aimed to analyze attributes of real-world studies in FDA's decision-making and characteristics of full versus accelerated approvals through a systematic review of oncology product approvals. Oncology approvals from 2015-2020 were reviewed from FDA.gov. Applications were screened for inclusion of RWE, and variables related to regulatory designations of the application, pivotal clinical trial, and real-world studies were extracted. FDA feedback was reviewed to identify takeaways and best practices for adequate RWE. Among 133 original and 573 supplemental approvals for oncology, 11 and 2, respectively, included RWE...
Source: Clinical Cancer Research - October 20, 2021 Category: Cancer & Oncology Authors: Bhakti Arondekar Mei Sheng Duh Rachel H Bhak Maral DerSarkissian Lynn Huynh Kelsey Wang John Wojciehowski Melody Wu Bryon Wornson Alexander Niyazov George D Demetri Source Type: research
Real-world Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application Approvals from 2015-2020
This study aimed to analyze attributes of real-world studies in FDA's decision-making and characteristics of full versus accelerated approvals through a systematic review of oncology product approvals. Oncology approvals from 2015-2020 were reviewed from FDA.gov. Applications were screened for inclusion of RWE, and variables related to regulatory designations of the application, pivotal clinical trial, and real-world studies were extracted. FDA feedback was reviewed to identify takeaways and best practices for adequate RWE. Among 133 original and 573 supplemental approvals for oncology, 11 and 2, respectively, included RWE...
Source: Clinical Cancer Research - October 20, 2021 Category: Cancer & Oncology Authors: Bhakti Arondekar Mei Sheng Duh Rachel H Bhak Maral DerSarkissian Lynn Huynh Kelsey Wang John Wojciehowski Melody Wu Bryon Wornson Alexander Niyazov George D Demetri Source Type: research
Real-world Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application Approvals from 2015-2020
This study aimed to analyze attributes of real-world studies in FDA's decision-making and characteristics of full versus accelerated approvals through a systematic review of oncology product approvals. Oncology approvals from 2015-2020 were reviewed from FDA.gov. Applications were screened for inclusion of RWE, and variables related to regulatory designations of the application, pivotal clinical trial, and real-world studies were extracted. FDA feedback was reviewed to identify takeaways and best practices for adequate RWE. Among 133 original and 573 supplemental approvals for oncology, 11 and 2, respectively, included RWE...
Source: Clinical Cancer Research - October 20, 2021 Category: Cancer & Oncology Authors: Bhakti Arondekar Mei Sheng Duh Rachel H Bhak Maral DerSarkissian Lynn Huynh Kelsey Wang John Wojciehowski Melody Wu Bryon Wornson Alexander Niyazov George D Demetri Source Type: research
Real world evidence in effectiveness, safety, and cost savings of generic levothyroxine: a systematic review
ConclusionFindings from this systematic review highlighted the limited and mixed evidence in real-world clinical and economic outcomes for generic levothyroxine. Continuous post-marketing monitoring and assessment of generic drugs are warranted to ensure treatment effectiveness, patient safety, and achieve financial savings in prescription costs. (Source: Endocrine)
Source: Endocrine - October 13, 2021 Category: Endocrinology Source Type: research
