Risk of bias assessment We will use the tool described in the Cochrane Collaboration Handbook to assess risk of bias in the included studies. The assessment will be performed by two independent reviewers and any disagreement will resolved by consensus. We will evaluate the risk of bias in the following domains: generation of allocation sequence, […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-07-15 15:30:412022-11-04 20:27:33(3 of 4) Network Meta-Analysis Series: Assessing Data
Earlier this year, the FDA released updated guidelines on the types and use of study population enrichment methods. They believe the use of enrichment can potentially provide increased efficiency in the clinical trial process. Our experts at Princeton Pharmatech have proven these benefits, at least in the development of Edaravone, a product approved in 2017 […]
https://www.princetonpharmatech.com/wp-content/uploads/2020/01/Amyotrophic-Lateral-Sclerosis-and-Frontotemporal-Degeneration-Journal-2-300x250-2.png206300princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-07-10 14:13:342020-01-21 17:02:39Is Enrichment Beneficial for ALS Research? We Say “Yes!”
Characteristics of included studies: We will generate descriptive statistics for the trial, and study population characteristics across all eligible trials, describing the types of comparisons and some important variables, either clinical or methodological (such as year of publication, age, severity of illness, sponsorship and clinical setting). We will present the evidence in the network diagram […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-07-08 11:30:422022-11-04 20:28:57(2 of 4) Network Meta-Analysis: Statistical Synthesis of Study Data
Background Network meta-analysis provides a global estimate of effectiveness of intervention regimes, by establishing a network between regimes combining both direct and indirect evidence from trial studies. Meta-analyses of randomized controlled trials are considered the top of the hierarchy of clinical evidence. However, oftentimes, head-to-head comparisons are not available or are insufficient to answer a […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-07-01 16:40:482023-04-25 19:11:12(1 of 4) Network Meta-Analysis Series: Relative Safety and Efficacy of New Marketing Drugs
Since the passage of the 21st Century Cures Act (aka Cures Act) in 2016, the FDA has been releasing new protocols and programs to expedite the approval process for new medical drugs and devices. One such new program is the Real-world Evidence (RWE) program that allows for the use of data collected outside of clinical […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-06-19 11:30:332022-11-04 20:25:22Making Sense of the FDA’s Real World Data Program
(3 of 4) Network Meta-Analysis Series: Assessing Data
in Network Meta-Analysis SeriesRisk of bias assessment We will use the tool described in the Cochrane Collaboration Handbook to assess risk of bias in the included studies. The assessment will be performed by two independent reviewers and any disagreement will resolved by consensus. We will evaluate the risk of bias in the following domains: generation of allocation sequence, […]
Is Enrichment Beneficial for ALS Research? We Say “Yes!”
in FDA GuidelinesEarlier this year, the FDA released updated guidelines on the types and use of study population enrichment methods. They believe the use of enrichment can potentially provide increased efficiency in the clinical trial process. Our experts at Princeton Pharmatech have proven these benefits, at least in the development of Edaravone, a product approved in 2017 […]
(2 of 4) Network Meta-Analysis: Statistical Synthesis of Study Data
in Network Meta-Analysis SeriesCharacteristics of included studies: We will generate descriptive statistics for the trial, and study population characteristics across all eligible trials, describing the types of comparisons and some important variables, either clinical or methodological (such as year of publication, age, severity of illness, sponsorship and clinical setting). We will present the evidence in the network diagram […]
(1 of 4) Network Meta-Analysis Series: Relative Safety and Efficacy of New Marketing Drugs
in Network Meta-Analysis SeriesBackground Network meta-analysis provides a global estimate of effectiveness of intervention regimes, by establishing a network between regimes combining both direct and indirect evidence from trial studies. Meta-analyses of randomized controlled trials are considered the top of the hierarchy of clinical evidence. However, oftentimes, head-to-head comparisons are not available or are insufficient to answer a […]
Making Sense of the FDA’s Real World Data Program
in Real World DataSince the passage of the 21st Century Cures Act (aka Cures Act) in 2016, the FDA has been releasing new protocols and programs to expedite the approval process for new medical drugs and devices. One such new program is the Real-world Evidence (RWE) program that allows for the use of data collected outside of clinical […]