Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval

scientific article

Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval is …
instance of (P31):
scholarly articleQ13442814

External links are
P356DOI10.1111/1468-0009.12261
P8608Fatcat IDrelease_gxe3tnm745do5g7ae3udal7uwi
P932PMC publication ID5461381
P698PubMed publication ID28589600

P50authorJohn IoannidisQ6251482
P2093author name stringRadhika Gupta
Huseyin Naci
Olivier J Wouters
P2860cites workCharacteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic reviewQ26781716
The Cochrane Collaboration's tool for assessing risk of bias in randomised trialsQ27860509
Measuring inconsistency in meta-analysesQ27860655
Therapeutic-class wars--drug promotion in a competitive marketplaceQ28239304
Power failure: why small sample size undermines the reliability of neuroscienceQ29547474
Efficacy and safety of cholesterol-lowering treatment: prospective meta-analysis of data from 90,056 participants in 14 randomised trials of statinsQ29547856
Contradicted and initially stronger effects in highly cited clinical researchQ29620013
Comparison of evidence of treatment effects in randomized and nonrandomized studiesQ30699759
The ClinicalTrials.gov Results Database — Update and Key IssuesQ33834724
Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.Q34089761
Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancerQ34189974
The Hartung-Knapp-Sidik-Jonkman method for random effects meta-analysis is straightforward and considerably outperforms the standard DerSimonian-Laird methodQ35096756
Accelerated approval of oncology products: a decade of experienceQ35923181
Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort studyQ36087521
Use of surrogate outcomes in US FDA drug approvals, 2003-2012: a survey.Q36329179
Increasing value and reducing waste in research design, conduct, and analysisQ36420861
Issues in using progression-free survival when evaluating oncology productsQ37231532
Non-publication of large randomized clinical trials: cross sectional analysis.Q37266348
Accelerated Approval of Oncology Products: The Food and Drug Administration ExperienceQ37855388
Innovating by Developing New Uses of Already-Approved Drugs: Trends in the Marketing Approval of Supplemental IndicationsQ38111059
How good is "evidence" from clinical studies of drug effects and why might such evidence fail in the prediction of the clinical utility of drugs?Q38242465
FDA designations for therapeutics and their impact on drug development and regulatory review outcomes.Q38351467
The Strength of Association Between Surrogate End Points and Survival in Oncology: A Systematic Review of Trial-Level Meta-analysesQ38534280
Extensions of indication throughout the drug product lifecycle: a quantitative analysisQ38666332
Physicians' Knowledge About FDA Approval Standards and Perceptions of the "Breakthrough Therapy" Designation.Q39821304
A refined method for the meta‐analysis of controlled clinical trials with binary outcomeQ43848299
Accelerated approval scrutinized: confirmatory phase 4 studies on new drugs languishQ44489755
Post-approval trials of new medicines: widening use or deepening knowledge? Analysis of 10 years of etanerceptQ44566796
Mega-trials for blockbustersQ46205856
Drug development and FDA approval, 1938-2013.Q48072423
Improving the drug development process: more not less randomized trialsQ48092634
A Randomized Trial Testing US Food and Drug Administration "Breakthrough" LanguageQ50786134
A simple confidence interval for meta-analysisQ51640531
Surrogate Endpoints And FDA’s Accelerated Approval ProcessQ56908800
Why do we need some large, simple randomized trials?Q70760033
The impact of incremental innovation in biopharmaceuticals: drug utilisation in original and supplemental indicationsQ86076165
P433issue2
P407language of work or nameEnglishQ1860
P304page(s)261-290
P577publication date2017-06-01
P1433published inMilbank QuarterlyQ6850820
P1476titleTiming and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval
P478volume95

Reverse relations

cites work (P2860)
Q64247108Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments
Q42281334Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13.
Q38623810Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration.
Q90167033Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis
Q49611970Factors associated with post-marketing research for approved indications for novel medicines approved by both the FDA and EMA between 2005 and 2010: A multivariable analysis
Q90564383Generating comparative evidence on new drugs and devices after approval
Q55277805Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis.
Q65002828Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis.
Q58718992The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs

Search more.