Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer.
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Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic reviewClinical studies in lysosomal storage diseases: Past, present, and futureBiomarker-Defined Subsets of Common Diseases: Policy and Economic Implications of Orphan Drug Act CoverageThe economic burden of fragile x syndrome: healthcare resource utilization in the United States.Why do health technology assessment coverage recommendations for the same drugs differ across settings? Applying a mixed methods framework to systematically compare orphan drug decisions in four European countriesIntroduction to a supplement on innovative approaches to studying health outcomes in rare diseases.Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012.Reporting of serious adverse events during cancer clinical trials to the institutional review board: an evaluation by the research on adverse drug events and reports (RADAR) project.A comparison of interventional clinical trials in rare versus non-rare diseases: an analysis of ClinicalTrials.gov.Value-based reimbursement decisions for orphan drugs: a scoping review and decision framework.An empirical review of major legislation affecting drug development: past experiences, effects, and unintended consequences.Pivotal clinical trials of novel ophthalmic drugs and medical devices: retrospective observational study, 2002-2012Can the EVIDEM Framework Tackle Issues Raised by Evaluating Treatments for Rare Diseases: Analysis of Issues and Policies, and Context-Specific Adaptation.Hartung-Knapp-Sidik-Jonkman approach and its modification for random-effects meta-analysis with few studiesTrends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study.FDA Policy and Cardiovascular Medicine.Oncology drug development and approval of systemic anticancer therapy by the U.S. Food and Drug AdministrationChanging the Paradigm for the Treatment and Development of New Therapies for FSGS.Systematic review of available evidence on 11 high-priced inpatient orphan drugs.Clinical evidence for orphan medicinal products-a cause for concern?Bayesian approach to the assessment of the population-specific risk of inhibitors in hemophilia A patients: a case study.Reconciling uncertainty of costs and outcomes with the need for access to orphan medicinal products: a comparative study of managed entry agreements across seven European countries.Recommendations from the European Working Group for Value Assessment and Funding Processes in Rare Diseases (ORPH-VAL).From promising molecules to orphan drugs: Early clinical drug developmentBrentuximab Vedotin (SGN-35), an antibody-drug conjugate for the treatment of CD30-positive malignancies.Benefit and harms of new anti-cancer drugs.Characteristics of pharmacogenomics/biomarker-guided clinical trials for regulatory approval of anti-cancer drugs in Japan.Proof-of-concept rare cancers in drug development: the case for rhabdomyosarcoma.Strategies for postmarketing surveillance of drugs for rare diseases.The future of proteasome inhibitors in relapsed/refractory multiple myeloma.Innovative research methods for studying treatments for rare diseases: methodological review.Involving patients in reducing decision uncertainties around orphan and ultra-orphan drugs: a rare opportunity?FDA designations for therapeutics and their impact on drug development and regulatory review outcomes.Do Contemporary Randomized Controlled Trials Meet ESMO Thresholds for Meaningful Clinical Benefit?The 21st century cures act: Opportunities and challenges.Clinical Evidence Supporting US Food and Drug Administration Approval of Otolaryngologic Prescription Drug Indications, 2005-2014.Toward a jurisprudence of drug regulation.Clinical benefit, price and approval characteristics of FDA-approved new drugs for treating advanced solid cancer, 2000-2015.Pharmacogenomic biomarkers as inclusion criteria in clinical trials of oncology-targeted drugs: a mapping of ClinicalTrials.gov.Disconnected by design: analytic approach in treatment networks having no common comparator.
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P2860
Characteristics of clinical trials to support approval of orphan vs nonorphan drugs for cancer.
description
2011 nî lūn-bûn
@nan
2011 թուականի Յունիսին հրատարակուած գիտական յօդուած
@hyw
2011 թվականի հունիսին հրատարակված գիտական հոդված
@hy
2011年の論文
@ja
2011年論文
@yue
2011年論文
@zh-hant
2011年論文
@zh-hk
2011年論文
@zh-mo
2011年論文
@zh-tw
2011年论文
@wuu
name
Characteristics of clinical tr ...... vs nonorphan drugs for cancer.
@ast
Characteristics of clinical tr ...... vs nonorphan drugs for cancer.
@en
Characteristics of clinical tr ...... vs nonorphan drugs for cancer.
@nl
type
label
Characteristics of clinical tr ...... vs nonorphan drugs for cancer.
@ast
Characteristics of clinical tr ...... vs nonorphan drugs for cancer.
@en
Characteristics of clinical tr ...... vs nonorphan drugs for cancer.
@nl
prefLabel
Characteristics of clinical tr ...... vs nonorphan drugs for cancer.
@ast
Characteristics of clinical tr ...... vs nonorphan drugs for cancer.
@en
Characteristics of clinical tr ...... vs nonorphan drugs for cancer.
@nl
P2093
P356
P1476
Characteristics of clinical tr ...... vs nonorphan drugs for cancer.
@en
P2093
Aaron S Kesselheim
Jerry Avorn
Jessica A Myers
P304
P356
10.1001/JAMA.2011.769
P407
P577
2011-06-01T00:00:00Z