Cargando…

Methods for identification and confirmation of targeted subgroups in clinical trials: A systematic review

Important objectives in the development of stratified medicines include the identification and confirmation of subgroups of patients with a beneficial treatment effect and a positive benefit-risk balance. We report the results of a literature review on methodological approaches to the design and ana...

Descripción completa

Detalles Bibliográficos
Autores principales:	Ondra, Thomas, Dmitrienko, Alex, Friede, Tim, Graf, Alexandra, Miller, Frank, Stallard, Nigel, Posch, Martin
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Taylor & Francis 2016
Materias:	Articles
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4732423/ https://www.ncbi.nlm.nih.gov/pubmed/26378339 http://dx.doi.org/10.1080/10543406.2015.1092034

Ejemplares similares

Adaptive seamless clinical trials using early outcomes for treatment or subgroup selection: Methods, simulation model and their implementation in R
por: Friede, Tim, et al.
Publicado: (2020)

Recent advances in methodology for clinical trials in small populations: the InSPiRe project
por: Friede, Tim, et al.
Publicado: (2018)

Optimizing Trial Designs for Targeted Therapies
por: Ondra, Thomas, et al.
Publicado: (2016)

Systematic reviews in paediatric multiple sclerosis and Creutzfeldt-Jakob disease exemplify shortcomings in methods used to evaluate therapies in rare conditions
por: Unkel, Steffen, et al.
Publicado: (2016)

Identification of subgroup effect with an individual participant data meta-analysis of randomised controlled trials of three different types of therapist-delivered care in low back pain
por: Hee, Siew Wan, et al.
Publicado: (2021)

A comparison of subgroup identification methods in clinical drug development: Simulation study and regulatory considerations
por: Huber, Cynthia, et al.
Publicado: (2019)

A Comparison of Methods for Treatment Selection in Seamless Phase II/III Clinical Trials Incorporating Information on Short-Term Endpoints
por: Kunz, Cornelia Ursula, et al.
Publicado: (2015)

A recursive partitioning approach for subgroup identification in individual patient data meta‐analysis
por: Mistry, Dipesh, et al.
Publicado: (2018)

Optimized adaptive enrichment designs
por: Ondra, Thomas, et al.
Publicado: (2017)

Dose‐finding methods for Phase I clinical trials using pharmacokinetics in small populations
por: Ursino, Moreno, et al.
Publicado: (2017)

Software tools for implementing simulation studies in adaptive seamless designs: introducing R package ASD
por: Parsons, Nick, et al.
Publicado: (2011)

Robustness of testing procedures for confirmatory subpopulation analyses based on a continuous biomarker
por: Graf, Alexandra Christine, et al.
Publicado: (2018)

Data-driven treatment selection for seamless phase II/III trials incorporating early-outcome data
por: Kunz, Cornelia Ursula, et al.
Publicado: (2014)

Flexible selection of a single treatment incorporating short‐term endpoint information in a phase II/III clinical trial
por: Stallard, Nigel, et al.
Publicado: (2015)

Value of information methods to design a clinical trial in a small population to optimise a health economic utility function
por: Pearce, Michael, et al.
Publicado: (2018)

Blinded versus unblinded estimation of a correlation coefficient to inform interim design adaptations
por: Kunz, Cornelia U., et al.
Publicado: (2016)

Subgroup identification in clinical trials via the predicted individual treatment effect
por: Ballarini, Nicolás M., et al.
Publicado: (2018)

Determination of the optimal sample size for a clinical trial accounting for the population size
por: Stallard, Nigel, et al.
Publicado: (2016)

Quantitative approaches underpinning decision making
por: Posch, Martin, et al.
Publicado: (2019)

Decision-theoretic designs for small trials and pilot studies: A review
por: Hee, Siew Wan, et al.
Publicado: (2015)

Analysis of clinical trials using SAS: a practical guide
por: Dmitrienko, Alex
Publicado: (2005)

Does the low prevalence affect the sample size of interventional clinical trials of rare diseases? An analysis of data from the aggregate analysis of clinicaltrials.gov
por: Hee, Siew Wan, et al.
Publicado: (2017)

Efficient Adaptive Designs for Clinical Trials of Interventions for COVID-19
por: Stallard, Nigel, et al.
Publicado: (2020)

A critical review of graphics for subgroup analyses in clinical trials
por: Ballarini, Nicolás M., et al.
Publicado: (2020)

Reporting and interpretation of subgroup analyses in heart failure randomized controlled trials
por: Khan, Muhammad Shahzeb, et al.
Publicado: (2020)

Analysis of clinical trials using SAS: a practical guide
por: Dmitrienko, Alex, et al.
Publicado: (2017)

Immunotherapy for people with clinically isolated syndrome or relapsing-remitting multiple sclerosis: treatment response by demographic, clinical, and biomarker subgroups (PROMISE)—a systematic review protocol
por: Lehnert, Thomas, et al.
Publicado: (2022)

Causal inference methods for small non-randomized studies: Methods and an application in COVID-19
por: Friedrich, Sarah, et al.
Publicado: (2020)

Serum peptide reactivities may distinguish neuromyelitis optica subgroups and multiple sclerosis
por: Metz, Imke, et al.
Publicado: (2016)

Identification of targeted therapy for an aggressive subgroup of muscle-invasive bladder cancers
por: Lebret, Thierry, et al.
Publicado: (2015)

Identification of Neuroblastoma Subgroups Based on Three-Dimensional Telomere Organization()()
por: Kuzyk, Alexandra, et al.
Publicado: (2016)

Identification of the novel HLA‐B*51:01:01:78 allele and confirmation of extended sequence of B*18:01:26
por: Ulrich, Silvia, et al.
Publicado: (2022)

An adaptive seamless phase II/III clinical trial design incorporating short-term endpoint information
por: Stallard, Nigel
Publicado: (2011)

An alternative method to analyse the biomarker‐strategy design
por: Kunz, Cornelia Ursula, et al.
Publicado: (2018)

Analysis, identification and visualization of subgroups in genomics
por: Völkel, Gunnar, et al.
Publicado: (2020)

Sensor Management Method of Giving Priority to Confirmed Identified Targets
por: Ding, Chunshan, et al.
Publicado: (2023)

Characterization of the RND family of multidrug efflux pumps: in silico to in vivo confirmation of four functionally distinct subgroups
por: Godoy, Patricia, et al.
Publicado: (2010)

Optimizing subgroup selection in two‐stage adaptive enrichment and umbrella designs
por: Ballarini, Nicolás M., et al.
Publicado: (2021)

Bayesian Approaches for Confirmatory Trials in Rare Diseases: Opportunities and Challenges
por: Ursino, Moreno, et al.
Publicado: (2021)

Work-related outcomes in randomised placebo-controlled pain trials: a systematic review and meta-analysis
por: Wolf, Ingmar, et al.
Publicado: (2014)

Cannot write session to /tmp/vufind_sessions/sess_digge1kllff765g04k5bk7to05