Cargando…

A platform trial in practice: adding a new experimental research arm to the ongoing confirmatory FLAIR trial in chronic lymphocytic leukaemia

BACKGROUND: The FLAIR trial in chronic lymphocytic leukaemia has a randomised, controlled, open-label, confirmatory, platform design. FLAIR was successfully amended to include an emerging promising experimental therapy to expedite its assessment, greatly reducing the time to reach the primary outcom...

Descripción completa

Detalles Bibliográficos
Autores principales:	Howard, Dena R., Hockaday, Anna, Brown, Julia M., Gregory, Walter M., Todd, Susan, Munir, Tahla, Oughton, Jamie B., Dimbleby, Claire, Hillmen, Peter
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BioMed Central 2021
Materias:	Methodology
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7792072/ https://www.ncbi.nlm.nih.gov/pubmed/33419469 http://dx.doi.org/10.1186/s13063-020-04971-2

Ejemplares similares

Assessment of ibrutinib plus rituximab in front-line CLL (FLAIR trial): study protocol for a phase III randomised controlled trial
por: Collett, Laura, et al.
Publicado: (2017)

GA101 (obinutuzumab) monocLonal Antibody as Consolidation Therapy In CLL (GALACTIC) trial: study protocol for a phase II/III randomised controlled trial
por: Oughton, Jamie B., et al.
Publicado: (2017)

Designs for adding a treatment arm to an ongoing clinical trial
por: Bennett, Maxine, et al.
Publicado: (2020)

Chemotherapy plus Ofatumumab at Standard or Mega dose in relapsed CLL (COSMIC) trial: study protocol for a phase II randomised controlled trial
por: Howard, Dena R., et al.
Publicado: (2016)

Obinutuzumab as consolidation after chemo‐immunotherapy: Results of the UK National Cancer Research Institute phase II/III GALACTIC trial
por: Munir, Talha, et al.
Publicado: (2022)

Adding a treatment arm to an ongoing clinical trial: a review of methodology and practice
por: Cohen, Dena R, et al.
Publicado: (2015)

Flexible trial design in practice - stopping arms for lack-of-benefit and adding research arms mid-trial in STAMPEDE: a multi-arm multi-stage randomized controlled trial
por: Sydes, Matthew R, et al.
Publicado: (2012)

Changes to aspects of ongoing randomised controlled trials with fixed designs
por: Coskinas, Xanthi, et al.
Publicado: (2020)

Statistical consideration when adding new arms to ongoing clinical trials: the potentials and the caveats
por: Lee, Kim May, et al.
Publicado: (2021)

How do multi-stage, multi-arm trials compare to the traditional two-arm parallel group design – a reanalysis of 4 trials
por: Barthel, FM-S, et al.
Publicado: (2009)

Bayesian adaptive designs for multi-arm trials: an orthopaedic case study
por: Ryan, Elizabeth G., et al.
Publicado: (2020)

Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial
por: Sydes, Matthew R, et al.
Publicado: (2009)

Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform
por: Treweek, Shaun, et al.
Publicado: (2015)

This is a platform alteration: a trial management perspective on the operational aspects of adaptive and platform and umbrella protocols
por: Schiavone, Francesca, et al.
Publicado: (2019)

Choosing an imbalance metric for covariate-constrained randomization in multiple-arm cluster-randomized trials
por: Ciolino, Jody D., et al.
Publicado: (2019)

Construct validity of Advanced Practice Role Delineation tool: A confirmatory factor analysis
por: Jokiniemi, Krista, et al.
Publicado: (2022)

Changing platforms without stopping the train: experiences of data management and data management systems when adapting platform protocols by adding and closing comparisons
por: Hague, Dominic, et al.
Publicado: (2019)

A confirmatory factor analysis of the metabolic syndrome in adolescents: an examination of sex and racial/ethnic differences
por: Gurka, Matthew J, et al.
Publicado: (2012)

Optimizing a Bayesian hierarchical adaptive platform trial design for stroke patients
por: Gao, Guangyi, et al.
Publicado: (2022)

Practical guidance for running late-phase platform protocols for clinical trials: lessons from experienced UK clinical trials units
por: Love, Sharon B., et al.
Publicado: (2022)

Familywise error control in multi‐armed response‐adaptive trials
por: Robertson, D. S., et al.
Publicado: (2019)

Type I error rates of multi-arm multi-stage clinical trials: strong control and impact of intermediate outcomes
por: Bratton, Daniel J., et al.
Publicado: (2016)

Estimating outcomes and cost effectiveness using a single-arm clinical trial: ofatumumab for double-refractory chronic lymphocytic leukemia
por: Hatswell, Anthony J., et al.
Publicado: (2017)

A Bayesian comparative effectiveness trial in action: developing a platform for multisite study adaptive randomization
por: Brown, Alexandra R., et al.
Publicado: (2016)

Whole‐brain 3D FLAIR at 7T using direct signal control
por: Beqiri, Arian, et al.
Publicado: (2018)

Solar flair.
por: Manuel, John S
Publicado: (2003)

Impact of lack-of-benefit stopping rules on treatment effect estimates of two-arm multi-stage (TAMS) trials with time to event outcome
por: Choodari-Oskooei, Babak, et al.
Publicado: (2013)

Fostering emotional, social, physical and educational wellbeing in rural India: the methods of a multi-arm randomized controlled trial of Girls First
por: Leventhal, Katherine Sachs, et al.
Publicado: (2015)

“Areas of Worklife scale” (AWS) short version (Spanish): a confirmatory factor analysis based on a secondary school teacher sample
por: Masluk, B., et al.
Publicado: (2018)

Feasibility of Imported Self-Management Program for Elderly People with Chronic Pain: A Single-Arm Confirmatory Trial
por: Ikemoto, Tatsunori, et al.
Publicado: (2020)

Accelerating clinical development of HIV vaccine strategies: methodological challenges and considerations in constructing an optimised multi-arm phase I/II trial design
por: Richert, Laura, et al.
Publicado: (2014)

Construction and optimization of gene expression signatures for prediction of survival in two-arm clinical trials
por: Theilhaber, Joachim, et al.
Publicado: (2020)

Ibrutinib induces chromatin reorganisation of chronic lymphocytic leukaemia cells
por: Holmes, Katie B., et al.
Publicado: (2019)

A response‐adaptive randomization procedure for multi‐armed clinical trials with normally distributed outcomes
por: Williamson, S. Faye, et al.
Publicado: (2019)

The Arm Movement Detection (AMD) test: a fast robotic test of proprioceptive acuity in the arm
por: Mrotek, Leigh Ann, et al.
Publicado: (2017)

Differences in the INR evaluation of two different thromboplastins in patients with positivity to lupus anticoagulant in ongoing oral anticoagulation
por: Ferrazzi, Paola, et al.
Publicado: (2010)

Haplotype allelic classes for detecting ongoing positive selection
por: Hussin, Julie, et al.
Publicado: (2010)

Experiences in the design and implementation of phase II trials in CLL
por: Cohen, Dena R, et al.
Publicado: (2011)

Development and validation of an indirect ELISA as a confirmatory test for surveillance of infectious bovine rhinotracheitis in vaccinated herds
por: Bertolotti, Luigi, et al.
Publicado: (2015)

The value of the pragmatic-explanatory continuum indicator summary wheel in an ongoing study: the bullous pemphigoid steroids and tetracyclines study
por: Bratton, Daniel J, et al.
Publicado: (2012)

Cannot write session to /tmp/vufind_sessions/sess_seh7lokihts9hbl0e9rhotvvaq