Adaptive platform trials: definition, design, conduct and reporting considerations

Herman Goossens | Donald A. Berry | Lorenzo Trippa | Stephane Heritier | Alex John London | Giovanni Parmigiani | Kathy Giusti | Brian M. Alexander | Kert Viele | J. Michael Gaziano | Michael Krams | Andrew W. Lo | Lisa M. LaVange | Janet Woodcock | Colin McArthur | Ariel Dora Stern | Timothy F. Cloughesy | Scott Berry | Mark Trusheim | Mary Brophy | Louis Fiore | Laura J. Esserman | Derek C. Angus | Christopher W. Seymour | Patrick Y. Wen | Ryan Ferguson | Marc J. M. Bonten | Philip Lavori | D. Berry | H. Goossens | G. Parmigiani | A. Lo | P. Lavori | L. Esserman | A. Barker | M. Krams | C. Seymour | D. Angus | P. Wen | L. Trippa | T. Cloughesy | J. Woodcock | J. Gaziano | N. Shapiro | B. Alexander | R. Lewis | M. Bonten | L. LaVange | K. Rowan | A. Stern | S. Heritier | C. Ritchie | J. Perlmutter | M. Paoloni | M. Buxton | L. Fiore | S. Berry | K. Viele | D. Simeone | A. London | L. Derde | M. Trusheim | Anna Barker | Meredith Buxton | Jane Perlmutter | Nathan I. Shapiro | Diane M. Simeone | Kay Larholt | Ryan Ferguson | Melissa Paoloni | Kathryn M. Rowan | Sarah C. Gaffey | Roger Lewis | Steven A. R. Webb | Steven Arnold | Christopher Butler | Lennie P. G. Derde | Bradley Hyman | Victoria Manax | Genevieve O’Neill | Elizabeth A. Petzold | Craig Ritchie | Bradley Smith | Bradley Spellberg | Colin McArthur | K. Larholt | S. Webb | Victoria G. Manax | Bradley Hyman | K. Giusti | Christopher Butler | Steven Arnold | M. Brophy | Genevieve O’Neill | Bradley Smith | Bradley Spellberg | Ryan E Ferguson | Bradley T. Hyman | Derek C. Brian M. Scott Meredith Roger Melissa Steven A. Angus Alexander Berry Buxton Lewis Paoloni | V. Manax | Elizabeth A Petzold | Bradley L. Smith | J. M. Gaziano

[1]  P. Wen,et al.  Individualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT): A Bayesian Adaptive Platform Trial to Develop Precision Medicines for Patients With Glioblastoma , 2019, JCO precision oncology.

[2]  T. Cloughesy,et al.  Platform trials arrive on time for glioblastoma. , 2018, Neuro-oncology.

[3]  Kristian Thorlund,et al.  Key design considerations for adaptive clinical trials: a primer for clinicians , 2018, British Medical Journal.

[4]  D. Angus,et al.  Rationale and Design of an Adaptive Phase 2b/3 Clinical Trial of Selepressin for Adults in Septic Shock. Selepressin Evaluation Programme for Sepsis-induced Shock-Adaptive Clinical Trial. , 2018, Annals of the American Thoracic Society.

[5]  Amitabh Chandra,et al.  Innovation Incentives and Biomarkers , 2018, Clinical pharmacology and therapeutics.

[6]  A. London.  Learning health systems, clinical equipoise and the ethics of response adaptive randomisation , 2017, Journal of Medical Ethics.

[7]  Andrew W. Lo,et al.  Re-inventing drug development: A case study of the I-SPY 2 breast cancer clinical trials program. , 2017, Contemporary clinical trials.

[8]  A. Stern,et al.  Adaptive Platform Trials: The Clinical Trial of the Future? , 2017 .

[9]  Brian M Alexander,et al.  Adaptive Global Innovative Learning Environment for Glioblastoma: GBM AGILE , 2017, Clinical Cancer Research.

[10]  J. Woodcock,et al.  Master Protocols to Study Multiple Therapies, Multiple Diseases, or Both. , 2017, The New England journal of medicine.

[11]  Icmje admin,et al.  International Committee of Medical Journal Editors Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals , 2017 .

[12]  Lorenzo Trippa,et al.  Bayesian Baskets: A Novel Design for Biomarker-Based Clinical Trials. , 2017, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[13]  HP Selker,et al.  PIPELINEs: Creating Comparable Clinical Knowledge Efficiently by Linking Trial Platforms , 2016, Clinical pharmacology and therapeutics.

[14]  Anne M Wallace,et al.  Adaptive Randomization of Veliparib-Carboplatin Treatment in Breast Cancer. , 2016, The New England journal of medicine.

[15]  Michael Hogarth,et al.  Adaptive Randomization of Neratinib in Early Breast Cancer. , 2016, The New England journal of medicine.

[16]  J. Greene,et al.  Assessing the Gold Standard--Lessons from the History of RCTs. , 2016, The New England journal of medicine.

[17]  Philip W Lavori,et al.  Integrating Randomized Comparative Effectiveness Research with Patient Care. , 2016, The New England journal of medicine.

[18]  R. Kolamunnage-Dona,et al.  Biomarker-Guided Adaptive Trial Designs in Phase II and Phase III: A Methodological Review , 2016, PloS one.

[19]  S. Berry,et al.  Efficiencies of platform clinical trials: A vision of the future , 2016, Clinical trials.

[20]  José Luis Molinuevo,et al.  Development of interventions for the secondary prevention of Alzheimer's dementia: the European Prevention of Alzheimer's Dementia (EPAD) project. , 2016, The lancet. Psychiatry.

[21]  Tze Leung Lai,et al.  Adaptive design of confirmatory trials: Advances and challenges. , 2015, Contemporary clinical trials.

[22]  Derek C Angus,et al.  Fusing Randomized Trials With Big Data: The Key to Self-learning Health Care Systems? , 2015, JAMA.

[23]  F. Hirsch,et al.  Innovative Clinical Trials: The LUNG‐MAP Study , 2015, Clinical pharmacology and therapeutics.

[24]  Jürgen Hummel,et al.  Using simulation to optimize adaptive trial designs: applications in learning and confirmatory phase trials , 2015 .

[25]  J. Connor,et al.  The platform trial: an efficient strategy for evaluating multiple treatments. , 2015, JAMA.

[26]  Lorenzo Trippa,et al.  Brain Malignancy Steering Committee clinical trials planning workshop: report from the Targeted Therapies Working Group. , 2015, Neuro-oncology.

[27]  Qinghui Zhou,et al.  [Recommendations for the conduct, reporting, editing and publication of scholarly work in medical journals]. , 2014, Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology.

[28]  Gideon Blumenthal,et al.  Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis , 2014, The Lancet.

[29]  Jason T Connor,et al.  The utility of Bayesian predictive probabilities for interim monitoring of clinical trials , 2014, Clinical trials.

[30]  Lorenzo Trippa,et al.  Biomarker-based adaptive trials for patients with glioblastoma--lessons from I-SPY 2. , 2013, Neuro-oncology.

[31]  Roger M. Stein,et al.  Commercializing biomedical research through securitization techniques , 2012, Nature Biotechnology.

[32]  G. Parmigiani,et al.  Bayesian adaptive randomized trial design for patients with recurrent glioblastoma. , 2012, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[33]  S. Wooding,et al.  The answer is 17 years, what is the question: understanding time lags in translational research , 2011, Journal of the Royal Society of Medicine.

[34]  B. Freidlin,et al.  Outcome--adaptive randomization: is it useful? , 2011, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[35]  Bradley P. Carlin,et al.  Bayesian Adaptive Methods for Clinical Trials , 2010 .

[36]  D. Berry,et al.  I‐SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy , 2009, Clinical pharmacology and therapeutics.

[37]  D. Berry.  Bayesian clinical trials , 2006, Nature Reviews Drug Discovery.

[38]  M. Horsburgh,et al.  AUCKLAND DISTRICT HEALTH BOARD , 2003 .

[39]  Alastair Baker,et al.  Crossing the Quality Chasm: A New Health System for the 21st Century , 2001, BMJ : British Medical Journal.

[40]  Patrick D. Larkey,et al.  Bridging Different Eras in Sports , 1999 .

[41]  Giovanni Parmigiani,et al.  Meta-Analysis of Migraine Headache Treatments: Combining Information from Heterogeneous Designs , 1999 .

[42]  James R. Dixon,et al.  The International Conference on Harmonization Good Clinical Practice guideline. , 1999, Quality assurance.