Reporting of master protocols towards a standardized approach: A systematic review

[1]  M. Hoelscher,et al.  Innovative trial designs are practical solutions for improving the treatment of tuberculosis. , 2012, The Journal of infectious diseases.

[2]  Danna Zhou,et al.  d. , 1840, Microbial pathogenesis.

[3]  J. Doroshow,et al.  Molecular analysis for therapy choice: NCI MATCH. , 2014, Seminars in oncology.

[4]  M. Parmar,et al.  A multi-arm multi-stage clinical trial design for binary outcomes with application to tuberculosis , 2013, BMC Medical Research Methodology.

[5]  C. Lih,et al.  Considerations of developing an NGS assay for clinical applications in precision oncology: The NCI-MATCH NGS assay experience. , 2017, Current problems in cancer.

[6]  P. Alam ‘K’ , 2021, Composites Engineering.

[7]  David M Hyman,et al.  Basket Studies: Redefining Clinical Trials in the Era of Genome-Driven Oncology. , 2018, Annual review of medicine.

[8]  E. Ben-Chetrit,et al.  Efficacy and Safety of Canakinumab in Patients with Periodic Fever Syndromes (Colchicine-Resistant FMF, HIDS/MKD and TRAPS): Results from a Phase 3, Pivotal, Umbrella Trial , 2017 .

[9]  H. Goossens,et al.  A trial like ALIC4E: why design a platform, response-adaptive, open, randomised controlled trial of antivirals for influenza-like illness? , 2018, ERJ Open Research.

[10]  Mark Davies,et al.  Clinical trial design and dissemination: comprehensive analysis of clinicaltrials.gov and PubMed data since 2005 , 2018, British Medical Journal.

[11]  N. Takebe,et al.  Perspectives on research activity in the USA on Cancer Precision Medicine. , 2015, Japanese journal of clinical oncology.

[12]  V. Goh,et al.  EP-1277: Optimising RT dose for anal cancer - the development of three clinical trials in one platform , 2017 .

[13]  L. Collette,et al.  A multinational, multi-tumour basket study in very rare cancer types: The European Organization for Research and Treatment of Cancer phase II 90101 'CREATE' trial. , 2019, European journal of cancer.

[14]  D. Moher,et al.  Preferred reporting items for systematic reviews and meta-analyses: the PRISMA Statement , 2009, BMJ : British Medical Journal.

[15]  U. Jäger,et al.  Combined integrated protocol/basket trial design for a first-in-human trial , 2016, Orphanet Journal of Rare Diseases.

[16]  J. Connor,et al.  Answering patient-centred questions efficiently: response-adaptive platform trials in primary care. , 2018, The British journal of general practice : the journal of the Royal College of General Practitioners.

[17]  J. Bernhard,et al.  Prostate specific antigen doubling time as auxiliary end point in hormone refractory prostatic carcinoma. , 2003, European urology.

[18]  Mithat Gönen,et al.  Variance prior specification for a basket trial design using Bayesian hierarchical modeling , 2019, Clinical trials.

[19]  Hiroyuki Sato,et al.  Master protocol trials in oncology: Review and new trial designs , 2018, Contemporary clinical trials communications.

[20]  S. Spector,et al.  Improvement in lipids after switch to boosted atazanavir or darunavir in children/adolescents with perinatally acquired HIV on older protease inhibitors: results from the Pediatric HIV/AIDS Cohort Study , 2018, HIV medicine.

[21]  M. Socinski,et al.  First comprehensive report of impact of genomic alterations, chemotherapy, targeted therapy and immunotherapy on outcomes in the genomics driven squamous master protocol LungMAP. , 2018 .

[22]  G. Alagic,et al.  #p , 2019, Quantum Inf. Comput..

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

[24]  Robin Patel,et al.  MASTERMIND: Bringing Microbial Diagnostics to the Clinic , 2017, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[25]  H. Horlings,et al.  Adaptive phase II randomized trial of nivolumab after induction treatment in triple negative breast cancer (TONIC trial): Final response data stage I and first translational data. , 2018 .

[26]  H. Kourie,et al.  Why balls are not put inside the basket? A reflection on testicular cancer clinical trial design , 2016, Investigational New Drugs.

[27]  David Moher,et al.  Does use of the CONSORT Statement impact the completeness of reporting of randomised controlled trials published in medical journals? A Cochrane reviewa , 2012, Systematic Reviews.

[28]  Richard Kaplan The FOCUS4 design for biomarker stratified trials. , 2015, Chinese clinical oncology.

[29]  Richard Simon,et al.  Improving Clinical Trial Efficiency: Thinking outside the Box. , 2015, American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting.

[30]  Brian P Hobbs,et al.  A multi‐source adaptive platform design for testing sequential combinatorial therapeutic strategies , 2018, Biometrics.

[31]  J. Radich,et al.  Intergroup LEAP trial (S1612): A randomized phase 2/3 platform trial to test novel therapeutics in medically less fit older adults with acute myeloid leukemia , 2018, American journal of hematology.

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

[33]  Richard Simon,et al.  Genomic AlterationDriven Clinical Trial Designs in Oncology , 2016, Annals of Internal Medicine.

[34]  Mary W Redman,et al.  Lung-MAP--framework, overview, and design principles. , 2015, Chinese clinical oncology.

[35]  D. Berry,et al.  Signature program: a platform of basket trials , 2018, Oncotarget.

[36]  D. Sargent,et al.  Statistical controversies in clinical research: basket trials, umbrella trials, and other master protocols: a review and examples. , 2016, Annals of oncology : official journal of the European Society for Medical Oncology.

[37]  Steven J. M. Jones,et al.  Canadian profiling and targeted agent utilization trial (CAPTUR/PM.1): A phase II basket precision medicine trial. , 2018 .

[38]  Udayan Guha,et al.  Molecular profiling and targeted therapy for advanced thoracic malignancies: a biomarker-derived, multiarm, multihistology phase II basket trial. , 2015, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[39]  Adaptive and Novel Trial Designs : An Overview of Key Methodologies and Issues in Critical Appraisal , 2018 .

[40]  H. Goossens,et al.  A trial like ALIC 4 E: why design a platform, response-adaptive, open, randomised controlled trial of antivirals for influenza-like illness? , 2018 .

[41]  Chengjie Xiong,et al.  The DIAN-TU Next Generation Alzheimer's prevention trial: Adaptive design and disease progression model , 2017, Alzheimer's & Dementia.

[42]  M. Parmar,et al.  Incorporating Biomarker Stratification into STAMPEDE: an Adaptive Multi-arm, Multi-stage Trial Platform , 2017, Clinical oncology (Royal College of Radiologists (Great Britain)).

[43]  David Wholley,et al.  Lung Master Protocol (Lung-MAP)—A Biomarker-Driven Protocol for Accelerating Development of Therapies for Squamous Cell Lung Cancer: SWOG S1400 , 2015, Clinical Cancer Research.

[44]  Mithat Gönen,et al.  An efficient basket trial design , 2017, Statistics in medicine.

[45]  H. Gabra,et al.  OCTOPUS: A randomised, multi-centre phase II umbrella trial of weekly paclitaxel+/- novel agents in platinum-resistant ovarian cancer—Vistusertib (AZD2014). , 2017 .

[46]  Brian P Hobbs,et al.  Controlled multi-arm platform design using predictive probability , 2018, Statistical methods in medical research.

[47]  M. Parmar,et al.  Testing many treatments within a single protocol over 10 years at MRC Clinical Trials Unit at UCL: Multi-arm, multi-stage platform, umbrella and basket protocols , 2017, Clinical trials.

[48]  Lorenzo Trippa,et al.  Bayesian response‐adaptive designs for basket trials , 2017, Biometrics.

[49]  G. G. Stokes "J." , 1890, The New Yale Book of Quotations.

[50]  Thomas de Quincey [C] , 2000, The Works of Thomas De Quincey, Vol. 1: Writings, 1799–1820.

[51]  Donald A Berry,et al.  The Brave New World of clinical cancer research: Adaptive biomarker‐driven trials integrating clinical practice with clinical research , 2015, Molecular oncology.

[52]  Mary W Redman,et al.  The Master Protocol Concept. , 2015, Seminars in oncology.

[53]  M. Parmar,et al.  Issues in applying multi-arm multi-stage methodology to a clinical trial in prostate cancer: the MRC STAMPEDE trial , 2009, Trials.

[54]  T. Dalgleish,et al.  Study protocol for a randomised, controlled platform trial estimating the effect of autobiographical Memory Flexibility training (MemFlex) on relapse of recurrent major depressive disorder , 2018, BMJ Open.

[55]  J. Blay,et al.  Vemurafenib for BRAF V600–Mutant Erdheim-Chester Disease and Langerhans Cell Histiocytosis: Analysis of Data From the Histology-Independent, Phase 2, Open-label VE-BASKET Study , 2017, JAMA oncology.

[56]  Veronica Bunn,et al.  Comparison of multi-arm multi-stage design and adaptive randomization in platform clinical trials. , 2017, Contemporary clinical trials.

[57]  A. Italiano,et al.  Abstract PD5-04: An open-label, phase II basket study of olaparib and durvalumab (MEDIOLA): Updated results in patients with germlineBRCA-mutated (gBRCAm) metastatic breast cancer (MBC) , 2019, Poster Discussion Abstracts.

[58]  J. Machiels,et al.  Personalized biomarker-based treatment strategy for patients with squamous cell carcinoma of the head and neck: EORTC position and approach. , 2018, Annals of oncology : official journal of the European Society for Medical Oncology.

[59]  Robert A Bonomo,et al.  Leading Antibacterial Laboratory Research by Integrating Conventional and Innovative Approaches: The Laboratory Center of the Antibacterial Resistance Leadership Group. , 2017, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[60]  R. Sampath,et al.  Informing Antibiotic Treatment Decisions: Evaluating Rapid Molecular Diagnostics To Identify Susceptibility and Resistance to Carbapenems against Acinetobacter spp. in PRIMERS III , 2015, Journal of Clinical Microbiology.

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

[62]  V. Moreno,et al.  Activity of lurbinectedin (PM01183) as single agent and in combination in patients with endometrial cancer , 2017 .

[63]  S. Ornes Core Concept: Basket trial approach capitalizes on the molecular mechanisms of tumors , 2016, Proceedings of the National Academy of Sciences.

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

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

[66]  Brian P Hobbs,et al.  Bayesian basket trial design with exchangeability monitoring , 2018, Statistics in medicine.

[67]  P. Alam ‘V’ , 2021, Composites Engineering: An A–Z Guide.

[68]  Martha Donoghue,et al.  Accelerating Pediatric Cancer Drug Development: Challenges and Opportunities for Pediatric Master Protocols , 2019, Therapeutic innovation & regulatory science.

[69]  Jay J H Park,et al.  Critical concepts in adaptive clinical trials , 2018, Clinical epidemiology.

[70]  T. Peters-Strickland,et al.  Optimization of a Digital Medicine System in Psychiatry. , 2016, The Journal of clinical psychiatry.

[71]  J. Ioannidis,et al.  New clinical trial designs in the era of precision medicine: An overview of definitions, strengths, weaknesses, and current use in oncology. , 2019, Cancer treatment reviews.

[72]  M. Parmar,et al.  Evaluating many treatments and biomarkers in oncology: a new design. , 2013, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.

[73]  P. Alam ‘L’ , 2021, Composites Engineering: An A–Z Guide.

[74]  Michael A Proschan,et al.  Design of a Randomized Controlled Trial for Ebola Virus Disease Medical Countermeasures: PREVAIL II, the Ebola MCM Study. , 2016, The Journal of infectious diseases.

[75]  V. Papadimitrakopoulou,et al.  Master protocols in lung cancer: experience from Lung Master Protocol. , 2018, Current opinion in oncology.

[76]  Scott M Berry,et al.  A response adaptive randomization platform trial for efficient evaluation of Ebola virus treatments: A model for pandemic response , 2016, Clinical trials.

[77]  Heidi Ledford,et al.  ‘Master protocol’ aims to revamp cancer trials , 2013, Nature.

[78]  Joon-Oh Park,et al.  VIKTORY trial: Report on AZD1775/paclitaxel in TP53 mutation (+) GC, selumetinib/paclitaxel in ras aberrant GC, AZD5363/paclitaxel in PIK3CA mt and biomarker negative, savolitinib/docetaxel in met (+), and vistusertib/paclitaxel in RICTOR(+) GC. , 2017 .

[79]  Peter Gluchowski,et al.  F , 1934, The Herodotus Encyclopedia.

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

[81]  D. Ecker,et al.  Rapid Molecular Diagnostics, Antibiotic Treatment Decisions, and Developing Approaches to Inform Empiric Therapy: PRIMERS I and II. , 2016, Clinical infectious diseases : an official publication of the Infectious Diseases Society of America.

[82]  P. Chi,et al.  Basket trial of TRK inhibitors demonstrates efficacy in TRK fusion-positive cancers , 2018, Journal of Hematology & Oncology.

[83]  Adaptive and platform trials in remote damage control resuscitation , 2018, The journal of trauma and acute care surgery.

[84]  R. Butler,et al.  FOCUS4: MAMS Trial Design in Action. Early Closure of FOCUS4-D (Pan-HER 1, 2 and 3 Inhibitor Versus Placebo) in Advanced Colorectal Cancer (aCRC) Patients, with Tumours Wildtype (WT) for KRAS, NRAS, BRAF and PIK3CA , 2017 .

[85]  M. Socinski,et al.  MA16.10 Lung-MAP (S1400) Lung Master Protocol: Accrual and Genomic Screening Updates , 2017 .

[86]  P. Alam ‘A’ , 2021, Composites Engineering: An A–Z Guide.

[87]  U. Matulonis,et al.  The NCI-MATCH trial and precision medicine in gynecologic cancers. , 2018, Gynecologic oncology.

[88]  R. Mannel,et al.  Is the NCI MATCH trial a match for gynecologic oncology? , 2016, Gynecologic oncology.

[89]  P. Alam ‘E’ , 2021, Composites Engineering: An A–Z Guide.

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

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

[92]  J Jack Lee,et al.  Bayesian adaptive randomization designs for targeted agent development , 2008, Clinical trials.

[93]  R. Beckman,et al.  Adaptive Design for a Confirmatory Basket Trial in Multiple Tumor Types Based on a Putative Predictive Biomarker , 2016, Clinical pharmacology and therapeutics.

[94]  J. Hainsworth,et al.  Targeted Therapy for Advanced Solid Tumors on the Basis of Molecular Profiles: Results From MyPathway, an Open-Label, Phase IIa Multiple Basket Study. , 2018, Journal of clinical oncology : official journal of the American Society of Clinical Oncology.