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Approved Requests to Use Johnson and Johnson Data*

Date of Approval YODA Project Protocol Number

PI and Affiliation

Research Proposal Product(s) of Interest

YODA Project Review and Data Holder Due Diligence Assessment

Project Status
Nov. 19, 2014 2014-0340 Heidi Storgaard, MD, PhD; University of Copenhagan, Center for Diabetes Research The effects of SGLT-2 inhibitors in patients with type 2 diabetes: a systematic review with meta-analysis of randomised trials INVOKANA

YODA Project Review

Due Diligence Assessment

Complete; Published in PLOSONE November 11, 2016. Article available here.
Nov. 26, 2014 2014-0333 Guru Sonpavde, MD; University of Alabama, Birmingham (UAB) School of Medicine RECIST response as a surrogate endpoint in metastatic castration-resistant prostate cancer: Retro-spective analysis of COU-AA-203 and COU-AA-301 ZYTIGA

YODA Project Review

Due Diligence Assessment

Unknown; data access revoked, investigator has not reported results as requested.
Nov. 26, 2014 2014-0334 Raymond Cross, MD, MS; University of Maryland, Baltimore Gender differences in weight gain in patients with inflammatory bowel disease treated with Infliximab REMICADE

YODA Project Review

Due Diligence Assessment

Ongoing
Dec. 8, 2014 2014-0291 Michael Ward, MD, PhD; National Institute of Arthritis and Musculo-skeletal and Skin Diseases Comparative effective-ness of tumor necrosis factor alpha inhibitors in ankylosing spondylitis SIMPONI REMICADE

YODA Project Review

Due Diligence Assessment

Complete; Published in J Rheumatol January 15, 2018. Article available here.
Dec. 9, 2014 2014-0364 Stefan Leucht, MD; Department of Psychiatry and Psycho-therapy, Technische Universität München Initial severity and efficacy of anti-psychotics for schizophrenia and bipolar mania: Individual patient level analyses of placebo-controlled trials INVEGA
INVEGA SUSTENNA
RISPERDAL

YODA Project Review

Due Diligence Assessment

Ongoing
Dec. 18, 2014 2014-0317 John Carlson, PhD; Michigan State University Risperidone for conduct problems: do improved indicators of emotional dysregulation mediate improved behavioral outcomes? RISPERDAL CONSTA

YODA Project Review

Due Diligence Assessment

Incomplete; results reported here.
Jan. 20, 2015 2014-0401 Peter Higgins, PhD, MD, MSc; University of Michigan Can machine learning algorithms using general labs predict biologic remission for patients on thiopurines in the SONIC trial? REMICADE

YODA Project Review

Due Diligence Assessment

Ongoing
Mar. 5, 2015 2015-0416 Kristina Rother, MD; National Institute of Health Bone safety of canagliflozin, aSGLT2 inhibitor, in type 2 diabetes: A retrospective analysis to evaluate fracture risk. INVOKANA

YODA Project Review

Due Diligence Assessment

Incomplete; results reported here.
Mar. 30, 2015 2015-0339 Atsushi Sakuraba, MD, PhD; University of Chicago Impact of the dose of immuno-modulators on pharmaco-kinetics of biologics: Patient level meta-analysis of randomized controlled trials REMICADE
SIMPONI

YODA Project Review

Due Diligence Assessment

Ongoing
May 26, 2015 2015-0514 Geoffrey Mospan, PharmD; Wingate University School of Pharmacy Comparison of 5-Day Course of Levofloxacin vs 10-Day Course of Ciprofloxacin Therapy in Males with Urinary Tract Infection LEVAQUIN

YODA Project Review

Due Diligence Assessment

Complete; Published in J Am Board Fam Med November 2016. Article available here.
Jun. 10, 2015 2015-0522 Byron Vaughn, MD; University of Minnesota Impact of Infliximab Concen-trations on Combination Therapy for Crohn’s Disease REMICADE

YODA Project Review

Due Diligence Assessment

Incomplete; results reported here.
Jul. 27, 2015 2015-0500 Urban Emmenegger, MD; Sunnybrook Odette Cancer Centre Studying the Risk of Harmful Drug-Drug Interactions (DDI) in Patients with Castration-Resistant Prostate Cancer (CRPC) Treated with Abiraterone (ABI) ZYTIGA

YODA Project Review

Due Diligence Assessment

Ongoing
Aug. 7, 2015 2015-0527 Byron Vaughn, MD; University of Minnesota Optimizing Infliximab in IBD: Developing a model to determine the optimal interval for monitoring infliximab concen-trations REMICADE

YODA Project Review

Due Diligence Assessment

Incomplete; results reported here.
Sep. 8, 2015 2015-0560 Alexis Ogdie, MD MSCE; University of Pennsylvania Construct and Content Validity of Instruments Used in Clinical Trials of Psoriatic Arthritis SIMPONI STELARA

YODA Project Review

Due Diligence Assessment

Ongoing
Oct. 6, 2015 2015-0565 Srikala Sridhar, MD, MSc; Princess Margaret Cancer Center Understanding reasons for screen failures in late phase trials in advanced GU cancers ZYTIGA

YODA Project Review

Due Diligence Assessment

Ongoing
Oct. 20, 2015 2015-0612 Siddharth Singh, MD, MS; University of California, San Diego Impact of Obesity on Disease Course and Response to Biologic Therapy in Inflammatory Bowel Disease: A Post-
Hoc Analysis of RCTs
REMICADE SIMPONI

YODA Project Review

Due Diligence Assessment

Complete; Published in Inflamm Bowel Dis May 18, 2018; and Am J Gastroenterol June 5, 2018. Articles available here and here.
Oct. 23, 2015 2015-0587 Gustavo Velásquez, MD, MPH; Brigham and Women's Hospital Estimating the effect of bedaquiline on MDR-TB culture conversion and treatment outcomes using marginal structural models SIRTURO

YODA Project Review

Due Diligence Assessment

Ongoing
Dec. 29, 2015 2015-0644 Hwanhee Hong, PhD; Johns Hopkins Bloomberg School of Public Health Generalizing treatment effects for bipolar disorder and schizophrenia to the US population: Generalizability of network meta-analysis

INVEGA            INVEGA SUSTENNA RISPERDAL RISPERDAL CONSTA TOPAMAX

YODA Project Review

Due Diligence Assessment

Ongoing
Dec. 29, 2015 2015-0676 Robin Emsley, MD; University of Stellenbosch Investigating the construct validity of supersensitivity psychosis: An analysis of data from two antipsychotic discontinuation studies

RISPERDAL RISPERDAL CONSTA

YODA Project Review

Due Diligence Assessment

Incomplete: results reported here
Jan. 22, 2016 2015-0649 Chunhua Weng, PhD; Columbia University Population Representativeness of Clinical Trial Study Samples

INVEGA            INVEGA SUSTENNA REMICADE RISPERDAL RISPERDAL CONSTA TOPAMAX

YODA Project Review

Due Diligence Assessment

Incomplete; results reported here.
Jan. 29, 2016 2015-0678 Sharon-Lise Normand, PhD; Harvard Medical School Heterogeneous Causal Effects: Drug Exposure & Safety INVEGA

YODA Project Review

Due Diligence Assessment

Complete; Published in NPJ Schizophr June 27, 2018. Article available here.
Feb. 24, 2016 2015-0691 Siddharth Singh, MD, MS; University of California, San Diego Impact of Biologic Therapy on the Risk of Arterial and Venous Thromboembolic Events in Chronic Autoimmune Diseases: A Post-Hoc Analysis of RCTs

REMICADE SIMPONI

YODA Project Review

Due Diligence Assessment

Incomplete; results reported here.
Feb. 24, 2016 2016-0716 Linda Valeri, PhD; McLean Hospital Mediation analysis to explain comparative efficacy of antipsychotic medications for treatment of schizophrenia in short-term RCT INVEGA

YODA Project Review

Due Diligence Assessment

Complete; Published in NPJ Schizophr June 27, 2018. Article available here.
Feb. 24, 2016 2016-0725 Jayesh Kamath, MD, PhD; University of CT Health Center Investigation of Racial and Ethnic Differences in Cardiometabolic Health of Patients with Schizophrenia/Schizoaffective Disorder INVEGA            INVEGA SUSTENNA

YODA Project Review

Due Diligence Assessment

Ongoing
Feb. 24, 2016 2016-0734 Lawrence Mbuagbaw, MD, PhD, MPH; McMaster University Safety of Bedaquiline (BDQ) in the treatment of multi-drug resistant tuberculosis: a protocol for an individual patient data meta-analysis SIRTURO

YODA Project Review

Due Diligence Assessment

Complete; Published in World Health Organization Report in 2017. Article available here.
Mar. 1, 2016 2015-0677 Shomron Ben-Horin, MD; Sheba Medical Center Meta-analysis: Duration of inflammatory bowel disease and its impact on efficacy of biologic drugs REMICADE SIMPONI

YODA Project Review

Due Diligence Assessment

Ongoing
Mar. 29, 2016 2015-0617 Karestan Koenen, PhD; Harvard School of Public Health Diagnostics for Informative Censoring in Efficacy and Effectiveness Trials of Schizophrenia Therapy INVEGA

YODA Project Review

Due Diligence Assessment

Ongoing
Apr. 5, 2016 2016-0766 Jamie Joseph, PhD; University of California, San Diego Gastrointestinal disease impact on antipsychotic induced weight gain and metabolic syndrome in schizophrenia: analysis of randomized controlled trials INVEGA            INVEGA SUSTENNA RISPERDAL

YODA Project Review

Due Diligence Assessment

Incomplete; results reported here.
Apr. 20, 2016 2016-0738 Christophe Moreno, MD, PhD; CUB Hôpital Erasme Efficacy and safety of Sofosbuvir and Simeprevir for the Treatment of Chronic Hepatitis C genotype 4: a pooled analysis of existing data OLYSIO

YODA Project Review

Due Diligence Assessment

Unknown; data access revoked, investigator has not reported results as requested.
Apr. 20, 2016 2016-0767 Dick Menzies, MD, MSc; McGill University Determinants of treatment outcomes of multidrug-resistant tuberculosis (MDR-TB): an Individual Patient Data (IPD) Meta-Analysis - Update SIRTURO

YODA Project Review

Due Diligence Assessment

Incomplete; results reported here.
Apr. 27, 2016 2016-0774 Craig French, MD; Monash University Individual patient data meta-analysis of four multicenter, randomized, controlled trials evaluating epoetin alfa in critically ill trauma patients PROCRIT

YODA Project Review

Due Diligence Assessment

Incomplete; results reported here.
May 19, 2016 2016-0897 Mark Corbett, MSc; University of York A systematic review and economic evaluation of certolizumab pegol and secukinumab for treating active psoriatic arthritis STELARA

YODA Project Review

Due Diligence Assessment

Complete; Published in Health Technology Assessment October 2017. Article available here.
May 23, 2016 2016-0884 Jose Miguel Fernandez, PhD; Universidad Pompeu Fabra A Meta-analysis of current treatments' efficacy for Relapsed Ovarian Cancer DOXIL

YODA Project Review

Due Diligence Assessment

Incomplete; results reported here.
May 24, 2016 2016-0698 Andreas Goebel, MD; University of Liverpool Placebo response in rheumatoid arthritis REMICADE
SIMPONI

YODA Project Review

Due Diligence Assessment

Incomplete; results reported here.
Jun. 7, 2016 2016-0912 Mark Huffman, MD, MPH; Northwestern University, Feinberg School of Medicine Reproduction analysis of the THERMOCOOL® SMARTTOUCH™ Catheter for the Treatment of Symptomatic Paroxysmal Atrial Fibrillation trial THERMOCOOL SMARTTOUCH Catheter

YODA Project Review

Due Diligence Assessment

Complete; Published in JAMA Cardiology October 2017. Article available here.
Jun. 13, 2016 2016-0919 Purna Kashyap, MBBS; Mayo Clinic Comparative efficacy of biologics in resolving extraintestinal manifestations of IBD: a systematic review and metaanalysis REMICADE

YODA Project Review

Due Diligence Assessment

Ongoing
Jun. 17, 2016 2016-0880 Stefan Leucht, MD; Department of Psychiatry and Psycho-therapy, Technische Universität München Incidence of death and other SAEs related to second generation antipsychotic or placebo treatment in RCTs - a systematic review and meta-analysis INVEGA            INVEGA SUSTENNA RISPERDAL RISPERDAL CONSTA

YODA Project Review

Due Diligence Assessment

Complete; Published in Lancet Psychiatry August 2018. Article available here.
Jul. 7, 2016 2016-0979 Antonio Finelli, MD, MSc; Princess Margaret Cancer Centre Predictors of radiographic progression in metastatic castration-resistant prostate cancer: Retrospective analysis of COU-AA-301 ZYTIGA

YODA Project Review

Due Diligence Assessment

Ongoing
Jul. 12, 2016 2016-0903 Jean Frederic Colombel, MD; Mount Sinai Medical Center Use of TNF antagonist therapies with or without steroids for induction in Crohn’s disease: A Meta-analysis REMICADE

YODA Project Review

Due Diligence Assessment

Ongoing
Aug. 17, 2016 2016-0765 Philip Bath, BSc MB BS MD FRCPath FRCP FESO FAHA DSc; University of Nottingham Improving the statistical analysis of cognitive outcomes in randomised controlled trials: The ‘Optimising the Analysis of Cognition’ Collaboration RAZADYNE

YODA Project Review

Due Diligence Assessment

Ongoing
Aug. 24, 2016 2016-0969 Suzanne Reeves, PhD; University College London Identifying individual factors predictive of extrapyramidal side effects (EPS) in Alzheimer's disease RISPERDAL

YODA Project Review

Due Diligence Assessment

Unknown; data access revoked, investigator has not reported results as requested.
Sep. 1, 2016 2016-1058 Daniel Moreira, MD, MHS; University of Illinois at Chicago Predictors of survival in metastatic castration-resistant prostate cancer ZYTIGA

YODA Project Review

Due Diligence Assessment

Ongoing
Sep. 1, 2016 2016-1057 Benjamin Teply, MD; University of Nebraska Medical Center Incidence of visceral metastasis at time of progression on abiraterone for metastatic castration-resistant prostate cancer ZYTIGA

YODA Project Review

Due Diligence Assessment

Ongoing
Sep. 28, 2016 2016-0995 Laura Coates, MBChB, PhD; University of Leeds Identifying the optimal target for Psoriatic Arthritis – a retrospective analysis to identify which target best predicts improved long term outcomes SIMPONI

YODA Project Review

Due Diligence Assessment

Incomplete; results reported here.
Sep. 28, 2016 2016-1046 Adam Cheifetz, MD; Beth Israel Deaconess Medical Center Serum infliximab concentration and prevention of clinical or endoscopic post-operative recurrence after an ileocolonic resection for Crohn’s disease REMICADE

YODA Project Review

Due Diligence Assessment

Incomplete; results reported here.
Sep. 30, 2016 2016-1005 Adam Chekroud, MSc; Yale University Identification of multivariate, clinical patterns predicting treatment response to paliperidone in schizophrenia INVEGA
INVEGA SUSTENNA
RISPERDAL
RISPERDAL CONSTA

YODA Project Review

Due Diligence Assessment

Ongoing
Oct. 12, 2016 2016-1038 Anthony Daniels, BS; UCB Biosciences Development and validation of historical control using placebo data from pediatric epilepsy studies TOPAMAX

YODA Project Review

Due Diligence Assessment

Ongoing
Nov. 10, 2016 2016-1107 Frank Scott, MD, MSCE; University of Colorado Anschutz Medical Campus The impact of anti-TNF drug levels on rates of fistula healing in individuals with Crohn’s Disease REMICADE

YODA Project Review

Due Diligence Assessment

Ongoing
Nov. 23, 2016 2016-1103 Paul Toren, MD; Université Laval The neutrophil to leukocyte ratio (NLR) in metastatic castrate resistant prostate cancer(mCRPC) patients treated with abiraterone acetate ZYTIGA

YODA Project Review

Due Diligence Assessment

Ongoing
Nov. 23, 2016 2016-1122 Antonio Finelli, MD, MSc; Princess Margaret Cancer Centre Predictors of radiographic progression in metastatic castration-resistant prostate cancer: Retrospective analysis of COU-AA-302 ZYTIGA

YODA Project Review

Due Diligence Assessment

Ongoing
Nov. 30, 2016 2016-0960 Gary Rosner, ScD; Johns Hopkins University Bayesian Methods for Comparative Effectiveness Research PROCRIT

YODA Project Review

Due Diligence Assessment

Ongoing
Jan. 10, 2017 2016-1171 Girish Kulkarni, MD, PhD, FRCSC; University of Toronto/Princess Margaret Cancer Centre Predictors of Survival in a Trial of Abiraterone Acetate for Men with Metastatic Castration-Resistant Prostate Cancer and No Prior Chemotherapy ZYTIGA

YODA Project Review

Due Diligence Assessment

Incomplete; results reported here.
Jan. 20, 2017 2017-1276 Adam Cheifetz, MD; Beth Israel Deaconess Medical Center Defining a therapeutic drug window in patients treated with infliximab for fistulizing Crohn’s disease REMICADE

YODA Project Review

Due Diligence Assessment

Ongoing
Feb. 2, 2017 2016-1136 Guillermo de Velasco, MD, PhD; University Hospital 12 de Octubre Impact of statins on outcomes in patients with castration resistant prostate cancer treated with abiraterone ZYTIGA

YODA Project Review

Due Diligence Assessment

Ongoing
Mar. 1, 2017 2016-1176 Peter Higgins, PhD, MD, MSc; University of Michigan Can Machine Learning Algorithms Using General Labs Predict Biologic Remission for Patients on ustekinumab? STELARA

YODA Project Review

Due Diligence Assessment

Ongoing
Mar. 13, 2017 2017-1356 Yao Zhu, MD; Fudan University Does Body Mass Index predict efficacy of abiraterone acetate therapy in patients with metastatic castration-resistant
prostate cancer?
ZYTIGA

YODA Project Review

Due Diligence Assessment

Ongoing
Apr. 4, 2017 2017-1456 Lihi Eder, MD, PhD; University of Toronto, Women's College Research Institute The efficacy of biologic medications in improving depressive symptoms in patients with PsA – Patient-level metaanalysis SIMPONI
STELARA

YODA Project Review

Due Diligence Assessment

Ongoing
Apr. 6, 2017 2017-1521 Mark Weiser, MD; Sheba Medical Center Predictors of Relapse following Maintenance Treatment of Antipsychotic Drug or Placebo in patients with SCZ, schizoaffective disorder and BPD INVEGA
INVEGA SUSTENNA
RISPERDAL CONSTA
RISPERDAL

YODA Project Review

Due Diligence Assessment

Ongoing
Apr. 17, 2017 2017-1451 José da Silva, PhD; Centro Hospitalar e Universitário de Coimbra Long-term Impact of Patient Global Assessment on radiographic damage and physical function in patients with RA in Remission vs "near-remission" SIMPONI
REMICADE

YODA Project Review

Due Diligence Assessment

Ongoing
Apr. 24, 2017 2017-1466 Adam Kapelner, PhD; Queens College, CUNY The use of clinical experimental data to build personalized medicine models and the evaluation of their effectiveness and statistical significance INVOKANA

YODA Project Review

Due Diligence Assessment

Ongoing
May 24, 2017 2017-1676 Hiroyuki Uchida, MD, PhD; Keio University School of Medicine Placebo Effects in Schizophrenia INVEGA
RISPERDAL

YODA Project Review

Due Diligence Assessment

Ongoing
Jun. 1, 2017 2017-1701 Hiroyuki Uchida, MD, PhD; Keio University School of Medicine Response to Placebo Treatment and Non-response to Active Drug Treatment in Clinical Trials of Long-Acting Injectable Antipsychotics for Schizophrenia INVEGA SUSTENNA
RISPERDAL

YODA Project Review

Due Diligence Assessment

Ongoing
Jun. 6, 2017 2016-1196 Maya Buch, PhD, FRCP, MBChB; University of Leeds From clinical trials to routine care: understanding patient response to biologics in rheumatoid arthritis REMICADE

YODA Project Review

Due Diligence Assessment

Ongoing
Jun. 7, 2017 2017-1671 Andrea Tricco, PhD; St. Michael's Hospital Comparative safety and effectiveness of cognitive enhancers for Alzheimer's dementia: a systematic review and IPD NMA RAZADYNE

YODA Project Review

Due Diligence Assessment

Ongoing
Aug. 3, 2017 2017-1856 Ashwin Ananthakrishnan, MD, MPH; Massachusetts General Hospital Impact of Age on Safety and Efficacy of Biologic Therapy for Inflammatory Bowel Disease REMICADE
SIMPONI
STELARA

YODA Project Review

Due Diligence Assessment

Ongoing
Aug. 7, 2017 2017-1746 David McAllister, MBChB, MD, MPH; University of Glasgow Heterogeneity in relative treatment efficacy by age, sex, socioeconomic status and comorbidity REMICADE
SIMPONI
STELARA
INVOKANA
TOPAMAX
RISPERDAL
RAZADYNE

YODA Project Review

Due Diligence Assessment

Ongoing
Aug. 8, 2017 2017-1706 Zenas Yiu, MBChB;University of Manchester, UK Comparison of “real-life” clinical practice to clinical trials– a propensity score standardization method STELARA

YODA Project Review

Due Diligence Assessment

Ongoing
Aug. 21, 2017 2017-1966 Jose Rubio, MD;The Zucker Hillside Hospital, Northwell Health Breakthrough antipsychotic maintenance medication: An individual participant data meta-analysis of individuals adherent with long acting injectables INVEGA SUSTENNA
RISPERDAL CONSTA

YODA Project Review

Due Diligence Assessment

Ongoing
Aug. 29, 2017 2017-1846 Andreas Heinz, MD; Department of Psychiatry und Psychotherapy, Charité-Universitätsmedizin Berlin Discontinuation symptoms in antipsychotics: Individual patient level analyses of randomized controlled trials INVEGA
INVEGA SUSTENNA
RISPERDAL
RISPERDAL CONSTA

YODA Project Review

Due Diligence Assessment

Ongoing
Aug. 30, 2017 2017-2031 Neeraj Narula, MD; McMaster University Association between Patient-reported Outcomes and Endoscopic Healing in Ulcerative Colitis: A meta-analysis REMICADE

YODA Project Review

Due Diligence Assessment

Ongoing
Sep. 25, 2017 2017-2306 Siddharth Singh, MD, MS; University of California, San Diego Continuing or Stopping 5-ASA in Biologic-Treated Patients with Moderate-Severe Ulcerative Colitis: A Post-Hoc Analysis of RCTs REMICADE
SIMPONI

YODA Project Review

Due Diligence Assessment

Complete; Published in Am J Gastroenterol June 21 2018. Article available here.
Sep. 25, 2017 2017-1816 Angus Jones, PhD; University of Exeter MASTERMIND: Stratification of response to SGLT2 inhibitor glucose lowering therapy INVOKANA

YODA Project Review

Due Diligence Assessment

Ongoing
Nov. 21, 2017 2017-2326 Liana Fraenkel, MD, MPH; Yale University School of Medicine Development of a Global Outcome Measure for Rheumatoid Arthritis Clinical Trials SIMPONI

YODA Project Review

Due Diligence Assessment

Ongoing
Dec. 8, 2017 2017-2486 Elizabeth Wright, PhD; NIDDK/NIH Neutropenia in myelosuppressed cancer patients treated with recombinant human erythropoietin (EPO) PROCRIT

YODA Project Review

Due Diligence Assessment

Ongoing
Jan. 9, 2018 2017-2381 Diane van der Woude, MD, PhD; Leiden University Medical Center Effect of rheumatoid factor and anticitrullinated peptide antibody on the efficacy of bDMARDs in patients with RA SIMPONI
REMICADE

YODA Project Review

Due Diligence Assessment

Ongoing
Jan. 9, 2018 2017-2651 Christian Fankhauser, MD; University Hospital of Zurich Do alpha blockers and 5α-reductase inhibitors influence survival and urinary function in patients with castration resistant prostate cancer? ZYTIGA

YODA Project Review

Due Diligence Assessment

Ongoing
Feb. 22, 2018 2018-2761 Mary Lucy Marques, MD; Leiden University Medical Center Relationship between decreased bone mineral density and syndesmophyte development: a multilevel analysis in patients with Ankylosing Spondylitis REMICADE

YODA Project Review

Due Diligence Assessment

Ongoing
Apr. 27, 2018 2018-3061 Siddharth Singh, MD, MS; University of California, San Diego Development of a Clinical Prediction Tool for Treatment Outcomes in Infliximab-treated Patients with Moderate-Severe Ulcerative Colitis REMICADE

YODA Project Review

Due Diligence Assessment

Ongoing
Mar. 22, 2018 2018-2801 Xianming Tan, PhD; University North Carolina at Chapel Hill Development and applications of new safety analysis methods for randomized clinical trials ZYTIGA

YODA Project Review

Due Diligence Assessment

Ongoing
May 16, 2018 2018-3126 Siddharth Singh, MD, MS; University of California, San Diego Concomitant 5-ASA in Biologic-Treated Patients with Moderate-Severe Crohn’s Disease: A Post-Hoc Analysis of RCTs REMICADE
STELARA

YODA Project Review

Due Diligence Assessment

Ongoing
May 16, 2018 2018-3121 Siddharth Singh, MD, MS; University of California, San Diego Speed of onset of infliximab and golimumab in patients with moderate-severely active ulcerative colitis: A Post-Hoc Analysis of RCTs REMICADE
SIMPONI

YODA Project Review

Due Diligence Assessment

Ongoing

*The YODA Project posts approved proposals once data access has been granted.

Submitted Data Requests Withdrawn/Not Approved*

The following data requests could not be fulfilled due to patient privacy concerns, data element availability, data security concerns, or lack of research proposal clarity.

Date of Submission YODA Project Protocol Number PI and Affiliation Research Proposal Product(s) of Interest

YODA Project Review

and

Data Holder Due Diligence Assessment

Project Status
Nov. 4, 2014 2014-0287 William J. Sandborn, MD; University of California, San Diego Post hoc analysis of the ACT-1 & ACT-2 trials to simulate individualized dosing regimens using a predictive model REMICADE

YODA Project Review

Due Diligence Assessment

*Request originally approved but subsequently withdrawn: data could not be downloaded as requested

Feb. 27, 2015 2015-0406 Nicola Schieda, MD FRCP(C); University of Ottawa Is primary tumor in prostate cancer a reliable target lesion (measurable disease) at contrast-enhanced (CE) CT ZYTIGA

YODA Project Review

Due Diligence Assessment

*Request originally approved but subsequently withdrawn: CT scans not available due to patient privacy concerns

Apr. 21, 2015 2015-0501 Anthony Otley, MD, MSc; IWK Health Centre Towards An Improved Pediatric Crohn’s Disease Activity Index: Integrating Clinical Trial And Registry Data To Identify Key Drivers Of Change REMICADE

YODA Project Review

Due Diligence Assessment

*Request originally approved but subsequently withdrawn: data could not be downloaded as requested

Jun. 29, 2015 2015-0539 Alexandra Sturm, PhD; University of California, Los Angeles Applications of Item Response Theory to Clinical ADHD Research: Analysis of the Psychometric Properties of the ADHDRS-IV CONCERTA

YODA Project Review

Due Diligence Assessment

*Request originally approved but subsequently withdrawn: data could not be downloaded as requested

Aug. 12, 2015 2015-0556 Sigrid Nelson, MSc; Robarts Clinical Trials Operating Characteristics of Centrally-Read Endoscopic Indices and a Novel Patient Reported Outcome Measure for Crohn's Disease REMICADE

YODA Project Review

Due Diligence Assessment

*Request withdrawn prior to approval determination: endoscopy videos not available due to patient privacy concerns

Sep. 17, 2015 2015-0592 Yang Yan, MS; Holmusk Detection of uninformative clinics during the trial of a new drug using statistical and machine learning techniques CONCERTA INVEGA INVEGA SUSTENNA RISPERDAL RISPERDAL CONSTA RAZADYNE Not completed, request withdrawn

*Request withdrawn prior to approval determination: revisions to proposal requested, but never resubmitted

Jun. 25, 2016 2016-0994 Alex Sturm, PhD; University of California, Los Angeles Applications of Item Response Theory to Clinical ADHD Research: Analysis of the ADHDRS-IV and Increased Precision of Treatment Effect Estimation CONCERTA

YODA Project Review

Due Diligence Assessment

*Request originally approved but subsequently withdrawn: insufficient resources
Jul. 13, 2016 2016-1026 Issa Dahabreh, MD; Brown University Making Better Use of Randomized Trials: Assessing Applicability and Transporting Causal Effects INVOKANA Due Diligence Assessment

*Request withdrawn prior to approval determination: revisions to proposal requested, but never resubmitted

*The YODA Project posts withdrawn/unapproved proposals at the time the decision is made.

*Last update: August 13, 2018

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