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Approved Requests to Use Johnson and Johnson Data*

Date of Approval YODA Project Protocol Number PI Affiliation Project Title Product(s) of Interest Research Proposal 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 Click here to view Click here to view 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 Click here to view Click here to view Ongoing
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 Click here to view Click here to view 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 Click here to view Click here to view Ongoing
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
Click here to view Click here to view 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 Click here to view Click here to view Ongoing
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 Click here to view Click here to view 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 Click here to view Click here to view Ongoing
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
Click here to view Click here to view 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 Click here to view Click here to view 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 Click here to view Click here to view Ongoing
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 Click here to view Click here to view 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 Click here to view Click here to view Ongoing
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 Click here to view Click here to view 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 Click here to view Click here to view 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
REMICADESIMPONI Click here to view Click here to view Ongoing
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 Click here to view Click here to view 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 Click here to view Click here to view 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

Click here to view Click here to view 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

Click here to view Click here to view Ongoing
Jan. 29, 2016 2015-0678 Sharon-Lise Normand, PhD Harvard Medical School Heterogeneous Causal Effects: Drug Exposure & Safety INVEGA Click here to view Click here to view Ongoing
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

Click here to view Click here to view Ongoing
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 Click here to view Click here to view Ongoing
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 Click here to view Click here to view 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 Click here to view Click here to view Ongoing
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 Click here to view Click here to view 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 Click here to view Click here to view Ongoing
April 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 Click here to view Click here to view Ongoing
April 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 Click here to view Click here to view Ongoing
April 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 Click here to view Click here to view Ongoing
April 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 Click here to view Click here to view Incomplete; Results reported available 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 Click here to view Click here to view Ongoing
May 23, 2016 2016-0884 Jose Miguel Fernandez, PhD Universidad Pompeu Fabra A Meta-analysis of current treatments' efficacy for Relapsed Ovarian Cancer DOXIL Click here to view Click here to view Ongoing
May 24, 2016 2016-0698 Andreas Goebel, MD University of Liverpool Placebo response in rheumatoid arthritis REMICADE
SIMPONI
Click here to view Click here to view Ongoing
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 Click here to view Click here to view Ongoing
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 Click here to view Click here to view 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 Click here to view Click here to view Ongoing
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 Click here to view Click here to view 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 Click here to view Click here to view 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 Click here to view Click here to view 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 Click here to view Click here to view Ongoing
Sep. 1, 2016 2016-1058 Daniel Moreira, MD, MHS University of Illinois at Chicago Predictors of survival in metastatic castration-resistant prostate cancer ZYTIGA Click here to view Click here to view Ongoing
Sep. 1, 2016 2016-1057 Benjamin Teply, MD Johns Hopkins University Incidence of visceral metastasis at time of progression on abiraterone for metastatic castration-resistant prostate
cancer
ZYTIGA Click here to view Click here to view 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 Click here to view Click here to view Ongoing
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 Click here to view Click here to view Ongoing
Sep. 30, 2016 2016-1005 Adam Chekroud, MSc Yale University Identification of multivariate, clinical patterns predicting treatment response to paliperidone in schizophrenia INVEGA
INVEGA SUSTENA
RISPERDAL
RISPERDAL CONSTA
Click here to view Click here to view 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 Click here to view Click here to view 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 Click here to view Click here to view 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 Click here to view Click here to view Ongoing
Nov. 30, 2016 2016-0960 Gary Rosner, ScD Johns Hopkins University Bayesian Methods for Comparative Effectiveness Research PROCRIT Click here to view Click here to view 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 Click here to view Click here to view Ongoing
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 Click here to view Click here to view 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 Click here to view Click here to view 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 Click here to view Click here to view 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 Click here to view Click here to view 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
Click here to view Click here to view 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
Click here to view Click here to view 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 Affiliation Project Title Product(s) of Interest Research Proposal Data Holder Due Diligence Assessment
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

Click here to view

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

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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

Click here to view

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

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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

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

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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

Click here to view

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

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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

Click here to view

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

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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

Click here to view

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

Not completed, request withdrawn

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

*Last update: May 30, 2017

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