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| Date of Approval | YODA Project Protocol Number |
PI and Affiliation |
Research Proposal | Product(s) of Interest |
YODA Project Review and Data Partner 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 | Complete; Published in PLOSONE November 11, 2016. | |
| 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 | 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 | Complete; Published in Inflamm Bowel Dis July 2, 2019. | |
| 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 | Complete; Published in J Rheumatol January 15, 2018. | |
| 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 |
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 | Incomplete; results reported. | |
| 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 | Complete; Published in Clin Gastroenterol Hepatol. March 2018. | |
| 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 | Incomplete; results reported. | |
| 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 |
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 | Complete; Published in J Am Board Fam Med November 2016. | |
| Jun. 10, 2015 | 2015-0522 | Byron Vaughn, MD; University of Minnesota | Impact of Infliximab Concen-trations on Combination Therapy for Crohn’s Disease | REMICADE | Incomplete; results reported. | |
| 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 | 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 | Incomplete; results reported. | |
| 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 | 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 | Incomplete; results reported. | |
| 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 | Complete; Published in Inflamm Bowel Dis May 18, 2018; and Am J Gastroenterol June 5, 2018. | |
| 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 | Incomplete; results reported. | |
| 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 |
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 |
Incomplete: results reported. | |
| 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 |
Incomplete; results reported. | |
| Jan. 29, 2016 | 2015-0678 | Sharon-Lise Normand, PhD; Harvard Medical School | Heterogeneous Causal Effects: Drug Exposure & Safety | INVEGA |
Complete; Preprinted in arXiv, published in NPJ Schizophr June 27, 2018,and in Med Decis Making August 2, 2019. |
|
| 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 |
Incomplete; results reported. | |
| 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 | Complete; Published in NPJ Schizophr June 27, 2018. | |
| 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 | 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 | Complete; Published appendix in World Health Organization Report 2017, and in Emerg Infect Dis. May 2019. | |
| 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 | 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 | Complete; results reported. | |
| 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 | Incomplete; results reported. | |
| 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 | 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 | Incomplete; results reported. | |
| 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 | Incomplete; results reported. | |
| 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 | Complete; Published in Health Technology Assessment October 2017. | |
| May 23, 2016 | 2016-0884 | Jose Miguel Fernandez, PhD; Universidad Pompeu Fabra | A Meta-analysis of current treatments' efficacy for Relapsed Ovarian Cancer | DOXIL | Incomplete; results reported. | |
| May 24, 2016 | 2016-0698 | Andreas Goebel, MD; University of Liverpool | Placebo response in rheumatoid arthritis |
REMICADE SIMPONI |
Incomplete; results reported. | |
| 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 | Complete; Published in JAMA Cardiology October 2017. | |
| 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 | 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 | Complete; Published in Lancet Psychiatry August 2018 and July 2019. | |
| 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 | 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 | 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 | 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 | 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 | Incomplete; results reported. | |
| 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 | Complete. Published in Prostate June 2019. | |
| 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 | Incomplete; results reported. | |
| 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 | Incomplete; results reported. | |
| 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 |
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 | 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 | 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 | Complete; Published in Eur Urol Oncol. January 2019. | |
| 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 | Ongoing; Published in Can Urol Assoc J November 5, 2018. | |
| Nov. 30, 2016 | 2016-0960 | Gary Rosner, ScD; Johns Hopkins University | Bayesian Methods for Comparative Effectiveness Research | PROCRIT | 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 | Incomplete; results reported. | |
| 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 | 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 | 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 | Complete; Published in JAMA Network Open May 3, 2019. | |
| 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 | 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 |
Ongoing | |
| Apr. 6, 2017 | 2017-1521 | Keturah Faurot, PA, MPH, PhD; University of North Carolina at Chapel Hill | 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 |
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 |
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 | Ongoing | |
| May 24, 2017 | 2017-1676 | Hiroyuki Uchida, MD, PhD; Keio University School of Medicine | Placebo Effects in Schizophrenia |
INVEGA RISPERDAL |
Complete; Published in Acta Psychiatr Scand September 9, 2018. | |
| 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 |
Complete; Published in J Clin Psychiatry December 4, 2018. | |
| 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 | 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 | 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 |
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 |
Complete; Published in BMC Med. November 12, 2019. | |
| 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 | Complete; Published in Br J Dermatol. March 1, 2019. | |
| 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 |
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 |
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 | Complete; Published in Clin Gastroenterol Hepatol June 15, 2018. | |
| 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 |
Complete; Published in Am J Gastroenterol June 21 2018. | |
| Sep. 25, 2017 | 2017-1816 | Angus Jones, PhD; University of Exeter | MASTERMIND: Stratification of response to SGLT2 inhibitor glucose lowering therapy | INVOKANA | 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 | Ongoing | |
| Dec. 8, 2017 | 2017-2486 | Elizabeth Wright, PhD; NIDDK/NIH | Neutropenia in myelosuppressed cancer patients treated with recombinant human erythropoietin (EPO) | PROCRIT | Ongoing | |
| Dec. 12, 2017 | 2017-2511 | Raphaël Porcher, PhD; Université Paris Descartes | Policy-aware evaluation of personalized treatment strategies | INVOKANA | 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 |
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 | Incomplete; results reported. | |
| Jan. 31, 2018 | 2018-2686 | Benjamin Kearns, MSc; The University of Sheffield | Exploring the impact of different analysis and extrapolation methods for time-to-event data on estimates of lifetime cost-effectiveness | ZYTIGA | 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 | 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 | Incomplete; results reported. | |
| 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 | Ongoing | |
| May 2, 2018 | 2017-2036 | Antonio Fojo MD, PhD; Columbia University | Determine the growth and regression rate constant and the fractional cell kill of abiraterone acetate in prostate cancer | ZYTIGA | 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 |
Ongoing | |
| May 16, 2018 | 2018-2931 | Sophie Derolez; University Hospital of Tours | Influence of demographic and environmental factors on anti-TNF efficacy in rheumatoid arthritis: a systematic review and meta-analysis of RCT |
REMICADE SIMPONI |
Ongoing | |
| May 18, 2018 | 2018-3051 | Nobuhisa Kanahara, PhD, MD; Chiba University | Dopamine supersensitivity psychosis in randomized controlled studies of long-acting injectable vs. oral agents of the same atypical antipsychotic | RISPERDAL | Ongoing | |
| May 21, 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 |
Complete; Published in Clin Gastroenterol Hepatol May 18 2019. | |
| May 25, 2018 | 2018-3156 | Jasper Stevens, PhD; University Medical Center Groningen | Pharmacokinetics in type 2 diabetes mellitus patients using bedaquiline for tuberculosis (PANDEMIC) | SIRTURO | Ongoing | |
| Jul. 13, 2018 | 2018-3236 | Annemarie de Vries, MD, PhD; Erasmus University Medical Center | Thiopurines versus anti-TNFa for the prevention of postoperative recurrence in Crohn’s disease – a meta-analysis of individual patient data | REMICADE | Ongoing | |
| Sep. 28, 2018 | 2018-3131 | Siddharth Singh, MD, MS; University of California, San Diego | Treatment outcomes with biologics in moderate-severely active Crohn’s disease stratified by ileal vs. colonic disease location |
REMICADE |
Ongoing | |
| Sep. 28, 2018 | 2018-3556 | Ryan Ungaro, MD, MS; Icahn School of Medicine at Mount Sinai | Influence of Race and Ethnicity on the Efficacy of Biologic Drugs for Inflammatory Bowel Disease |
REMICADE |
YODA Project Review Due Diligence Assessment |
Approved. DUA or Data Preparation in Progress* |
| Oct. 4, 2018 | 2018-3011 | David Lorente, MD; Hospital Provincial de Castellon | Clinical Significance and Factors Associated with PSA Progression in mCRPC Patients Treated with Abiraterone | ZYTIGA | Ongoing | |
| Nov. 28, 2018 | 2018-3321 | Pascal Chanu, PharmD; Genentech | Evaluation of longitudinal serum M protein or free light chain dynamics to predict survival in patients with relapsed/refractory multiple myeloma | DARZALEX | Ongoing | |
| Nov. 28, 2018 | 2018-3737 | Shailja Shah, MD; Vanderbilt University | Gender-based Differences in Response to Therapy in Inflammatory Bowel Disease |
REMICADE SIMPONI STELARA |
Ongoing | |
| Dec. 3, 2018 | 2018-3743 | Mirjana Stanic Benic, MD; University Hospital Center, Rijeka | The impact of biological interventions on health-related quality of life in adults with Crohn's disease |
REMICADE STELARA |
Ongoing | |
| Dec. 17, 2018 | 2018-3765 | Ahmad Abuhelwa, PhD; University of South Australia | Predictors of therapeutic and adverse effect outcomes of golimumab | SIMPONI | Ongoing | |
| Dec. 17, 2018 | 2018-3745 | David Lorente, MD; Hospital Provincial de Castellón | Association of Quality of Life Measures with Outcome in Metastatic Castration-resistant Prostate Cancer | ZYTIGA | Ongoing | |
| Dec. 20, 2018 | 2018-3704 | Daniel Aletaha, MD, MsC, MBA; Medical University Vienna | Identifying factors related to high placebo response rates in patients with active rheumatoid arthritis despite prior treatment with biological agents |
PLIVENSIA SIMPONI |
YODA Project Review Due Diligence Assessment |
Approved. DUA or Data Preparation in Progress* |
| Dec. 21, 2018 | 2018-3476 | Vivek Rudrapatna, MD, PhD; University of California, San Francisco | Efficacy of Crohn’s Disease Treatment Stratified by Disease Phenotype |
REMICADE STELARA |
Ongoing | |
| Jan. 25, 2019 | 2018-3813 | Rebeca Lozano, MD; Spanish National Cancer Research Centre (CNIO) | External validation of a prognostic nomogram for first-line therapy in metastatic castration-resistant prostate cancer | ZYTIGA | Ongoing | |
| Jan. 30, 2019 | 2018-3821 | Robert McCutcheon, MBBS, MRCPsych; King's College London | Variability in antipsychotic response |
INVEGA INVEGA-SUSTENNA RISPERDAL |
YODA Project Review Due Diligence Assessment |
Approved. DUA or Data Preparation in Progress* |
| Feb. 18, 2019 | 2019-3827 | Andreas Heinz, MD; Charité - Universitätsmedizin Berlin | Prediction of outcome and adverse events in antipsychotic treatment |
INVEGA INVEGA-SUSTENNA RISPERDAL-CONSTA RISPERDAL |
Ongoing | |
| Apr. 9, 2019 | 2019-3850 | Yang Li, PhD; School of Statistics, Renmin University Of China | A new randomization procedure: pairwise sequential randomization (PSR), properties and applications in both causal inference and clinical trials | INVOKANA | Ongoing | |
| May 3, 2019 | 2019-3865 | Robert Gniadecki, MD; University of Alberta | Alternative Data Presentation For Treatment Outcomes in Psoriasis | STELARA | Ongoing | |
| May 13, 2019 | 2019-3886 | Lin Wang, MD; Johns Hopkins School of Public Health | The relative efficacy and safety of enzalutamide, apalutamide, abiraterone, and darolutamide for nonmetastatic castration-resistant prostate cancer | ZYTIGA |
YODA Project Review Due Diligence Assessment |
Approved. DUA or Data Preparation in Progress* |
| May 17, 2019 | 2019-3893 | Michael Ward, MD; NIH | Predicting Treatment Response to Tumor Necrosis Factor Inhibitors in patients with ankylosing spondylitis |
SIMPONI REMICADE |
Ongoing | |
| Jun. 18, 2019 | 2019-3829 | Lee Van Horn, PhD; University of New Mexico | Predicting Individual Treatment Effects for Doxil/Caelyx in Malignant Ovarian Cancer | DOXIL |
YODA Project Review Due Diligence Assessment |
Approved. DUA or Data Preparation in Progress* |
| Jul. 15, 2019 | 2019-3943 | Adam Cheifetz, MD; Beth Israel Deaconess Medical Center | Defining a therapeutic drug window for infliximab induction therapy in pediatric patients with moderate-to-severe Crohn’s disease | REMICADE | Ongoing | |
| Jul. 17, 2019 | 2019-3941 | Søren Dinesen Østergaard, MD, PhD; Aarhus University | Factors moderating estimates of antipsychotic efficacy in schizophrenia |
INVEGA INVEGA-SUSTENNA RISPERDAL |
Ongoing | |
| Jul. 31, 2019 | 2019-3864 | Kin Wah Fung, MD; National Library of Medicine | Identification of Research Common Data Elements in HIV/AIDS |
EDURANT PROCRIT PREZISTA |
YODA Project Review Due Diligence Assessment |
Approved. DUA or Data Preparation in Progress* |
| Aug. 23, 2019 | 2019-3936 | Charles Iaconangelo PhD; Pharmerit, LP | Unbiased Treatment Efficaacy Detection Methods with Patient Centered Outcomes |
INVEGA-SUSTENNA ZYTIGA RAZADYNE DARZALEX |
YODA Project Review Due Diligence Assessment |
Approved. DUA or Data Preparation in Progress* |
| Aug. 23, 2019 | 2019-3938 | Gustavo Turecki, MD, PhD; Douglas Mental Health University Institue | Machine learning prediction of remission in patients given augmented treatment in major depression |
CONCERTA RISPERDAL |
YODA Project Review Due Diligence Assessment |
Approved. DUA or Data Preparation in Progress* |
| Aug. 23, 2019 | 2019-3958 | Bo Cao, PhD; University of Alberta | Machine Learning for predicting treatment efficacy and clinical categorizations across mental health disorders |
CONCERTA INVEGA INVEGA-SUSTENNA RISPERDAL-CONSTA RISPERDAL TOPAMAX |
YODA Project Review Due Diligence Assessment |
Approved. DUA or Data Preparation in Progress* |
| Sep. 9, 2019 | 2019-3980 | Neeraj Narula, MD, FRCPC; McMaster University | Impact of Ulcer Size and Extent of Inflammation On Ability To Achieve Endoscopic Healing In Crohn’s Disease: A SONIC post hoc Analysis | REMICADE | Ongoing | |
| Oct.3, 2019 | 2019-3978 | Alexander Hodkinson, PhD; University of Manchester | Safety of Risperidone and Paliperdone in schizophrenia and bipolar disorder diagnosed patients - a systematic review and meta-analysis |
INVEGA INVEGA-SUSTENNA RISPERDAL RISPERDAL-CONSTA |
YODA Project Review Due Diligence Assessment |
Approved. DUA or Data Preparation in Progress* |
*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, lack of research proposal clarity, or lack of research resources.
| Date of Submission | YODA Project Protocol Number |
PI and Affiliation |
Research Proposal | Product(s) of Interest |
YODA Project Review and Data Partner 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 | *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 | *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 | *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 | *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 | *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 | Alexandra 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 | *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 | *Request withdrawn prior to approval determination: revisions to proposal requested, but never resubmitted | |
| Jul. 24, 2018 | 2017-2711 | Iñaki Troconiz, PhD; Navarra University | A Quantitative Systems Pharmacology model for Crohn's Disease | STELARA |
Not completed, request withdrawn |
*Request withdrawn prior to approval determination: revisions to proposal requested, but never resubmitted; data could not be downloaded as requested |
| Feb. 6, 2018 | 2018-2746 | KT Park, MD, MS; Stanford University | Early Infliximab Drug Exposure and Outcomes in Children with Crohn’s Disease | REMICADE | *Request originally approved but subsequently withdrawn: insufficient resources | |
| Mar. 28, 2018 | 2018-2946 | Sujana Movva, MD; Fox Chase Cancer Center | Safety of re-administration of trabectedin in soft tissue sarcoma patients experiencing CK elevation | YONDELIS | *Request originally approved but subsequently withdrawn | |
| Mar. 2, 2019 | 2019-3842 | Adam Cheifetz, MD; Beth Israel Deaconess Medical Center | Defining a therapeutic drug window following induction ustekinumab therapy in patients with active fistulizing Crohn’s disease | STELARA |
|
*Request originally approved but subsequently withdrawn: anticipated insufficient values |
| Mar. 27, 2019 | 2019-3840 | Maya Koren-Michowitz, MD; Shamir (Assaf Harofe Medical Center) | Identifying clinical and ECG findings predicting for tachyarrhythmia in patients on ibrutinib treatment | IMBRUVICA | *Request withdrawn prior to approval determination: ECG scans not available due to patient privacy concerns |
*The YODA Project posts withdrawn/unapproved proposals at the time the decision is made.
*Last update: November 13, 2019