Published Proposals

Access to clinical trial data provides opportunities to conduct further research that can help advance medical science or improve patient care. This helps ensure the data provided by research participants are used to maximum effect in the creation of knowledge and understanding.

Proposal Number	Sponsor/Funder	Title	Lead researcher	Affiliation	Publication(s)
631	GSK	Predictors of BPH Progression	Dr. Stephen Freedland, MD	Duke UniversityDurham, North CarolinaUSA	https://cancerpreventionresearch.aacrjournals.org/content/early/2017/04/27/1940-6207.CAPR-17-0019 https://cancerpreventionresearch.aacrjournals.org/content/early/2015/01/31/1940-6207.CAPR-14-0260 https://doi.org/10.1016/j.juro.2017.08.108 https://doi.org/10.18632/oncotarget.10690 https://dx.doi.org/10.1016/j.eururo.2015.12.002 http://dx.doi.org/10.1016/j.juro.2017.04.075 https://doi.org/10.1002/pros.23041
647	GSK	Assessing and Reporting Heterogeneity of Treatment Effect in Randomized Clinical Trials	David M. Kent, MD, MSc	Institute for Clinical Research and Health Policy Studies, Tufts Medical CentBoston, MAUSA	Kent DM, Nelson J, Dahabreh IJ, Rothwell PM, Altman DG, Hayward RA. Risk and treatment effect heterogeneity: re-analysis of individual participant data from 32 large clinical trials. Int J Epidemiol. 2016 Jul 3. pii: dyw118. [Epub ahead of print] PMID: 27375287 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5841614/
651	GSK	Descriptive evaluation of SAE reporting rates in vaccine clinical trials among Latin American children.	Thomas Verstraeten	P95 Pharmacovigilance and Epidemiology ServicesLeuven, BE	Baay M, Bollaerts K, Struchiner C, Verstraeten T. Background rates of disease in Latin American children from a rotavirus vaccine study. Hum Vaccin Immunother. 2017 Apr 25:1-5. doi: 10.1080/21645515.2017.1320007. PMID: 28441094 https://www.tandfonline.com/doi/full/10.1080/21645515.2017.1320007
669	GSK	A multi-center, double-blind, placebo controlled study of paroxetine and imipramine in adolescents with unipolar major depression - efficacy and adverse outcomes.	Jon Jureidini	University of Adelaide	Le Noury J, Nardo JM, Healy D, et al. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ 2015;351:h4320. https://www.bmj.com/content/351/bmj.h4320
674	GSK	Antiepileptic drug monotherapy for epilepsy: an overview of systematic reviews andnetwork meta-analysis	Antony Marson	University of Liverpool	https://doi.org/10.1136/bmj.j1390 https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD011412.pub3/full
911	GSK	Outcome Measures in Systemic Lupus Erythematosus: Constructing a Meaningful Response Index from Existing Clinical Trial Data	Lindsy Forbess, MD, MSc	Cedars-Sinai Medical CenterLos Angeles, CAUS	Failure of a systemic lupus erythematosus response index developed from clinical trial data: lessons examined and learned. Forbess LJ, Bresee C, Wallace DJ, Weisman MH. Lupus. 2017 Jan 1:961203317692433. doi: 10.1177/0961203317692433. [Epub ahead of print] PMID: 28173737 https://journals.sagepub.com/doi/10.1177/0961203317692433
930	GSK	MASTERMIND: Stratification of glycaemic response the ADOPT and RECORD studies	Professor Andrew Hattersley, M.D. FRS	University of Exeter Medical SchoolExeter, UK	https://doi.org/10.2147/CLEP.S179555 https://doi.org/10.2337/dc18-0344
945	ViiV	THE CD4/CD8 RATIO AS A PREDICTOR OF NON-AIDS EVENTS DURING ANTIRRETROVIRAL THERAPY: CONFIRMATION OF ITS PREDICTIVE VALUE AND IMPACT OF MARAVIROC IN TREATMENT-EXPERIENCED PATIENTS	Santiago Moreno	University Hospital Ramón y CajalMadrid, Spain	Serrano-Villar S, Caruana G, Zlotnik A, Pérez-Molina JA, Moreno S. Effects of Maraviroc versus Efavirenz in Combination with Zidovudine-Lamivudine on the CD4/CD8 Ratio in Treatment-Naive HIV-Infected Individuals. Antimicrobial Agents and Chemotherapy. 2017; 61(12). doi: 10.1128/AAC.01763-17.PMID: 28993335. https://aac.asm.org/content/61/12/e01763-17.full
946	GSK	Assessing models for changes in tumour size over time and how they relate to survival times.	Raluca Eftimie	Division of Mathematics, University of DundeeDundee, UK	Mistry, H.B., Orrell, D. & Eftimie, R. Model based analysis of the heterogeneity in the tumour size dynamics differentiates vemurafenib, dabrafenib and trametinib in metastatic melanoma. Cancer Chemother Pharmacol 81, 325-332 (2018). https://doi.org/10.1007/s00280-017-3486-3
977	GSK	The implication of central adjudication of COPD exacerbations by experts for treatment effect estimates and sample size calculation	Milo Puhan	University of ZurichZurich, CH	Bias away from the null due to miscounted outcomes? A case study on the TORCH trial Stefanie Muff, Milo A Puhan, Leonhard Held January 1, 2017 https://doi.org/10.1177/0962280217694403
993	GSK	A Spirometric Z-Score Based Reappraisal of the TORCH Study(GSK-SCO30003): Salmeterol and Fluticasone Propionate in COPD.	Carlos A. Vaz Fragoso, MD	Yale University School of Medicine	https://www.tandfonline.com/doi/abs/10.1080/15412555.2018.1424815
998	GSK	Determination of minimally important difference for short form 36 and Facit Fatigue for Systemic lupus erythematosus	Meenakshi Jolly, MD, MSCP	Rush University Medical CenterChicago, ILUSA	Devilliers H, Annapureddy N, Jolly M. Minimal Clinically Important Differences for Generic Patient Reported Outcomes Tools in SLE [abstract]. Arthritis Rheumatol. 2016; 68 (suppl 10). https://acrabstracts.org/abstract/minimal-clinically-important-differences-for-generic-patient-reported-outcomes-tools-in-sle/
1000	GSK	Review of fever and febrile convulsion rates in children after trivalent influenza vaccine.	Dr Jean Li-Kim-Moy, MBBS, FRACP	National Centre for Immunisation Research and SurveillanceThe Children's Hospital at WestmeadSydney, AU	Li-Kim-Moy, Jean, Wood, Nicholas, Jones, Cheryl, Macartney, Kristine, and Booy, Robert. (2018), Impact of fever and antipyretic use on influenza vaccine immune responses in children. 10.1097/INF.0000000000001949 https://journals.lww.com/pidj/Fulltext/2018/10000/Impact_of_Fever_and_Antipyretic_Use_on_Influenza.3.aspx
1028	ViiV	Impact of dolutegravir on CD4+/CD8+ ratio and CD4+ percentage in HIV-infected naive patients.	José Ramón Blanco	Hospital San Pedro - Center for Biomedical Research of La Rioja (CIBIR), SPAIN	https://doi.org/10.1016/j.cmi.2017.11.016
1058	ViiV	Ritonavir-boosted protease inhibitor-based versus non-nucleoside reverse transcriptase inhibitor-based highly active antiretroviral therapy regimens: a systematic review and individual patient data me	Alvaro H Borges	Centre for Health & Infectious Diseases ResearchRigshospitalet, University of CopenhagenCHIP, Department of Infectious Diseases and Rheumatology,Section 2100, FinsencentretBlegdamsvej 9DK-2100 Copenhagen ØDenmark	https://doi.org/10.1093/cid/ciw236
1078	Lilly	Nocebo effects in the treatment of bipolar disorder: Results from an individual study participant level meta-analysis of the placebo arm of olanzapine clinical trials	Seetal Dodd	Barwon Health	Dodd S, Walker AJ, Brnabic AJM, Hong N, Burns A, Berk M. Incidence and characteristics of the nocebo response from meta-analyses of the placebo arms of clinical trials of olanzapine for bipolar disorder. Bipolar Disord. 2018;00:1-9. https://doi.org/10.1111/bdi.12662
1079	ViiV	The effects of maraviroc versus efavirenz in combination with zidovudine/abacavir on the CD4/CD8 ratio in treatment-naïve HIV-infected individuals.	Sergio Serrano-Villar, MD PhD	Deparment of Infectious DiseasesUniversity Hospital Ramón y CajalMadrid, Spain.	Serrano-Villar S, Caruana G, Zlotnik A, Pérez-Molina JA, Moreno S. Effects of Maraviroc versus Efavirenz in Combination with Zidovudine-Lamivudine on the CD4/CD8 Ratio in Treatment-Naive HIV-Infected Individuals. Antimicrobial Agents and Chemotherapy. 2017; 61(12). doi: 10.1128/AAC.01763-17.PMID: 28993335. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5700350/
1084	GSK	Studies on the relationship between corticosteroids and unfavorable medical effects. A study based on the BLISS-52 and BLISS-76 clinical trials.	Ronald van Vollenhoven, MD, PhD	Karolinska InstituteDepartment of MedicineStockholm, Sweden	"Relationship between glucocorticoid dose and adverse events in systemic lupus erythematosus: data from a randomized clinical trial." DOI:10.1080/03009742.2017.1336570 https://www.tandfonline.com/doi/abs/10.1080/03009742.2017.1336570
1088	GSK	A study to identify risk factors that modify Rotarix efficacy and influence the time to rotavirus gastroenteritis among vaccinated and unvaccinated African infants.	Joann Gruber	University of North Carolina at Chapel Hill	Gruber JF, Becker-Dreps S, Hudgens MG, Brookhart MA, Thomas JC, Jonsson Funk M. Timing and predictors of severe rotavirus gastroenteritis among unvaccinated infants in low- and middle-income countries. Epidemiol Infect 2018;146(6):698-704. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5895523/ Gruber JF, Becker-Dreps S, Hudgens MG, Brookhart MA, Thomas JC, Jonsson Funk M. Timing of Rotavirus Vaccine Doses and Severe Rotavirus Gastroenteritis among Vaccinated Infants in Low- and Middle-Income Countries. Epidemiology 2018. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6167161/
1090	GSK	Validating the test-negative case-control design for estimating rotavirus vaccine effectiveness using gold-standard randomized controlled trial data from South Africa and Malawi (Rota-037)	M. Elizabeth Halloran	Fred Hutchinson Cancer Research Center; Department of Biostatistics, University of Washington	http://dx.doi.org/10.1016/j.vaccine.2016.10.077
1100	Boehringer Ingelheim	Systolic blood pressure level and risk of intracerebral hemorrhage.	Jacoba P Greving	Julius Center for Health Sciences and Primary Care UMC Utrecht	http://www.neurology.org/content/88/2/177.full.html
1103	GSK	A study on the possible association between antidepressant response to SSRIs and proneness for side effects	Elias Eriksson, MD, PhD	University of GothenburgGothenburg, Sweden	https://doi.org/10.1038/mp.2017.147
1136	Takeda	Can Machine Learning Algorithms using General Labs Predict Clinical Remission and Mucosal Healing for Patients on Vedolizumab?	Peter Higgins	University of Michigan	https://onlinelibrary.wiley.com/doi/epdf/10.1111/apt.14510
1137	GSK	Immunotherapy trial simulators: Using mathematical, computational and statistical techniques to simulate trial design for new products in the treatment, vaccination and immunoprophylaxis of disease.	Roy Anderson, PhD	Imperial College LondonLondonUK	Cite this article: Hadjichrysanthou C, Caue¨t E, Lawrence E, Vegvari C, de Wolf F, Anderson RM. 2016 Understanding the within-host dynamics of influenza A virus: from theory to clinical implications. J. R. Soc. Interface 13: 20160289. http://dx.doi.org/10.1098/rsif.2016.0289
1140	Boehringer Ingelheim	Evaluation of the effect of incidental beta blocker use on clinical response to the EGFR TKI, afatinib	John Heymach, MD, PhD	MD Anderson Cancer Center	https://clinicalstudydatarequest.com/Approved-Requests-DataSharingAgreement-Published.aspx
1141	GSK	Multivariate methods for meta-analysis of vaccine studies with multiple correlated outcomes	Merryn Voysey	Nuffield Department of Primary Care Health Sciences, University of Oxford	http://jamanetwork.com/journals/jamapediatrics/fullarticle/2627571
1148	Lilly	Meta-analysis of the risk of relapse in bipolar disorder	Dr. Joaquim Radua	FIDMAG Germanes Hospitalàries & King’s College London	Radua et al. Meta-analysis of the risk of subsequent mood episodes in bipolar disorder. Psychotherapy and Psychosomatics, in Press. DOI: 10.1159/000449417
1154	GSK	Developing New Outcome Measures for SLE by Deconvoluting Available Datasets	Peter E. Lipsky, MD	Lupus Research InstituteNew York, NYUSA	https://onlinelibrary.wiley.com/doi/full/10.1002/art.40522
1173	GSK, Lilly	Initial severity and antidepressant efficacy for anxiety disorders: an individual patient data meta-analysis	Ymkje Anna de Vries	Interdisciplinary Center Psychopathology and Emotion regulation, Department of Psychiatry, University Medical Center Groningen, the Netherlands	https://doi.org/10.1002/da.22737
1224	GSK	INTERACTION BETWEEN MENINGOCOCCAL SEROGROUP B VACCINE (BEXSERO™) AND ROUTINE INFANT VACCINES ON THE RISK OF OCCURRENCE AND RECURRENCE OF ADVERSE EVENTS FOLLOWING IMMUNIZATION.	Gaston De Serres	Institut National de Santé Publique du Québec(INSPQ)andLaval University	http://dx.doi.org/10.1136/bmjopen-2018-026953
1257	GSK	An independent evaluation of the cardiovascular risk of rosiglitazone: meta-analysis of GSK’s publicly available clinical trial data	Joseph S. Ross, MD, MHS	Yale University School of MedicineYale-New Haven Hospital Center for Outcomes Research and Evaluation	https://doi.org/10.1136/bmj.l7078
1292	Lilly	Applications of Item Response Theory to Clinical ADHD Research: Analysis of the ADHDRS-IV and Modeling Response to Treatments and Item-Level Treatment Sensitivity	Alex Sturm	University of California, Los Angeles	Sturm, A., McCracken, J. T., & Cai, L. (2017). Evaluating the Hierarchical Structure of ADHD Symptoms and Invariance Across Age and Gender. Assessment. 2017 Jun 1:1073191117714559. doi: 10.1177/1073191117714559.
1320	GSK	Utility of a measure of Lupus Low Disease Activity State in SLE	Pei Xuan Ong (Emily)	Monash Health	https://ard.bmj.com/content/early/2019/01/24/annrheumdis-2018-214427
1323	Lilly	Detection of uninformative clinics during the trial of a new drug using statistical and machine learning techniques	Praveen Deorani	KKT Technology pte. Ltd.	Craig, Kevin & Liman, Christian & Yan, Yang & Goyal, Shubham & Roy, Nawal. (2017). More of what works: Detection of informative sites during the conduct of clinical trials using machine learning. 10.13140/RG.2.2.11323.62242.
1331	Boehringer Ingelheim	Impact of baseline diabetes and obesity statuses on outcomes post-ischemic stroke	Colleen Bauza	Medical University of South Carolina in Public Health Sciences	Bauza, Colleen; Martin, Renee; Yeatts, Sharon D.; Borg, K; Magwood, Gayenell; Selassie, Anbesaw; and Ford, Marvella E. (2018) Determining the joint effect of obesity and diabetes on all-cause mortality and cardiovascular-related mortality following an ischemic stroke. 10.1155/2018/4812712 Bauza, Colleen; Martin, Renee; Yeatts, Sharon D.; Borg, K; Magwood, Gayenell; Selassie, Anbesaw; and Ford, Marvella E. (2018) Determining the joint effect of obesity and diabetes on functional disability at 3-months and on all-cause mortality at 1-year following an ischemic stroke. 10.1186/s12902-018-0255-1
1374	GSK	A novel representation of vaccine efficacy trial datasets for use in computer simulation of vaccination policy	Michael M. Wagner	University of Pittsburgh	Tajgardoon M, Wagner MM, VisweswaraS, Zimmerman RK. A Novel Representation of Vaccine Efficacy Trial Datasets for use in Computer Simulation of Vaccination Policy. AMIA Summits on Translational Science Proceedings. 2018;2017:389. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5961808/
1403	ViiV	Mathematical modeling of the HIV transmission risk during the first 24 weeks after initiation of antiretroviral therapy in naïve HIV-infected MSM	Juan Berenguer	Hospital General Universitario Gregorio Marañón	Abstract can be found here, presented at 9th IAS Conference on HIV Science, July 2017, Paris, France: http://www.ias2017.org/LinkClick.aspx?fileticket=m3LSDs1z4QY%3d&;tabid=577&portalid=1 see page 502, abstract # WEPEC0967: "HIV transmission from condomless anal intercourse differs by initial ART regimen in HIV-infected MSM"
1430	GSK	Comparison of various remission criteria for SLE. A study based on the BLISS-52 and BLISS-76 clinical trials.	Ronald van Vollenhoven	Department of Medicine, Solna	Parodis I#, Emamikia S#, Gomez A, Gentline C, Arkema EV, Chatzidionysiou K, van Vollenhoven RF. Evaluation of Definitions Of Remission In Systemic Lupus Erythematosus (DORIS): a post-hoc analysis of two randomised clinical trials. The Lancet Rheumatology. 2019 Sep; [Accepted; In production] #Contributed equally https://www.thelancet.com/journals/lanrhe/article/PIIS2665-9913(19)30049-9/fulltext
1455	Boehringer Ingelheim	Prediction of major bleeding in atrial fibrillation patients with a history of stroke or transient ischemic attack	Jacoba Greving	Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, the Netherlands	http://stroke.ahajournals.org/content/early/2017/09/20/STROKEAHA.117.019183/tab-article-info
1456	ViiV	Impact of ongoing side effects on the efficacy of initial antiretroviral therapy	Andrew Carr	St Vincent's Hospital, Sydney	http://www.croiconference.org/sessions/fda-snapshot-algorithm-may-overestimate-efficacy-initial-art
1457	Lilly	Initial severity and efficacy of antipsychotics for schizophrenia and bipolar mania: Individual participant level analyses of placebo-controlled studies.	Stefan Leucht	Department of Psychiatry and Psychotherapy TU-München	https://www.ncbi.nlm.nih.gov/pubmed/28939419
1470	Takeda, UCB	The efficacy of biologic drugs in short-duration versus long-duration inflammatory bowel disease	Shomron Ben-Horin M.D.	Gastroenterology Department, First Affiliated Hospital of Sun-YatSen University, Guangzhou, China	Ben-Horin S, Zhao Y, Guo J, Mao R, Novack L, Sergienko R, Zhang J, Kobayashi T, Hibi T, Chowers Y, Colombel JF, Peyrin-Biroulet L, Kaplan G, Chen MH. Efficacy of biological drugs in short-duration versus long-duration inflammatory bowel disease: a protocol for a systematic review and an individual-patient level meta-analysis of randomised controlled trials. BMJ Open. 2019 Jan 25;9(1):e024222
1473	Roche	Comparison of the pharmacokinetics of oral once-monthly 150mg ibandronate between ethnic Europeans and Taiwan post-menopausal osteoporotic women across two phase 1 studies	Keh-Sung Tsai	(1) Department of Laboratory Medicine, National Taiwan University Hospital(2) Institute of Epidemiology and Preventive Medicine, National Taiwan University	https://link.springer.com/article/10.1007%2Fs00198-019-05127-y
1475	Boehringer Ingelheim	Predicting safety and efficacy of afatinib treatment of NSCLC	Assoc/Prof Michael Sorich	Flinders Centre for Innovation in Cancer, Flinders University, Adelaide, Australia	Cancers 2018, 10, 384; doi:10.3390/cancers10100384 https://www.mdpi.com/2072-6694/10/10/384
1528	GSK	A Swapping Method for Average Treatment Effect Estimation	Bimal Sinha	Statistics, the University of Maryland at Baltimore County (UMBC)	https://www.tci-thaijo.org/index.php/thaistat/article/view/163194/117937
1569	GSK	Melancholic symptoms in bipolar depression and response to lamotrigine	Dr. Evyn Peters	Department of Psychiatry, University of Saskatchewan (U of S), Saskatchewan, Canada	Peters, E. M., Bowen, R., & Balbuena, L. (2018). Melancholic Symptoms in Bipolar II Depression and Responsiveness to Lamotrigine in an Exploratory Pilot Study. Journal of clinical psychopharmacology. DOI: 10.1097/JCP.0000000000000947 https://journals.lww.com/psychopharmacology/Fulltext/2018/10000/Melancholic_Symptoms_in_Bipolar_II_Depression_and.18.aspx
1575	GSK, Lilly	Early improvement in individual symptoms and response to antidepressants in patients with major depressive disorder	Ymkje Anna de Vries	Interdisciplinary Center Psychopathology and Emotion regulation, University Center of Psychiatry, University Medical Center Groningen, the Netherlands	https://doi.org/10.1192/bjp.2018.122
1593	GSK	JANUVIA/JANUMET HTA Submission(Germany)	Dr. Rainer Woker	MSD Sharp & Dohme GmbH	https://www.g-ba.de/informationen/nutzenbewertung/398/
1595	Boehringer Ingelheim, GSK, Lilly, Roche	A Novel Approach to Developing Comprehensive Profile of Adverse Event (AE) Data from Clinical Trials	Sharayu Paranjpe	Cytel Statistical Software and Services Pvt. Ltd	arxiv.org biostats.bepress.com
1599	Roche	Predictors of exposure, adverse and therapeutic effects of BRAF/MEK inhibitors in advanced melanoma.	Michael Sorich	Flinders University	https://www.ncbi.nlm.nih.gov/pubmed/30758912
1622	ViiV	A systematic literature review and Individual patient-level data enhanced network meta-analysis to determine the comparative efficacy and safety of first-line HIV antiretroviral therapies	Steve Kanters	School of Population and Public Health	Kanters, S. (2019). Comparative efficacy and safety of first-line treatments for HIV patients for clinical guideline development and the impact of individual patient data. University of British Columbia. https://open.library.ubc.ca/collections/ubctheses/24/items/1.0383244 doi 10.14288/1.0383244
1624	Lilly	A Meta-analysis of Tardive Dyskinesia Rates in Studies Comparing Second Generation Antipsychotics (SGAs) with each other or to First-Generation Antipsychotics (FGAs).	Christoph U Correll	The Zucker Hillside Hospital	Carbon M, Kane JM, Leucht S, Correll CU. Tardive dyskinesia risk with first-and second-generation antipsychotics in comparative randomized controlled trials: a meta-analysis. World Psychiatry. 2018 Oct;17(3):330-340. doi: 10.1002/wps.20579. PubMed PMID: 30192088; PubMed Central PMCID: PMC6127753.
1626	GSK	Factors associated with Prostate Cancer in Prostate Needle Biopsy	Daniel M. Moreira	University of Illinois at Chicago	https://doi.org/10.1016/j.juro.2018.06.018
1629	GSK	Assessing sex-differences and the effect of timing of vaccination on immunogenicity, reactogenicity and efficacy of vaccines in young children	Merryn Voysey	University of Oxford	https://doi.org/10.1016/j.vaccine.2017.09.002
1630	GSK	A framework for individualized prediction of the rate and severity of asthma exacerbations	Mohsen Sadatsafavi	Faculty of Pharmaceutical Sciences and Faculty of Medicine, University of British Columbia	https://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2018.197.1_MeetingAbstracts.A7412
1633	ViiV	Comparative effect of dolutegravir and raltegravir on CD4+/CD8+ ratio, CD4%, and multiple T-cell marker recovery. SPRING-2 study.	Jose Ramon Blanco	Hospital San Pedro - Center for Biomedical Research of La Rioja (CIBIR), SPAIN	Blanco JR, Alejos B, Moreno S. Immune recovery markers in a double blind clinical trial comparing dolutegravir and raltegravir based regimens as initial therapy (SPRING-2). PLoS One. 2020 Jan 16;15(1):e0226724. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0226724
1640	GSK	Effect of Fluticasone/Salmeterol on Chronic Bronchitis Symptoms and Associated Patient Reported Outcomes: a post-hoc analysis of the TORCH trial	Victor Kim	Lewis Katz School of Medicine, Temple University.	https://www.atsjournals.org/doi/abs/10.1164/ajrccm-conference.2018.197.1_MeetingAbstracts.A7727
1695	GSK	Outcome measures and baseline predictors of response to belimumab treatment.	Ioannis Parodis	Department of Medicine, Rheumatology Unit, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden	Ioannis Parodis, Sharzad Emamikia, Alvaro Gomez, Iva Gunnarsson, Ronald F. van Vollenhoven & Katerina Chatzidionysiou (2018): Clinical SLEDAI-2K zero may be a pragmatic outcome measure in SLE studies, Expert Opinion on Biological Therapy, https://www.tandfonline.com/doi/full/10.1080/14712598.2019.1561856 http://dx.doi.org/10.1136/annrheumdis-2018-214880 https://academic.oup.com/rheumatology/advance-article/doi/10.1093/rheumatology/kez191/5510116?guestAccessKey=3ad38e37-5e79-460f-af2b-37672a291dee Antimalarial agents diminish while methotrexate, azathioprine and mycophenolic acid increase BAFF levels in systemic lupus erythematosus. Hernández-Breijo B, Gomez A, Soukka S, Johansson P, Parodis I. Autoimmun Rev. 2019 Aug 10:102372. doi: 10.1016/j.autrev.2019.102372 https://doi.org/10.1016/j.autrev.2019.102372
1731	GSK	Host characteristics impacting Rotarix immunogenicity and correlates of protection for rotavirus gastroenteritis, a multi-site pooled analysis of individual-level clinical trial data	Julia M. Baker	Department of Epidemiology, Rollins School of Public Health, Emory University	http://ars.samrc.ac.za/ARS%202019/ARS%20posters/Baker%20Oral%20polio%20vaccine%20interferes%20.pdf http://ars.samrc.ac.za/ARS%202019/ARS%20posters/Baker%20Assessing%20serum%20anti.pdf
1732	Astellas, Boehringer Ingelheim, GSK, Lilly, Novartis, Roche, Sanofi, Takeda, UCB	Assessing heterogeneity in relative treatment efficacy by age, sex and comorbidity.	Dr David A McAllister	University of Glasgow	https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-019-1427-1#article-info Hanlon, P., Hannigan, L., Rodriguez-Perez, J. et al. Representation of people with comorbidity and multimorbidity in clinical trials of novel drug therapies: an individual-level participant data analysis. BMC Med 17, 201 (2019) DOI: 10.1186/s12916-019-1427-1
1741	Lilly	Predictors of exposure, therapeutic and adverse effects of drugs used in the treatment of advanced breast cancer and advanced colorectal cancer.	Dr Ashley Mark Hopkins	Flinders University	https://www.frontiersin.org/articles/10.3389/fonc.2019.00789/full Lim, H.H., Hopkins, A.M., Rowland, A. et al. Targ Oncol (2019) 14: 743. https://doi.org/10.1007/s11523-019-00683-z
1779	GSK	Evaluation of the effect of inhaled corticosteroids (ICS) on blood eosinophil count (EOS) in patients with COPD	Professor Jørgen Vestbo DMSc FRCP FERS	Division of Infection, Immunity and Respiratory MedicineUniversity of Manchester, UK	https://erj.ersjournals.com/content/52/suppl_62/OA2125
1907	GSK	Critical characterization of the impact of clinical-pathological tumoral features on recurrence risk dynamics of NSCLS.	Tommaso De Pas	European institute of Oncology , Milan	https://doi.org/10.1016/j.ejca.2019.11.005
2082	GSK	Assessing the difference in results of aggregate data meta-analysis and individual patient data meta-analysis	Diwakar Jha	Birla Institute of Technology, Mesra	sdfg sdf
2084	GSK	Relationship between plasma levels of a1-Antitrypsin levels and the severity of airflow limitation	Marc Miravitlles	Pneumology Department. Hospital Universitari Vall d'Hebron. Barcelona, Spain	https://www.archbronconeumol.org/en-serum-levels-alpha1-antitrypsin-their-relationship-articulo-S1579212920300100 DOI: 10.1016/j.arbres.2019.03.001
5453	Roche	Evaluation of Postmastectomy Radiotherapy in Women with HER-2 positive Breast Cancer	Youssef Zeidan	American University of Beirut, Medical Center	Abi Jaoude J, de Azambuja E, Makki M, et al. Post-Mastectomy Radiation Therapy in Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer Patients: Analysis of the HERA Trial. Int J Radiat Oncol Biol Phys. 2020;106(3):503-510. doi:10.1016/j.ijrobp.2019.10.022
5459	GSK	Placebo Effects in Asthma Randomized Clinical Trials: Their Magnitudes, Causes and Potential for Improving Care	Shawn D. Aaron	The Ottawa Hospital Research Institute, University of Ottawa	https://www.atsjournals.org/doi/full/10.1513/AnnalsATS.201901-071OC
11567	Astellas, GSK, Novartis	Proposal Title	Test Lead Researcher	Test Company of Lead Researcher