Research Focus

Clinical Epidemiology, Public Health & Health Systems

Area of Research

Routinely collected health data, Pragmatic trials and novel study designs, Meta-Research

• 2019 – 2021   COVID-evidence: a living database of trials on interventions for COVID-19 Swiss National Science Foundation (Principal Applicant)
• 06/2020 – present Impact of the COVID-19 outbreak on pathomechanisms, treatment, and outcome of acute stroke at Stroke Units and Stroke Centers in Switzerland Schweizerische Herzstiftung (Co Applicant) 
• 2019 – 2021   Swiss Cancer League: “Emerging trends and developments in cancer treatment innovation: expansion of the CEIT-Cancer project (exCEIT)” (Principal Applicant)
• 2019 – 2022   Swiss National Science Foundation: “Generalizability, applicability and pragmatism of clinical trials and their impact on treatment effect estimates: a metaepidemiological study” (Principal Applicant)
• 2017 – 2020   Swiss Cancer League: “Comparative Effectiveness of Treatments for Cancer in Off-label indications – Contrasting Evidence to Reimbursement Reality” (Co Applicant)
• 2017 – 2018   Mach-Gaensslen Stiftung: “Comparative Effectiveness of Innovative Treatments for Cancer in Off-label Indications” (Principal Applicant)
• 2015 – 2018   Swiss Cancer League: “Clinical decision-making with novel cancer treatments: a meta-epidemiological study on the post-approval generation of clinical evidence” (Principal Applicant)
• 2014 – 2015   Forschungsfonds der Universität Basel: “Comparative treatment effects of onlabel and off-label drug use” (Principal Applicant)
• 2014 – 2015   Gottfried und Julia Bangerter-Rhyner-Stiftung: “Concordance of treatment effects of 'real world’ observational data and randomized controlled trials investigating the same health care intervention” (Principal Applicant)

National Collaborations

1. Departments of Medical Oncology and of Haematology, University Hospital Basel and University of Basel (PD Dr. Dr. B. Kasenda)
2. University Medical Library Basel, University of Basel (Dr. Hannah Ewald, PD Dr. Christian Appenzeller-Herzog)
3. Cochrane Switzerland, Institute for Social & Preventive Medicine, Centre Hospitalier Universitaire Vaudois, Lausanne (Dr. E. von Elm)
4. Swiss Tropical and Public Health Institute, University of Basel
5. Centre for Primary Health Care, University of Basel (Prof. A. Zeller)
6. Neurology & Stroke Center & University Center for Medicine of Aging & Rehabilitation, University of Basel, Felix-Platter Hospital Basel (Prof. S. Engelter)
7. Kantonsspital St. Gallen, Departement Onkologie/Hämatologie (PD Dr. M. Joerger)
8. University Children's Hospital Basel, University of Basel (Dr. J. Bielicki, Dr. D. Fischer)
9. Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel (Prof. A. Widmer, Prof. N Khanna)
10. Breast Center, University Hospital Basel (Prof. W. Weber)
11. Department of Neurology, University Hospital Basel  (Prof. L. Bonati)
12. Division of Endocrinology, Diabetology and Metabolism, University Hospital Basel (Prof. M. Donath)
13. Department of Rheumatology, University Hospital Basel (Prof. T. Daikeler)

International Collaborations

I currently work with more than hundred collaborators worldwide, including

1. Meta-Research Innovation Center at Stanford (METRICS), Stanford University, USA (John Ioannidis, Steve Goodman and research fellows) 
2. Meta-Research Innovation Center at Berlin (METRIC-B), Berlin Institute of Health / Charité and Max Delbrück Center, Berlin, Germany (John Ioannidis and research fellows) 
3. QUEST Center for transforming biomedical research, Berlin Institute of Health / Charité and Max Delbrück Center, Berlin, Germany (Ulrich Dirnagl and research fellows) 
4. Cochrane Germany, University Medical Center Freiburg, Germany (Joerg Meerpohl)
5. Florian Naudet, University of Rennes Clinical Investigation Center (INSERM 1414), Rennes, France 
6. Paula Williamson, Associate Pro-Vice Chancellor for Strategy, chair of COMET-Initiative, Co-Director of Clinical Trials Research Centre, University of Liverpool Institute of Translational Medicine, Department of Biostatistics, UK 
7. Gerald Gartlehner, Cochrane Austria; /Department for Evidence-based Medicine and Clinical Epidemiology, Danube University Krems, Austria; Research Triangle Institute International, University of North Carolina Evidence-based Practice Center, USA 
8. David Moher, Chair of the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network, director of the Center for Journalogy, Ottawa Hospital Research Institute, Canada 
9. Malcolm Macleod, Professor of Neurology and Translational Neuroscience and Academic Lead for Research Improvement and Research Integrity, University of Edinburgh, UK 
10. Deborah Zarin, Program Director for Advancing the Clinical Trials Enterprise at the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard and former Director of ClinicalTrials.gov (NIH), USA
11. Stanford Prevention Research Center, Department of Medicine, Stanford University, CA, USA (R. Stafford)
12. Ole Fröbert, Department of Cardiology, Örebro University Hospital, Sweden 
13. Trial Forge Initiative, Department of Health Services Research, University of Aberdeen, UK (S. Treweek and others)
14. B. Speich, Centre for Statistics in Medicine, University of Oxford, UK 
15. A. Agarval, Department of Medicine, University of Toronto, ON, Canada 
16. Department of Health Research Methods, Evidence and Impact, McMaster University ON, Canada (Gordon Guyatt and others)
17. T.V. Pereira, Health Technology Assessment Unit, Institute of Education and Health Sciences, Oswaldo Cruz German Hospital, Brazil 
18. F. Sclafani, Department of Medicine, The Royal Marsden NHS Foundation Trust J. Martin-Liberal, Catalan Institute of Oncology (ICO) Hospitalet, Melanoma, Sarcoma and GU Tumors Unit, Barcelona, Spain
19. H Verkooijen, Julius Center Research Program Cancer, UMC Utrecht, Netherlands
20. R. Al-Shahi Salman, Division of Clinical Neurosciences, Centre for Clinical Brain Sciences, University of Edinburgh, UK
21. RECORD-group (E. Benchimol, Institute for Clinical Evaluative Sciences, Ottawa, Ontario, Canada; S. Langan, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, UK and others)
22. L. Kwakkenbos, Behavioural Science Institute, Clinical Psychology, Radboud University, Nijmegen, Gelderland, Netherlands
23. B. Thombs, Lady Davis Institute for Medical Research, Jewish General Hospital, Montréal, Quebec, Canada
24. M. Zwarenstein, University of Western Ontario and Institute for Clinical Evaluative Sciences, Canada 
25. Nicole Skoetz, Cochrane Cancer, Cologne, Germany

Topic Areas

• Routinely collected data, Real-World-Evidence, Pragmatic trials, Novel study designs
• Traditional Randomized Controlled Trials
• Health Services Research and Pharmacoepidemiology
• Oncology, drug development and regulation
• Covid-19
• Evidence Syntheses, Systematic Reviews and Meta-Analyses 
• General Clinical Epidemiology and Meta-Research
• Various

 SELECTED SCIENTIFIC PROJECTS

1. Routinely collected data, Real-World Evidence, Pragmatic trials, Novel study designs

• Agreement of treatment effects from randomized trials using routinely collected data for outcome assessment and traditional trials; Meta-epidemiology; [METRICS, Stanford University, Stanford, USA] 
• CONSORT extension for RCTs using cohorts and routinely collected health data; Research Methods & Reporting; [Radboud University, Nijmegen, McGill University, Montreal, Canada and many more] 
• COVID-19: Trial platform for preventive and treatment strategies during epidemic and pandemic outbreaks: Immunocompromised Host Collaborative Swiss Cohorts Based Trial Platform Initiative; RCT; funded by Swiss National Science Foundation (SNSF)
• CEIT-RWE: Real-World Evidence to complement approval studies; Meta-epidemiology; [Department of Medical Oncology, University Hospital Basel, Basel, Switzerland] 
• A standardized protocol tool and eLearning programme for research using routinely-collected health data: A RECORD initiative to improve methods; Research Methods & Reporting
• PragMeta - Meta-research on pragmatic randomized clinical trials; Meta-epidemiology; www.pragmeta-org; [QUEST, Cochrane Germany, Cochrane Austria, METRICS, University of Rennes, France; Jiménez Díaz University Hospital, Madrid, Spain and many more]

2. Traditional Randomized Controlled Trials

• OPBC-02/ PREPEC: Pre- versus sub-pectoral implant-based breast reconstruction after skin-sparing mastectomy or nipple-sparing mastectomy : A pragmatic, multicenter, randomized, superiority trial; RCT; funded within Investigator Initiated Clinical Trial (IICT) scheme of Swiss National Science Foundation (SNSF); [Breast Center, University Hospital Basel, Switzerland]
• OSPIC: Oral corticosteroids for post-infectious cough in adults; RCT; funded within Investigator Initiated Clinical Trial (IICT) scheme of Swiss National Science Foundation (SNSF); [Centre for Primary Health Care, University of Basel, Basel, Switzerland]
• ESTREL: Enhancement of Stroke Rehabilitation with Levodopa, RCT; funded within Investigator Initiated Clinical Trial (IICT) scheme of Swiss National Science Foundation (SNSF); [Department of Neurology, University Hospital Basel and Felix-Platter Spital Basel, Basel, Switzerland]
• THE KIDS-STEP STUDY: Adjunct corticosteroid therapy in hospitalised children with community acquired pneumonia (CAP), RCT; funded within Investigator Initiated Clinical Trial (IICT) scheme of Swiss National Science Foundation (SNSF), [University Children's Hospital Basel, Basel, Switzerland]
• CITrUS trial: Single-dose versus 3-day cotrimoxazole prophylaxis in transurethral resection or greenlight laser vaporisation of the prostate, RCT; funded within NFP 72 scheme of Swiss National Science Foundation (SNSF), [Department of Urology and Division of Infectious Diseases and Hospital Epidemiology, University Hospital Basel, Basel, Switzerland]

3. Oncology, drug development and regulation

• CEIT-cancer: The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project, CEIT-cancer.org, [Department of Medical Oncology, University Hospital Basel, Basel, Switzerland and many more]
• CEIT-OLU: Reimbursment of and access to off-label use (OLU) in oncology, CEIT-cancer.org, [Department of Medical Oncology, University Hospital Basel, Basel, Switzerland]
• CEIT-OLU: Association of off-label use (OLU) and clinical outcomes in oncology, CEIT-cancer.org, [Department of Medical Oncology, University Hospital Basel, Basel, Switzerland]
• CEIT-reporting: Comparison of results of pivotal randomized trials for novel oncology drugs reported in journal articles, trial registries and FDA approval documents, CEIT-cancer.org, [Department of Medical Oncology, University Hospital Basel, Basel, Switzerland]
• CEIT-QoL: Quality of life benefits of novel cancer drugs, CEIT-cancer.org, [Department of Medical Oncology, University Hospital Basel, Basel, Switzerland and many more]
• Tumor characteristics in randomised trials testing target-specific anticancer drugs, Research Methods & Reporting, [Department of Medical Oncology, University Hospital Basel, Basel, Switzerland and many more]

4. COVID-19

• COVID-evidence: a living database of trials on interventions for COVID-19, COVID-evidence.org, [METRICS, Stanford University, Stanford, USA and many more]
• Core Outcome Set for COVID-19 prevention studies, Research Methods & Reporting, [COMET-initiative; University of Liverpool, UK and many more]
• Association of convalescent plasma use with mortality in COVID-19 patients: an international collaborative meta-analysis, Systematic Review and Meta-analysis, [METRICS, Stanford University, Stanford, USA and many more
• Association of hydroxychloroquine or chloroquine use with mortality in COVID-19 patients: an international collaborative meta-analysis, Systematic Review and Meta-analysis, [METRICS, Stanford University, Stanford, USA and many more]

 5. General clinical epidemiology / methods of design, analysis and conduct

• Consideration of confounding in epidemiologic studies, Research Methods & Reporting, [METRICS, Stanford University, Stanford, USA]
• Time-to-event analyses in meta-analyses, EbM Meta-Crowd; Meta-epidemiology, [Cochrane Cancer, Cologne, Germany and many more]
• Patient Involvement to Inform the Design of a Clinical Trial in Postbariatric Hypoglycemia, Research Methods & Reporting, [Division of Endocrinology, Diabetology and Metabolism, University Hospital Basel, Basel, Switzerland]
• Causal models (Marginal structural models) to analyze randomized clinical trials, Research Methods & Reporting, [METRICS, Stanford University, Stanford, USA]
• Costs and resource use of randomized clinical trials, Research Methods & Reporting; MAking Randomized Trials more Affordable group

6. Various

• Giant Cell Arteritis in Polymyalgia rheumatica, Epidemiology; Prediction score development, [Department of Rheumatology, University Hospital Basel, Switzerland]
• Colchicine for prevention of cardiovascular events, Cochrane Review 
• The Open Science dashboard, Research and education, [Ottawa Hospital Research Institute, Ottawa, Canada]