Clinical Research Lunch:
Making Trial Research Better!
In this seminar series, we will present basic principles and current research findings on the design of clinical trials. We will explain these new developments using practical examples from our daily work at DKF.
With regard to patient-centeredness, methodological validity and relevance for everyday clinical care, we want to show ways to further improve clinical trials. We are looking forward to exciting discussions.
Topics & Dates 2023
Genotype-Informed Versus Empirical Management Of VirEmia (GIVE MOVE): an Open-Label RCT among Children and Adolescents Living With HIV in Lesotho and Tanzania - Recruitment Challenges and Mitigation Strategies
Children and adolescents living with HIV experience high rates of treatment failure. Genotypic resistance testing (GRT) to inform treatment is often unavailable in resource-limited settings. GIVE MOVE, an ongoing two-country randomised controlled trial, assesses the impact of an intervention package involving provision of GRT and GRT-informed expert recommendations for onward treatment (compared with standard viral load-informed onward treatment) on viral suppression and other clinical outcomes, aiming to inform future clinical guidelines. In this DKF lunch, the study will be discussed with an operational focus on encountered recruitment challenges and how these were overcome.
The study will be presented by Niklaus Labhardt, Head of the Division of Clinical Epidemiology and theInternational Clinical and Health Services Research (ICHSR) Unit at DKF, and Jennifer Brown, a Postdoc / Project Leader in ICHSR. ICHSR focuses on research to address current challenges in global health, with ongoing studies on infectious (notably HIV) as well as emerging non-communicable diseases (including cardiovascular diseases and mental health) conducted in Lesotho, Tanzania, Malawi, and South Africa.
Speaker
Prof. Dr. med. Niklaus Labhardt
Head of Clinical Epidemiology, Department of Clinical Research
Unit Head International Clinical and Health Services Research (ICHSR)
Time
Tuesday, 14 February 2023, 12.30-13.30
Location
Hörsaal 4, Klinikum 1
Universitätsspital Basel, Spitalstrasse 21
Target audience
Interested parties in clinical research (clinical researchers, PhD students, research assistants, study staff, etc.)
Direction
PD Dr. med. Lars G. Hemkens, MPH
Senior Scientist Klinische Epidemiologie, DKF
Topics & Dates 2022
Data of more than half a million patients of the five Swiss university hospitals are now searchable in the SPHN Federated Query System (FQS). The FQS enables researchers to do project feasibility assessments, based on the patient’s consent and in a privacy preserving, federated manner.
Speaker
In this Research Lunch, Sabine Österle will present the SPHN FQS tool and how it can be applied for clinical research. Sabine is a team lead for data interoperability at the Personalized Health Informatics (PHI) group of the SIB Swiss Institute of Bioinformatics, which manages the Swiss Personalized Health Network (SPHN) Data Coordination Centre (DCC) and the BioMedIT project. SPHN is a national initiative with the goal of developing, implementing and validating a coordinated data infrastructure, in order to make health-relevant data interoperable and shareable for research in Switzerland.
Time
Tuesday, 13 December 2022, 12.30-13.30
Location
Hörsaal 4, Klinikum 1
Universitätsspital Basel, Spitalstrasse 21
Target audience
Interested parties in clinical research (clinical researchers, PhD students, research assistants, study staff, etc.)
Direction
PD Dr. med. Lars G. Hemkens, MPH
Senior Scientist Klinische Epidemiologie, DKF
The area of our lives that is changing most rapidly and innovatively is digital. Digital devices and wearables for patient assessment can integrate research into care with the goal of providing real-world evidence of high quality and validity. Digital biomarkers aim to comprehensively detect subtle disease progression, earlier than standard biomarkers.
Speakers
In this research lunch, Dr. med. Tim Woelfle, PD Dr. med. Johannes Lorscheider and PD Dr. med. Lars Hemkens will present the concepts of "digital biomarker" and provide insights in their work on developing and validating digital biomarkers at the Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB). The RC2NB is dedicated to improving clinical, imaging, biochemical, molecular, and cellular characterization of neurological diseases and understanding the benefits and side effects of newly developed therapies. RC2NB has a strong focus on multiple sclerosis and the development of digital biomarkers is one the main activities of the center.
Time
Tuesday, 22 November 2022, 12.30-13.30
Location
Hörsaal 4, Klinikum 1
Universitätsspital Basel, Spitalstrasse 21
Target audience
Interested parties in clinical research (clinical researchers, PhD students, research assistants, study staff, etc.)
Direction
PD Dr. med. Lars G. Hemkens, MPH
Senior Scientist Klinische Epidemiologie, DKF
... Future core metrics used to measure open science practices
The critical importance of Open Science is increasingly recognised and underlined by statements of core research organisations:
The Swiss National Science Foundation states: “For years, the SNSF and other organisations have been demanding open science as the new normal. The corona crisis drastically confirms the validity of this demand.”
The European Commission states: “Open science is a policy priority for the European Commission and the standard method of working under its research and innovation funding programmes as it improves the quality, efficiency and responsiveness of research. When researchers share knowledge and data as early as possible in the research process with all relevant actors it helps diffuse the latest knowledge. And when partners from across academia, industry, public authorities and citizen groups are invited to participate in the research and innovation process, creativity and trust in science increases.“
But how can we identify what we are doing to truly practice open science? And how can we identify where we are doing more than just publishing open access articles? How can we measure our success and determine whether our research is open, more reproducible, more transparent, and more useful to patients and society?
New metrics can help us. They can determine where we are doing a good job and where we can or should improve. They were developed with the support of leading academic institutions around the world, including the University of Basel, and supported by the Wellcome Trust. At this Clinical Research Lunch, Prof. David Moher will present these metrics as the results of a global project that identified 19 open science practices proposed as basis of institutional dashboards to transparently indicate guidance towards better and more open science.
Speaker
Dr. David Moher, Ottawa Hospital Research Institute; University of Ottawa, Canada
Professor Moher is a clinical epidemiologist in the Clinical Epidemiology Program at the Ottawa Hospital Research Institute, where he directs the Centre for Journalology. He is also professor at the School of Epidemiology and Public Health at the University of Ottawa, and a fellow of the Royal Society of Canada and of the Canadian Academy of Health Sciences. Professor Moher has spent several years conducting research in open science.
Zeit
Dienstag, 21. Juni 2022, 12.30-13.30
Ort
Dieses Seminar findet online über Zoom statt.
Meeting ID: 673 2896 9385
Passcode: 564205
Zielpublikum
Interessierte in klinischer Forschung (klinisch Forschende, PhD Studierende, wissenschaftliche Assistenten, Studienfachpersonal, etc.)
Leitung & Moderation
PD Dr. med. Lars G. Hemkens, MPH
Senior Scientist Klinische Epidemiologie, DKF
... the bizarre construct of so-called external validity
- Why are pragmatic trials key for personalized medicine, real world evidence, and treatment decisions?
- Why do we need non-representative studies, where is the end of the real world and evidence-based treatment decisions?
- How do we ensure that our clinical studies deliver useful answers for future patients and important subgroups?
Dieses Research Lunch beleuchtet die Konzepte personalisierter Medizin und pragmatischer Studien aus Sicht von Klinik, klinischer Forschung und Wissenschaftstheorie. Wie können wir mit unserer Forschung genau die Fragen beantworten, die uns interessieren und unseren Patienten direkt weiterhelfen?
Brauchen wir Subgruppen-Analysen, um Patienten besser zu behandeln oder um Forschung besser zu planen, oder für beides? Auf welche Herausforderungen müssen wir achten und wo müssen wir besonders vorsichtig sein?
Referenten
PD Dr. Dr. Benjamin Kasenda, Medizinische Onkologie, University of Basel and University Hospital Basel
PD Dr. Lars G. Hemkens MPH, Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), DKF, University of Basel and University Hospital Basel
Zeit
Dienstag, 24. Mai 2022, 12.30-13.30
Ort
Hörsaal 3, Klinikum 1, 2. OG,
Spitalstrasse 21, Universitätsspital Basel
Zielpublikum
Interessierte in klinischer Forschung (klinisch Forschende, PhD Studierende, wissenschaftliche Assistenten, Studienfachpersonal, etc.)
Leitung & Moderation
PD Dr. med. Lars G. Hemkens MPH
Referent
Prof. Dr.med. Stefan Sauerland, M.san.
Leiter Ressort Nichtmedikamentöse Verfahren IQWiG (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen), Köln, Deutschland
Stefan Sauerland lehrt an der Universität zu Köln und war er von 1998 bis 2009 am II. Chirurgischen Lehrstuhl der Universität zu Köln, dann am Institut für Forschung in der Operativen Medizin (IFOM) der Universität Witten/Herdecke tätig. Er leitet seit 2010 das Ressort Nichtmedikamentöse Verfahren am IQWiG (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen). Das IQWiG hat in Deutschland u.a. den gesetzlichen Auftrag, Vor- und Nachteile von medizinischen Verfahren zu bewerten, also zum Beispiel verschiedene Arzneimittel oder Operationsverfahren untereinander zu vergleichen.
In seinem Vortrag wird er über die Konzeption und Bewertung von Klinischen Studien zu chirurgischen und Medizinprodukte-Interventionen sprechen und auch auf Diagnostika, patienten-relevante Endpunkte und digitale Anwendungen eingehen.
Leitung & Moderation
PD Dr. med. Lars G. Hemkens, MPH
Senior Scientist Klinische Epidemiologie, DKF
Zielpublikum
Interessierte in klinischer Forschung (klinisch Forschende, PhD Studierende, wissenschaftliche Assistenten, Studienfachpersonal, etc.)
Zeit
Dienstag, 18. Januar 2021, 12.30-13.30
Ort/Format
Aufgrund der aktuellen Situation findet diese Veranstaltung online vai Zoom statt.
Sprache
Dieses Seminar findet auf Deutsch statt.