The Winter School “Gender-sensitive inclusive design of clinical trials” conveys scientific and practical methods for closing the gender data gap in clinical trial design. We will focus on gender-sensitive aspects of planning, design and recruitment, data collection, practice and logistical structures, as well as regulatory structures. Over five days, participants will learn how to combine theoretical knowledge with practical examples and how to develop their own models for clinical studies and scientific research.
GenDect aims to provide participants with practical, actionable gender-sensitive methods for each phase of clinical studies. Participants will learn practical approaches to improve the inclusion of underrepresented groups and the generalizability and transferability of research results, with the goal to enhance the overall quality of clinical studies. Additionally, the course promotes interdisciplinary exchange and offers opportunities to develop innovative solutions for closing the gender data gap in practice.
Key learning areas include:
Raising Awareness: Raise awareness of the influence of gender and intersectional aspects in clinical research. Reflect on potential gender-related biases in clinical studies.
Getting to know tools for implementation: Consider gender-sensitive aspects from the outset in the research design of clinical studies. Discuss practical examples of implementation.
Focus on Practice and Translation: Apply person-centered, co-creative teaching and learning methods of Design Thinking to develop your own gender-sensitive clinical studies.
Networking: Interdisciplinary and cross-generational exchange and networking with international experts in the field of gender-sensitive clinical trial design
Welcome: (Getting to know each other/ Interactive presentation of participants’ own clinical studies/ questions, etc.)
Input: Introduction to the history of sex/gender-sensitive medicine and the role of this winter school (Sabine Oertelt-Prigione, Bielefeld & Nijmegen)
Input: Data basis or gaps in sex/gender sensitivity of clinical practice guidelines (Awa Naghipour, Bielefeld)
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Consideration of sex and intersectional aspects, e.g. (dis)ability, racism
(Tanja Sappok, Bielefeld, tbc)
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Data-Collection in clinical practice and large data sets
(Alison Berner, London)
Input: Standardization, Sex/Gender Aspects in FHIR/FAIR Data
(Carina Vorisek, Berlin)
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Logistical aspects, inclusive development of a Clinical Research Unit
(Tilo Grosser, Bielefeld / Marie von Lilienfeld, Bochum)
Input:
Data-Collection in clinical practice and large data sets
(Alison Berner, London)
Input: Standardization, Sex/Gender Aspects in FHIR/FAIR Data
(Carina Vorisek, Berlin)
Input:
Regulatory agencies and their approach to sex/gender
(Sieta de Vries & (23) Ineke Havinga | LinkedIn
Ineke Havinga, NL)
Discussion/Roundtable: Inclusive trial design in practice (various perspectives: physicians, patients, logistics, etc.)
(Marie von Lilienfeld, Alison Berner, patient representative)
Input: Intersectional Analyses in Healthcare Research (Mathias Nielsen, Copenhagen)
Practical format: Interactive trial design using Design Thinking methods (Experts available as mentors)
Die geschlechtersensible Medizin findet immer häufiger Eingang in medizinische Curricula. Dennoch ist eine flächendeckende Implementierung noch weit entfernt und häufig müssen Expert*innen Überzeugungs- und Informationsarbeit leisten, um das Thema zu positionieren. Im Rahmen dieser Aktivitäten werden Train-the-Trainer Seminare oft als Option angeboten, wobei zukünftige Dozierende das Thema kennenlernen und erfahren können. Für diese Seminare sind jedoch praktische Instrumente notwendig.
Im Rahmen des Juni-Besuches der Gender-Gastprofessorin Londa Schiebinger an der Universität Bielefeld werden wir in dem eintägigen Workshop/Hackathon „Gamification für geschlechtersensible und intersektionale Lehre“ am 19. Juni einige dieser Instrumente erarbeiten. Angelehnt an die intersectional design cards (https://intersectionaldesign.com/), die Prof. Londa Schiebinger zusammen mit der Londoner Designerin Hannah Jones entwickelt hat, werden wir interaktiv weitere Instrumente erstellen. Neben der Gruppenarbeit und dem Austausch werden die internationale Gamification und Inclusivity Expertin Vivian Acquah und die Vorstandsfrau des International Gender und Design Networks, Claudia Herling, ebenfalls Keynotes für die Teilnehmenden halten und als Mentorinnen die Teams begleiten. Yuen Yen Tsai wird uns als Gaming-erfahrene Moderatorin durch den Tag führen.
Ab 18.30 Uhr folgt ein informelles Get-Together, an dem Kurzentschlossene auch teilnehmen können.
Sprache des Workshops ist Englisch (Keynotes und Moderation) und Deutsch (Gruppenarbeit).