Conference: Representative clinical trials
The same medicine may have different effects on different people. Representation of different populations such as elderly, pregnant women, children and ethnic groups are important in clinical trials to ensure safe and effective medicines for all. If there is not diversity in the test-population for a medicinal product, we know less about how it will work in practice, where patients will be diverse. This entails a higher risk of adverse effects or no effect at all. Data driven paradigms of healthcare such as precision medicine, stresses the importance of representation, where a lack of representation in clinical trials may result in critical biases in healthcare in the future.
Representation does not come easy and lack of representation may be a conscious and justified choice, due to for example ethical, scientific and practical considerations. Representation must be balanced against e.g. ensuring sound data and the protection of vulnerable populations.
This conference will bring together researchers from law, ethics and social sciences and stakeholders from public authorities, healthcare providers, industry and patient organizations to share knowledge, experiences and concerns on the development of representative clinical trials.
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12:00 - 12:10 |
Welcome Jakob Wested, industrial postdoc |
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12:10 - 12:35 |
Ethical Values and Reasoning in Representation in Clinical Trials Nana C. H. Kongsholm, Assistant professor |
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12:35 - 13:00 |
Vulnerability in research ethics Katla Heðinsdóttir, Ph.D., special advisor |
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13:00 – 13:25 |
Whose right to scientific progress? Katharina Ó Cathaoir, Associate professor |
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13:25 – 13:45 |
Panel / Q & A Stine Hasling Mogensen, PhD, Special advisor, Danish Medicines Agency’s Data Analytics Center (DAC) |
| 13:45 – 14:00 | Break |
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14:00 – 14:25 |
Interview study: What is pharma-industry’s experiences and thoughts on representation Johanne Damgaard Brandt, Scientific advisor |
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14:25 – 14:50 |
Representation and neglect in a Multilevel governance perspective Karsten Vrangbæk, Professor |
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14:50 – 15:10 |
Panel / Q & A Moderated by Christine E. Hallgreen, Associate professor Center for Regulatory Science (CORS), University of Copenhagen |
| 15:10 - 15:20 | Break |
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15:20 – 15:45 |
Are EU regulation ready for representation in clinical trials? Jakob Wested, industrial postdoc |
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15:45 - 16:10 |
From regulation to representation: The EU paediatric regulation–what do we get from it? Helle Christiansen, PhD-fellow & special advisor |
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16:10 – 16:50 |
Panel debate with all speakers / Q&A Moderated by Professor Timo Minssen, Center for Advanced Studies in Biomedical Innovation Law (CeBIL), University of Copenhagen |
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16:50 - 17:00 |
Concluding remarks Jakob Wested |
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17:00 |
Drinks reception in “Pejsestuen” |
Background
Developing Policies for Neglected Populations (DePNeP) is a project-collaboration between researchers at the faculties of law, humanities, social science and health University of Copenhagen and the Danish Medicines Agency, funded by a grant from the Crown Princess Mary Center.
You can read more about the project here.
Registration
Please use this registration form no later than May 13, 2022, 10:00.
For registration inquiries please contact maryna.pagels@jur.ku.dk.