Women in clinical trials

Medicon Valley Alliance invites you to join this network meeting on Women in clinical trials.

Women are underrepresented in clinical studies – especially in phase I trials were only 29 – 34 % of participants in Phase I trials are female. And 74 % of clinical trials do not report outcome by sex. But why is that?

Is the reason for fewer women in clinical research mainly because researchers worry about the costs and legal issues if a participant gets pregnant? Also, does it seem like including women in studies brings extra expenses for sponsors because they might react differently to the new drugs, and age-related differences make things more complex? Does the tradition of leaving out certain groups affect how many women join clinical trials? And how do new rules about representation impact getting more women involved?

Even though involving more women in trials can be more expensive and trickier for sponsors, it’s important. This helps us really understand how drugs work. If a drug has more problems or doesn’t work well in women, it can be even more expensive to take it off the market later. Including more women in studies gives us a better picture of how drugs work and how different groups might react to them.

In this meeting we will hear from different experts, that will enlighten us on the EU regulatory perspective, the costs of including women, and on how to recruit more women.

Date: Tuesday, 5th March, 2024
Time: 14:00 – 18:00
Venue: Medicon Village, Auditorium, Building Inspira, Scheelevägen 4, Lund, Sweden

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Program

Speakers

	Jakob Wested, industrial postdoc at the Danish Medicines Agency’s Data Analytics Center (DAC) and Center for Advanced studies in biomedical innovation law (CeBIL) at the Faculty of Law, University of Copenhagen. Jakob has worked in a broad range of interdisciplinary and collaborative projects within the life science domain. From patenting of platform technologies in synthetic biology to regulation of orphan drugs, precision medicine and representation in clinical trials.
	Dr. Christopher Ball (MD, MBA) is a biotech asset partner at IQVIA. He helps high-potential biotechs accelerate time to market, reduce risk and maximize peak sales by providing access to IQVIA’s evidence-based insights and tailored holistic solutions. He has previously worked as CEO of a US commercial-stage biotech, a venture capital investor and in strategic marketing at Johnson and Johnson. He started his career as a medical doctor and is trained in internal medicine and clinical epidemiology. Christopher holds a pathology degree from the University of Cambridge, a medical degree from the University of Oxford and an MBA from the Wharton School of Business, University of Pennsylvania. He has written an award-winning book on evidence-based medicine.
	Sofie Sibia works as Director of Development and is responsible for the Healthcare Services department at IDTM (International Doping Tests & Management). She has a research background and comes most recently from Karolinska University Hospital in Stockholm, where she worked to establish structures for the clinical research community, ensuring optimal conditions for the execution of high-quality clinical trials.
	Dr. Marta Mas, MD, PhD, is the Executive Director of Medical Writing at TFSHealthScience with 20+ years of clinical research experience. She specializes in study design and clinical development plans (phases I to IV) and holds positions as an Associate Professor of Pharmacology at Universitat Pompeu Fabra de Barcelona. A member of key organizations like the European Medical Writers Association, Dr. Mas, a medical doctor and PhD in Neuropsychopharmacology, has authored 25 articles in indexed scientific journals, showcasing her expertise.
	Dr. Fritz Wieser is a Ob/Gyn who received his MD from the Vienna Medical University (Vienna, Austria). After completing his gynecology residency at the Dept of Gynecology at the University Hospital in Vienna, he did a fellowship in Reproductive Medicine at UCSF in San Francisco, CA. Fritz has over 20 years of clinical and research experience in a broad range of indications including endometriosis, fibroids, menopause, gynecological cancer, chronic pain and medical device. Previously to joining Fortrea as Medical Director, Dr. Wieser was a Global Medical Director at Merck KGaA (Darmstadt, GE) and served as Assistant Professor in the Department of Obstetrics and Gynecology at Emory University School of Medicine in Atlanta, Georgia. During the time at Emory University, Dr. Wieser worked as NIH funded investigator and sub-investigator for many gynecology studies.
	Marianne Pilgaard is the chief executive officer for Trial Nation, a public-private non-profit association. Trial Nation support stakeholder engagement in clinical trial processes, strengthen clinical trials infrastructure and framework conditions, all with the purpose of increasing the number of clinical trials in pharmaceuticals and medtech solutions in Denmark. Prior to joining Trial Nation, she spent over twenty years in leadership roles with Novo Nordisk, a pharmaceutical multinational, in roles across the value chain and predominantly within different aspects of clinical research. During that time, she also contributed to the Swedish national public-private strategic innovation programme Swelife which has the goal to strengthen Life Science in Sweden and to improve public health. She is an active contributor to life science platforms in Denmark and internationally.

Deadline for registration is 29th February

The MVA Women’s Health network
Joining the MVA Women’s Health Network is free of charge but is limited to Medicon Valley Alliance members. Non-member organizations and companies are welcome to attend one network event to evaluate the relevance in joining the network. For more information please contact Katrine Brems Olsen kbo@mva.org

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Sources:

• Cottingham & Fischer, 2020 – Gendered Logics of Biomedical Research: Women in U.S. Phase I Clinical Trials – Social Problems, Volume 69, Issue 2, May 2022, Pages 492–509
• Geller et al., 2018 – A Study to Evaluate Compliance With Inclusion and Assessment of Women and Minorities in Randomized Controlled Trials – Acad Med. 2018 April ; 93(4): 630–635
• Fultinavičiūtė, 2022 – Sex and science: underrepresentation of women in early-stage clinical trials