To improve the evidence base and applicability of results from drug trials to women
Discussions focused on identifying the critical issues that are required to develop recommendations toward improving the evidence base and applicability of drug trial results to women. It was recognized that to achieve success would require stakeholder engagement from the pharmaceutical industry and international drug regulatory bodies to improve the way drug trials are conducted. Women also need to be educated on how to inquire about their prescribed medications.
Participants at the inaugural meeting:
Members identified several action items that would lead to achievement of the goals:
1) Provide an economic argument for industry and regulatory stakeholders to increase attention to sex and gender as variables during drug development.
2) Delineate the current status of processes and procedures used by regulatory agencies in Canada (Health Canada), the US, and Europe (the EMA) for integrating women in drug development. For example, determining how sex and gender are considered in guidance documents produced by the International Conference on Harmonization, determining if there are gaps in appropriate guidance, implementation or both?
3) Draft a document to identify specific goals for the initiative and/or an academic consensus statement(s) for publication over the next five years.
4) Engage scientific journal editors in the accountability process for reporting and publishing sex-disaggregated data from preclinical and clinical trials.
5) Organize a regular schedule of meetings to make progress on this file.
Members recognized that specific goals needed to be identified to improve the evidence base around the efficacy, safety and tolerability of drugs in women. These goals might include: 1) ensuring that female cells and experimental animals and women are appropriately represented in preclinical and clinical research, respectively; 2) increasing sex-by-age reporting and transparency in reporting of results from drug trials; 3) putting in place a systematic and effective post-marketing surveillance program to study adverse drug reactions in women in the real world setting; 4) ensuring that a credible agency recommends which drugs are safe and effective in women at any given time.
By skype : Karolina Kublickiene, Paula Rochon Regrets : Flavia Franconi, Ineke Klinge
Matera-Group 3rd Meeting in Berlin, Charite´-Universitätsmedizin Berlin, Institut für Geschlechterforschung in der Medizin.
Photo: Ute Seeland Local participants were Danielle Day, Paula Rochon Flavia Franconi, Karolina Kublickiene, Hester den Ruijter, Vera Regitz-Zagrosek, Cara Tannenbaum, Ineke Klinge, (from left to right).
The Matera Group met from 30.11.2016 to 01.12.2016 at GIM, Charité Berlin, kindly sponsored by the German Society of Gender medicine (DGesGM) and the Canadian institute of Health Research (CIHR). The participants exchanged their views how to improve applicability of drug trials to women and discussed necessary steps in more detail. An action plan was established.
Video participants were Marjorie Jenkins, and Virginia Miller.
Flavia Franconi opened with an overview delineating the need to improve the applicability of drug trials to women. Discussion followed on what parameters are and should be included in drug trials as markers of sex (genes, hormonal status, sex-specific confounders and many more) or gender. Vera Regitz-Zagrosek commented that for the first time in Europe gender will now be included in a BMBF funded project, in cooperation with L Schiebinger, Stanford, that she will be starting in 2017.
Danielle Day presented the position of the pharmaceutical industry. She made the very important point, that business relevant arguments for the inclusion of sex and gender must be identified. She discussed what gender medicine could offer to industry. It could be a door opener to make contacts to practitioners and to patients and it would be important to contact the right persons to use this mechanism.
Cara Tannenbaum discussed the uptake of sex and gender in medical journals. She referred to the SAGER guidelines and explained how difficult it is to propose guidelines to journal editors and convince them to implement new guidelines. There is also resistance from authors and resistance from reviewers who are frequently not competent in evaluating topics related to gender. One alternative might be to identify a pool of “sex and gender-competent” reviewers and one from this pool should be included in every review process, but the practicality of such might be limiting.
Vera Regitz-Zagrosek discussed recent research evidence on sex differences that were detected in clinical trials. She presented some areas from recent research where significant sex differences have been found in the action and requirement of drugs and tried to identify some areas where unmet needs exist, e.g. diabetes therapy, use of biologica in rheumatic diseases, HIV treatment, and others.
Karolina Kublickiene suggested that the Matera group improve awareness through generating a Facebook page and securing a domain for a homepage. In order to improve and develop an economical basis for the goals of the group, she will initiate contact with the health economical school in Stockholm and to initiate a collaboration between Astra Zeneca KI and partners at Matera group. She offered to explore possible ways to to financially support Matera group activities.
Hester den Ruijter opened an informal discussion, and referred to the Dutch intiative Women Inc, an organization that started media campaigns for sex- and gender equality in medicine. With this initiative, they were successful in securing a 12 million euro grant from the Dutch ministry of health for research on this topic. Women Inc also involved the insurance companies in the initiative. Ineke and Hester will explore possible collaborations with Women Inc.
Ineke Klinge discussed strategic developments. It was decided to develop an action plan where any of the participants should take on a well-defined task, specify within one week, how he or shewould fulfill this task and report on progress made at the OSSD Meeting in Montreal.
Virginia Miller was participating via internet video connection and made valuable suggestions how to integrate the Matera Group into existing structures among others the society for health research. She also suggested that the group write a reply to a paper published in the in British Medical Journal that minimized the need to consider sex and genderas variables impacting health outcomes. (Comment VRZ 08-12-16. The reply was written printed within two days).
Paula Rochon outlined the strategy for an academic review paper. She gave an excellent overview on the milestones for the incorporation of sex and gender considerations into clinical research and discussed how this could be kept and used for the modification of drug trials now.
A final discussion took place at the end of the meeting. It was agreed that all speakers would make their slides or parts of their slides available for a homepage, that the Matera proceedings should be placed on a homepage presently at GIM and that short summaries should be provided from all speakers.
Finally, it was decided to register all interested scientists who want to participate, as Matera-Alliance members. However, the core group should be those who initiated the group.
A fourth meeting was held on May 16th at the Annual Scientific Meeting for the Organization for the Study of Sex Differences in Montreal. Delegates from the pharmaceutical industry attended to provide input on opportunities to accelerate the delivery of personalized drug therapy at the point of care. A vision started to emerge, which valued leveraging the power of a global academic-pharma-regulatory agency partnership to fundamentally change and transform the status quo. Participants voiced interest in creating and implementing a multi-stakeholder roadmap that enables basic scientists, clinical trialists, regulatory agencies, payers, physicians and patients to play a more active role in the way drugs and biologics are developed, tested, approved and prescribed in a tailored, sex-specific fashion.
Strategies for engaging different countries, for launching this website, and for harnessing the data available from pharmacovigilance surveillance systems in different countries were discussed. Members will reconvene in the fall of 2017.
|Cara Tannenbaum||Scientific Director, CIHR Institute of Gender and Health
Professor, Faculties of Medicine and Pharmacy, Université de Montréal
|Canadian Institutes of Health Research, Canada|
|Danielle Day||Associate Director Medical Affairs||Fractyl Laboratories, USA|
|Hester Den Ruijter||Associate Professor Experimental Cardiology||University Medical Center, Utrecht, The Netherlands|
|Kristian Vinter Juul||Medical Science Director, Scientific Affairs Urology||Ferring Pharmaceuticals, Copenhagen, Denmak|
|Helen Kellar-Wood||Immunoscience Lead, Diversity & Patient Engagement||BMS (Bristol-Myers Squibb), USA|
|Nadine Kolas||Senior Policy Analyst, Health Products and Foods Branch||Health Canada|
|Karolina Kublickiene||CEO, Center for Gender Medicine at Karolinska Institute||Karolinska Institutet, Sweden|
|Director for the Division of Sex and Gender in Emergency Medicine||Brown University, Boston, USA|
|Virginia Miller||Director of the Mayo Clinic Women’s Health Research Center||Mayo Clinic, USA|
|Nahal Nasseri||Director of Medical Affairs, Cardiovascular and metabolic diseases and Women’s Health||Merck, Canada|
|Jens Peter Nørgaard||Executive Director Global Medical Affairs Urology||Ferring Pharmaceuticals, Copenhagen, Denmark|
|Vera Regitz-Zagrosek||Director Berlin Institute of Gender Medicine||Berlin Institute of Gender Medicine, Germany|
|Paula Rochon||VP Research, Women’s College Hospital||University of Toronto, Canada|
|Pol Vandenbroucke||Vice President, Medical Strategy||Pfizer, USA|
|Helen Yeh||Executive Director Oral Anti-diabetics||AstraZeneca, USA|
|Janine Clayton||Director, Office of Research on Women’s Health||NIH, Bethesda, Maryland, USA|
|Larry Cahill||Professor, University of California||Irvine, USA|
|Jeff Mogil||Professor, McGill University||Montreal, Canada|
|Vinicius Tragante de O||Researcher||University Medical Center, Utrecht, The Netherlands|