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IMPROVING THE APPLICABILITY OF DRUG TRIALS TO WOMEN
November 30th – December 1st, 2016 Berlin (Germany)
Initiative to Improve Sex and Gender Research in Pharmacology
Matera-Group 3rd Meeting in Berlin, Charite´-Universitätsmedizin Berlin, Institut für Geschlechterforschung in der Medizin
Zugeschaltet per Videokonferenz waren die Expertinnen aus den USA: Marjorie Jenkins, Pamela Scott und Virginia Miller
The "Matera Group" was founded in April 2016 by international leading gender experts from European and American gender societies, representatives of pharmaceutical industry, FDA, NIH and CIHR to promote gender sensitive research in pharmacology and the applicability of results to women in the real world. Partners from all over the world are now associated.
The main focus was on the clinical trials of the detection of sex- and gene-specific factors and the lack of applicability of the results to women. While the observance of the biological sex ("sex") is gradually accepted, there are hardly any concepts for the integration of the socio-cultural dimension ("gender"). As a problem, the lack of awareness of the pharmaceutical industry, the physicians and patients, and the lack of financial incentives have been identified. Another problem is the still low acceptance of gender sensitive research in the scientific community, in specialist magazines and in the review process.
Various activities have been launched with stakeholders, including regulatory and funding organizations, journal editors, government agencies, industry and patient care groups. A first major success was the publication of an opinion on an extremely gender hostile review in the BMJ (Miller, Tannenbaum, Regitz-Zagrosek) -http: //www.bmj.com/content/355/bmj.i5826/rapid-responses
1: Miller LR, Marks C, Becker JB, Hurn PD, Chen WJ, Woodruff T, McCarthy MM,
Sohrabji F, Schiebinger L, Wetherington CL, Makris S, Arnold AP, Einstein G,
Miller VM, Sandberg K, Maier S, Cornelison TL, Clayton JA. Considering sex as a
biological variable in preclinical research. FASEB J. 2017 Jan;31(1):29-34. doi:
10.1096/fj.201600781R. Review. PubMed PMID: 27682203.
2: Schiebinger L, Leopold SS, Miller VM. Editorial policies for sex and gender
analysis. Lancet. 2016 Dec 10;388(10062):2841-2842. doi:
10.1016/S0140-6736(16)32392-3. PubMed PMID: 27979394.
3: Miller VM, Kararigas G, Seeland U, Regitz-Zagrosek V, Kublickiene K, Einstein
G, Casanova R, Legato MJ. Integrating topics of sex and gender into medical
curricula-lessons from the international community. Biol Sex Differ. 2016 Oct
14;7(Suppl 1):44. PubMed PMID: 27785346; PubMed Central PMCID: PMC5073937.