How to optimize and evaluate diversity in gynecologic cancer clinical trials: statements from the GCIG Barcelona Meeting.

Autor:	Sehouli J; Gynecology with Center for Oncological Surgery, Charite Universitatsmedizin Berlin, Berlin, Germany jalid.sehouli@charite.de.; North-Eastern German Society of Gynaecological Oncology (NOGGO eV), Berlin, Germany., Boer J; North-Eastern German Society of Gynaecological Oncology (NOGGO eV), Berlin, Germany., Brand AH; Westmead Hospital, Westmead, New South Wales, Australia.; The Gynecologic Cancer InterGroup, Kingston, Ontario, Canada., Oza AM; Medical Oncology & Hematology, Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada., O'Donnell J; The Gynecologic Cancer InterGroup, Kingston, Ontario, Canada., Bennett K; The Gynecologic Cancer InterGroup, Kingston, Ontario, Canada., Glaspool R; Beatson West of Scotland Cancer Centre, Glasgow, UK., Lee CK; NHMRC Clinical Trials Centre, The University of Sydney, Camperdown, New South Wales, Australia., Ethier JL; Division of Medical Oncology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada., Harter P; Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte Evangelische Huyssens-Stiftung/Knappschaft GmbH, Essen, Germany.; AGO Study Group, Wiesbaden, Germany., Seebacher-Shariat V; AGO Austria, Innsbruck, Austria.; Medical University of Vienna, Vienna, Austria., Chang TC; Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan.; Chang Gung University, Taoyuan, Taiwan., Cohen PA; Australia New Zealand Gynaecological Oncology Group (ANZGOG), Camperdown, New South Wales, Australia., van Gorp T; Gynaecological Oncology, KU Leuven University Hospitals Leuven, Leuven, Belgium., Chavez-Blanco A; The Gynecologic Cancer InterGroup, Kingston, Ontario, Canada., Welch S; Department of Oncology, Western University Schulich School of Medicine & Dentistry, London, Ontario, Canada., Hranovska H; National Academy of Medical Sciences of Ukraine, Kiiv, Ukraine., O'Toole S; Cancer Trials Ireland, Dublin, Ireland., Lok CAR; Department of Gynaecologic Oncology, Netherlands Cancer Institute, Amsterdam, Noord-Holland, The Netherlands., Madariaga A; 12 de Octubre University Hospital, Madrid, Comunidad de Madrid, Spain.; European Organisation for Research and Treatment of Cancer, Brussels, Belgium., Rauh-Hain JA; The University of Texas MD Anderson Cancer Center, Houston, Texas, USA., Perez Fidalgo A; Medical Oncology, Hospital Clinico Universitario, Valencia, Spain., Tan D; National University Cancer Institute, Singapore., Michels J; Gustave Roussy, Villejuif, Île-de-France, France.; Université Paris-Saclay, Villejuif, Île-de-France, France., Pothuri B; NYU Langone Health Perlmutter Cancer Center, New York, New York, USA., Fujiwara N; Department of Palliative Medicine and Advanced Clinical Oncology, IMSUT Hospital of the Institute of Medical Science, The University of Tokyo, Minato-city, Tokyo, Japan.; Gynecologic Oncology Trial and Investigation Consortium (GOTIC), Moroyama, Japan., Rosengarten O; Medical Gyneco-Oncology Unit, Shaare Zedek Medical Center, Jerusalem, Jerusalem, Israel., Nishio H; Department of Obstetrics and Gynecology, Keio Univesity School of Medicine, Tokyo, Japan.; Japanese Gynecologic Oncology Group (JGOG), Tokyo, Japan., Kim SI; Obstetrics and Gynecology, Seoul National University Hospital, Seoul, Korea (the Republic of)., Mukopadhyay A; Kolkata Gynecological Oncology Trials and Translational Research Group (KolGOTrg), Kolkata, India., Piovano E; Azienda Ospedaliero Universitaria Citta della Salute e della Scienza di Torino, Torino, Piemonte, Italy., Cecere SC; Dep. of Experimental Uro-Gynecological Oncology, National Cancer Institute Institute for Hospitalization and Care Scientific Foundation Pascale, Naples, Italy., Kohn EC; Clinical Investigations Branch, Cancer Therapy Evaluation Program, National Cancer Institute, Rockville, Maryland, USA., Mukherjee U; GynaeOncology Trials Group UK (GCG UK), London, UK., Nasser S; Department of Gynecology with Center of Oncological Surgery, Charite Universitatsmedizin Berlin, Berlin, Germany.; Pan-Arabian Research Society of Gynecological Oncology, Berlin, Germany., Lindemann K; Department of gynecological oncology, Oslo University Hospital, Oslo, Norway.; Nordic Society of Gynaecological Oncology (NSGO), Copenhagen, Denmark., Croke J; Princess Margaret Hospital Cancer Centre, Toronto, Ontario, Canada., Chen X; Tongji University Dongfang Hospital, Shanghai, Shanghai, China., Geissler F; Department of Gynecology and Gynecological Oncology, Hospital for Women, University Hospital Basel, Basel, Switzerland.; Swiss GO Trial Group, Basel, Switzerland., Bookman MA; The Gynecologic Cancer InterGroup, Kingston, Ontario, Canada.; Kaiser Permanente Northern California, Oakland, California, USA.
Jazyk:	angličtina
Zdroj:	International journal of gynecological cancer : official journal of the International Gynecological Cancer Society [Int J Gynecol Cancer] 2024 Nov 04; Vol. 34 (11), pp. 1677-1684. Date of Electronic Publication: 2024 Nov 04.
DOI:	10.1136/ijgc-2024-005982
Abstrakt:	Findings from clinical trials have led to advancement of care for patients with gynecologic malignancies. However, restrictive inclusion of patients into trials has been widely criticized for inadequate representation of the real-world population. Ideally, patients enrolled in clinical trials should represent a broader population to enhance external validity and facilitate translation of outcomes across all relevant groups. Specifically, there has been a systematic lack of data for underrepresented groups, with many studies failing to report or differentiate study participants based on sociodemographic domains, such as race and ethnicity. As such, the impact of treatment in these underrepresented groups is poorly understood, and clinical outcomes according to various sociodemographic factors are infrequently assessed. Inclusion of diverse trial participants, with different racial and ethnic background, is essential for the understanding of factors that may impact clinical outcomes. Therefore, we conducted a multi-national meeting of clinical trial groups and industry with the goal of increasing equity, diversity, and inclusion in gynecologic cancer clinical trials and to address barriers to recruitment, participation, and harmonization of data collection and reporting. These Gynecologic Cancer Intergroup (GCIG) statements present recommendations and strategies for the gynecologic cancer research community to improve equity, diversity, and inclusion in gynecologic cancer clinical trials. Competing Interests: Competing interests: Alison Brand reports grants/contracts from the Australian Government Department of Health and Aged Care Medical Research Future Fund, Australia and New Zealand Gynaecological Oncology Group (ANZGOG); and is Director ANZGOG, Chair GCIG. Michael Bookman reports consultancy fees paid to the institution from Immunogen independent DSMB. Sabrina Chiara Cecere reports travel support from AstraZeneca, Clovis, GSK, MSD; honoraria from AstraZeneca, Clovis, GSK, MSD; participation on a Data Safety Monitoring Board or Advisory Board from AstraZeneca, Clovis, GSK, MSD. Paul A. Cohen reports grants/contracts from the Australian Government Department of Health and Aged Care Medical Research Future Fund, Cancer Council Western Australia, Australia and New Zealand Gynaecological Oncology Group (ANZGOG); honoraria and educational events from AstraZeneca, MSD; advisory boards with AstraZeneca, Reliis; non-remunerated leadership roles as Director ANZGOG, Chair Research Advisory Committee ANZGOG, Education Committee Chair, International Gynecological Cancer Society, Expert Advisory Group Australian Centre for Prevention of Cervical Cancer, Editorial Board Member International Journal Gynecological Cancer; stock in Reliis Ltd. Jennifer Croke reports honoraria from American Society of Radiation Oncology (Member, Sexual and Gender Minority Affinity Working Group), Canadian Association of Radiation Oncology (Annual Scientific Meeting lead), Merck. Josie Ethier reports consultancy fees from AstraZeneca; honoraria from AstraZeneca, GSK, Merck; advisory board participation with AstraZeneca, Eisai, GSK, Merck. Franziska Geissler reports grants/contracts from International Research Fellowship, Swiss Cancer Research Foundation & Swiss Cancer League and Research Fund for Excellent Junior Researchers University of Basel 2024. Rosalind Glasspool reports grants/contracts from Clovis Oncology; consultancy fees from Clovis Oncology, GSK, Novartis; honoraria from GSK; travel support from GSK, MSD; participation on a Data Safety Monitoring Board or Advisory Board from IDMC Matao trial; leadership or fiduciary roles at IGCS Advocacy committee chair, IGCS board member, Chair of Scottish Gynaecological Cancer Trials Group; receipt of equipment, materials, drugs, medical writing, gifts or other services from AstraZeneca, GSK, Novartis; other financial or non-financial interests with Allarity Therapeutics, AstraZeneca, Immunogen, GSK. Philipp Harter reports grants/contracts from AstraZeneca, Clovis, Genmab, GSK, Immunogen, Novartis, Roche, Seagen; consultancy fees from Miltenyi; honoraria from Amgen, AstraZeneca, Clovis, Daiichi Sankyo, Eisai, Exscientia, GSK, Immunogen, Karyopharm, Mersana, MSD, Roche, Sotio, Stryker, Zai Lab; travel support from AstraZeneca; participation on a Data Safety Monitoring Board or Advisory Board at AstraZeneca, Clovis, Eisai, GSK, Immunogen, MSD, Miltenyi, Novartis, Roche. Chee Khoon Lee reports grants/contracts from Amgen, AstraZeneca, Merck, Roche; honoraria from Amgen, AstraZeneca, Gilead, GSK, Janssen, Merck, Merck kGA, Novartis, Roche, Takeda. Kristina Lindemann reports grants/contracts from GSK (research funding paid to institution); honoraria, consultancy fees, or advisory board fees from AstraZeneca, Eisai, GSK, MSD, Nycode; part of the Data Safety Monitoring Committee for Karyopharm.Ainhoa Madariaga reports honoraria from AstraZeneca, Clovis, GSK, MSD, Pharma & PharmaMar; travel support from AstraZeneca, GSK, MSD; participation on a Data Safety Monitoring Board or Advisory Board from AbbVie, AstraZeneca, GSK, MSD. Asima Mukhopadhyay reports grants/contracts from the Indian Council of Medical Research for the IPIRIC academic study which endorses the principles of EDIM; honoraria from KGOG; advisory board at CannariaBio; Secretary KolGoTrg, Executive Board Member GCIG; part funding support for the IPIROC trial for drug procurement from BDR Pharma. Amit Oza reports grants/contracts from Amgen, AstraZeneca; consultancy fees from BMS; advisory board participation with AstraZeneca and GSK; other financial or non-financial interests with AstraZeneca, GSK. Elisa Piovano reports travel support from AstraZeneca, GSK. Bhavana Pothuri reports grants/contracts from Agenus, Alkermes, AstraZeneca, Acrivon, Celgene, Celsion/Immunon, Clovis Oncology, Duality Bio, Eisai, Immunogen, Incyte, Imab, InxMed, Karyopharm Therapeutics, Lily, LOXO/Lily, Merck, Mersana, Novocure, Onconova, NRG Oncology, Roche/Genentech, Seagen, Sutro, Takeda, Tesaro/GSK, Toray, VBL Therapeutics, Xencor; consultancy fees from AstraZeneca, Celsion, Duality Bio, Eisai, GOG Foundation, Imvax Inc, Incyte Corporation, InxMed, Lily, Onconova Therapeutics, Regeneron, SeaGen, Signatera, Sutro Biopharma, Tesaro/GSK; honoraria from Albert Einstein-Montefiore, Bioascend, Colorado University, Curio, Lankenau Hospital, OncLive, PERS, PeerView, Vanium, Yale University; travel support from GOG Partners; advisory boards with AstraZeneca, Celsion/Immunon, GOG Foundation, Imab, Imvax, Incyte, InxMed, Lily, Merck, Mersana, Nuvation, Sutro, Tesaro/GSK; leadership or fiduciary roles in GOG Partners, NYOB Society VP, SGO Board of Directors, SGO Clinical Practice Committee Chair, SGO COVID-19 Taskforce co-chair. Jose Alejandro Rauh-Hain reports grants/contracts from NIH, Department of Defense, American Cancer Society; support for the present manuscript from Guidepoint Consulting, Sago. Ora Rosengarten reports consultancy fees from AstraZeneca, Medison, MSD, Neopharm; travel support from AstraZeneca, MSD; lecture honoraria from AstraZeneca. Jalid Sehouli reports grants/contracts from AstraZeneca, Eisai, GSK, Merck, MSD, Novocure, Roche, Tesaro; consultancy fees from AstraZeneca, Clovis, Eisai, GSK, Immunogen, Incyte, MSD, Novocure; honoraria from AstraZeneca, Bristol Myers Squibb, Clovis, Eisai, GSK, Immunogen, Incyte, MSD, Novartis, Novocure; travel support from AstraZeneca, Eisai, GSK, Immunogen, Incyte, MSD, Novocure, Roche; advisory boards with AstraZeneca, Bayer, Bristol Myers Squibb, Clovis, GSK, Immunogen, Incyte, MSD, Novocure, PharmaMar; leadership or fiduciary roles at AGO, ASCO, Deutsche Stiftung Eierstockkrebs, ENGAGE, ESGO, GCIG, Medical writing (MSD). David Tan reports receiving research funding from the National Medical Research Council (NMRC) Clinician Scientist Award Senior Investigator Grant (CSASI21jun-0003), the Pangestu Family Foundation Gynaecological Cancer Research Fund; and product samples from AstraZeneca, Eisai, MSD (non-financial interest) for research trials. Institutional research grants from AstraZeneca, Bayer, Karyopharm Therapeutics, Roche; personal fees for advisory board membership from AstraZeneca, Bayer, BioNTech, Boehringer Ingelheim, Daiichi Sankyo, Eisai, Genmab, GSK, MSD, PMV Pharma, Roche; personal fees as an invited speaker from AstraZeneca, Eisai, GSK, Merck Serono, MSD, Roche, Takeda; travel support from AstraZeneca, Eisai, GSK, Merck Serono, MSD, Roche, Takeda; current non-renumerated role as protocol chair of Asia Pacific Gynecologic Oncology Trials Group (APGOT); previous non-renumerated role as Chair of the Asia Pacific Gynecologic Oncology Trials Group (APGOT); a previous non-renumerated role as the Society President of the Gynecologic Cancer Group Singapore; non-renumerated membership of the Board of Directors of the GCIG; ownership of stocks/shares of Asian Microbiome Library (AMiLi). Toon Van Gorp reports consultancy fees (via institution) from AbbVie, AstraZeneca, BioNTech, Cancer Communications and Consultancy Ltd, Eisai, GSK, ImmunoGen, Incyte, Karyopharm, MSD/Merck, OncXerna Therapeutics, Seagen, Tubulis, Zentalis; corporate sponsored research (via institution) from Amgen, AstraZeneca, Roche; honoraria for lectures (via institution) from AstraZeneca, Eisai, GSK, ImmunoGen, MSD; travel support from AstraZeneca, ImmunoGen, MSD, PharmaMar; grants/contracts from Amgen, AstraZeneca, Roche; chair of the Belgian and Luxembourg Gynaecological Oncology Group. Stephen Welch reports honoraria from AstraZeneca, Eisai, GSK, Merck; advisory boards with Eisai, Incyte, GSK, Roche, Takeda.All other authors declare no conflict of interest. (© IGCS and ESGO 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.)
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