TY - JOUR
T1 - How to optimize and evaluate diversity in gynecologic cancer clinical trials
T2 - statements from the GCIG Barcelona Meeting
AU - Sehouli, Jalid
AU - Boer, Jolijn
AU - Brand, Alison H
AU - Oza, Amit M
AU - O'Donnell, Jennifer
AU - Bennett, Katherine
AU - Glaspool, Ros
AU - Lee, Chee Khoon
AU - Ethier, Josee-Lyne
AU - Harter, Philipp
AU - Seebacher-Shariat, Veronika
AU - Chang, Ting-Chang
AU - Cohen, Paul A
AU - van Gorp, Toon
AU - Chavez-Blanco, Adriana
AU - Welch, Stephen
AU - Hranovska, Hanna
AU - O'Toole, Sharon
AU - Lok, Christianne A R
AU - Madariaga, Ainhoa
AU - Rauh-Hain, Jose Alejandro
AU - Perez Fidalgo, Alejandro
AU - Tan, David
AU - Michels, Judith
AU - Pothuri, Bhavana
AU - Fujiwara, Noriko
AU - Rosengarten, Ora
AU - Nishio, Hiroshi
AU - Kim, Se Ik
AU - Mukopadhyay, Asima
AU - Piovano, Elisa
AU - Cecere, Sabrina Chiara
AU - Kohn, Elise C
AU - Mukherjee, Uma
AU - Nasser, Sara
AU - Lindemann, Kristina
AU - Croke, Jennifer
AU - Chen, Xiaojun
AU - Geissler, Franziska
AU - Bookman, Michael A
N1 - © IGCS and ESGO 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.
PY - 2024/11/4
Y1 - 2024/11/4
N2 - 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.
AB - 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.
KW - Humans
KW - Female
KW - Genital Neoplasms, Female/therapy
KW - Clinical Trials as Topic/standards
KW - Patient Selection
KW - Cultural Diversity
U2 - 10.1136/ijgc-2024-005982
DO - 10.1136/ijgc-2024-005982
M3 - Article
C2 - 39496422
SN - 1048-891X
VL - 34
SP - 1677
EP - 1684
JO - International Journal of Gynecological Cancer
JF - International Journal of Gynecological Cancer
IS - 11
ER -
