D Ross Camidge1, Haeseong Park2, Karen E Smoyer3, Ira Jacobs4, Lauren J Lee4, Zemfira Askerova4, Justin McGinnis5, Yousef Zakharia6. 1. Division of Medical Oncology, University of Colorado Hospital, Aurora, CO 80045, USA. 2. Division of Oncology, Siteman Cancer Center, Washington University in St. Louis, MO 63110, USA. 3. Envision Pharma Group, Philadelphia, PA 19109, USA. 4. Pfizer, Inc., NY 10017, USA. 5. Pfizer, Inc., La Jolla, CA 92121, USA. 6. University of Iowa, Holden Comprehensive Cancer Center, Iowa City, IA 52242, USA.
Abstract
Aim: To provide an assessment of published literature on the demographic representation in Phase I trials of biopharmaceutical oncology agents. Materials & methods: We conducted a rapid evidence assessment to identify demographic representation reported in Phase I clinical trials for biopharmaceutical oncology agents published in 2019. Results: Globally, the population was predominantly White/Caucasian (62.2%). In the USA, the distribution was heavily skewed toward White/Caucasian (84.2%), with minimal representation of Blacks/African-Americans (7.3%), Asians (3.4%), Hispanics/Latinos (2.8%) or other race/ethnicity groups. Conclusion: Our data highlight that Phase I oncology trials do not reflect the population at large, which may perpetuate health disparities. Further research is needed to understand and address barriers to participation, particularly among under-represented groups.
Aim: To provide an assessment of published literature on the demographic representation in Phase I trials of biopharmaceutical oncology agents. Materials & methods: We conducted a rapid evidence assessment to identify demographic representation reported in Phase I clinical trials for biopharmaceutical oncology agents published in 2019. Results: Globally, the population was predominantly White/Caucasian (62.2%). In the USA, the distribution was heavily skewed toward White/Caucasian (84.2%), with minimal representation of Blacks/African-Americans (7.3%), Asians (3.4%), Hispanics/Latinos (2.8%) or other race/ethnicity groups. Conclusion: Our data highlight that Phase I oncology trials do not reflect the population at large, which may perpetuate health disparities. Further research is needed to understand and address barriers to participation, particularly among under-represented groups.
Authors: Aiman J Faruqi; John A Ligon; Julia W Cohen; Srivandana Akshintala; Brigitte C Widemann; Nirali N Shah Journal: Oncologist Date: 2022-08-05 Impact factor: 5.837