Abstract 3202
Background
Patient access to clinical trials is a fundamental aspect of drug development, particularly phase 1 oncology trials recruiting patients with advanced cancers. Adequate representation of both male and female patients in early phase trials is necessary to determine the impact of gender on safety, pharmacokinetics, and other parameters evaluated. Underrepresentation of women in oncology clinical research has been demonstrated in the past. We sought to determine whether a similar trend exists in phase 1 clinical trials.
Methods
All phase 1 trials published in the Journal of Clinical Oncology (JCO) between 2010 – 2018 were reviewed and the following parameters determined: patient population; total number of participants; number and percentage of Male and Female participants. To ensure reliability, two independent reviews were conducted. This abstract focused on the subset of studies targeting a population of adult and pediatric non-tumor specific advanced cancer patients with no treatment options for their disease. The expected representation of male and female patients within this population was assumed to be 1:1. The absolute difference in percentage between 50% and the observed percentage of patients who were male and female was calculated.
Results
73 phase 1 clinical trials were published in JCO reviewed including 3,855 patients. 4 trials did not report the male/female distribution and were excluded from the analysis. 27 (37%) studies were conducted in a population of advanced cancer patient, including 1,719 patients. The average absolute percentage difference between the expected and observed population was +2% for the male population and -4% for the female population. Wilcox Signed Rank Test demonstrated borderline statistical significance of this result (0=0.058).
Conclusions
Based on a cohort of 27 phase 1 studies published in JCO, it appears that underrepresentation of women in oncology clinical trials extends to phase 1 clinical development. It may be necessary for oncology phase 1 protocols to address the issue of adequate gender representation within the patient population enrolled. Attention should be given to identifying the barriers for women participation in trials to ensure adequate patient access, and representation in this critical stage of drug development.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Syneos Health.
Funding
Syneos Health.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
4228 - Clinical Evaluation of Drug-Eluting Bead Transcatheter Arterial Chemoembolization(D-TACE) versus Conventional TACE in Treatment of unresectable Hepatocellular Carcinoma
Presenter: Yi Chen
Session: Poster Display session 1
Resources:
Abstract
3930 - Safety profile of tepotinib in patients with advanced solid tumors: pooled analysis of phase I and II data
Presenter: Thomas Decaens
Session: Poster Display session 1
Resources:
Abstract
5373 - Drug-drug interaction profile of tepotinib with CYP3A and P-gp substrates
Presenter: Juergen Heuer
Session: Poster Display session 1
Resources:
Abstract
5455 - Bioavailability of tepotinib: impact of omeprazole and food
Presenter: Juergen Heuer
Session: Poster Display session 1
Resources:
Abstract
2618 - Tislelizumab Exposure-Response Analyses of Efficacy and Safety in Patients with Advanced Tumors
Presenter: Chi-Yuan Wu
Session: Poster Display session 1
Resources:
Abstract
2563 - Population Pharmacokinetics of Tislelizumab in Patients with Advanced Tumors
Presenter: Chi-Yuan Wu
Session: Poster Display session 1
Resources:
Abstract
2021 - The Addition of Metformin to Systemic Anticancer Therapy
Presenter: Jung Han Kim
Session: Poster Display session 1
Resources:
Abstract
5243 - Growth modulation index (GMI) as a comparative measure of clinical activity of larotrectinib versus prior systemic treatments in adult and pediatric TRK fusion cancer patients
Presenter: Antoine Italiano
Session: Poster Display session 1
Resources:
Abstract
598 - Analysis of the overall survival and main surrogates used for FDA approvals in solid and hematological malignancies.
Presenter: Maria Kleniewska-Wieczor
Session: Poster Display session 1
Resources:
Abstract
5381 - Comparison of intratumoral docetaxel exposure in cancer patients between nanoparticle entrapped docetaxel (CPC634) and conventional docetaxel (Cd): the CriTax study
Presenter: Ruben Van Eerden
Session: Poster Display session 1
Resources:
Abstract