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
2066 - Second-line (2L) real-world treatment (tx) patterns and outcomes in patients (pts) with advanced/metastatic non-small cell lung cancer (NSCLC) treated with first line (1L) immuno-oncology (IO) monotherapy (mono tx)
Presenter: Denis Talbot
Session: Poster Display session 1
Resources:
Abstract
5919 - Real-world effectiveness of nivolumab monotherapy after prior systemic therapy in advanced non-small cell lung cancer (NSCLC) in the United States
Presenter: David Stenehjem
Session: Poster Display session 1
Resources:
Abstract
3368 - Pembrolizumab as first-line treatment in NSCLC with PD-L1 ≥50%: Real life results from an all-comer population
Presenter: Nikolaj Frost
Session: Poster Display session 1
Resources:
Abstract
3775 - Patients with metastatic non-small cell lung cancer without molecular alterations or PD-L1 expression in Germany. Treatment and first outcome from the prospective German Registry Platform CRISP (AIO-TRK-0315)
Presenter: Frank Griesinger
Session: Poster Display session 1
Resources:
Abstract
3926 - Impact of second-line (2L) immune checkpoint inhibitors (ICIs) on the treatment (Tx) of advanced non-small cell lung cancer (NSCLC) in a UK centre: a REAL-Oncology analysis from the I-O Optimise initiative
Presenter: Michael Snee
Session: Poster Display session 1
Resources:
Abstract
5068 - First line pembrolizumab for NSCLC with PD-L1 TPS > 50% in a first French real life cohort
Presenter: Karim Amrane
Session: Poster Display session 1
Resources:
Abstract
1182 - Interstitial lung disease induced by immune-checkpoint inhibitors correlates with prognosis of advanced non-small-cell lung cancer patients
Presenter: Teppei Sugano
Session: Poster Display session 1
Resources:
Abstract
2297 - Phase II study to evaluate the peripheral blood mononuclear cell biomarker for nivolumab efficacy on previously treated non-small cell lung cancer subjects (NEJ029B: IMMUNITY-ONE)
Presenter: Yosuke Kawashima
Session: Poster Display session 1
Resources:
Abstract
2739 - Efficacy and safety of nintedanib + docetaxel in lung adenocarcinoma patients (pts) following treatment with immune checkpoint inhibitors (ICIs): Updated results of the ongoing non-interventional study (NIS) VARGADO (NCT02392455)
Presenter: Christian Grohe
Session: Poster Display session 1
Resources:
Abstract
1357 - Upfront atezolizumab chemoimmunotherapy-associated Immune-related adverse events in patients with advanced non-small cell lung cancer
Presenter: Francis Mogollon-Duffo
Session: Poster Display session 1
Resources:
Abstract