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
5519 - Is there a difference of Palliative care problems and needs between cancer and non-cancer hospitalized elderly patients?
Presenter: Ioanna Chatzi
Session: Poster Display session 1
Resources:
Abstract
2505 - There is a lack of clinical research for patients with cancer in palliative care
Presenter: Marie Vinches
Session: Poster Display session 1
Resources:
Abstract
5273 - Specialist Palliative Care (SPC) in Haematological Malignancy: Establishing practices in a UK Tertiary Cancer Centre (TCC)
Presenter: Emma Kedgley
Session: Poster Display session 1
Resources:
Abstract
5864 - Evaluation of the relationship between the attachment styles and psychological resilience of cancer patients receiving chemotherapy
Presenter: Fatma Bugdayci Basal
Session: Poster Display session 1
Resources:
Abstract
770 - Gefitinib along with Methotrexate as palliative therapy in PS 3 and above in metastatic squamous cell carcinoma head and neck cancer patients
Presenter: Vidya Dusi
Session: Poster Display session 1
Resources:
Abstract
4232 - High intensity end-of-life care in pediatrics, adolescent and young adult patients with cancer using an administrative database.
Presenter: Seiko Bun
Session: Poster Display session 1
Resources:
Abstract
4845 - Embedded outpatient palliative care service within the oncology clinic: Preliminary experience in Hacettepe Oncology Hospital
Presenter: Deniz Can Guven
Session: Poster Display session 1
Resources:
Abstract
3270 - Internet-based stepped care for individuals with cancer and concurrent anxiety or depression symptoms – results from a randomized controlled trial
Presenter: Birgitta Johansson
Session: Poster Display session 1
Resources:
Abstract
5503 - Impact of Cognitive-Behavioral-Therapy (CBT) on levels of anxiety, depression and distress in cancer patients (pts)
Presenter: Daniela Tregnago
Session: Poster Display session 1
Resources:
Abstract
5553 - Cytokine genetic variations and worse quality of life among family caregivers of head and neck cancer patients in palliative care
Presenter: Daniel Pequeno
Session: Poster Display session 1
Resources:
Abstract