Progression-free survival is recognized as an important endpoint in oncology clinical trials. In clinical trials aimed at new drug development, the target population often comprises patients that are refractory to standard therapy with a tumor that shows rapid progression. This situation would increase the bias of the hazard ratio calculated for progression-free survival, resulting in decreased power for such patients. Therefore, new measures are needed to prevent decreasing the power in advance when estimating the sample size. Here, I propose a novel calculation procedure to assume the hazard ratio for progression-free survival using the Cox proportional hazards model, which can be applied in sample size calculation. The hazard ratios derived by the proposed procedure were almost identical to those obtained by simulation. The hazard ratio calculated by the proposed procedure is applicable to sample size calculation and coincides with the nominal power. Methods that compensate for the lack of power due to biases in the hazard ratio are also discussed from a practical point of view.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1002/pst.1973 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Efficacy and safety of neoadjuvant bevacizumab plus chemotherapy in locally advanced gastric cancer patients: a retrospective, comparative study.
World J Surg Oncol
January 2025
Colorectal Surgery Department, The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University/ Hunan Cancer Hospital, No. 283 Tongzipo Road, Yuelu District, Changsha, Hunan, 410013, China.
Objective: The clinical benefits of neoadjuvant bevacizumab plus chemotherapy in locally advanced gastric cancer patients are controversial. This study intended to evaluate the efficacy and safety of neoadjuvant bevacizumab plus chemotherapy in these patients.
Methods: In this retrospective study, 71 locally advanced gastric cancer patients receiving neoadjuvant bevacizumab plus chemotherapy or neoadjuvant chemotherapy alone were divided into bevacizumab plus chemo group (N = 23) and chemo group (N = 48).
Impact of estimated glomerular filtration rate (eGFR) on in-hospital mortality: an age- and HIV status-specific retrospective cohort study in Uganda.
BMC Nephrol
January 2025
Department of Internal Medicine, Naguru Referral Hospital, Kampala, Uganda.
Background: Limited studies have explored the relationship between estimated Glomerular Filtration Rate(eGFR) and in-hospital mortality(IHM) in low-income sub-Saharan African countries. This study aimed to explores this association, offering insights into its impact in resource-limited settings.
Methods And Results: We retrospectively included 226 patients(age 45.
Background: The proportion of people living with HIV (PLHIV) in Guangxi who are men who have sex with men (MSM) increased rapidly to nearly 10% in 2023; notably, over 95% of this particular population is currently receiving antiretroviral therapy (ART). This study aimed to describe the survival of MSM PLHIV, depict the characteristics and trends of changes in CD4 T cell counts, CD4/CD8 T cell ratio, and viral load, and explore immunological indicators that may be related to mortality during different stages of treatment.
Methods: Immunological indicators of MSM PLHIV receiving ART were extracted and categorized into baseline, mid-treatment, and last values.
Association between lactate dehydrogenase levels and all-cause mortality in ICU patients with heart failure: a retrospective analysis of the MIMIC-IV database.
BMC Cardiovasc Disord
January 2025
Nanhai Family Practice Hospital, Foshan, Guangdong, 528200, People's Republic of China.
Background: Heart failure (HF) patients admitted to the intensive care unit (ICU) often face high short-term mortality rates. This study aims to investigate the relationship between lactate dehydrogenase (LDH) levels and all-cause mortality in critically ill patients with HF.
Methods: Data from the MIMIC-IV database were extracted for subjects eligible for HF diagnosis.
The interaction network and potential clinical effectiveness of dimensional psychopathology phenotyping based on EMR: a Bayesian network approach.
BMC Psychiatry
January 2025
West China Biomedical Big Data Center, West China Hospital, Sichuan University, Chengdu, China.
The current DSM-oriented diagnostic paradigm has introduced the issue of heterogeneity, as it fails to account for the identification of the neurological processes underlying mental illnesses, which affects the precision of treatment. The Research Domain Criteria (RDoC) framework serves as a recognized approach to addressing this heterogeneity, and several assessment and translation techniques have been proposed. Among these methods, transforming RDoC scores from electronic medical records (EMR) using Natural Language Processing (NLP) has emerged as a suitable technique, demonstrating clinical effectiveness.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!