Predictors of Success of Phase II Pediatric Oncology Clinical Trials
| Autor: | Glenn M. Marshall, Murray D. Norris, Jennifer A. Byrne, Maria Tsoli, David S. Ziegler, Chelsea Mayoh, Siva Sivarajasingam, Laura Franshaw |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Oncology Cancer Research medicine.medical_specialty Drug Evaluation Preclinical Phases of clinical research Guidelines as Topic Logistic regression Pediatrics 03 medical and health sciences 0302 clinical medicine Clinical Trials Phase II as Topic Internal medicine Neoplasms medicine Pediatric oncology Humans Child business.industry Standard treatment Cancer medicine.disease Clinical trial Exact test Regimen 030104 developmental biology Pediatric Oncology Research Design 030220 oncology & carcinogenesis business |
| Popis: | BACKGROUND. There are limited data to predict which novel childhood cancer therapies are likely to be successful. To help rectify this, we sought to identify the factors that impact the success of phase II clinical trials for pediatric malignancies. MATERIALS AND METHODS. We examined the impact of 24 preclinical and trial design variables for their influence on 132 phase II pediatric oncology clinical trials. Success was determined by an objective assessment of patient response, with data analyzed using Fisher's exact test, Pearson's chi‐square test, and logistic regression models. RESULTS. Trials that evaluated patients with a single histological cancer type were more successful than those that assessed multiple different cancer types (68% vs. 47%, 27%, and 17% for 1, 2–3, 4–7, and 8+; p |
| Databáze: | OpenAIRE |
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