TRTH-05. PREDICTORS OF SUCCESS OF PHASE 2 PAEDIATRIC ONCOLOGY CLINICAL TRIALS
| Autor: | Glenn M. Marshall, Jennifer A. Byrne, Maria Tsoli, Murray D. Norris, Siva Sivarajasingam, Laura Franshaw, David S. Ziegler |
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| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Cancer Research
medicine.medical_specialty Multivariate analysis Paediatric oncology business.industry Cancer Logistic regression medicine.disease Patient response Clinical trial Abstracts Clinical research Oncology Internal medicine medicine Chi-square test Neurology (clinical) Intensive care medicine business |
| Popis: | The rarity of childhood cancer, and high cure rates, mean only a limited number of novel therapies can be tested in patients with relapsed or refractory disease. Despite this, most novel therapeutic strategies fail in early phase trials. Of those that successfully pass through the different stages of clinical development, there is little evidence to identify the factors that influenced success. To better improve clinical success rates, we examined the impact of 23 preclinical and trial design variables for their influence on the success of 135 Phase 2 paediatric oncology clinical trials. Trial success was determined by an objective assessment of patient response, with data analysed using Fisher’s Exact or Pearson’s Chi-Square tests, and multivariate analysis using logistic regression models. For 61% of trials (83/135), no relevant preclinical experiments were performed. For those trials where preclinical studies were carried out (52/135 [39%]), there was no evidence the conduct of any preclinical experiments made the trial more likely to succeed. The only factors that positively influenced success related to trial design. Trials that evaluated patients with a single histological cancer type were significantly more likely to succeed than those that assessed multiple cancer types (67% versus 47%, 27%, and 17% for 1, 2–3, 4–7 and 8+; P |
| Databáze: | OpenAIRE |
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