Are ongoing trials on hematologic malignancies still excluding older subjects?

Several hematological malignancies, e.g. multiple myeloma, myelodysplastic syndromes and chronic myeloid leukemia are more prevalent in older subjects. Nevertheless, older patients have been frequently excluded from clinical trials investigating the treatment of hematological malignancies. This exclusion might represent an important cause of undertreatment of these patients. This study assessed the presence and the extent of underrepresentation of older individuals in ongoing CTs on hematological malignancies registered in an online open-access CT registry maintained by the World Health Organization (WHO). Our findings confirm that the exclusion of older people due to age or other criteria is still widespread. Descriptive statistics have been performed for discrete and continuous variables. The analysis of contingency tables for categorical variables was supported by Pearson’s χ2 test or Fisher's exact test for sparse tables or for tables larger than 2 × 2. Univariable logistical regression models were used to identify variables more associated with the specific cause of exclusion on the basis of χ2 Wald statistics (P>χ2 Wald <=0.25). A linearity study was performed for continuous variables and transformations have been applied when necessary. Any variable whose univariable test has P<0.25 has been chosen as a candidate for the multivariable logistical regression models. Multivariable logistical regression model computation with automatic selection of the best model (backward and stepwise methods) has been performed to discover variables significantly associated with each cause of exclusion using SAS software (version 9.2, SAS Institute Inc., Cary, NC, USA).