ABSTRACT
The burden of cancer exerts a disproportionate impact across different regions and population subsets. Disease-specific attributes, coupled with genetic and socioeconomic factors, significantly influence cancer treatment outcomes. Precision oncology promises the development of safe and effective options for specific ethnic phenotypes and clinicodemographic profiles. Currently, clinical trials are concentrated in resource-rich geographies with younger, healthier, white, educated, and empowered populations. Vulnerable and marginalized people are often deprived of opportunities to participate in clinical trials. Despite consistent endeavors by regulators, industry, and other stakeholders, factors including diversity in trial regulations and patient and provider-related cultural, logistic, and operational barriers limit the inclusiveness of clinical trials. Understanding and addressing these constraints by collaborative actions involving regulatory initiatives, industry, patient advocacy groups, community engagement in a culturally sensitive manner, and designing and promoting decentralized clinical trials are vital to establishing a clinical research ecosystem that promotes equity in the representation of population subgroups.
Subject(s)
Clinical Trials as Topic , Medical Oncology , Neoplasms , Humans , Neoplasms/therapy , Neoplasms/ethnology , Patient Selection/ethicsABSTRACT
Non-isothermal degradations were applied to carry out simulation studies to analyse the influence of some factors on the accuracy and precision of stability parameters of drugs, to establish the best work conditions in experimental studies of stability using non-isothermal methodology. These factors were: random error added, sampling frequency, heating model, extent of drug degradation, amplitude of temperature range and mean temperature. Simulation studies were realized for a first-order degradation process. A weighted non-linear regression was used to determine the stability parameters which were statistically evaluated. An ANOVA analysis and post hoc comparisons tests were made to determine the statistical significance of the influence of each factor studied on the central value and on the precision of stability parameters of drugs. Univariant general linear model allowed to establish quantitatively the effect of the variability of the factors studied on the variability on the precision of the kinetic parameters. It was found that the influence of the studied factors was not statistically significant (p>0.05) on the activation energy (E(a)) and shelf-life (t(90)) values. Nevertheless, four of the six analysed factors influenced with statistical significance on the precision of the shelf-life according the following decreasing order of importance: random error added, extent of drug degradation, amplitude of temperature range and heating model.
Subject(s)
Algorithms , Drug Stability , Pharmaceutical Preparations/chemistry , Analysis of Variance , Data Interpretation, Statistical , Kinetics , Reproducibility of Results , Technology, Pharmaceutical/methods , TemperatureABSTRACT
Eight cases of acute gastroenteritis, two caused by enteropathogenic "E. coli", with secondary cow's milk protein intolerance were studied. Diagnosis was established clinically and by means of intestinal biopsy, before and after a milk challenge. The role of acute gastroenteritis as a trigger of cow's milk protein intolerance and other factors contributing to the appearance of that complication are discussed. The mechanisms leading to intractable diarrhoea in a situation of prolonged gastroenteritis are also commented.
