Dr. Hughes' research program focuses on statistical methods related to the design and analysis of clinical trials. He is the statistician for a number of trials, notably through his work as Director of the Statistical Center of the Pediatric AIDS Clinical Trials Group.
Current research includes the development of methods for evaluating surrogate markers using meta-analysis of results from a number of clinical trials. This methodology is being applied in a project directed by Dr Hughes, in collaboration with the HIV Surrogate Marker Collaborative Group, to assess the value of early treatment-induced changes in CD4 cell counts and viral load as surrogate markers for the development of AIDS.
Other work related to clinical trial design includes methods for multivariate censored data, with a particular emphasis on censored measurements of biomarkers. Such measurements include symptom scores in rhinitis trials and virologic measurements in HIV trials.
A major area of research concerns the design and analysis of phase I/II clinical trials. One project concerns finding the dose of a drug that maximizes the success of treatment (i.e. is both safe and effective) rather than just find the maximal tolerated dose. Another project involves methodology for dose selection studies in pediatric populations when there is usually safety, efficacy and pharmacological data available from adult studies that can be incorporated into design and/or analysis.