Michael David Hughes

Michael David Hughes is a Professor of Biostatistics at Harvard T.H. Chan School of Public Health, where he also serves as Director of the Center for Biostatistics in AIDS Research. His primary affiliation is with the Department of Biostatistics, and he serves as Principal Investigator of the Statistical and Data Management Center (SDMC) for the AIDS Clinical Trials Group (ACTG), funded by the National Institutes of Health.

Dr. Hughes' research program focuses on statistical methods related to the design and analysis of clinical trials and observational studies, particularly in the context of HIV research. He is well-known for his work on the development of methods for evaluating surrogate markers using meta-analysis of results from multiple clinical trials, with an important early application being the assessment of CD4 cell counts and viral load as surrogate markers for AIDS development. His statistical research is strongly motivated by problems encountered in collaborative HIV research, with ongoing interests including the design and analysis of phase I/II clinical trials, bridging trials between populations, and statistical methods for diagnostic and biomarker evaluation.

His work on dose-finding studies is particularly notable, including research to identify drug doses that maximize treatment success (both safety and efficacy) rather than just finding maximal tolerated doses, and methodology for dose-finding in special populations like infants and pregnant women. Much of his biomarker research is motivated by the need to identify less expensive and more accessible technologies for resource-limited countries.

Dr. Hughes has led major research initiatives through multiple NIH grants, including the current UM1AI068634 grant running until 2027 for the Statistical and Data Management Center of the ACTG. His recent publication record shows a strong dual focus on HIV research and COVID-19 pandemic response, with significant contributions to platform trial design (such as the ACTIV-2 trial), viral kinetics, and treatment resistance studies. His work bridges biostatistics methodology with practical clinical applications in infectious disease treatment.

As Principal Investigator of the Statistical and Data Management Center for the AIDS Clinical Trials Group, Dr. Hughes leads a substantial research team that undertakes numerous studies of HIV interventions globally, including research on co-infections like tuberculosis and hepatitis. His team collaborates extensively on international health research addressing HIV treatment challenges across diverse populations and resource-limited settings.