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Workshop 5: Biomarkers in HIV and Cancer Research (April 18-22, 2005)

Organizers: Victor De Grutolla, Mark Segal, Alan Perelson, Jeremy Taylor, and Steve Skates

This workshop addresses the issue of the medical application of new scientific technologies, such as microarray and PCR. The medical applications will include use of measurements based on these technologies as biomarkers for diagnosis, disease progression, and effects of treatment. The disease areas in which applications will be considered include HIV and other viral infections, and cancer.

HIV: The new technologies have directly impacted clinical management of HIV infection. HIV gene sequencing is used to evaluate drug susceptibility and thereby select treatment regimens for drug-experienced patients. PCR technology makes it possible to count HIV RNA particles in body compartments. Such measures allow evaluation of drug efficacy in suppressing virus both in plasma and in genital secretions. They also allow modeling of HIV dynamics, providing insight into the mechanisms of drug action. In addition to viral genomics, human genomics is also a developing area of research. In particular, there is interest in determining whether polymorphisms in specific host genes explain patient variability in treatment response, toxicity, and pharmacokinetics of antiretroviral drugs.

The sessions will include methods for relating HIV genotype to resistance phenotype; methods for modeling the accumulation of HIV resistance mutations; and relationship of host genomics to treatment response, toxicity, and pharmacokinetics of ARV therapy.

CANCER: Biomarkers are an important component of oncology practice at present, particularly in monitoring for cancer recurrence and in early detection of some cancers. However, with the recent explosion of genomic and proteomic technologies, biomarkers have the potential to contribute far more broadly to cancer research and oncology practice, including the following areas: early detection of cancer in asymptomatic subjects; differential diagnosis for patients presented with symptoms; monitoring for recurrence; risk stratification for clinical trial eligibility or selection of subjects for prevention/early detection strategies; prognosis; aid in therapeutic decision-making; monitoring the course of therapy; and surrogate endpoints for clinical trials.

Statistical challenges abound in all these areas, ranging from methods to identify suitable biomarkers to optimization of their application. Tight collaboration between statisticians, biologists, surgeons, and physicians, where biological and medical knowledge is incorporated in the statistical modeling whenever possible, will likely increase the chances of biomarkers realizing their full potential impact.

This workshop aims to highlight the statistical challenges involved in the areas of HIV and cancer research and medical practice, present statistical research in progress, and provide a forum for discussing current answers to the statistical challenges and future directions.