Vision for Clinical Research at the CCR

he close association between basic and clinical research that exists within the CCR enables our clinical program to benefit from a dynamic, collaborative environment that drives our advances in translational research. Distinct from a comprehensive cancer center, our clinical program is a low-volume, high-intensity clinical/translational research enterprise focused intensely upon a small number of patients with cancer or AIDS-related illnesses. Patient volunteers who participate in our clinical trials receive state-of-the-art therapies and approaches to diagnosis and treatment. Genomic profiling is becoming a very important addition to these cutting-edge approaches.

The desire to obtain maximal information from every clinical protocol offered at the Clinical Center drives our investment in genomic profiling. Analysis of every biospecimen donated by patients enrolled in our clinical trials is a major part of our information gathering. Our clinical researchers use a wealth of technologies and analysis platforms to obtain sophisticated data from each biospecimen collected. Aware that such molecular information may soon be critically relevant to establishing markers of drug response or patient stratification—information needed to usher new drugs through clinical trials more efficiently—we have established a centralized facility of human biospecimens for clinical research. We collect material using standardized methods and approaches to ensure that samples are of the highest quality. This care at the outset makes subsequent analysis both possible and reliable.

Our newly established Clinical Molecular Profiling Core is at the heart of our commitment to biospecimen collection and our capacity to perform sophisticated analysis. This core, headed by Paul Meltzer, PhD, will coordinate a complex series of genetic and genomic analyses on human samples collected during a patient’s participation in clinical trials. The samples, with patient consent, will be procured under NCI’s new guidelines for biospecimens and will be subjected to the most advanced technologies to interrogate the underlying disease using as many approaches as are feasible, based on the amount and type of tissue available. We will analyze and mine our acquired data to advance our understanding of the underlying mechanisms and process of cancer, and we will correlate clinical results with molecular targets and pathways where possible.

With much optimism, I welcome this addition to our clinical infrastructure. With this powerful technology, we will accelerate our ability to move discoveries made at the laboratory bench to the clinical setting and benefit many cancer patients.

Lee J. Helman, MD
Scientific Director for Clinical Research