Prescription Drug and User Fee Act (PDUFA V)
PDUFA is important to ensuring that the Food and Drug Administration has sufficient resources and knowledge to modernize its capabilities to review state of the art clinical trials and potential new brain tumor therapies for safety and efficacy. National Brain Tumor Society supports reauthorization of PDUFA in 2012.
Systems Biology Cancer Research
Systems biology cancer research is an important methodology for understanding the complexity of brain tumors and the microenvironment that enables them. By integrating bioinformatics, biology, physics, engineering and genomics, teams of researchers have a greater opportunity to analyze biological data created for all stages of therapeutic development. Our public policy work encourages the National Cancer Institute’s investment in systems biology and we are working with partner organizations to strengthen the field.
Human Subjects Rules and Informed Consent
For the first time in decades the federal Department of Health and Human Services is reviewing and reforming regulations governing informed consent of human subjects and the responsibilities of investigational review boards (IRBs). National Brain Tumor Society advocates for specific improvements to the rules to make them more understandable to patients and to improve the efficiency of IRBs.
Brain Tumor Tissue Collection/Handling/Storage and Sharing
The need to collect brain tumor tissue suitable for research purposes presents a significant challenge to researchers and a set of rights-â€based issues for patients. Despite several government driven efforts at establishing tissue banks, there continues to be significant disparity in those researchers and institutions that have access to brain tumor tissue and those that do not. National Brain Tumor Society is examining the landscape of public policy related to tumor tissue and will develop policy and advocacy recommendations./p>