DIA/FDA Statistics 2015 Forum

The added clinical value, and in some countries the economic value, of a new intervention is systematically evaluated to determine whether it should be included in health benefit plans or disease management programs and be reimbursed by health care providers. Health technology assessment (HTA) can help determine if a new technology is clinically effective, and where appropriate cost effective, relative to current interventions used in routine clinical practice. Consideration of HTA activities are integral to the drug development process for new interventions, and early awareness of activities required to support HTAs can impact clinical study designs, and improve and enhance the evidence generated during the clinical development program. This session gives an overview of HTAs, particularly in terms of statistical issues and challenges statisticians will need to address.