OBJECTIVES: Given the high level of investment in clinical trials, both in terms of time and expense, there has been a movement towards establishing data standards for clinical trials with the potential to generate considerable savings to the industry. Although not standardized, an opportunity exists to use health data in the planning and implementation of clinical trials and economic studies to increase the likelihood of successful study results, which critically affect the future of the drug product. “Real world” secondary health data have the advantages of large sample sizes and represent a broad range of patients. Trials that focus on the collection of health economic data present additional challenges for which secondary health data can help inform the study design. For example, health care expenditure data tend to be highly skewed, which generally requires that health economic trials be larger than efficacy trials. By applying the proposed inclusion and exclusion criteria of clinical trials to large retrospective databases, one can assess whether there are enough patients with the condition of interest to enable the trial to be conducted, the statistical power to detect differences in clinical and economic outcomes, the geographic distribution of these patients, and the composite profiles in terms of medical co-morbidities, concomitant medications, demographics, and health care expenditures. These profiles can impact expected enrollment rates, targeted investigator profile and appropriate length of follow up for study subjects, either supporting or supplanting the traditional telephone or fax-based protocol feasibility surveys. This presentation will describe the kinds of secondary health data available and how these data can be applied to expedite and enhance the planning and design of clinical and health economic research trials. We will present a case study demonstrating the value for evidence-based design of clinical and health economic research with secondary use of health data.