CHALLENGES IN MEETING EVIDENCE NEEDS OF PAYER, PHYSICIAN, PATIENT AND INDUSTRY STAKEHOLDERS FOR NOVEL THERAPEUTICS Pauer L, Gavaghan M, Chang Y OBJECTIVES: Evidence development programs for novel therapeutics must simultaneously demonstrate safety, efficacy, clinical significance, economic value and effectiveness to meet diverse stakeholder requirements.  This is further complicated by variable evidence needs across global markets and resource limitations.  Understanding how to address all stakeholder perspectives for treatments in ophthalmology was accomplished through primary research.  METHODS: Conducting primary research through in-depth phone interviews and advisory board meetings with patient, payer and clinical stakeholders in three ophthalmic conditions: chronic, non-infectious posterior uveitis, wet age-related macular degeneration and glaucoma provided important insights.  Patient research questions focused on identifying patient burden and unmet needs.  Further research with physicians and payers was accomplished through evaluating diverse criteria applied to assessing clinical and economic evidence plans. RESULTS: When therapeutic areas lack universally accepted clinical guidelines that can be relied upon to guide treatment decisions, payers rely heavily on clinicians to understand current standard of care and accepted endpoints.  Clinician leaders, interestingly, were not in universal agreement. Moreover, physicians and payers differed on use of economic endpoints and appropriate therapeutic comparators. Physicians differed on the endpoints that would be most relevant for demonstrating treatment response and how to address the patient burden.  Overall, clinicians were more willing to consider clinical trial endpoints that differed from those endpoints found in published data. Payers preferred to have consistent endpoints to facilitate indirect comparisons between treatments. CONCLUSIONS: The differing needs of payer and clinician stakeholders create additional barriers for development planning for novel therapeutics, particularly when published treatment guidelines are not available.  Manufacturers must consider multi-stakeholder insights across global markets in clinical trial design development. Santen Pharmaceuticals, Emeryville, CA, USA. GfK Market Access, Wayland, MA, USA.