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Study Endpoints

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Chairperson. Chad Gwaltney, ERT and Annabel Nixon, PRMA Consulting Ltd


  • To develop, share, evaluate, and disseminate information on the selection, development and qualification of study endpoints, including patient reported outcomes (PROs), clinician reported outcomes (ClinROs), observer reported outcomes (ObsROs), and other rating scales, and biomarkers (such as vital signs, peak flow rates, or electrocardiograms), for use to demonstrate efficacy in medical product development;
  • To facilitate open discussion and communication among all stakeholders in the development and approval of new health technologies, including sponsors, regulators, marketing and reimbursement professionals, regarding requirements for validity and acceptability of study endpoints;
  • To educate, train, and develop professionals in the biopharmaceutical and healthcare industries about best practices in the development, validation, implementation and application of study endpoints; and
  • To reach out to other organizations directly or indirectly concerned with the definition of endpoints in medical interventions, inside and outside the DIA, with the purpose of sharing information, working towards best practices, and a consortium approach to instrument/product development.

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Media PlayerInstant Download! Beyond Taxonomy  

This audiosynchronized presentation explores the taxonomy of study endpoints and its importance to study design.

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