A recent Open Forum Infectious Diseases editorial highlights the development and application of the ARLG’s Desirability of Outcome Ranking (DOOR) endpoint for acute bacterial skin and skin structure infection (ABSSSI) trials. DOOR is a patient-centric benefit-risk framework that ranks each participant’s overall outcome by incorporating clinical response, complications, adverse events, and mortality, rather than evaluating benefits and harms separately.

The manuscript, “Development and Application of a Desirability of Outcome Ranking (DOOR) Endpoint for Acute Bacterial Skin and Skin Structure Infections,” describes how a multidisciplinary committee adapted an infectious diseases DOOR endpoint for ABSSSI and retrospectively applied it to two previous randomized registrational trials, OASIS-1 and OASIS-2, both comparing omadacycline with linezolid. The study team found that DOOR can be used in ABSSSI clinical trials to help individual patients and clinicians better understand the risks and benefits of different treatment options for skin infections.

The editorial, “What’s Behind DOOR Number 2? Recent Applications From Post-Hoc Analyses of Infectious Diseases Randomized Clinical Trials,” underscores the value of DOOR as an innovative, supplemental strategy to compare the benefits and risks of treatments being evaluated in infectious disease trials, including ABSSSI studies.

The ARLG has incorporated DOOR across a range of studies and, in collaboration with the National Institutes of Health (NIH), the US Food and Drug Administration (FDA), and patient advocate representatives, has developed standardized DOOR outcomes for multiple infectious syndromes.

Visit the ARLG Innovative Research Tools and Methods page for more information about DOOR and tools to design studies using DOOR endpoints.