Medicine Based Evidence for Individualized Decision Making: Case Study of Systemic Lupus Erythematosus.

Background: To guide management decisions for an index patient, evidence is required from comparisons between approximate matches to the profile of the index case, where some matches contain responses to treatment and others act as controls.

Methods: We describe a method for constructing clinically relevant histories/profiles using data collected but unreported from 2 recent phase 3 randomized controlled trials assessing belimumab in subjects with clinically active and serologically positive systemic lupus erythematosus. Outcome was the Systemic lupus erythematosus Responder Index (SRI) measured at 52 weeks.

Clinical development of a recombinant Ebola vaccine in the midst of an unprecedented epidemic.

The 2014-2016 Ebola outbreak caused over 28,000 cases and 11,000 deaths. Merck & Co. Inc.

Self-reported Barriers to Adherence and Persistence to Treatment With Injectable Medications for Type 2 Diabetes.

Purpose: This study explored the barriers that adult Americans experience when taking injectable medications for type 2 diabetes, from the time of filling the initial prescription through the decision to discontinue the medication.

Methods: An Internet-based survey was conducted in 2 waves among adult patients (N = 2000) who had received a physician prescription for insulin, liraglutide, or exenatide once weekly (QW), regardless of whether the prescription was filled by a pharmacy. In wave 1, patients were surveyed on their medication history and experience and, if relevant, the medication discontinuation process.

Right answers, wrong questions in clinical research.

To ensure that clinical research arrives at the "right" answers to the right questions for patients, studies should be designed to more closely approximate real-world use of therapeutics and devices.