Application in different study designsDownloads

A research team develops a new monoclonal antibody checkpoint inhibitor for advanced melanoma that has shown promise in animal studies as well as high efficacy and low toxicity in early phase human clinical trials. The research team would now like to compare this drug to existing standard of care immunotherapy for advanced melanoma. The research team decides to conduct a non-randomized study where the novel drug will be offered to patients who are deemed to be at risk for toxicity with the current standard of care immunotherapy, while patients without such risk factors will receive the standard treatment. Which of the following best describes the level of evidence that this study can offer?

A medical research study is evaluating an investigational novel drug (medication 1) as compared with standard therapy (medication 2) in patients presenting to the emergency department with myocardial infarction (MI). The study enrolled a total of 3,000 subjects, 1,500 in each study arm. Follow-up was conducted at 45 days post-MI. The following are the results of the trial: Endpoints Medication 1 Medication 2 P-Value Primary: death from cardiac causes 134 210 0.03 Secondary: hyperkalemia 57 70 0.4 What is the relative risk of death from a cardiac cause, expressed as a percentage? (Round to the nearest whole number.)