A 35 year-old female comes to your office complaining of a sore throat. She has two children who were recently diagnosed at a separate clinic with Streptococcal pharyngitis. Her temperature is 100.8 F (38.2 C), blood pressure is 120/74 mmHg, pulse is 72/min, and respirations are 16/min. A rapid strep test performed in your office is positive. The patient is allergic to penicillin. You are participating in a clinical trial testing the effectiveness and tolerability of a new, low dose, extended release form of azithromycin. You are aware that azithromycin has been approved by the Food and Drug Administration for several years and that the clinical trial is using the same drug but with a slightly different cap around the pill and a lower dose. Given the small changes in the drug, what is your responsibility in notifying the patient?

Question

A 35 year-old female comes to your office complaining of a sore throat.  She has two children who were recently diagnosed at a separate clinic with Streptococcal pharyngitis.  Her temperature is 100.8 F (38.2 C), blood pressure is 120/74 mmHg, pulse is 72/min, and respirations are 16/min.  A rapid strep test performed in your office is positive.  The patient is allergic to penicillin.  You are participating in a clinical trial testing the effectiveness and tolerability of a new, low dose, extended release form of azithromycin.  You are aware that azithromycin has been approved by the Food and Drug Administration for several years and that the clinical trial is using the same drug but with a slightly different cap around the pill and a lower dose.  Given the small changes in the drug, what is your responsibility in notifying the patient?

Quizplus · Accepted Answer

Explanation: Patients must always be fully informed about any clinical trial in which they are enrolled, and voluntary written consent must be obtained. According to the American Medical Association's policies, clinical trials designed primarily for treatment must have the following principles: a physician/patient relationship must exist, a physician must act in the best interest of the patient, and written consent must be obtained from the patient after full disclosure of all aspects of the clinical trial is given to the patient's satisfaction. Before giving the low dose azithromycin to this patient, the physician must first inform the patient in detail about the clinical trial and obtain voluntary written consent from the patient. (Choice A)Despite the fact that azithromycin has been used safely for years, the new formulation being studied is still experimental. (Choice C) Patients must be fully informed to their satisfaction about the clinical trial. However, this patient must also provide written consent. (Choice D) Azithromycin may have efficacy in treating Streptococcal pharyngitis. This patient, however, will be part of a clinical trial that involves a new formulation of azithromycin and must be informed regardless of the likely clinical outcome. (Choice E)The question does not suggest that the new azithromycin formulation is being compared to either a placebo or other existing medication. As a result, patient bias is not a real issue. In addition, even in the setting of a double-blind trial, the patient must be fully informed and provide written consent to participate, with the knowledge that she could be given a placebo or alternative treatment. Educational objective: Patients participating in clinical trials must always be fully informed and are required to provide voluntary written consent.

A 35 Year-Old Female Comes to Your Office Complaining of a Sore