Title: When to Withdraw a Subject from a Study
Author: Adrienne Carpenter
Description: A patient’s psoriasis worsens while taking study medication. Her condition should improve once she has taken drugs that have worked for her before, but are not allowed in the study.
Keyword(s): role conflict, withdrawal from study, randomized control trial (placebo), research related injuries, questionable risk-benefit assessment, beneficence, duty of care
Based On: (Brewer, 2007)
Case: Phyllis had been receiving treatment for psoriasis for seven years from her physician, Dr. Williams, when he suggested that she would make an ideal candidate for a study in which he involved. Dr. Williams had signed on with a pharmaceutical company sponsor to investigate a new psoriasis drug through a randomized, placebo controlled trial. The study required that subjects discontinue any use of other drugs for psoriasis, with only the study drug being used during the trial. For Phyllis, this would mean that she would discontinue her current and effective treatment, methotrexate. She enrolled in the study. Her condition began to deteriorate after stopping the methotrexate; by the time she was well into the active portion of the study, she had developed psoriatic arthritis. Although the study will only last for three weeks longer, and her condition is likely to improve after re-starting the methotrexate, Dr. Williams is aware that her condition may worsen further (i.e. blistering of skin, arthritic symptoms) in the interim. However, if Dr. Williams withdraws her from the study, then the data collected on her will not be included.
- Dr. Williams recognizes that his duties as a researcher (ensuring an adequate sample for the study) and his duties as a physician (protecting the best interest of his patient) are in conflict. What should Dr. W. do?
- What should Dr. Williams advise Phyllis to do? If she expresses an interest in “holding out” until the completion of the study, what ought Dr. Williams do? Should he advise her otherwise or accept her decision?
- What factors should Dr. W. consider in advising Phyllis?
Source: Brewer, S. (2007). Mock trials are unique compliance training tools. Protecting Human Subjects, 15.