Physician, Researcher, or Both?

A s i a n B i o e t h i c s R e v i e w D e c e m b e r 2 0 0 8 i n a u g u r a l e d i t i o n 58 Physician, Researcher, or Both? Research Ethics You are the principal investigator of a double-blind, placebo-controlled clinical trial investigating the efficacy of a new drug XTX007 to treat symptoms of constipation associated with irritable bowel syndrome. You need another three (3) more patients to meet your recruitment target of 40 subjects before the recruitment closing date next month. The pharmaceutical company sponsoring the trial has promised in the contract a bonus payment of S$5,000 to you if you are able to achieve the pre-set recruitment target of 40 participants. This is in addition to the S$800 payment to you for each patient recruited (over and above the fee paid to your institution for cost incurred in conducting this study at your hospital — use of facilities, materials and professional services). The central data safety monitoring board (DSMB) for the study has asked for an increase in the intensity of surveillance due to concerns about recent reports of serious adverse events “possibly related” to the trial drug XTX007 (two cases of cardiac rhythm abnormality, two cases of acute myocardial infarction, and three cases of acute liver dysfunction). Mrs L, a 63-year-old retiree, has been a patient of yours for the last seven years. She has severe constipation associated with irritable bowel syndrome, which has been unresponsive thus far to available treatment. She read one of your recruitment posters about the XTX007 study and is interested in participating in your clinical trial on XTX007. However, she does not fit the eligibility criteria of “episode of liver disease in the last six months, including acute hepatitis” due to her diagnosis of viral hepatitis three months ago. She asks that you disregard this “minor” disqualifying condition, because the drug is not available outside the trial setting. Chin Jing Jih C A S E C O R N E R 58 Asian Bioethics Review December 2008 inaugural edition ...