Ethical Issues in Prescribing Drugs to Older Adults for Whom Representative Randomized Trial Data Is Lacking

点击翻译按钮获取中文摘要

Older adults are often underrepresented in or even excluded from the randomized controlled trials (RCTs) leading to FDA approval of new drugs, but for many drugs they then represent the majority of patients receiving the drug in routine care after approval. Drugs demonstrated to have certain outcomes in trials of younger populations may not have similar effectiveness in older adults, and such use may also put patients in underrepresented older age groups at increased risk for unexpected side effects. The current R01 grant (“Understanding effectiveness of new drugs in older adults shortly after market entry”) evaluates a framework for developing more timely and robust insight regarding the effectiveness of new FDA-approved drugs in older adults. This supplemental application augments the R01 grant with bioethics research examining the issues in prescribing drugs for older patients when RCTs leading to FDA approval did not include those patients. We will explore the bioethical implications of the use of drugs in populations different from those recruited into their pivotal RCTs, including the need for enhanced disclosure as part of informed consent procedures and regulatory changes that would make approvals conditional on evidence generated in real- world patient populations. These goals will be pursued by conducting focus groups with older adult patients and semi-structured interviews with prescribers. Based on the results of these research efforts, we will formulate regulatory and clinical practice recommendations to promote patient autonomy and informed decision making.