Comparative Assessment of Non-trial Access to Investigational Medical Products in the U.S. and Japan
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ORIGINAL RESEARCH
Comparative Assessment of Non‑trial Access to Investigational Medical Products in the U.S. and Japan Haruka Nakada, JD, PhD1 · Kelly McBride Folkers, MA2 · Kyoko Takashima, MPH, PhD3 Received: 9 June 2020 / Accepted: 9 October 2020 © The Drug Information Association, Inc 2020
Abstract The U.S. and Japan have preapproval access systems for patients who have exhausted approved treatment options. We compare the systems of both countries and discuss some ethical concerns surrounding non-trial access to investigational drugs. Notable points of comparison of the two countries’ systems include cost of non-trial access to investigational drugs and purpose of the non-trial access system. All stakeholders and the public must understand the ethical issues associated with non-trial preapproval access systems. The current non-trial access programs in both countries depends on pharmaceutical companies’ voluntary decisions about whether patients get access to investigational products. Moreover, the potential for inequity of access raises ethical concerns. Non-trial preapproval access is an exceptional way to practice medicine with various ethical and safety concerns, so we suggest that the scope and eligibility for using these pathways should thus be limited. Keywords Clinical trial · Non-trial access · Preapproval access · Research ethics
Introduction Access to investigational medical treatments before they are approved for sale and marketing, also known as preapproval access, can be considered as a “last resort” for patients who have exhausted approved treatment options. Globally, the main way that patients access investigational medical products before they are approved is by participating in clinical trials. However, there are various barriers to trial participation, including difficulties accessing a clinic, strict medical eligibility criteria, physicians’ attitudes toward clinical research [1], the types of treatment center [2], and patients’ age [3]. Haruka Nakada and Kelly McBride Folkers have contributed equally to this work. * Haruka Nakada [email protected] 1
Division of Bioethics and Healthcare Law, Center for Public Health Sciences, National Cancer Center, 5‑1‑1, Tsukiji, Chuo‑ku, Tokyo 104‑0045, Japan
2
Division of Medical Ethics, NYU Grossman School of Medicine, New York, USA
3
Medical Genomics Center, National Center for Global Health and Medicine, Tokyo, Japan
Patients who cannot participate in clinical trials may seek alternative ways of receiving investigational medical products. The U.S. Food and Drug Administration (FDA) has developed its expanded access (EA) pathway that allows patients with life-threatening or serious illnesses to request access to investigational treatments [4]. Patients, through their physicians, must request access to an investigational medical product from its manufacturer, and if the manufacturer agrees to provide the product, physicians must seek FDA review and institutional review board (IRB) approval of their treatment plan. The Right to Try Ac
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