Bunnik Eline M, Aarts Nikkie, van de Vathorst Suzanne
Department of Medical Ethics and Philosophy of Medicine, Erasmus MC, University Medical Centre Rotterdam, Wytemaweg 80, 3015 CN Rotterdam, The Netherlands.
Amsterdam Medical Centre (AMC), Department of General Practice, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.
J Pharm Policy Pract. 2017 Feb 21;10:10. doi: 10.1186/s40545-017-0100-3. eCollection 2017.
When patients are told that standard medical treatment options have been exhausted, their treating physicians may start looking for promising new drugs that are not yet approved, and still under investigation. Some patients can be included in clinical trials, but others cannot. It is not widely known that these patients might still be eligible for trying investigational drugs, in a therapeutic context. Worldwide, public and private parties are seeking to change this by informing patients and physicians about opportunities for expanded access and/or by facilitating its processes. When expanded access becomes available to larger groups of patients, ethical issues gain prominence, including informed consent, funding issues, disparities in access, and potential adverse effects on clinical drug development. Physicians, patients and policy-makers should not shift the responsibility to address these issues to pharmaceutical companies, but work together to resolve them.
当患者被告知标准医疗治疗方案已用尽时，他们的主治医生可能会开始寻找尚未获批且仍在研究中的有前景的新药。一些患者可以纳入临床试验，但其他患者则不行。鲜为人知的是，在治疗背景下，这些患者可能仍有资格尝试研究性药物。在全球范围内，公共和私人机构都在寻求通过向患者和医生宣传扩大用药机会和/或简化其流程来改变这种情况。当更多患者群体能够获得扩大用药时，伦理问题就变得突出，包括知情同意、资金问题、用药差异以及对临床药物研发的潜在不利影响。医生、患者和政策制定者不应将解决这些问题的责任推给制药公司，而应共同努力解决这些问题。
