Wermeling D P, Selwitz A S
Drug Product Evaluation Unit, College of Pharmacy, University of Kentucky, Lexington 40536.
Ann Pharmacother. 1993 Jul-Aug;27(7-8):904-11. doi: 10.1177/106002809302700719.
Our principal objective is to make readers aware of conflicting demands placed on investigators and the pharmaceutical industry regarding inclusion of women and minorities in clinical research. Tremendous pressures have been placed to expedite the drug approval process. Moreover, during the last decade certain segments of society, particularly women and minorities, have demanded greater participation in clinical drug trials and earlier access to investigational drug therapies. Regulations that have served the clinical research community (pharmaceutical industry, investigators, institutional review boards) as guidelines for safe conduct of human clinical trials are being challenged by social and political change. This article provides an overview of some of the controversy relative to federal regulations governing clinical trials; scientific concerns; social, political and legal trends; and ethical principles applied to human clinical research.
Literature for this paper was retrieved from a variety of sources including the nonmedical press, editorials, peer-reviewed journals, Department of Health and Human Services regulations, National Institutes of Health policy, the Belmont Report, and regulations of the Food and Drug Administration.
Scientists evaluating new therapeutic agents ask specific research questions to assess safety, efficacy, and the mechanism(s) of action. Because of concerns for scientific validity, safety, liability, and convenience, many early evaluations of new drugs involve patient populations that may not represent the ultimate users of a new drug. Federal regulations and ethical principles allow certain groups of people to be excluded from early research proposals because they are thought to be putting themselves at greater risk by participating than are other groups. However, women, minorities, and other populations are demanding greater access to investigational drugs. The focus has changed from protection from research risks and burdens to the potential benefits a person or class of people may obtain by participating in a study.
Scientists, the pharmaceutical industry, regulators, and society must agree on a safe and efficient mechanism for new drug development that permits more equitable participation of subjects in the various phases of research.
我们的主要目的是让读者了解在临床研究中纳入女性和少数族裔方面，研究者和制药行业面临的相互冲突的要求。加快药物审批流程面临着巨大压力。此外，在过去十年中，社会的某些群体，特别是女性和少数族裔，要求更多地参与临床药物试验，并更早地获得试验性药物治疗。曾作为临床研究界（制药行业、研究者、机构审查委员会）进行人类临床试验安全操作指南的法规，正受到社会和政治变革的挑战。本文概述了与临床试验联邦法规相关的一些争议；科学问题；社会、政治和法律趋势；以及应用于人类临床研究的伦理原则。
本文的文献来自多种渠道，包括非医学媒体、社论、同行评审期刊、卫生与公众服务部法规、国立卫生研究院政策、《贝尔蒙报告》以及食品药品监督管理局的法规。
评估新治疗药物的科学家会提出特定的研究问题，以评估安全性、有效性和作用机制。出于对科学有效性、安全性、责任和便利性的考虑，许多新药的早期评估涉及的患者群体可能并不代表新药的最终使用者。联邦法规和伦理原则允许某些人群被排除在早期研究方案之外，因为他们被认为参与研究比其他群体面临更大风险。然而，女性、少数族裔和其他人群要求更多地获得试验性药物。关注点已从保护人们免受研究风险和负担，转变为个人或某类人群参与研究可能获得的潜在益处。
科学家、制药行业、监管机构和社会必须就一种安全有效的新药研发机制达成一致，该机制应允许受试者在研究的各个阶段更公平地参与。
