5.53 问题：一名受试者能否同时参加多个临床研究？

5.53 Q. Can a subject be enrolled in morethan one investigational study at one time?

回答：根据种做法，但法规也没有禁止这种做法。根据指导意见，参与一项以上的临床研究可能会增加受试者的风险，尤其是因为他们可能接触到一种以上的研究产品，而这些产品的安全性可能不太清楚。受试者还可能发现很难理解多个方案中所有的风险和提及的获益，更不用说满足需求了。

A. According to the draft FDA guidance oninformed consent from July 2014, the FDA strongly discourages this practice,but there is no regulation that prohibits such a practice. According to theguidance, enrollment in more than one clinical investigation could increaserisks to subjects, particularly because they may be exposed to more than oneinvestigational product for which the safety profile may not be wellunderstood. Subjects may also find it difficult to understand all the risks and proposed benefits, much less meet the demands, of multiple protocols.

申办者还通常在方案中包括禁止使用相关合并用药的内容，或限制（通过排除标准）纳入在指定时间段内参与另一项临床研究的受试者（例如，受试者可以参加新的临床研究之前的洗脱期）。

Sponsors also generally includeprohibitions related to the use of concomitant medications in the protocol orrestrict (via exclusion criteria) inclusion of subjects who have participatedin another clinical investigation within a specified period of time (forexample, the washout period before a subject can enroll in a new clinicalinvestigation).

合并药物的禁止隐含着这样一种观点，即受试者不应参与一项以上的临床研究。

Implied in the prohibitions on concomitantmedications is the idea that subjects should not participate in more than one clinical investigation.

此外，2013年6月FDA发布了关于“联合开发两种或两种以上新试验药物以供联合使用”的指南。本指南中使用的联合开发是指同时开发两种或两种以上新的试验药物产品，用于联合治疗疾病或医学状况。目的是协助那些计划共同开发两种或两种以上新试验药物产品的申办者，这些产品将作为单独的药物，作为固定组合或联合包装药物组合使用。该指南就如何解决两种或两种以上新试验药物联合开发过程中可能出现的科学和监管问题提供了推荐和建议

In addition, in June 2013, FDA issued a guidance on “Co-development of Two or More New Investigational Drugs for Use inCombination.” Co-development as used in the guidance refers to the concurrent development of two or more new investigational drug products that are intended to be used in combination to treat a disease or condition. The purpose is to assist sponsors electing to co-develop two or more new investigational drug products to be marketed as individual agents intended to be used in combinationas a fixed-combination or co-packaged drug. The guidance provides recommendations and advice on how to address certain scientific and regulatoryissues that may arise during co-development of two or more new investigationaldrugs.