Strüver Vanessa
Hochschule Hannover, University of Applied Sciences and Arts, Faculty III - Media, Information, and Design, Hannover, Germany.
Curr Ther Res Clin Exp. 2017 Oct 16;86:2-8. doi: 10.1016/j.curtheres.2017.10.002. eCollection 2017.
The aim was to identify theoretically expected as well as actually reported benefits from drug development and the importance of individual patient benefits compared to the collective benefits to society in general.
Ethical guidelines require that clinical research involving humans offer the potential for benefit. A number of characteristics can be applied to define research benefit. Often benefit is categorized as being either direct or indirect. Indirect benefits can involve collective benefits for society rather than any benefits to the trial patient or subject. The purpose of this review was to examine which potential individual and societal benefits were mentioned as being expected in publications from government experts and which were mentioned in publications describing completed drug development trial results.
Literature on research benefit was first identified by searching the PubMed database using several combinations of the key words and . The search was limited to articles published in English. A Google search with the same combinations of key words but without any language limitation was then performed. Additionally, the reference lists of promising articles were screened for further thematically related articles. Finally, a narrative review was performed of relevant English- and German-language articles published between 1996 and 2016 to identify which of several potential benefits were either theoretically expected or which were mentioned in publications on clinical drug development trial results.
The principal benefits from drug development discussed included 2 main types of benefit, namely individual benefits for the patients and collective benefits for society. Twenty-one of an overall total of 26 articles discussing theoretically expected benefits focused on individual patient benefits, whereas 17 out of 26 articles mentioned collective benefits to society. In these publications, the most commonly mentioned theoretically expected individual patient benefit was the chance to receive up-to-date care (38.1%). A general increase in knowledge about health care, treatments, or drugs (70.6%) was the most commonly mentioned theoretically expected benefit for society. In contrast, all 13 publications reporting actual benefits of clinical drug development trials focused on personal benefits and only 1 of these publications also mentioned a societal benefit. The most commonly mentioned individual benefit was an increased quality of life (53.9%), whereas the only mentioned collective benefit to society was a general gain of knowledge (100.0%).
Both theoretically expected and actually reported benefits in the majority of the included publications emphasized the importance of individual patient benefits from drug development rather than the collective benefits to society in general. The authors of these publications emphasized the right of each individual patient or subject to look for and expect some personal benefit from participating in a clinical trial rather than considering societal benefit as a top priority. From an ethical point of view, the benefits each individual patient receives from his or her participation in a clinical trial might also be seen as a societal benefit, especially when the drug or device tested, if approved for marketing, would eventually be made available for other similar patients from the country in which the clinical trial was conducted.
旨在确定药物研发在理论上预期的以及实际报道的益处，以及相较于对社会的集体益处而言个体患者益处的重要性。
伦理准则要求涉及人类的临床研究应具有潜在益处。可以运用一些特征来界定研究益处。益处通常可分为直接益处或间接益处。间接益处可能涉及对社会的集体益处，而非对试验患者或受试者的任何益处。本综述的目的是考察在政府专家的出版物中预期会提及哪些潜在的个体和社会益处，以及在描述已完成药物研发试验结果的出版物中会提及哪些益处。
首先通过使用关键词的几种组合在PubMed数据库中进行搜索来识别有关研究益处的文献。搜索仅限于以英文发表的文章。然后进行谷歌搜索，使用相同的关键词组合但无任何语言限制。此外，对有前景文章的参考文献列表进行筛选以查找更多主题相关文章。最后，对1996年至2016年间发表的相关英文和德文文章进行叙述性综述，以确定在理论上预期的几种潜在益处中哪些，或者在临床药物研发试验结果出版物中提到了哪些。
所讨论的药物研发的主要益处包括2种主要类型的益处，即患者个体益处和社会集体益处。在总共26篇讨论理论上预期益处的文章中，有21篇关注个体患者益处，而26篇文章中有17篇提到了对社会的集体益处。在这些出版物中，理论上预期的最常被提及的个体患者益处是有机会接受最新治疗（38.1%）。对医疗保健、治疗方法或药物的总体知识增加（70.6%）是理论上预期的对社会最常被提及的益处。相比之下，所有13篇报道临床药物研发试验实际益处的出版物都关注个人益处，其中只有1篇出版物也提到了一项社会益处。最常被提及的个体益处是生活质量提高（53.9%），而唯一提到的对社会的集体益处是知识的总体增加（100.0%）。
在所纳入的大多数出版物中，理论上预期的和实际报道的益处都强调了药物研发中个体患者益处的重要性，而非对社会的集体益处。这些出版物的作者强调每个个体患者或受试者有权从参与临床试验中寻求并期望获得一些个人益处，而不是将社会益处视为首要优先事项。从伦理角度来看，每个个体患者从参与临床试验中获得的益处也可能被视为一项社会益处，特别是当所测试的药物或器械如果获批上市，最终将可供进行临床试验所在国家的其他类似患者使用时。
