A群脑膜炎球菌结合疫苗临床开发过程中的伦理挑战与经验教训
Ethical Challenges and Lessons Learned During the Clinical Development of a Group A Meningococcal Conjugate Vaccine.
作者信息
Martellet Lionel, Sow Samba O, Diallo Aldiouma, Hodgson Abraham, Kampmann Beate, Hirve Siddhivinayak, Tapia Milagritos, Haidara Fadima Cheick, Ndiaye Assane, Diarra Bou, Ansah Patrick Odum, Akinsola Adebayo, Idoko Olubukola T, Adegbola Richard A, Bavdekar Ashish, Juvekar Sanjay, Viviani Simonetta, Enwere Godwin C, Marchetti Elisa, Chaumont Julie, Makadi Marie-Francoise, Pallardy Flore, Kulkarni Prasad S, Preziosi Marie-Pierre, LaForce F Marc
机构信息
Meningitis Vaccine Project, PATH, Ferney-Voltaire, France.
Centre pour le Développement des Vaccins, Bamako, Mali.
出版信息
Clin Infect Dis. 2015 Nov 15;61 Suppl 5(Suppl 5):S422-7. doi: 10.1093/cid/civ598.
BACKGROUND
The group A meningococcal vaccine (PsA-TT) clinical development plan included clinical trials in India and in the West African region between 2005 and 2013. During this period, the Meningitis Vaccine Project (MVP) accumulated substantial experience in the ethical conduct of research to the highest standards.
METHODS
Because of the public-private nature of the sponsorship of these trials and the extensive international collaboration with partners from a diverse setting of countries, the ethical review process was complex and required strategic, timely, and attentive communication to ensure the smooth review and approval for the clinical studies. Investigators and their site teams fostered strong community relationships prior to, during, and after the studies to ensure the involvement and the ownership of the research by the participating populations. As the clinical work proceeded, investigators and sponsors responded to specific questions of informed consent, pregnancy testing, healthcare, disease prevention, and posttrial access.
RESULTS
Key factors that led to success included (1) constant dialogue between partners to explore and answer all ethical questions; (2) alertness and preparedness for emerging ethical questions during the research and in the context of evolving international ethics standards; and (3) care to assure that approaches were acceptable in the diverse community contexts.
CONCLUSIONS
Many of the ethical issues encountered during the PsA-TT clinical development are familiar to groups conducting field trials in different cultural settings. The successful approaches used by the MVP clinical team offer useful examples of how these problems were resolved.
CLINICAL TRIALS REGISTRATION
ISRCTN17662153 (PsA-TT-001); ISRTCN78147026 (PsA-TT-002); ISRCTN87739946 (PsA-TT-003); ISRCTN46335400 (PsA-TT-003a); ISRCTN82484612 (PsA-TT-004); CTRI/2009/091/000368 (PsA-TT-005); PACTR ATMR2010030001913177 (PsA-TT-006); PACTR201110000328305 (PsA-TT-007).
背景
A群脑膜炎球菌疫苗（PsA-TT）的临床开发计划包括2005年至2013年期间在印度和西非地区开展的临床试验。在此期间，脑膜炎疫苗项目（MVP）在按照最高标准进行符合伦理的研究方面积累了丰富经验。
方法
由于这些试验的赞助具有公私合作性质，且与来自不同国家背景的合作伙伴开展了广泛的国际合作，伦理审查过程十分复杂，需要进行具有策略性、及时性和专注性的沟通，以确保临床研究顺利通过审查和获批。研究人员及其现场团队在研究前、研究期间和研究后都建立了牢固的社区关系，以确保参与人群参与研究并拥有研究的自主权。随着临床工作的推进，研究人员和赞助商对知情同意、妊娠检测、医疗保健、疾病预防和试验后获取等具体问题做出了回应。
结果
取得成功的关键因素包括：（1）合作伙伴之间持续对话，以探讨和回答所有伦理问题；（2）在研究期间以及国际伦理标准不断演变的背景下，对新出现的伦理问题保持警惕并做好准备；（3）注意确保方法在不同社区背景下都是可接受的。
结论
在PsA-TT临床开发过程中遇到的许多伦理问题，对于在不同文化背景下进行现场试验的团队来说并不陌生。MVP临床团队采用的成功方法为解决这些问题提供了有益范例。
临床试验注册
ISRCTN17662153（PsA-TT-001）；ISRTCN78147026（PsA-TT-002）；ISRCTN87739946（PsA-TT-003）；ISRCTN46335400（PsA-TT-003a）；ISRCTN82484612（PsA-TT-004）；CTRI/2009/091/000368（PsA-TT-005）；PACTR ATMR2010030001913177（PsA-TT-006）；PACTR201110000328305（PsA-TT-007）。
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