Department of Clinical Immunology and Rheumatology, Hospital Edouard Herriot, 69437 Lyon Cedex 03, France.
Ann Rheum Dis. 2011 Oct;70(10):1713-8. doi: 10.1136/ard.2011.154252. Epub 2011 Jul 22.
Rheumatoid arthritis (RA) is one of the most appropriate conditions for the application of personalised medicine as a high degree of heterogeneity has been recognised, which remains to be explained. Such heterogeneity is also reflected in the large number of treatment targets and options. A growing number of biologics as well as small molecules are already in use and there are promising new drugs in development. In order to make the best use of treatment options, both targeted and non-targeted biomarkers have to be identified and validated. To this aim, new rules are needed for the interaction between academia and industry under regulatory control. Setting up multi-centre biosample collections with clear definition of access, organising early, possibly non-committing discussions with regulatory authorities, and defining a clear route for the validation, qualification and registration of the biomarker-drug combination are some of the more critical areas where effective collaboration between the drug industry, academia and regulators is needed.
类风湿关节炎（RA）是个性化医学应用的最适宜条件之一，因为已经认识到存在高度的异质性，但这种异质性仍有待解释。这种异质性也反映在大量的治疗靶点和选择上。越来越多的生物制剂和小分子药物已经在使用中，并且有许多有前途的新药正在开发中。为了充分利用治疗选择，必须确定和验证有针对性和非靶向的生物标志物。为此，需要在监管控制下制定学术界和工业界之间的新规则。建立具有明确准入定义的多中心生物样本库，与监管机构进行早期、可能无约束力的讨论，并为生物标志物-药物组合的验证、资格和注册定义明确的途径，是药物行业、学术界和监管机构之间需要进行有效合作的一些更为关键的领域。
