PubMed · 15291843
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A Darracott Vaughan, Jack McAninch. 2004. Conversations.. https://doi.org/10.1111/j.1464-410x.05069.x
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Major advances in basic-science rheumatology research have been achieved in various fields including molecular techniques, signaling pathways, experimental strategies, and in several bench-to-bedside approaches. Using laser-mediated microdissection, small areas of interest in a given diseased tissue can be analyzed in a high-resolution setting. Molecular imaging, especially the combination of labeled molecules such as albumin that are metabolized by active cells together with smart probes, can be used to visualize key mechanisms in rheumatoid synovial tissue in a real-time setting. Recently discovered microparticles and Toll-like receptors have been found to be dominant players in innate immunity-driven inflammation and destruction in the rheumatoid joint. Moreover, long-lived plasma cells appear to be a major factor in resistance to immunosuppressive drugs in autoimmune disease. With regard to bench-to-bedside strategies, various targeted therapies including various gene transfer strategies yielded promising preclinical results.
The Convention on Human Rights and Biomedicine, its Additional Protocol, the European Parliament's Good Clinical Practice (GCP)-Directive as well as the German Medicines Law and GCP-Decree all require certain forms of "benefit" for participants of clinical trials and other forms of clinical-evaluative research. However, they do not provide any attempt to define e. g. "direct benefit" or group benefit -- contrary to our text. It additionally discusses qualitative and quantitative aspects and the inherently probabilistic nature of any benefit from clinical research. Clinically most relevant study types and designs (such as placebo-controlled trials; diagnostic studies of phases 1 - 3) do not offer any potential individual benefit at least for parts of the samples, they are at best beneficial for the group of similarly affected patients. At present those trials if including incapacitated adults not able to give informed consent are forbidden by German law, a situation different from that of trials involving minors.
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