Medical Ethics and Legal Medicine Laboratory EA4569, Paris Descartes University, Centre Universitaire des Saints-Pères, Paris, France.
Cancer Research for Personalized Medicine (CARPEM), Paris Descartes, APHP (HEGP, Cochin, Necker) INSERM, Paris, France.
Sci Eng Ethics. 2018 Feb;24(1):307-322. doi: 10.1007/s11948-017-9880-8. Epub 2017 Mar 9.
The practice and development of modern medicine requires large amounts of data, particularly in the domain of cancer. The future of personalized medicine lies neither with "genomic medicine" nor with "precision medicine", but with "data medicine" (DM) (big data, data mining). The establishment of this DM has required far-reaching changes, to establish four essential elements connecting patients and doctors: biobanks, databases, bioinformatic platforms and genomic platforms. The "transformation" of scientific research areas, such as genetics, bioinformatics and biostatistics, into clinical specialties has generated a new vision of care. Molecular tumor boards (MTB) are one response to these changes and are now providing better access to next-generation sequencing (NGS) and new cancer treatments to patients with inoperable or metastatic cancers, and those for whom the usual treatment has failed. However, MTB face a crucial ethical challenge: maintaining and improving the trust of patients, clinicians, researchers and industry in academic medical centers supported by private or public funding rather than providing genetic data directly to private companies. We believe that, in this era of DM, appropriate modern digital communication networks will be required to maintain this trust and to improve the organization and effectiveness of the system. There is, therefore, a need to reconsider the form and content of informed consent (IC) documents at all academic medical centers and to introduce dynamic and electronic informed consent (e-IC).
现代医学的实践和发展需要大量的数据,尤其是在癌症领域。个性化医学的未来既不在于“基因组医学”,也不在于“精准医学”,而在于“数据医学”(DM)(大数据、数据挖掘)。建立这种 DM 需要进行深远的变革,以建立连接患者和医生的四个基本要素:生物库、数据库、生物信息学平台和基因组平台。遗传学、生物信息学和生物统计学等科研领域的“转化”为临床专业领域带来了新的护理视角。分子肿瘤委员会(MTB)是对这些变化的一种回应,现在为无法手术或转移性癌症患者以及常规治疗失败的患者提供了更好的下一代测序(NGS)和新的癌症治疗方法。然而,MTB 面临着一个关键的伦理挑战:在由私人或公共资金支持的学术医疗中心中,维护和提高患者、临床医生、研究人员和行业对遗传数据的信任,而不是直接将遗传数据提供给私人公司。我们认为,在这个 DM 时代,需要适当的现代数字通信网络来维护这种信任,并改善系统的组织和效率。因此,有必要重新考虑所有学术医疗中心的知情同意(IC)文件的形式和内容,并引入动态和电子知情同意(e-IC)。