Quality assurance in clinical trials--the role of pathology.
In the last two decades, our knowledge about cancer genetics and cancer biology increased exponentially. Deep sequencing now allows rapid and cost-effective analysis of entire cancer genomes. Dysregulation of cell growth, cell survival, tissue homeostasis, and immune surveillance have been recognize...
| Publicado en: | Virchows Archiv: European Journal of Pathology Vol. 468; no. 1; pp. 83 - 93 |
|---|---|
| Autor principal: | |
| Formato: | research Journal Article |
| Publicado: |
Springer Nature
Jan2016
|
| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=112926860&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 112926860 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 09456317 O1Z jtl: Virchows Archiv: European Journal of Pathology issn: 09456317 maglogo: N pubinfo: dt: Jan2016 vid: 468 iid: 1 pid: 237 pub: Springer Nature place: New York, New York artinfo: ui: 112926860 112926860 NLM26427655 112926860 10.1007/s00428-015-1857-x NLM26427655 112926860 ppf: 83 ppct: 10 formats: fmt: @attributes: type: P tig: atl: Quality assurance in clinical trials--the role of pathology. aug: au: Röcken, Christoph Röcken, Christoph affil: Department of Pathology, Christian-Albrechts-University, Arnold-Heller-Str. 3, Haus 14 24105 Kiel Germany sug: subj: Quality Assurance Methods Pathology Standards Pathology Methods Clinical Trials Quality Assurance Standards Human ab: In the last two decades, our knowledge about cancer genetics and cancer biology increased exponentially. Deep sequencing now allows rapid and cost-effective analysis of entire cancer genomes. Dysregulation of cell growth, cell survival, tissue homeostasis, and immune surveillance have been recognized as hallmarks of cancer. In parallel, diagnostic surgical pathology has been harmonized and consensus diagnostic criteria for cancer classification have been developed by initiatives of the World Health Organization, the International Agency for Research on Cancer, and the Union for International Cancer Control. Pharmaceutical companies developed novel drugs targeting specific molecules in signaling pathways, which has allowed the development of the concept of precision medicine. Now, we are facing a large number of clinical trials which bring together these advances and will explore efficacy of novel treatment regimens. Assessment of the efficacy of a new drug is often coupled with the simultaneous assessment of the capacity of tissue-based biomarkers to predict response of individual patients (companion diagnostics/precision medicine). Patients with histologically similar tumors might respond differently to the same drug. This review summarizes the diverse roles played by surgical pathologists involved in clinical trials, with a special focus on quality assurance of diagnostic, laboratory, and reporting standards. pubtype: Academic Journal doctype: research Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
|---|