Analyses of the Rationale and Implementation of Research Biopsies in Oncology Clinical Trials at a Tertiary Cancer Center.
Background. Biomarkers in clinical trials have led to massive incorporation of research biopsies, with potentially risks and no direct benefit for patients. In 2018, the American Society of Clinical Oncology (ASCO) released an ethical framework to provide guidance on incorporating research biopsies...
| Publicado en: | Oncologist Vol. 26; no. 12; pp. 1062 - 1071 |
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| Autores principales: | , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Oxford University Press / USA
Dec2021
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| 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=154632414&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 154632414 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10837159 IJ7 jtl: Oncologist issn: 10837159 maglogo: N pubinfo: dt: Dec2021 vid: 26 iid: 12 pid: 622 pub: Oxford University Press / USA artinfo: ui: 154632414 151724566 154632414 154632414 10.1002/onco.13906 154632414 ppf: 1062 ppct: 9 formats: tig: atl: Analyses of the Rationale and Implementation of Research Biopsies in Oncology Clinical Trials at a Tertiary Cancer Center. aug: au: OLYMPIOS, NATHALIE COLLET, LAETITIA PAESMANS, MARIANNE JUNGELS, CHRISTIANE KOTECKI, NURIA AWADA, AHMAD AFTIMOS, PHILIPPE affil: Medical Oncology Clinic, Institut Jules Bordet -- Université Libre de Bruxelles, Brussels, Belgium sug: subj: Implementation Science Research, Medical Biopsy Oncology Clinical Trials Ethical Issues Tertiary Health Care Cancer Care Facilities Human Hospitals Belgium Belgium American Society of Clinical Oncology Conceptual Framework Research Ethics Logistic Regression Models, Statistical Descriptive Statistics Neoplasm Metastasis Multivariate Analysis ab: Background. Biomarkers in clinical trials have led to massive incorporation of research biopsies, with potentially risks and no direct benefit for patients. In 2018, the American Society of Clinical Oncology (ASCO) released an ethical framework to provide guidance on incorporating research biopsies in cancer clinical trials. Materials and Methods. We collected biopsy requirements of cancer clinical trials conducted at Institut Jules Bordet (IJB) between 2015 and 2019 to examine adherence with the ASCO Ethical Framework. We used logistic regression models to test the association between the request for biopsy, the request for tissue, and the adherence to the ASCO framework as well as some trial characteristics. Results. Between January 2015 and December 2019, 178 oncological studies were conducted at IJB. Of these, 138 (78%) were sponsored by industry, 132 (74%) were phase II and III studies, and 141 (79%) concerned metastatic disease. Tissue was required for inclusion for 119 (67%) studies, among which 59 required at least one new biopsy. Adherence to ASCO's Ethical Framework was 67% for studies requiring tissue and went down to 39% for studies requiring at least one new biopsy. In multivariate analysis, requests for tissue or new biopsies increased in early-phase studies (p < .001, p < .001, respectively) and in studies investigating innovative treatments (immunotherapy or targeted therapies; p < .01, p = .02). Compliance to the ASCO framework significantly decreased with time (p < .001) and in early-phase studies (p < .001). Conclusion. Numerous studies required tissue or new biopsies for exploratory objectives of unknown clinical utility. Requests for tissue increased over the years, whereas compliance to ASCO's Ethical Framework decreased. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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