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Lessons learned from COVID-19 for clinical research operations in Italy: what have we learned and what can we apply in the future?
Cagnazzo, Celeste; Besse, Marie-Georges; Manfellotto, Dario; Minghetti, Paola; Cazzaniga, Sara; Cottini, Lorenzo; Fontanella, Andrea; Maruti, Ilaria; Stabile, Stefano; Testoni, Sara; Trogu, Paola; Sinno, Valentina; Gussoni, Gualberto.
  • Cagnazzo C; Department of Public Health and Pediatrics, University of Turin, Turin, Italy.
  • Besse MG; Medical Affairs, Servier Italia SpA, Rome, Italy.
  • Manfellotto D; Department of Internal Medicine, Hospital Fatebenefratelli-AFaR, Rome, Italy.
  • Minghetti P; Department of Pharmaceutical Sciences, University of Milan, Milan, Italy.
  • Cazzaniga S; Janssen-Cilag SpA, Milan, Italy.
  • Cottini L; High Research, Milan, Italy.
  • Fontanella A; Department of Internal Medicine, Madonna del Buonconsiglio Fatebenefratelli Hospital, Naples, Italy.
  • Maruti I; Roche SpA, Switzerland.
  • Stabile S; Oncology Department, Niguarda Cancer Center, Grande Ospedale Metropolitano Niguarda, Milan, Italy.
  • Testoni S; Biostatistics and Clinical Trials Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola (FC), Italy.
  • Trogu P; Bayer SpA, Milan, Italy.
  • Sinno V; Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.
  • Gussoni G; Clinical Research Department, "Centro Studi" FADOI, Milan, Italy.
Tumori ; 107(1): 6-11, 2021 Feb.
Article in English | MEDLINE | ID: covidwho-1067070
ABSTRACT
The coronavirus disease 2019 (COVID-19) pandemic has stressed the importance of health research as never before. In the specific domain of clinical research, the effort to rapidly find responses to health challenges and therapeutic hypotheses has highlighted the need for efficient, timely, ethically correct research. The guidelines published by the Agenzia Italiana del Farmaco have shown that some useful changes are feasible simple and rapid methods have been implemented to conduct clinical research in the emergency conditions of the pandemic, maintaining high levels of quality. In this perspective, four Italian scientific associations operating in clinical research have worked together to evaluate which measures, among the ones implemented during the pandemic, have been particularly significant and potentially effective under normal conditions or in case of emergencies, and that therefore will be useful in the future as well.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Biomedical Research / SARS-CoV-2 / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study Limits: Humans Country/Region as subject: Europa Language: English Journal: Tumori Year: 2021 Document Type: Article Affiliation country: 0300891620977916

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Biomedical Research / SARS-CoV-2 / COVID-19 Type of study: Experimental Studies / Observational study / Prognostic study Limits: Humans Country/Region as subject: Europa Language: English Journal: Tumori Year: 2021 Document Type: Article Affiliation country: 0300891620977916