Staff

Anna D’Ambrosio, Ethical Committee Secretary

Cecilia Ciacchella, Administrative Unit

Barbara Matrascia, Administrative Unit

Federica Struglia,Administrative Unit

Marco Canfora, Clinical Informatics

Andrea Sacconi, Bioinformatic

Matteo Pallocca, Bioinformatic

Eleonora Sperandio, Bioinformatic

Francesca Sperati, Biostatistician

Isabella Sperduti, Biostatistician

Irene Terrenato, Biostatistician

Silvia Cartolano, Research Nurse

Giulia Costantini, Research Nurse

Ilaria Farina, Research Nurse

Stefano Pacilli, Research Nurse

Valerio Basile, Biologist

Silvia Bastucci, Study Coordinator

Elisabetta Bozzoli, Study Coordinatr

Arabella Bufalo, Study Coordinator

Viviana Cangiano, Study Coordinator

Barbara Conforti, Study Coordinator

Marianna Ferrara, Study Coordinator

Paola Franzoso, Study Coordinator

Marianna Introna, Study Coordinator

Vittoria Iorio, Study Coordinator

Katia Messana, Study Coordinator

Francesca Nardozza, Study Coordinator

Agnese Provenziani, Study Coordinator

Alessandra Zambardi, Study Coordinator

Ashanti Zampa, Study Coordinator

Alessandro Zennaro, Study Coordinator

Mission

The Unit includes the Clinical Trial Center (CTC) and the Biostatistic and Bioinformatic Unit.


The main objectives of CTC are:




  • To promote clinical trialmanagement according to GCP and quality standard

  • To support researchers in clinical trial start-up and conduct

  • To empower ‘no-profit’ research and the role of IRE as sponsor

  • To monitor clinical trials coverage of different therapeutics area

  • To attract profit clinical trials and private investment


Its core consists of




  1. Ethical Committee Scientific Technical Office

    • monthly meeting organization

    • meeting minute

    • budget and agreement negotiation

    • authorization process

    • ncome management



  2. Study Coordinators

    • support researchers along all study phases from Site Qualification Visit to Study Closure in the fully respect of trial protocolandprocedures according to GCP



  3. Research Nurses

    • support Medical Doctors during patients visits and treatments (blood samples, vital signs, drug administration time, PRO, questionnaires, drug contability, phone contacts…)



  4. Research Biologist

    • process blood samples according to quality standard procedures




The CTC has strict relationships with




  1. Clinical Trial Monitoring

    • through SMART cloud platform to control trial status and patients accrual



  2. Institutional Review Board (CISC)

    • internal studies evaluation



  3. Translational Coordinators

    • to improve ‘from lab to bed’ research and studies



  4. Epidemiology and Tumor Registries

    • to evaluate study feasibility in terms of patients



  5. Hospital Pharmacy

    • to manage drug supply and contability



  6. Pharmacovigilance

    • to report Adverse Events according to EUDRAVigilance standard



  7. Biobank and Clinical Pathology

    • to manage samples according to high quality standard




The Biostatistical and Bioinformatic Unit gives statistical advice for the protocol design related to observational and experimental studies. It is a support for the researchers in study design choice, randomization procedures identification, sample size calculation and Case Report Form definition.


Furthermore, the staff performs statistical analysis of clinical and laboratory data and develops new technique ofdata analysis, as required from the always increasing complexity of available information. It performs also systematic reviews and meta-analysis on clinically relevant aspects.


The Computer Science section of the Unit develops and implements databases and web apps related to clinical trial and research projects as well as particular pathologies.The Clinical Informatics department is working on a cloud eCRF/DB based on REDCap, a platform employed by thousands of clinical researchers worldwide.


The Bioinformatic section of the Unit coordinates all the activities pertaining -omics and Big Data analysis in the institute. It provides a unique platform of discussion for all the bioinformaticians in IRE, bridges the communication from data scientist to the Information Technology department for High Performance Computing analysis of Next Generation Sequencing and other -omics data such as Nanostring.

Research Activities

The Biostatistic and Bioinformatic Unit implements the most advanced statistical and methodological techniques to analyze data arrays. Along with the basic ways of analyzing data multivariate approaches are followed using available softwares as SPSS, Medcalc, Comprehensive Meta-analysis, PASS, NCSS and specifìc routines developed in R environment. Data coming from our single center and multicenter studies are formally checked together with investigators and strategies are constantly discussed. Our support starts with the study design and sample size determination using the most appropriate and innovative clinical trial design, and goes on focusing on protocol development and randomization scheme. During the study we support the investigators with interim analysis and database management. When writing the paper we perform the analysis and discuss the interpretation of results. Our activity includes systematic reviews and meta-analysis as well as the most recent techniques of analysis as propensity score and network meta-analysis. In collaboration we study the possibility of reducing high-dimensional data to develop models for interpreting prognostic and predictive role of factors.

The Bioinformatic department started recently employing virtualization techniques such as Docker and Nextflowon High Performance Computing platforms in order to ensure total result reproducibility. During 2020 a “virtual machine recipe” was implemented with the basic toolbox needed for NGS data analysis. It also acts as a coordinating hub for many working groups of Alliance Against Cancer, such as ACC-Bioinformatics WP6 on Clinical Reporting and the data analysis of ACC-Immunotherapy.