Head: Patrizio Giacomini, MD
STAFF

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.

The CTC was established by Decree No. 308 dated 24 April 2018 and subsequently amended with Decree No. 602 dated 06 August 2018. The components of both the CTC and External Units is shown in Figure 8. The CTC performs the following functions:

• Coordinates and monitors the functional activities regarding the management of clinical trials within the IFO, acting as a qualified reference point;
• Guarantees greater control of the clinical trials to the Scientific Directions of Regina Elena and San Gallicano Institutes and IFOs Medical Office;
• Particular supports in the spontaneous non-profit research;
• Interacts with the Departments involved in experimental research activities, coordinating the activities of the experiments aimed at:
  1. Providing administrative, managerial, methodological and statistical services to researchers for the conception, design, planning, start-up phase, conduction, analysis and reporting of clinical studies so that these activities are carried out in compliance with the Good Clinical Practice (GCP) and the protocols;
  2. Supporting the management of authorization procedures as well as the conduction and financial reports of clinical studies;
  3. Promoting, in profit and non-profit research, the professional development of all participating researchers in terms of compliance with GCPs and regulatory aspects;
  4. Guaranteeing quality control of studies (experimental and observational studies) with profit and non-profit study promoters;
  5. Supporting monitoring of information regarding the feasibility of studies in terms of potentially enrolled patients;
  6. Increasing the synergistic collaboration between researchers involved in the studies;
  7. Evaluating the experiments proposed by researchers at IFO, for which IFO takes on the role of Promoter, and monitors the progress of the approved studies;
  8. Identifying areas of great strategic interest for the Institute and propose initiatives necessary for promoting clinical trial projects in these areas

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.