Integration of Health Records and Clinical Trials Data to Advance the Efficiency and Quality of Clinical Research

Transcription

1 Integration of Health Records and Clinical Trials Data to Advance the Efficiency and Quality of Clinical Research A. Amato, MD Director, Clinical Trial Center Fondazione Policlinico A. Gemelli Rome, Italy

2 Clinical research has been decreasing in Europe for almost a decade Clinical Research in Europe Clinical Trials in Italy and Europe Italy Europe Source: AIFA, 2016 The Clinical Trial Regulation (536/2014) is a great opportunity to reverse the trend Pivotal role of technology to skyrocket clinical research in Europe 2

3 Background A. Gemelli Hospital Founded in 1961 in Rome, Italy Part of the Catholic University of the Sacred Heart (UCSC), Milan, Italy (founded in 1921) Donated to Policlinico A. Gemelli Foundation on 1 August 2015 University Hospital since 1964: - Largest tertiary hospital in central Italy (1540 beds) - Highest no. of oncological admissions in Italy (>17,000/yr.) - Staff of 850 MD s and 2400 RN s - Turnover of 630M + in profit trials in non-profit trials in

4 Objectives of the Clinical Trial Center The objectives of the Clinical Trial Center are: To optimize the management of clinical studies at the experimental sites within the Gemelli Hospital (SMO) To provide specific training for the execution of clinical trials in Good Clinical Practice (GCP) To act as an academic CRO, also to foster the development of Investigator-Initiated Trials (collaborative networks) The functions of the Clinical Trial Center are then divided into: SMO Unit: governance unit of clinical trials GCP Training: to improve quality in trial execution CRO Unit: business unit of clinical trial services 4

5 Structure of the Clinical Trial Center Sponsors CROs Chief Medical Officer CTC Director Advisory Board Sponsors (Pharma, Institutions) Assistant GXP Quality Assurance Investigators Co-Investigators Administrative Unit (SMO) Clinical Unit (CRO) Administration Finance, Legal Project Management Customer Relationship Clinical Operations Regulatory & Medical Writing Safety Statistics & Data Management 1 Febbraio 2015

6 Clinical Trial UCSC SMO Unit GCP Training CRO Unit IRB Secretariat 6

7 Clinical Trial Policlinico Gemelli SMO Unit ( ) Profit and Non-Profit Studies Non-Profit Studies Profit Studies *2013: Creation of CTC Gemelli 7

8 Clinical Trial Management System CONTRACT BUDGET CRM & FEASIBI- LITY ETHICS COMMITTEE STUDY MONITORING AND INVOICING PHARMACY 8 WEBSITE

9 Clinical Trial Management System CONTRACT CRM & FEASIBI- LITY New Study BUDGET ETHICS COMMITTEE STUDY MONITORING AND INVOICING PHARMACY Sponsors/CROs Access Clinical Trial Grants IRB Pharmacy Senior Finance Investigators Privileges Center Office Management 9 WEBSITE

10 Clinical Trial Management System CONTRACT BUDGET CRM & FEASIBI- LITY 10

11 Clinical Trial Management System ETHICS COMMITTEE STUDY MONITORING AND INVOICING PHARMACY 11

12 Clinical Trial Management System 12 WEBSITE

13 CTMS and Electronic Health Records Overall flow of system integration: CTMS EHR (SI-DHE) 13

14 CTMS and Electronic Health Records Workflow of the Integration between CTMS and EHRs NEW STUDY Study Approval Patient Enrollment Request of Test(s) Delivery of Test(s) Record of Test(s) Patient Completed Invoice Changes in Test(s) 14

15 CTMS and Electronic Health Records Patient enrollment and assignment to the right treatment arm 15

16 CTMS and Electronic Health Records Selection and confirmation of clinical test(s) via a dedicated patient scheduling calendar, compliant with study flow-chart 16

17 17 CTMS and Electronic Health Records Performance of clinical test(s) via dedicated slots, separate from NHS Automatic recording of performed clinical test(s) into CTMS Tracking of patient towards his/her study completion (invoice)

18 CTMS and Electronic Health Records Integration with other in-house systems: Data warehouse of previous patients (feasibility assessments) ERP (invoicing and reporting) Project and portfolio management (planning and control of clinical studies, FTE analysis) Integration with external systems (f.i., Insite Platform) 18

19 Conclusions An academic CTC, with few distinctive advantages: - Focus of the SMO Unit towards effective start-up and timely completion of Profit studies - Customizable GCP training to improve quality of trial execution by research personnel - CRO Unit to offer services to Sponsors of clinical trials (especially Investigator-Initiated Trials) Focus on technology to help improve quality and efficiency of clinical research processes Strong interest in drug development partnerships with Industry and similar Institutions across Europe 19

20 THANK YOU FOR YOUR ATTENTION! Acknowledgements: L. Angerame (SMO Unit - CTC) M. Zona (SMO Unit CTC) R. Ceccarelli (ICT Dept) A. Ammendolia (ICT Dept)

21 Background A. Amato, MD Degree in Medicine (Catholic University, 1983), Post-graduate Training in General Surgery (Tor Vergata University, 1988) Sigma-Tau Pharmaceuticals ( ): Rome (ITA, ): Clinical Trial Manager Bethesda MD (USA, ): Medical Director, General Manager, Chief Operating Officer Rome (ITA, ): Corporate Director of Regulatory and Safety, Corporate Director of Product Development Registered Products: o Carnitor in hemodialysis (FDA); Matulane in Hodgkin s/gbm (FDA); o Eurartesim in uncomplicated malaria (EMA); Defitelio in severe VOD (EMA, FDA); Lutrate in prostate cancer (DP, Europe); Oncaspar in acute lymphoblastic leukemia (EMA) clinical trials (50+ Indications); 40+ INDs and CTAs; 50+ Meetings (FDA, EMA, CFDA); 20+ ODAs (FDA, EMA). 21

22 Unmet Needs Early exposure of patients to innovative treatments trough clinical trials trials is increasing and sought after especially in: Oncology, rare diseases Specific training in clinical research performed in GCP is currently limited in the Italian Schools of Medicine, resulting in weakness for: Academicians Hospital doctors and nurses General practitioners Industry physicians/clinicians Clinical research funds from public institutions are scarse and difficult to obtain Clinical research funds from pharma companies are sizeable, and go mainly (~60%) to Contract Research Organizations (CROs) 22

23 Clinical Trial Policlinico Gemelli GCP Training ( ) e 10 Maggio e 5 Luglio e 15 Novembre Maggio Novembre Maggio Settembre Novembre 2016 *2013: Creation of CTC Gemelli 23

24 Clinical Trial Policlinico Gemelli CRO Unit ( ) Total No. of Opportunities (= Studies) 133 Open/Closed Opportunities Open Closed Status Concept CDA Sinopsis Budget Bid Submitted Contract Letter of Intent Competitive Analysis Ongoing Rejected *2013: Creation of CTC Gemelli 24

25 Clinical Trial Management System CONTRACT BUDGET CRM & FEASIBI- New Study LITY Ethics Committee Pharmacy ETHICS COMMITTEE Contracts Budget Monitoring - Invoicing STUDY MONITORING AND INVOICING PHARMACY CLINICAL RESEARCH WEBSITE Clinical Research Dashboards Sponsors/CROs Access Clinical Trial Grants IRB Pharmacy Senior Investigators Privileges Center Office Management 25 WEBSITE