Sites in CEE A reliable place for clinical research? EM Phases Conference Prague Oct 2018 Dr. Darina Hrdličková

Development of Sites History of the clinical trial sites  - since the 1990s until now: - early single-investigator sites - sometimes without even knowledge of the institution Motivation for trials: - interest in the treatment offered - money - being a part of an international team - trips to meetings 2

Development of Sites Major changes: 1990s - 2018 - the role of institutions and private practices - the start of study co-ordinators, departments for clinical trials ...up to educated  sites with SOPs and clinical trials dedicated equipment and staff  …..and space for clinical trials conduct, monitoring and archiving Motivation: - Scientific and financial - Patients‘ benefit 3

Sites and remote monitoring Acceptance Usually negative in the beginning, sites were used to one point of contact and mostly lot of support Sites lack training and information Turning to positive: (at least sometimes) Some sites started to use the remote monitor as an „online advisor“ Some sites are happy with remote visits due to lack of space for monitoring In difficult situations they still look for support mostly from the CRAs that visit them 4

Sites and RBM Risk Based Monitoring - ICH GCP E6 (R2) comes via: Almost „real time“ data entry requirements More remote contacts More remote checks Communication with many partners AND within the site‘s team Requiring more equipment Requiring more sites‘ independence and skills The number of administrative tasks does not decrease Recording, scanning, faxing, mailing, PLUS The number of external vendors increases significantly Sites and RBM 5

Sites, Monitoring, and Vendors X ray central reader ECG central reader E-CRF provider Remote Monitor CRA Data Management (Queries) Patient Diary Tablet Subject reimbursement payments vendor Site payments vendor Central lab Patient questionnaires laptop Usernames Passwords Trainings Help/less lines Times No. Of studies ! Vendors are not the same!

Trends for the future Many countries still use the benefits of well organized healthcare systems Site teams are growing Site teams profesionalize Dedicated sites for clinical research Still many dedicated and motivated investigators Still many therapeutic areas with interested patients New approchaches to patient enrolment 7

Needs for the future More remote work x requirements for support from the sites Administrative burden does not seem to be decreasing Technical and computer knowledge requirements are increasing dramatically Training needed Equipment needed Resources needed PR needed 8

Thank you for your attention ! ? ? ? ? Thank you for your attention ! 9