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

2. 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

3. Development of Sites
Major changes: 1990s 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

4. 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

5. 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

6. 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!

7. 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

8. 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

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