WP09 Technology, support and monitoring


 

Work Package Lead: Dr Luis Silva

09. EVIDEM CONSULTORES SL – EVIDEM (ES)

 

Objectives:
Provide monitoring of the Randomised Clinical Trial (RCT) to ensure adherence to Good Clinical Practice (GCP).
Develop technical support and tools (Central reading, Drug Logistics, Web based ICT)
Use of new technologies as Sudoscan (IMPETO), Lifestyle monitoring (THl) and drug compliance
(AARDEX), Telemedicine (eDiagnostics)
Organisation of training events, materials and support tutorials
Coordination and change control of the Operations Manual

 

Main tasks:
1. Monitoring of the RCT to ensure GCPs:

  • The long duration of the RCT and its multinational / multicentric nature requires adequate monitoring to ensure consistency and adherence to the clinical trial protocol.
  • In addition of a web based information collection / sharing system (see next point for further information), a physical – on site monitoring of the centres becomes essential.
  • We plan 1 or 2 visits per recruiting center during the trial and ad-hoc supplementary visits if potential non compliance or other issues are identified.

2. Technical support (Global Logistics and Web based ICT):

  • The trial will use new technologies to facilitate the execution across different countries. A cornerstone will be the development of a web based solution. This solution will include integrated reporting, data management, transfer of images (such as rethinographies) real time reporting and validation, study metrics report etc. Physical hosting of the system will be provided as well.
  • This includes quality assurance and on-line (hot-line, office hours) support to clinical centres (for central reading of eye photos, data entry incidences, etc)
  • Drug and study materials will be stored and distributed through a validated logistic provider yet to be determined (i.e. Movianto) to ensure GDP compliance
  • A central reading center will be set up for the reading of rethinographies to ensure consistency and quality of this critical item (Primary endpoint).

3. Use of new technologies as Sudoscan, Lifestyle monitoring, telemedicine and drug compliance:

  • Microvascular complications in early diagnosed type 2 patients are of low prevalence and the aim of this research is to prove the importance of early intensive treatment in the prevention of such complications. Diabetic Autonomous Neuropathy (DAN) will be assessed via Sudoscan (Impeto Medical). This technology is supposed to provide with an early detection of DAN by measuring changes in the ionic content of sweat. The trial will not only measure the changes at the end of the study period but also its predictive value Lifestyle intervention has been proved as preventive of type 2 diabetes and our aim is to prove that intensive drug treatment will further increase the prevention of complications. It is thus pivotal to ensure that lifestyle changes are properly implemented to asses beyond any doubt the usefulness of drug intervention. We will provide intensive education/motivation (WP3) and a web based follow up tool to monitor adherence to the lifestyle intervention
In a long term, open-label trial, ensuring adherence to the treatment is critical. We plan to use innovative technology (AARDEX) to monitor (in a sample of the sample) the adherence to drug administration.

4. Organisation of Training events , materials and support tutorials:

  • To organise the training program and events coordinating the contributions from all other WPs. Certify the training of investigators and technicians
Establish Quality Control Program for periodical assessment of key indicators and re-training and re- certification if necessary.
  • Include support tutorials in the data management system.

5. Operations Manual:

  • All SME partners will contribute to the Operations’ Manual with the relevant procedures to clinical investigators.
The WP is in charge of developing and maintenance (change control) of the operations manual.

 

Scroll to Top