Centre Of Excellence – Remote Decentralised Clinical Trials - IMI2-2018-14-04

Deadline: Dec 11, 2018  
CALL EXPIRED

Specific Challenge:

For full details of the topic, please refer to the call text

Developing new medicines/health solutions and improving patient health rely on the successful conduct of clinical trials to generate relevant safety and efficacy data. Recruitment and retention of patients are some of the most challenging aspects in clinical trial protocol adherence. The 2017-global CISCRP survey reported the main barriers to patients’ participation as “lack of patients’ awareness of clinical trials” (~61%); and the “geography and the distance to the clinical site” (60%) . This geographical burden on patients, including the duration and number of clinical visits, also drives their decision to participate in a trial. In addition, within patients who consent, an alarming 30% dropout across all clinical trials is observed. Therefore, by the same token, improving the patients’ experience through protocol optimisation to ease the patient burden, whether perceived or real, should improve data quality and increase the probability of success.

Scope:

For full details of the topic, please refer to the call text

The action will focus on disaggregating the current model of running clinical trials, defining building blocks and mapping new technologies (e.g. telemedicine, mobile health…) to support the new DCT model. The objectives are: to demonstrate the feasibility of running remote DCTs in Europe. This will increase access of patients to clinical research, enriching clinical trial data from more diverse and representative patient population and improve patient experience during the trials, with a higher speed of recruitment and better retention.

Expected Impact:

For full details of the topic, please refer to the call text

• Increase flexibility of patient follow-up during clinical trials, reducing the burden both on patients and hospitals
• Increase the frequency and quality of data collection
• Improve patient recruitment and retention in trials.
• Accelerate clinical research and the access by the patients to more breakthrough innovative therapies.
• Support directly the update of the ICH guidelines all along the process by generating evidence.
• Reorganise the patient journey and the clinical environment
• Redefine the clinical trial framework in compliance with the EU regulations.