MRN are excited to announce that we are one of the consortium members participating in the recently launched Innovative Medicines Initiative, ‘Trials@Home’. This project has been created to explore decentralized clinical trials and bringing clinical trials to the patient in their communities using a mix of digital innovations and remote visits to enable any patient to take place in trials, regardless of location.
MRN is honored to be a part of this forward-thinking consortium and bring our wealth of knowledge, experience and expertise that we have gained from delivering remote and hybrid clinical trials for over 13 years. The consortium is a multi-disciplinary group that has representation from Sponsors, academic institutions and SMEs. Our involvement was initiated by our CEO, Graham Wylie and has been spearheaded by our Vice President of Corporate Services, Paul Bodfish. We look forward to being part of and contributing to what is an exciting and ground-breaking project.
You can read the full press releases by the IMI below.
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Innovative Medicines Initiative Launches ‘Trials@Home’
A major European project to bring clinical trials to the participant’s home.
Utrecht, October 7, 2019 – The Trials@Home consortium will explore the opportunities of moving clinical trials from the traditional clinic setting to the participant’s immediate surroundings. These so-called Remote Decentralised Clinical Trials (RDCTs) make use of new – digital – innovations and enable participants to visit a clinical trial centre less frequently, if at all. This makes it easier for larger, more diverse and remote populations to participate in clinical trials. These trials are expected to be conducted faster, more efficiently, and provide results that are more representative because the data is collected in the daily context of the participant (Real World Evidence). The research is to be conducted includes an inventory and evaluation of existing and new techniques for us in RDCTs as well as a pan-European pilot trial.
European grant for five years’ research
An international consortium of 31 members has received Innovative Medicines Initiative Funding, to map developments in the field of RDCTs, and to test different varies to arrive at concrete and practical recommendations to promote the widespread acceptance and implementation of RDCTs across Europe. The University Medical Center Utrecht and Sanofi are coordinating this forty million euros research project which will run for a total of five years. Currently, clinical trials are regarded as the best way to evaluate the effectiveness of interventions. Traditionally, a participant taking part in a clinical trial has to go to a clinical trial centre regularly for face-to-face evaluation. By harnessing new technologies and transferring the trial activities to the participant’s home or immediate surroundings, a trial can be less burdensome for them and produce results that can be better translated into daily practice.
The consortium will develop and test remote decentralised methods to streamline data collection, participant recruitment and retention. At the same time, it will ensure the participation of a greater number of volunteers that are more representative of the population at large. By augmenting face-to-face interaction with remote procedures, larger geographic regions will be accessible to foster the participation of unrepresented relevant populations.
A Multi-disciplinary Perspective
Trials@Home is a multi-stakeholder approach where academic partners, small and medium-sized enterprises (SMEs), private foundations, and EEPIA partners will closely collaborate with practitioners, patient organisations, IT professionals, and regulators to develop concrete methods, tools, and approaches that facilitate the broad acceptance of RDCTs in Europe. The consortium will also engage with stakeholders outside of the Trials@Home consortium to incorporate the views of patients/potential trial participants, researchers, healthcare providers, regulators, payers, Health Technology Assessors, and ethics bodies to ensure that the project’s outcomes are both actionable and achievable.
The research includes an inventory and evaluation of studies already conducted with remote elements, research into available technologies and research into the legislation and ethical requirements in different countries in the field of enabling technologies. The project will implement a study in which one group of participants will receive an intervention using the classical site-centred trial methodology, another group will participate remotely and a third group uses a partly traditional, partly remote hybrid model. The project team hopes to determine how the approaches compare in the trial and will show which approach produces the best results in terms of participant satisfaction, inclusion rate, costs, data quality and more.
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 831458. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.