Summary report: 1Η ΨΗΦΙΑΚΗ ΣΥΝΑΝΤΗΣΗ ΤΟΥ CLINICAL RESEARCH AND CLINICAL TRIALS INNOVATION FORUM

Thank you all for attending EL.E.F.I.’s Clinical Research and Clinical Trials Innovation Forum, the virtual meeting point, where innovative ideas on clinical research can be discussed openly. We had the opportunity to discuss trials in/after the COVID era, starting with Remote Clinical Trials.

The insightful introduction by ELEFI President, Varvara (Barbara) Baroutsou set the scene for the following discussion and informed us of current trends and innovations. Following the introduction, Anna Aletra, MSD/Country Lead Greece/Global Clinical Trials Operations, went into the definition of the term of Remote-Decentralized trials and the broadness of the terms with which these trials are referenced.  The concepts & distinct characteristics of Traditional-Hybrid-Decentralized Trials were highlighted. A brief overview of the Possible benefits & Challenges/Considerations of DCTs followed and the outline of existing Initiatives, Collaborations & Projects ongoing in support of either Hybrid or Completely Remote Clinical Trial set ups.

The IMI (Innovative Medicines Initiative) & the currently ongoing Project Trials@Home were highlighted as indicative examples amongst others. Finally, emphasis was placed on the number of stakeholders & Involved parties required to harmonise, find consensus and align in order for Decentralised Trials to become a standard working practise & reality starting from the Patients-Investigators-Sponsors/CROs-Authorities-External Service Providers to name but a few.

Then, Aggelina Mavraki, Sanofi CSU Head in Greece, shared the evolution of clinical trials throughout the years and the gradual introduction of e-solutions and innovative approaches in the operational scheme of the studies.  The COVID-19 pandemic accelerated the rhythm of new solutions’ implementation and lead us a step closer to the RDCT mindset.  Considering that the future is already here, we should work locally, with passion and commitment, to shape the environment that will include innovation in CTs but without compromising patient safety, data integrity, data protection and all ethical standards.

The fruitful conversation that followed the presentations identified areas for future discussions:

• GDPR
• Electronic Medical Records
• Telemedicine
• eConsent
• ePROS
• @ Home nursing and IP administration
• Clinical Trials available in Greece (site info)
• Regulatory concerns
• Remote SDV
• eRecruitment
• Safety reporting
• Ιmpact of remote clinical trials on the decision making for healthcare resource allocations

COVID-19 forced us to re-examine the way we work to ensure and achieve trial continuity.

We had a chance to experience some benefits of the DCT model. The Learning of 2020 demonstrated that collaboration and team approach are the optimal pathways forward for both building resilience and continuing to develop.

The discussion was initiated last Thursday and we all hope to shape the future of CTs having patients in the centre of our actions and choices!

The meeting was closed out with a wish for this 1st session of the Clinical Trials and Clinical Trial Innovation Forum to be a great start towards this direction.

Please send us your suggestions. We would like to hear your interests on future topics.

Next meeting to discuss one or more of the abovementioned topics on March 10^th 2021 at 17:00!

We hope to see everyone there!