11th November 2020

Newsletter November 2020

The pandemic has changed and, in many ways, distorted our lives. Every system has collapsed and, as it can be easily assumed, particularly the healthcare system is suffering from ineffectiveness, staff shortages and financial problems.
Donato Bonifazi, Chief Executive Officer of CVBF and President of AICRO, the Italian CRO Association, has given his mind about how the world of clinical trials has changed due to COVID-19 emergency.
We asked him to provide us some explanations and examples of how clinical trials, research and patients’ lives had to change course: “This pandemic has been unexpected and very destructive. In order to face and save patients affected from COVID-19, many hospitals have been compelled to stop studies about specific medical fields, burding also on therapeutical areas such as rare diseases and paediatrics, and this has stopped also the enrolment of new patients in clinical trials. Actually, we don’t know the ultimate effect of this pandemic, but if it goes on, we will lose the possibility to find new treatments and make patients’ life expectancies better.
The European Agency Medicine (EMA) has been really active in keeping in touch with developers who were studying treatments and vaccines for COVID-19, as they continue doing in these days; the Agency has provided a guideline with a set of criteria that developers should follow to submit their researches in order to render the situation clearer and facilitate clinical trial conduct.”
New frameworks and technologies are needed to accelerate the clinical research by avoiding unnecessary accesses of patients to centers. It’s time to bring innovation, decentralize trials, monitor remotely.

Donato Bonifazi
Chief Executive Officer CVBF

NEWS

Manifesto for EU COVID-19 Research

The European Commission has launched a manifesto to maximise the accessibility of research results in the fight against COVID-19. CVBF endorsed the manifesto and committed to make the generated results public and accessible without delay as well as to make scientific papers and research data available in open access without delay and following the FAIR principles via preprint servers or public repositories, with rights for others to build upon the publications and data and with access to the tools needed for their validation.

Last month, the European Brain Council (EBC) was able to provide feedback and input to the European Commission on the draft of the “First Horizon Europe Work Programme 2021-2022 of the Health Cluster”. The Consultation answer was discussed also in the framework of Share4Brain Translational Meeting that took place online on 28th and 29th September and provided the occasion to meet virtually not only all the partners of the project, including CVBF, but also the representatives of different Patient Associations of neurological and psychiatric disorders.

28 October 2020: First EPTRI-IT Meeting

On Wednesday 28 October, the first EPTRI-IT settlement meeting took place. Consolidation, strengthening and expansion are the goals that EPTRI-IT wants to achieve. EPTRI-IT will be constituted by a Joint Research Unit which entrusts the institutional leadership to the CNR (President of the General Assembly), the scientific leadership to INCiPiT (President of the Scientific Committee) and the coordination to CVBF thanks to the work of 3 resources: a Coordinator, a Joint Research Unit Manager and a Liaison Officer.

The EU has awarded €9.5m to AMELIE, a ground-breaking research project into the treatment of faecal incontinence. CVBF is involved in the AMELIE project as the beneficiary in charge of CRO-like activities, providing support to the Sponsor and the sites in the conduct of the study. The aim of this project is to develop a cell therapy to find a possible way to cure a disease that is suffered from almost 67 million people in Europe.

New video launched to get children, young people and families involved in c4c

The Patient and Public Involvement Cross – Cutting Team in the c4c project has released a video to inform the public about c4c programmes and work and also to keep families and children always in touch with c4c activities.

EPTRI at the EUROPE BIOBANK WEEK 2020

Europe Biobank Week 2020, the largest biobanking conference in Europe, will take place between 17-20 November in a virtual format for the first time. The conference is a joint effort of ESBB and BBMRI-ERIC. EPTRI has submitted two abstracts in the event that have been chosen as oral presentations.

EUPATI Fundamentals: a training about Patient Engagement addressed to professionals in academia and pharmaceutical industry

On 25-26 November 2020, a new EUPATI Fundamentals will start. This will be a training about “Patient Engagement addressed to professionals in academia and pharmaceutical industry” divided in 4 modules: principles of patient engagement; patient engagement roadmap; setting up a patient engagement activity; quality criteria in patient engagement.

Duchenne Patient Academy – Online Training
for Patient Advocates

The Duchenne Data Foundation has organised the fourth edition of the “Duchenne Patient Academy” that, due to the pandemic, this year will be held online. The training is open to DMD (Duchenne Muscular Dystrophy) / BMD (Becker Muscular Dystrophy) patient advocates with selected days and to all NMD (Neuromuscular Dystrophy) patient advocates.

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About the Author: Flogert Dollani

By Flogert DollaniPublished On: November 11th, 2020Categories: Newsletter0 Comments