EFCCA Academy 2020 - Training Certified Patient Experts
We are pleased to announce that our new edition of the EFCCA Academy offering specialized training for IBD patients started on November 18th 2020 via the EFCCA online learning platform. This training will focus on Clinical Trials and is composed of 3 modules:
First Module: “Clinical Trials basics” - 18 November 2020 via the EFCCA online learning platform
Professors Séverine Vermeire and Marc Ferrante from Department of Gastroenterology and Hepatology University Hospitals Leuven / KU Leuven in Belgium introduced the subject. Some of the themes covered were: the different phases in the development of medicines, the revolution in IBD treatment over the years, the efficacy of clinical trials and the safety also in real-world after drug approval. Upon completion of all training modules the Certified Patients will share their knowledge among IBD communities in their countries, teach member association representatives on the subject and also to play an active role with regards to cooperation with pharmaceutical companies at national level.
This first class was attended by 15 IBD patients from 12 countries: Belgium, Bulgaria, Estonia, France, Greece, Israel, Italy, Mexico, Poland, Portugal, Singapore and Spain.
Second Module: “Diving deeper into Clinical Trials” - 17 December 2020 via the EFCCA online learning platform
This module was presented by the following people:
Ana Sofia Correia, a clinical translator specialized in the linguistic validation of Patient-Reported Outcomes, will explain what are Patient-Reported Outcomes and Real-World Evidence, why PROs and RWE are so important and how PROs and RWE are collected.
Rob Camp, Senior Manager for Patient Engagement focused on CABs at EURORDIS will talk about Patient Engagement in clinical trials, Community Advisory Boards, Patient education as part of the Community Advisory Board process or as stand-alone (i.e., Train-the-Trainer).
Annick de Bruin, Senior Director of Research Services at the Center for Information and Study on Clinical Research Participation (CISCRP) will explain why a clinical trial is not the same as standard of care, the difference between the sponsor and the research team, what are eligibility criteria and how to be prepared before participation in a clinical trial.
Third Module: “Breaking the myths around clinical trials” - 25 January 2021 via the EFCCA online learning platform
Third Module
This module was presented by Prof. Ariel Liebert and speakers from Roche. Prof. Ariel Liebert from the Department of Gastroenterology and Nutrition Disorders, Nicolaus Copernicus University in Toruń (Poland), taught about Clinical trials guidelines, benefits and risks related to participation, the study drug, medical care in progress, participant’s insurance, what to ask before making a decision. He finished his presentation by talking about the most common myths around clinical studies.
A group of speakers from Roche covering a broad range of functions within the organisation and sharing their experience as part of the different role, such as Stefanie Derzsi – Patient Partnership Department, KT Park - Research and Development Department, Amanda Tatro - Medical Department, Jo Phipps - Regulatory Department and Laura Pope - Access Department, shed light in an interactive discussion on how industry is interacting with different stakeholders as part of the drug development process.
The end-of-course work assignments from the EFCCA Clinical Trials Academy from the class of 2020/2021 are now available on our website!
Check out the insightful projects completed by our talented students:
Frequently Asked Questions (FAQ) for Clinical Trials by Bastien Corsat (afa Crohn RCH France)
Bastien Corsat, volunteer and board member of afa Crohn RCH France, together with the board of the French association identified what would be the most useful tool for the IBD community to be acknowledged on clinical trials. And so, the idea of creating a Frequently Asked Questions (FAQ) document containing information about the following questions:
• Who can participate in a clinical study?
• How to find a clinical study?
• Which are the benefits and potential risks in doing a clinical trial?
• What questions to ask before making a decision?
• 6 myths about clinical trial
The document also contains useful links for the French IBD community.
Comic about Clinical Trials by Delphine Khuu (ASBL Crohn RCUH Belgium)
On the occasion of the September issue of the magazine “Crohnique of ASBL Crohn RCUH” Delphine Khuu, a volunteer of the Belgian association, has prepared a comic in which she has described in a very nice and funny way some of the main aspects concerning clinical trials from the patients’ point of view, like the first interview with the gastroenterologist, all the phases necessary for the implementation of a new therapeutic treatment, the advantages and disadvantages of participation, the doubts a patient may have and where to look for information. The comic concluded with a reflection on the importance of scientific research, as well as the importance of the patient’s active role and right to be informed.
Becaming a CT-Ambassador: Janek Kapper (EIBDA, Estonia)
As a result of the training received during the EFCCA Academy Janek Kapper, CEO of the Estonian IBD association, became “Clinical Trial Ambassador” with the aim of raising awareness of clinical trials among IBD patients in Estonia. Janek explains the reasons behind this: “I became Clinical Trial Ambassador because Estonian patients need more information about ongoing clinical trials, find out what is involved in clinical trials and learn about the criteria to get involved in clinical trials from trusted sources.” Janek helps Estonian patients with IBD in their research for reliable information, offering support at every stage of their research and identifying possible specialists and research centres to contact in order to be involved in clinical trials. More info here: clinicaltrialambassadors.com
Clinical trials - What every patient should know by Magdalena Sajak-Szczerba (J-elita, Poland)
We were pleased that our EFCCA Board member Magdalena Sajak-Szczerba participated in the EFCCA Academy on Clinical Trials and as results and with the support of MD/PhD Ariel Liebert, as well as one of the speaker of one of the training modules of the training, she prepared an informative article titled: “Clinical trials - What every patient should know” for the release of the quarterly magazine “J-elita” of the Polish association. The article describes very well all the reasons why a clinical trial is conducted, the different ones available, benefits and risk of participating in them, the process of developing a new drug and the introduction in the market. Special attention has been given to the vocabulary, the patients’ rights and the Polish pharmaceutical law which regulates the clinical studies in Poland
9th Annual Crohn’s & Colitis Patient Education Seminar by Nidhi Swarup (Crohn's and Colitis Society, Singapore)
On the occasion of the ninth annual Crohn’s & Colitis Patient Education Seminar which took place last 18 May, Nidhi Swarup, President of Crohn’s & Colitis Society of Singapore, had the opportunity to raise awareness around the theme of Clinical trials which, according to her, are limited in numbers in this part of the world, specially in IBD. She shared some information regarding the training she has received from EFCCA and encouraged attendees to be open to learn about such an important subject. The conversation was joined by three other IBD specialists from leading hospitals in Singapore who have been supporting patients diagnosed with Crohn’s Disease or Ulcerative Colitis for many years.
A Booklet on Clinical Trials for the Italian IBD Community by Raffaele Campanella (AMICI, Italy)
Raffaele Campanella, volunteer and President of the Regional AMICI Italia Onlus branch of Friuli-Venezia Giulia worked on a very detailed booklet for the Italian IBD community which will be published soon on the Amici Onlus website. The aim of the booklet is to explain in basic words the complex functions of clinical trials. He explained: “I hope that using text, schemes and drawings can be a useful way to help patients better understand the complex processes involved in Clinical Trials by stakeholders with several and sometimes non-coinciding interests. I would also like to give a good idea on how serious clinical trial organisation is involving scrupulous compliance with the procedures to help patients fight their disease. This is a small contribution to help people understand that this is the way that will allow science to turn IBD chronic diseases into curable ones.” Last November 2021 Raffaele also organized a webinar held by Dr. M. Marino, Principal Investigator of Clinical trials for IBD in Udine Hospital (Friuli-Venezia Giulia) for patients from Friuli-Venezia Giulia region.
Webinar Recap: Clinical Trials and Patient Participation in Greece by Vasiliki-Rafaela Vakouftsi and Anastasia Ntanou (HELLESCC, Greece)
On 17 April HELLESC organised a webinar sharing the knowledge acquired during the EFCCA Academy. Vasiliki - Rafaela Vakouftsi, General Secretary of HELLESCC and Anastasia Ntanou, Board Member of HELLESCC gave an overview on the subject of clinical trials and explained how important the active role of patients in this practice is. Their talk was joined by Ioannis Koutroumpakis, Professor of Gastroenterology, Head of Department of Gastroenterology University Hospital of Heraklion and Mrs. Kalliopi Fotinogiannopoulou, Gastroenterologist Department of Gastroenterology University Hospital of Heraklion. The sections of the webinar were: 1) Clinical trials: the active role of patients 2) Clinical trials for IBD in Greece The presentations have been followed by an open discussion with all participants.
Invitation to Webinar on Clinical Trials and Knowledge Gaps by Beatriz Capdevielle (Vivir con Crohn y CUCI A.C. Mexico)
On 26 June 2021 EFCCA Board member, Roberto Saldaña, presented a webinar on clinical trials for the Mexican association. In his presentation Roberto covered areas such as: health systems and standard of care, innovation cycle, introduction to clinical trials, ethics in clinical trials and informed consent and usual doubts that patient associations recommend to clarify before accepting participation. About 28 people participated, and from the question and answer question it became evident that there was an important lack of patients' knowledge. EFCCA is looking into expanding the training to ensure that patients have the best knowledge.
For more information about the origins of the EFCCA Academy go to: https://www.efcca.org/projects/efcca-academy
This training programme has been supported by an unrestricted grant from the following sponsors:
Background
The EFCCA Academy was created in 2018 following the results of several major surveys that highlighted the main unmet needs of the IBD community. Our pilot project was aimed at providing specialized training addressing some of these unmet needs and appointing Certified Patients to raise awareness on IBD. More info about the EFCCA Academy: https://www.efcca.org/projects/efcca-academy
For more information please send an email to:: mariastella.derocchis@efcca.org (and sanna.lonnfors@efcca.org in copy).