In 2006 the first capacity building sessions on Clinical Trials were held in France, Italy, Spain and Denmark eventually being offered at the EURORDIS Summer School in Barcelona.
In 2008, the EURORDIS Summer School expanded on these topics and more.
These sessions enabled us to collect comments, experiences and expectations in order to progressively optimise the e-learning tools and their content
These sessions enabled us to collect comments, experiences and expectations in order to progressively optimise the e-learning tools and their content
Facilitating autonomy and flexibility
The aim of this e-learning course is to provide an accessible tool that can fulfill immediate training requirements for all patient organisation representatives. Concretely this could be a situation where, in the course of planning a clinical study, representatives are asked to add their insight to the project.
Shifting from a traditional course to an e-learning tool may be frustrating because the face to face interaction is missing. To counteract this, we have tried to make the modules as flexible as possible allowing learners to organise their program according to their needs and the topics being studied.
Content adapted to learning styles
Each of the four modules (Methodology, Ethics, Research and Statistics) includes six topics divided into five sections corresponding to different learning approaches.
- A theoretical approach in the “Lesson” section (a concise 4-5 slide course)
- A practical approach in the “Case” section (authentic case study analysis)
- A semantic approach in the “Words” section proposing, in a hierarchical manner, terms relevant to each topic (the 400-word Glossary may also help you)
- A bibliographic approach with the “Documents” section providing 3-4 documents from different perspectives (regulatory, historical, controversial,...) in order to familiarise with studied concepts
- A challenging approach through 2 “problematic” quizzes
Whatever your initial choice is, you can also navigate through the sections to gain greater clarification on a subject. For example during the analysis phase of a case study, you can consult the “Lesson” section to consolidate material. Likewise examples of concepts acquired in the “Lesson” section can be consulted in the “Case” or “Documents” section.
In addition each module contains a self-evaluation questionnaire that can be used before starting the training to evaluate your knowledge, strengths and weakness, or later to measure your progresses.
All trainers successively involved in these past programmes have been contributors of this e-learning.
Dr Fabrizia Bignami, EURORDIS Therapeutic Development Director, EURORDIS representative in the EMA-Committee for Advanced Therapies
Mr Rob Camp, Board of Directors member of AIDS Treatment Activists Coalition, Current Co-Chair of the Drug Development Committee
Ms Agathe Desombre, Graphic Designer
Ms Dominique Donnet Kamel, responsible for the Patients’ Associations Mission of the French National Institute for Medical Research (INSERM)
Pr Bernard-Marie Dupont, Geneticist, Philosopher, President of the Institut Européen d’Ethique de la Santé (IESS)
Dr François Faurisson, Pharmacologist, EURORDIS Clinical Research Advisor
Dr Juan Garcia Burgos, Responsible for interactions with Patients, Consumers and HealthCare representatives, Professionals' Organisations in the Medical Information Sector of EMA , Product team leader and scientific secretary of the Efficacy Working Party within the Safety and Efficacy Sector of EMA
Mrs Lesley Greene, former President of EURORDIS, EURODIS representative at the EMA-Committee for Orphan Medicinal Products (COMP)
Mr François Houÿez, EURORDIS Health Policy Director, EURORDIS representative in the EMA-Patients’ and Consumers’ Working Party (PCWP)
ds Eric Koster MA, Member of the hospitals Ethics Committee, Member of the Institutional Review Board of MST as an ethicist
Dr Sílvia Mateu, Fundacio Puigvert, Barcelona
Dr Maria Mavris, EURORDIS Drug Development Programme Manager, Permanent observer at the COMP
Dr Màrius Morlans i Molina, Nephrologist at the University Hospital Vall d’Hebron. President of the Commission of Deontology of COMB, member of the Ethics Committee of Catalonia
Pr Fernando Andres Rodriguez-Trelles, Member of the EMA Paediatric Committee (PDCO), Member of the EMA Scientific Advice Working Group (SAWG), Member of the Human Scientific Committees working party with PCWP, Professor of Pharmacology at Madrid’s University
Dr Patrick Salmon, Senior Medical Officer, Irish Medicines Board, Alternate member of the Committee for Medicinal Products for Human Use (CHMP), Member of the COMP
Dr Markku Toivonen, Scientific Director, NDA, an international consulting firm specialised in drug regulatory affairs, Former Chairman of SAWG and former member of the CHMP
Pr Josep Torrent Farnell, Professor of Pharmacology, Therapeutics and Toxicology at the Autonomous University of Barcelona (UAB), Former chairman of the COMP, General Director Dr Robert Foundation, an organisation of the UAB specialised in medical continuing education
Dr Ferran Torres, Permanent member of the EMA-SAWP, Head of the Unit of Support on Statistics and Methodology. Hospital Clinic Barcelona, Associate Professor, Biostatistics Unit, School of Medicine, UAB.