EURORDIS training tools for patient representatives
As part of its efforts to continue training patient representatives to be recognised as fully-fledged stakeholders in medical research, EURORDIS has released a series of training tools that are freely available on its website www.eurordis.org/training-resourcesThe training tools aim at empowering rare disease patient representatives in the fields of:
- Clinical trials
- Drug development
- EU regulatory affairs
This unique training tool, tailored for European patient representatives, is presented by experts with extensive experience, and the material enables participants to put together a complete picture of drug development from clinical trial to market authorisation. “This preparation builds participants' capacities to act as experts in regulatory processes for their disease and to further their implication in drug development and advocacy actions,” states Dr. Maria Mavris from EURORDIS.
In the Clinical Research sub-section you can watch video presentations and learn more about clinical trials. Including the different aspects of clinical research such as: evidence‐based medicine, methodology, statistics and ethics, as well as drug development for small populations and the regulatory procedures available for drug licensing.In the European Medicines Agency sub-section you can watch video presentations providing an overview of the Agency and explaining the regulatory aspects of drug development and the work of the EMA. The different scientific committees of the EMA are described, with particular focus on the role of patient representatives in the Orphan Medicinal Products, Paediatric and Advanced Therapies committees.
The Health Technology Assessment sub-section provides a basic introduction to the subject. It was initially designed for patient advocates who had completed the preliminary face-to-face course (at the EURORDIS Summer School) who wanted to continue learning about the life of a medicinal product once it has received market authorisation. This sub-section explains the mechanisms involved in determining pricing and reimbursement of orphan drugs and therapies.
The Training tools are part of the EURORDIS Summer School for patient advocates on clinical trials and drug development – a capacity building programme, combining face-to-face seminars with web-based tools, for rare disease patient representatives involved at European level in the development, approval, information, and access to orphan drugs, paediatric drugs and advanced therapies. The videos and online tutorials enable Summer School participants to revise and refresh their knowledge, as well as providing a learning opportunity for all patient representatives to go deeper into a subject of their choice.
The Training section also provides more information about the experts who volunteer their time to deliver the presentations (Summer School Faculty or Trainers) and a contact list of patient advocates who have received training (Summer School Alumni) in order to facilitate networking.
A separate e-learning sub-section gathers tools developed by EURORDIS and INSERM for patient representatives who are interested in learning the basics of drug development and clinical trials. This can be used as continued training for Summer School participants or independent learning for member patient organisations. It is a good tool to test knowledge before and/or after attending the Summer School and complements the video presentations. It can also help you start your own training programme.
The e-Learning tool consists of three modules:
- Methodology
- Ethics
- Statistics
For each module there are several topics that are covered, such as: controlled trial, randomisation, criteria of inclusion and informed consent.
Five different learning approaches are available for each topic:
- Lesson: a theoretical approach
- Case: a practical approach
- Documents: a bibliographic approach
- Quiz: a challenging approach
- Words: a semantic approach
The Words approach includes a 400-word glossary of useful terms in the area of clinical trials and drug development. You can download a version of the glossary to use on your computer at http://summerschool.eurordis.org/.
All these activities are made possible thanks to the support of the European Commission and the Executive Agency for Health and Consumers, the AFM-Telethon, the DIA Philanthropy Programme, INSERM and the Foundacio Dr Robert.
For more information:
To access all Training tools, explore the E-learning and Summer School sections of EURORDIS Training Resources (in English)
This article was first published in the January 2012 issue of the EURORDIS newsletter
Author: Paloma Tejada
Photo credits: © EURORDIS
EURORDIS training tools for patient representatives www.eurordis.org
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