Virtual Library
Start Your Search
N. Bere
Author of
-
+
PA03 - Patient Support and Involvement in Research (ID 359)
- Event: WCLC 2016
- Type: Patient & Advocacy Session
- Track: Patient Support and Advocacy Groups
- Presentations: 1
- Moderators:J.C. King, P. Muszumanski
- Coordinates: 12/06/2016, 11:00 - 12:30, Schubert 6
-
+
PA03.04 - Patient Involvement in the Evaluation of Cancer Medicines: The EMA Experience (ID 6758)
11:45 - 12:00 | Author(s): N. Bere
- Abstract
- Presentation
Abstract:
Patient involvement in the evaluation of cancer medicines; the EMA experience The European Medicines Agency (EMA) is the authority which evaluates and monitors medicines across all EU Member States. Pharmaceutical companies wishing to market a new cancer medicine in Europe are obliged to apply for a licence through the EMA. With a remit to ensure that European citizens are provided with safe and effective medicines, the EMA realised early on that patients’ experience with their disease and its treatment is a fundamental parameter to include within the evaluation of medicines. The Agency’s engagement with these stakeholders has been a progressive journey whereby a steady increase in the numbers involved (76 in 2007 to 740 during 2015) has been coupled with a diversification of methodologies ensuring opportunities all along the medicines lifecycle. Learning from experience has also been paramount to ensure that the interaction is mutually beneficial and is carried out in the most optimal manner possible. Key milestones of EMA interaction with patients and consumers: Figure 1 The “framework of interaction” adopted by the EMA management board in 2005 provides the formal basis for involving patients and consumers in Agency activities and relies on five critical elements: A network of European patients and consumers organisations A forum of exchange: EMA Working Party with Patients and Consumers’ organisations A pool of patients acting as experts in their disease and its management Interaction with the EU Regulatory Network Capacity-building focusing on training and raising awareness about EU regulatory system Today patients and consumers are systematically involved in a wide range of EMA activities: Members of EMA Management Board and scientific committees Members of the EMA ‘Patients and Consumers Working Party’ Scientific advice procedures during medicines development; Discussions on benefit/risk evaluations; Review of information (e.g. package leaflet, safety communication); Topic groups and workshops The Agency works with a large network of organisations and individuals; organisations can register with the Agency and if they meet certain eligibility criteria they are then listed on the EMA website (EMA website). Individuals are also encouraged to register to be included in the EMA “individual experts’ stakeholder database” (registration form); they then receive targeted information and can be contacted for involvement in EMA activities. Patients usually participate in person or via written procedure and are involved as either representatives of their organisation or as individual experts, depending on the nature of the activity. There are opportunities for involvement all along the medicine’s evaluation lifecycle: Figure 2 EMA continually looks to further enhance its methods for gathering patient knowledge and preferences at each stage of the process and is investigating the use of additional tools to complement those already in-house. Surveys are regularly used to elicit feedback from both regulators and patients/consumers on their involvement, its added value to the process and identify areas for potential improvement. There are inevitably challenges to overcome, for example finding suitable patients (e.g. language barrier, availability), ensuring tailored support to facilitate and enhance participation, providing a clear definition of the patient role, addressing issues around confidentiality and representation and also how to measure the impact/value of the input. Evidence, including testimonies and concrete examples, has demonstrated that ultimately patient/consumer input: Brings the everyday aspects of living with a disease into the scientific discussions; Improves the quality of patient information and communication on medicines; Increases the dissemination of EMA outcomes. Today patients and consumers are a valued and integral part of the work at the EMA and their perspectives are considered an essential element for increasing transparency in the regulatory process and ensuring more meaningful decisions for all concerned.
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
