Patient Focused Medicines Development launches an online mapping & networking tool as ‘critical step’ to improve understanding of patient engagement landscape
Brussels, 25th October 2016
The Patient Focused Medicines Development (PFMD – www.pfmd.org) mapping tool is a unique publicly-accessible online tool and a ‘critical step’ that will fill gaps in patient engagement by capturing and mapping key information from patient engagement initiatives around the world. Patient Focused Medicines Development is a global partnership that aims to improve and standardize patient engagement by embedding patients as active partners in the design and development of research and medicines. Read more
June 28 2016
A specially-convened panel will tackle tough questions on patient engagement (PE) in front of a live audience at the DIA Annual Meeting in Philadelphia, Pennsylvania.
The Panel – Patient Involvement Today & Tomorrow: What’s In It For Patients? – will discuss how diverse stakeholders can apply PE in a meaningful way. Marc Boutin, Chief Executive Officer of the US National Health Council (NHC) and Panel Chair, said: “There is a lot of interest and excitement around patient involvement in health care, but no clear 360-degree view of the landscape. We have brought together experienced stakeholders who will face challenging and topical questions during the session and help us better understand the landscape, identify trends, and explore what the future of PE could look like.” Read more
Health stakeholders urged to ‘get on the map’ as on-line collection tool to capture global patient engagement goes live
June 27 2016
Health stakeholders are being urged to ‘get on the map’ using an on-line collection tool which launched today and is designed to capture key information from patient engagement (PE) initiatives across the globe.
Data collected through the tool will be used to produce a series of overview ‘maps’ of the PE landscape in the lifecycle of medicines development that will portray the global PE landscape through various perspectives to make them meaningful to diverse stakeholders. The maps will provide a searchable and dynamic ‘who’s who’ of PE. Read more
23rd BioCentury Back to School Issue: Let patients show the way in drug development Changing the Subject
September 7 2015
No longer content with a walk-on role as research subjects, and empowered by access to more information and the necessity of shouldering a bigger share of the healthcare bill, patients are demanding a speaking role on the global healthcare stage. At the same time, regulators and drug industry bodies have concluded that patient input is key to improving clinical trials, defining meaningful treatment outcomes and assessing the amount of risk that is acceptable for a given amount of benefit.
There is no phase of drug development that couldn’t be improved by a more active, thoughtful approach to patient engagement.
Reference: Schaeffer, S. and McCallister, E. “Changing the Subject.” BioCentury (2015)
July 7 2015
Regulators, industry and other drug stakeholders across the globe are being called on to join a new initiative to develop the first universal framework for systematically involving patients in drug development, regulatory review and market access decisions.
Improved patient involvement can drive the development of innovative medicines that deliver more relevant and impactful patient outcomes and make medicine development faster, more efficient, and more productive.
Reference: Brizmohun, N. “Universal framework is ‘crucial next step’ for involving patients in drug development.” Scrip Regulatory Affairs (2015)
April 27 2015
The purpose of medicines is to improve patients’ lives. Stakeholders involved in the development and lifecycle management of medicines agree that more effective patient involvement is needed to ensure that patient needs and priorities are identified and met. Despite the increasing number and scope of patient involvement initiatives, there is no accepted master framework for systematic patient involvement in industry-led medicines research and development, regulatory review, or market access decisions. Patient engagement is very productive in some indications, but inconsistent and fragmentary on a broader level. This often results in inefficient drug development, increasing evidence requirements, lack of patient-centered outcomes that address unmet medical needs and facilitate adherence, and consequently, lack of required therapeutic options and high costs to society and involved parties. Improved patient involvement can drive the development of innovative medicines that deliver more relevant and impactful patient outcomes and make medicine development faster, more efficient, and more productive. It can lead to better prioritization of early research; improved resource allocation; improved trial protocol designs that better reflect patient needs; and, by addressing potential barriers to patient participation, enhanced recruitment and retention. It may also improve trial conduct and lead to more focused, economically viable clinical trials. At launch and beyond, systematic patient involvement can also improve the ongoing benefit-risk assessment, ensure that public funds prioritize medicines of value to patients, and further the development of the medicine. Progress toward a universal framework for patient involvement requires a joint, precompetitive, and international approach by all stakeholders, working in true partnership to consolidate outputs from existing initiatives, identify gaps, and develop a comprehensive framework. It is essential that all stakeholders participate to drive adoption and implementation of the framework and to ensure that patients and their needs are embedded at the heart of medicines development and lifecycle management.
A framework of uniform standards that promotes full and meaningful patient involvement during the entire lifecycle of medicines is not only needed, it is the “crucial next step” to creating better medicines and getting them to market faster.
Reference: A. Hoos, J. Anderson, M. Boutin, L. Dewulf, J. Geissler, G. Johnston, A. Joos, M. Metcalf, J. Regnante, I. Sargeant, R. F. Schneider, V. Todaro, G. Tougas, Partnering with patients in the development and lifecycle of medicines: A call for action. Ther. Innov. Regul. Sci. 27 April 2015 (10.1177/21684790/5580384).