EUPATI and Patients in Medicines Research and Development: Guidance for Patient Involvement in Regulatory Processes

Frontiers in Medicine
David HaerryWolf See

Abstract

The importance and merits of greater patient involvement in medicines research and development (R&D) are commonly acknowledged and is thought to offer benefits for all involved parties. It improves discovery, development, and evaluation of new effective medicines, based, among others, on the collaborative identification and understanding of unmet needs, research priorities, optimization of clinical study design, as well as incorporating patient views in regulatory activities. It fosters increased transparency, trust and mutual respect between patients and other stakeholders and applies to all stages of medicines R&D, inclusive of regulation and licensing of medicines and appraisal by health technology assessment (HTA) bodies. In order to be effective and beneficial for all stakeholders, patient engagement as an integral part of medicines R&D needs clear and mutually agreed rules. Existing codes of practice for patient involvement do not comprehensively cover the full scope of patient engagement in all processes related to R&D. One specific aim of the European Patients' Academy on Therapeutic Innovation (EUPATI) was to close this gap through the development of guidance documents for pharmaceutical industry-led medicines R&D, eth...Continue Reading

References

Apr 26, 2007·The Annals of Pharmacotherapy·Elizabeth ManiasCaroline A Brand
May 5, 2007·BMJ : British Medical Journal·Alastair Kent
May 5, 2007·BMJ : British Medical Journal·Barbara Mintzes
Jan 24, 2012·Journal of Medical Ethics·Jonathan IvesSabi Redwod
Jan 5, 2013·Journal of Medical Ethics·Kristina Staley
Jan 19, 2013·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Ahmed M A Adlan, Gregory Y H Lip
Nov 30, 2013·PharmacoEconomics·Janine A van Til, Maarten J Ijzerman
Nov 6, 2015·Therapeutic Innovation & Regulatory Science·Anton HoosGervais Tougas
Jul 6, 2016·Frontiers in Microbiology·Amy O'Callaghan, Douwe van Sinderen
Jun 1, 2018·British Journal of Clinical Pharmacology·Adam Cohen, Sergio Bonini
May 1, 2016·Therapeutic Innovation & Regulatory Science·Gitte BorupNiels Westergaard

❮ Previous
Next ❯

Citations

Jul 19, 2019·British Journal of Clinical Pharmacology·Christine C Gispen-de WiedPieter Stolk
Jul 29, 2017·Health Expectations : an International Journal of Public Participation in Health Care and Health Policy·David EvansUNKNOWN North Bristol Microbiology Patient Panel
Aug 10, 2018·Therapeutic Innovation & Regulatory Science·Wendy SeligLisa Schlager
Dec 19, 2019·Frontiers in Medicine·Hugh Laverty, Pierre Meulien
Apr 9, 2020·Frontiers in Medicine·Eline van OverbeekeIsabelle Huys
May 5, 2020·Health Expectations : an International Journal of Public Participation in Health Care and Health Policy·Megan FeeneyKarlin Schroeder
Sep 30, 2020·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Katherine ChinchillaFlorence van Hunsel
Nov 5, 2020·International Journal of Environmental Research and Public Health·García-Martín MKhan Ks
Nov 25, 2020·Cancers·Everardo Delforge Saad, Marc Buyse
May 11, 2021·Therapeutic Innovation & Regulatory Science·Maria Cavaller-BellaubiElisa Ferrer
May 26, 2021·Pharmaceutical Medicine·Avani PatelJuliette Muszka
Jun 7, 2021·Journal of Translational Medicine·Dominik HartlAdrian Roth
Aug 25, 2021·Research Involvement and Engagement·David FeldmanUNKNOWN Patient Focused Medicines Development Working Groups 2B

❮ Previous
Next ❯

Software Mentioned

EUPATI

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

The Journal of Pharmacy and Pharmacology
Vangelis Karalis, Panos Macheras
International Journal of Technology Assessment in Health Care
Katherine Duthie, Kenneth Bond
Clinical Cancer Research : an Official Journal of the American Association for Cancer Research
Francesco PignattiMichel Marty
© 2022 Meta ULC. All rights reserved