A Paradigm Shift Towards Patient Involvement in Medicines Development and Regulatory Science: Workshop Proceedings and Commentary

Research output: Contribution to journalComment/debateResearchpeer-review

Standard

A Paradigm Shift Towards Patient Involvement in Medicines Development and Regulatory Science : Workshop Proceedings and Commentary. / Borup, Gitte; Bach, Karin Friis; Schmiegelow, Merete; Kildemoes, Helle Wallach; Bjerrum, Ole Jannik; Westergaard, Niels .

In: Therapeutic Innovation & Regulatory Science, Vol. 50, No. 3, 05.2016, p. 304-311.

Research output: Contribution to journalComment/debateResearchpeer-review

Harvard

Borup, G, Bach, KF, Schmiegelow, M, Kildemoes, HW, Bjerrum, OJ & Westergaard, N 2016, 'A Paradigm Shift Towards Patient Involvement in Medicines Development and Regulatory Science: Workshop Proceedings and Commentary', Therapeutic Innovation & Regulatory Science, vol. 50, no. 3, pp. 304-311. https://doi.org/10.1177/2168479015622668

APA

Borup, G., Bach, K. F., Schmiegelow, M., Kildemoes, H. W., Bjerrum, O. J., & Westergaard, N. (2016). A Paradigm Shift Towards Patient Involvement in Medicines Development and Regulatory Science: Workshop Proceedings and Commentary. Therapeutic Innovation & Regulatory Science, 50(3), 304-311. https://doi.org/10.1177/2168479015622668

Vancouver

Borup G, Bach KF, Schmiegelow M, Kildemoes HW, Bjerrum OJ, Westergaard N. A Paradigm Shift Towards Patient Involvement in Medicines Development and Regulatory Science: Workshop Proceedings and Commentary. Therapeutic Innovation & Regulatory Science. 2016 May;50(3):304-311. https://doi.org/10.1177/2168479015622668

Author

Borup, Gitte ; Bach, Karin Friis ; Schmiegelow, Merete ; Kildemoes, Helle Wallach ; Bjerrum, Ole Jannik ; Westergaard, Niels . / A Paradigm Shift Towards Patient Involvement in Medicines Development and Regulatory Science : Workshop Proceedings and Commentary. In: Therapeutic Innovation & Regulatory Science. 2016 ; Vol. 50, No. 3. pp. 304-311.

Bibtex

@article{9c7b73b822bc4189b3f88165000ba016,
title = "A Paradigm Shift Towards Patient Involvement in Medicines Development and Regulatory Science: Workshop Proceedings and Commentary",
abstract = "The Copenhagen Centre for Regulatory Science (CORS) and Biopeople at the University of Copenhagen held a workshop in May 2015 titled “Patient Involvement in Medicines Development and Approvals: A Paradigm Shift Towards True Patient Impact in Medicines Development and Regulatory Science” that acknowledged the importance of having patients more involved in the entire process of medicines research and development (R&D) and life cycle management. Four key stakeholders, representing patients, academia, industry, and regulatory authorities, each gave their view and perspective on the status and challenges of current patient involvement. From the 3 breakout sessions, it was concluded that patient-reported outcomes (ie, the report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else), was considered as an important tool when deciding endpoints. It was agreed that professionalization of the patient within medicine R&D to some extent would be necessary for obtaining influence. However, the industry should also seek to accommodate to the patient instead of waiting passively for patients to become educated. A much better organized and stronger involvement of patients was called for. However, this should not only rely on goodwill, but should preferably be implemented by legal requirements, so as to secure compliance by all stakeholders. An independent platform with the purpose of providing access to patient experience was proposed. A research and educational center such as CORS, which was founded on cross-sectorial and cross-disciplinary cooperation, is an example of an institution that could be a good starting point for hosting such a platform.",
author = "Gitte Borup and Bach, {Karin Friis} and Merete Schmiegelow and Kildemoes, {Helle Wallach} and Bjerrum, {Ole Jannik} and Niels Westergaard",
year = "2016",
month = "5",
doi = "10.1177/2168479015622668",
language = "English",
volume = "50",
pages = "304--311",
journal = "Drug Information Journal",
issn = "0092-8615",
publisher = "SAGE Publications",
number = "3",

}

RIS

TY - JOUR

T1 - A Paradigm Shift Towards Patient Involvement in Medicines Development and Regulatory Science

T2 - Workshop Proceedings and Commentary

AU - Borup, Gitte

AU - Bach, Karin Friis

AU - Schmiegelow, Merete

AU - Kildemoes, Helle Wallach

AU - Bjerrum, Ole Jannik

AU - Westergaard, Niels

PY - 2016/5

Y1 - 2016/5

N2 - The Copenhagen Centre for Regulatory Science (CORS) and Biopeople at the University of Copenhagen held a workshop in May 2015 titled “Patient Involvement in Medicines Development and Approvals: A Paradigm Shift Towards True Patient Impact in Medicines Development and Regulatory Science” that acknowledged the importance of having patients more involved in the entire process of medicines research and development (R&D) and life cycle management. Four key stakeholders, representing patients, academia, industry, and regulatory authorities, each gave their view and perspective on the status and challenges of current patient involvement. From the 3 breakout sessions, it was concluded that patient-reported outcomes (ie, the report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else), was considered as an important tool when deciding endpoints. It was agreed that professionalization of the patient within medicine R&D to some extent would be necessary for obtaining influence. However, the industry should also seek to accommodate to the patient instead of waiting passively for patients to become educated. A much better organized and stronger involvement of patients was called for. However, this should not only rely on goodwill, but should preferably be implemented by legal requirements, so as to secure compliance by all stakeholders. An independent platform with the purpose of providing access to patient experience was proposed. A research and educational center such as CORS, which was founded on cross-sectorial and cross-disciplinary cooperation, is an example of an institution that could be a good starting point for hosting such a platform.

AB - The Copenhagen Centre for Regulatory Science (CORS) and Biopeople at the University of Copenhagen held a workshop in May 2015 titled “Patient Involvement in Medicines Development and Approvals: A Paradigm Shift Towards True Patient Impact in Medicines Development and Regulatory Science” that acknowledged the importance of having patients more involved in the entire process of medicines research and development (R&D) and life cycle management. Four key stakeholders, representing patients, academia, industry, and regulatory authorities, each gave their view and perspective on the status and challenges of current patient involvement. From the 3 breakout sessions, it was concluded that patient-reported outcomes (ie, the report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else), was considered as an important tool when deciding endpoints. It was agreed that professionalization of the patient within medicine R&D to some extent would be necessary for obtaining influence. However, the industry should also seek to accommodate to the patient instead of waiting passively for patients to become educated. A much better organized and stronger involvement of patients was called for. However, this should not only rely on goodwill, but should preferably be implemented by legal requirements, so as to secure compliance by all stakeholders. An independent platform with the purpose of providing access to patient experience was proposed. A research and educational center such as CORS, which was founded on cross-sectorial and cross-disciplinary cooperation, is an example of an institution that could be a good starting point for hosting such a platform.

U2 - 10.1177/2168479015622668

DO - 10.1177/2168479015622668

M3 - Comment/debate

VL - 50

SP - 304

EP - 311

JO - Drug Information Journal

JF - Drug Information Journal

SN - 0092-8615

IS - 3

ER -

ID: 153372090