Harnessing the patient voice in real-world evidence: the essential role of patient-reported outcomes
Author:
Publisher
Springer Science and Business Media LLC
Subject
Drug Discovery,Pharmacology,General Medicine
Link
http://www.nature.com/articles/d41573-019-00088-7.pdf
Reference5 articles.
1. Engel, P. et al. Lessons learned on the design and the conduct of post-authorization safety studies: review of 3 years of PRAC oversight. Br. J. Clin. Pharmacol. 83, 884–893 (2016).
2. Kluetz, P. G. et al. Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada. Lancet Oncol. 19, e267–e274 (2018).
3. Calvert, M. et al. Maximising the impact of patient reported outcome assessment for patients and society. BMJ 364, k5267 (2019).
4. Kyte, D. et al. Reflections on the national patient-reported outcome measures (PROMs) programme: where do we go from here? J. R. Soc. Med. 109, 441–445 (2016).
5. Calvert, M. et al. Guidelines for inclusion of patient-reported outcomes in clinical trial protocols: the SPIRIT-PRO extension. JAMA 319, 483–494 (2018).
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