Results reported by patients and their use in clinical trials

Authors

  • Pedro Lopes Ferreira Professor Associado com Agregação da Faculdade de Economia da Universidade de Coimbra; Investigador do Centro de Estudos e Investigação em Saúde da Universidade de Coimbra; Membro da Comissão de Ética para a Investigação Clínica.

DOI:

https://doi.org/10.32385/rpmgf.v25i5.10670

Keywords:

Quality of life, Health, Patient-reported Outcomes, Regulation, Drug

Abstract

Patient reported outcomes and its utilization in clinical trials Objective: This paper aims at presenting recent developments and harmonisation attempts by various international organizations regarding the care that should be taken in dealing with patient reported outcomes, namely in clinical trials. Methods: A document search was performed focussing on the health related quality of life and patients related outcomes concepts, as well as their use in clinical trials and in the measurement of the efficacy and security of new drugs. Results: Among the main found documents, we may refer the ones from the European Agency for the Evaluation of Medicinal Products (EMEA) and from the Food and Drug Agency (FDA), including guidelines to be used in the clinical decision-making process, treatment monitoring and analysis of drug efficacy. Conclusion: Both documents agree on the importance of reliability and validity tests of the health outcomes measurement instruments used. They also agree on the care that should be taken when a measurement instrument is to be used in another language or another culture.

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Published

2009-09-01

Issue

Vol. 25 No. 5 (2009): Revista Portuguesa de Clínica Geral

Section

Brief Article

License

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How to Cite

Results reported by patients and their use in clinical trials. (2009). Portuguese Journal of Family Medicine and General Practice, 25(5), 552-9. https://doi.org/10.32385/rpmgf.v25i5.10670