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Patient involvement in benefit-risk assessment at the European Medicines Agency: A patient-informed analysis to determine the room for improvement by using quantitative patient preferences

Oude egbrink, Mart (2013) Patient involvement in benefit-risk assessment at the European Medicines Agency: A patient-informed analysis to determine the room for improvement by using quantitative patient preferences.

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Abstract:Objectives The European Medicines Agency is Europe’s regulatory authority for the market approval of drugs based on formal assessment of benefits and risks. Patients are increasingly involved in these assessments through their presence in appraisal committees. The aim of this study is to assess the possible value of stated preference methods in addition to current ways of patient involvement in the approval decisions by providing benefit and risk trade-offs from a patient perspective. Methods A document analysis was conducted to analyse the current ways and level of patient involvement in benefit-risk assessment. Second, an online questionnaire was used to assess the possible use and value of stated preference methods in representing the patient perspective in benefit-risk assessment. The questionnaire was send to 159 patients who have been involved in EMA activities during the year 2012. Results A total of 45 documents were thoroughly analyzed. The findings show that the current level of patient involvement in benefit-risk assessment is low. There are a number of barriers for patient involvement, such as the ad-hoc nature of patient consultations and the absence of a right to vote for patients. Thirty-seven (23%) out of 159 patients completed the questionnaire. Stated preference methods are not being used yet, but according to the patients stated preference methods could be used in benefit-risk assessment, in particular to increase the transparency of how the patient perspective in regulatory decisions is used. Conclusion From this study it appeared that current patient involvement in benefit-risk assessment at the EMA can be improved. While in the current benefit-risk assessments quantitative patient preferences are not considered, patients regard them as a future way of pursuing this improvement and achieving objectives of patient involvement. If patient preferences are used, several measures are however needed to facilitate their use. For the future, studies should take a broader focus considering stated preference methods one method available to involve patients.
Item Type:Essay (Master)
Faculty:BMS: Behavioural, Management and Social Sciences
Subject:85 business administration, organizational science
Programme:Health Sciences MSc (66851)
Link to this item:http://purl.utwente.nl/essays/64492
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