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Stakeholders’ views on the ethical challenges of pragmatic trials investigating pharmaceutical drugs
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Stakeholders’ views on the ethical challenges of pragmatic trials investigating pharmaceutical drugs
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Journal Article
Stakeholders’ views on the ethical challenges of pragmatic trials investigating pharmaceutical drugs
2016
Overview
Background
We explored the views of key stakeholders to identify the ethical challenges of pragmatic trials investigating pharmaceutical drugs. A secondary aim was to capture stakeholders’ attitudes towards the implementation of pragmatic trials in the drug development process.
Methods
We conducted semistructured, in-depth interviews among individuals from different key stakeholder groups (academia and independent research institutions, the pharmaceutical industry, regulators, Health Technology Assessment (HTA) agencies and patients’ organizations) through telephone or face-to-face sessions. Interviews were structured around the question “what challenges were experienced or perceived during the design, conduct and/or review of pragmatic trials.” Respondents were additionally asked about their views on implementation of pragmatic trials in the drug development process. Thematic analysis was used to identify the ethically relevant features across data sets.
Results
We interviewed 34 stakeholders in 25 individual sessions and four group sessions. The four perceived challenges of ethical relevance were: (1) less controlled conditions creating safety concerns, (2) comparison with usual care potentially compromising clinical equipoise, (3) tailored or waivers of informed consent affecting patient autonomy, and (4) minimal interference with “real-world” practice reducing the knowledge value of trial results.
Conclusions
We identified stakeholder concerns regarding risk assessment, use of suboptimal usual care as a comparator, tailoring of informed consent procedures and ensuring the social value of pragmatic trials. These concerns increased when respondents were asked about pragmatic trials conducted before market authorization.
Publisher
BioMed Central,BioMed Central Ltd,Springer Nature B.V
Subject
/ Attitude of Health Personnel
/ Beliefs, opinions and attitudes
/ Comparative Effectiveness Research - ethics
/ Drugs
/ Drugs, Investigational - adverse effects
/ Drugs, Investigational - therapeutic use
/ Ethics
/ Female
/ Health Knowledge, Attitudes, Practice
/ Health technology assessment
/ Humans
/ Male
/ Medicine
/ Patients
/ Pragmatic Clinical Trials as Topic - ethics
/ Pragmatic Clinical Trials as Topic - methods
/ Research Personnel - psychology
