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Stakeholders' views on the ethical challenges of pragmatic trials investigating pharmaceutical drugs.

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  • معلومة اضافية
    • Corporate Authors:
      Work Package 3 of the IMI GetReal Consortium
    • المصدر:
      Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
    • بيانات النشر:
      Original Publication: [London] : BioMed Central, 2006-
    • الموضوع:
      Attitude of Health Personnel* ; Health Knowledge, Attitudes, Practice* ; Research Design* ; Stakeholder Participation*; Drugs, Investigational/*therapeutic use ; Pragmatic Clinical Trials as Topic/*ethics ; Research Personnel/*psychology; Comparative Effectiveness Research/ethics ; Consent Forms/ethics ; Drugs, Investigational/adverse effects ; Female ; Humans ; Informed Consent/ethics ; Interviews as Topic ; Male ; Patient Safety ; Physician's Role ; Pragmatic Clinical Trials as Topic/methods ; Qualitative Research ; Risk Factors ; Therapeutic Equipoise ; Treatment Outcome
    • نبذة مختصرة :
      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.
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    • Contributed Indexing:
      Keywords: Comparative effectiveness; Drug research; Pragmatic clinical trial; Qualitative study; Research ethics
    • الرقم المعرف:
      0 (Drugs, Investigational)
    • الموضوع:
      Date Created: 20160824 Date Completed: 20171127 Latest Revision: 20181113
    • الموضوع:
      20240829
    • الرقم المعرف:
      PMC4994208
    • الرقم المعرف:
      10.1186/s13063-016-1546-3
    • الرقم المعرف:
      27550379