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Volumn 17, Issue 1, 2016, Pages

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

Author keywords

Comparative effectiveness; Drug research; Pragmatic clinical trial; Qualitative study; Research ethics

Indexed keywords

ARTICLE; DRUG INDUSTRY; DRUG MARKETING; DRUG RESEARCH; FEMALE; HEALTH PERSONNEL ATTITUDE; HUMAN; MALE; MEDICAL ETHICS; PATIENT AUTONOMY; PROFESSIONAL KNOWLEDGE; QUALITATIVE RESEARCH; RISK ASSESSMENT; SEMI STRUCTURED INTERVIEW; ATTITUDE TO HEALTH; COMPARATIVE EFFECTIVENESS; EQUIPOISE; ETHICS; INFORMED CONSENT; INTERVIEW; METHODOLOGY; PATIENT SAFETY; PERSONNEL; PHYSICIAN ATTITUDE; PROCEDURES; PSYCHOLOGY; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK FACTOR; STAKEHOLDER ENGAGEMENT; TREATMENT OUTCOME;

EID: 84983359390     PISSN: None     EISSN: 17456215     Source Type: Journal    
DOI: 10.1186/s13063-016-1546-3     Document Type: Article
Times cited : (14)

References (36)
  • 1
    • 11444261579 scopus 로고    scopus 로고
    • External validity of randomised controlled trials: "to whom do the results of this trial apply?"
    • Rothwell PM. External validity of randomised controlled trials: "to whom do the results of this trial apply?". Lancet. 2005;365(9453):82-93.
    • (2005) Lancet , vol.365 , Issue.9453 , pp. 82-93
    • Rothwell, P.M.1
  • 2
  • 3
    • 67649661825 scopus 로고    scopus 로고
    • Making trials matter: pragmatic and explanatory trials and the problem of applicability
    • Treweek S, Zwarenstein M. Making trials matter: pragmatic and explanatory trials and the problem of applicability. Trials. 2009;10:37.
    • (2009) Trials. , vol.10 , pp. 37
    • Treweek, S.1    Zwarenstein, M.2
  • 4
    • 84891674360 scopus 로고    scopus 로고
    • Making clinical trials more relevant: improving and validating the PRECIS tool for matching trial design decisions to trial purpose
    • Loudon K, Zwarenstein M, Sullivan F, Donnan P, Treweek S. Making clinical trials more relevant: improving and validating the PRECIS tool for matching trial design decisions to trial purpose. Trials. 2013;14:115.
    • (2013) Trials. , vol.14 , pp. 115
    • Loudon, K.1    Zwarenstein, M.2    Sullivan, F.3    Donnan, P.4    Treweek, S.5
  • 5
    • 84898748408 scopus 로고    scopus 로고
    • The imperative of overcoming barriers to the conduct of large, simple trials
    • Eapen ZJ, Lauer MS, Temple RJ. The imperative of overcoming barriers to the conduct of large, simple trials. JAMA. 2014;311(14):1397-8.
    • (2014) JAMA , vol.311 , Issue.14 , pp. 1397-1398
    • Eapen, Z.J.1    Lauer, M.S.2    Temple, R.J.3
  • 6
    • 0141684982 scopus 로고    scopus 로고
    • Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy
    • Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA. 2003;290(12):1624-32.
    • (2003) JAMA , vol.290 , Issue.12 , pp. 1624-1632
    • Tunis, S.R.1    Stryer, D.B.2    Clancy, C.M.3
  • 8
    • 84865497470 scopus 로고    scopus 로고
    • The role for pragmatic randomized controlled trials (pRCTs) in comparative effectiveness research
    • Chalkidou K, Tunis S, Whicher D, Fowler R, Zwarenstein M. The role for pragmatic randomized controlled trials (pRCTs) in comparative effectiveness research. Clin Trials. 2012;9(4):436-46.
    • (2012) Clin Trials , vol.9 , Issue.4 , pp. 436-446
    • Chalkidou, K.1    Tunis, S.2    Whicher, D.3    Fowler, R.4    Zwarenstein, M.5
  • 9
    • 84898667059 scopus 로고    scopus 로고
    • Ethics, regulation, and comparative effectiveness research: time for a change
    • Platt R, Kass NE, McGraw D. Ethics, regulation, and comparative effectiveness research: time for a change. JAMA. 2014;311(15):1497-8.
    • (2014) JAMA , vol.311 , Issue.15 , pp. 1497-1498
    • Platt, R.1    Kass, N.E.2    McGraw, D.3
  • 10
    • 63649136121 scopus 로고    scopus 로고
    • Explanatory and pragmatic attitudes in therapeutical trials
    • Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Clin Epidemiol. 2009;62(5):499-505.
    • (2009) J Clin Epidemiol , vol.62 , Issue.5 , pp. 499-505
    • Schwartz, D.1    Lellouch, J.2
  • 11
    • 52049095374 scopus 로고    scopus 로고
    • Clinical Epidemiology: Principles, Methods and Applications for Clinical Research
    • 2nd ed. Burlington (MA), USA: Jones & Bartlett Learning
    • Grobbee DE, Hoes AW. Clinical Epidemiology: Principles, Methods and Applications for Clinical Research. 2nd ed. Burlington (MA), USA: Jones & Bartlett Learning; 2015.
    • (2015)
    • Grobbee, D.E.1    Hoes, A.W.2
  • 13
    • 84964898331 scopus 로고    scopus 로고
    • Health Care Systems Research Collaboratory
    • Accessed 18 Aug
    • National Institutes of Health (NIH) Collaboratory. Health Care Systems Research Collaboratory. https://www.nihcollaboratory.org/Pages/default.aspx/. Accessed 18 Aug 2016.
    • (2016)
  • 14
    • 84948671470 scopus 로고    scopus 로고
    • Anticipated ethics and regulatory challenges in PCORnet: The National Patient-Centered Clinical Research Network
    • Ali J, Califf R, Sugarman J. Anticipated ethics and regulatory challenges in PCORnet: The National Patient-Centered Clinical Research Network. Account Res. 2016;23(2):79-96.
    • (2016) Account Res , vol.23 , Issue.2 , pp. 79-96
    • Ali, J.1    Califf, R.2    Sugarman, J.3
  • 15
    • 84983327948 scopus 로고    scopus 로고
    • New methods for RWE collection and synthesis
    • Accessed 18 Aug
    • IMI GetReal. New methods for RWE collection and synthesis. https://www.imi-getreal.eu/. Accessed 18 Aug 2016.
    • (2016)
  • 16
    • 84983328612 scopus 로고    scopus 로고
    • Adaptive pathways
    • Accessed 18 Aug
    • European Medicines Agency (EMA). Adaptive pathways. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000601.jsp. Accessed 18 Aug 2016.
    • (2016)
  • 17
    • 84942932829 scopus 로고    scopus 로고
    • Exploring the ethical and regulatory issues in pragmatic clinical trials
    • Califf RM, Sugarman J. Exploring the ethical and regulatory issues in pragmatic clinical trials. Clin Trials. 2015;12(5):436-41.
    • (2015) Clin Trials , vol.12 , Issue.5 , pp. 436-441
    • Califf, R.M.1    Sugarman, J.2
  • 18
    • 84902602802 scopus 로고    scopus 로고
    • Ethics and regulatory complexities for pragmatic clinical trials
    • Sugarman J, Califf RM. Ethics and regulatory complexities for pragmatic clinical trials. JAMA. 2014;311(23):2381-2.
    • (2014) JAMA , vol.311 , Issue.23 , pp. 2381-2382
    • Sugarman, J.1    Califf, R.M.2
  • 21
    • 84936847309 scopus 로고    scopus 로고
    • Pragmatic randomized trials in drug development pose new ethical questions
    • Kalkman S, van Thiel GJMW, Grobbee DE, van Delden JJM. Pragmatic randomized trials in drug development pose new ethical questions. Drug Discov Today. 2015;20(7):856-62.
    • (2015) Drug Discov Today , vol.20 , Issue.7 , pp. 856-862
    • Kalkman, S.1    Thiel, G.J.M.W.2    Grobbee, D.E.3    Delden, J.J.M.4
  • 22
    • 84942878641 scopus 로고    scopus 로고
    • Harms, benefits, and the nature of interventions in pragmatic clinical trials
    • Ali J, Andrews JE, Somkin CP, Rabinovich CE. Harms, benefits, and the nature of interventions in pragmatic clinical trials. Clin Trials. 2015;12(5):467-75.
    • (2015) Clin Trials , vol.12 , Issue.5 , pp. 467-475
    • Ali, J.1    Andrews, J.E.2    Somkin, C.P.3    Rabinovich, C.E.4
  • 23
    • 0004245184 scopus 로고    scopus 로고
    • Qualitative Inquiry and Research Design: Choosing among Five Traditions
    • 3rd ed. Thousand Oaks: SAGE Publications Ltd.
    • Creswell JW. Qualitative Inquiry and Research Design: Choosing among Five Traditions. 3rd ed. Thousand Oaks: SAGE Publications Ltd.; 2013.
    • (2013)
    • Creswell, J.W.1
  • 24
    • 84919709910 scopus 로고    scopus 로고
    • Obtaining real-world evidence: the Salford Lung Study
    • New JP, Bakerly ND, Leather D, Woodcock A. Obtaining real-world evidence: the Salford Lung Study. Thorax. 2014;69(12):1152-4.
    • (2014) Thorax , vol.69 , Issue.12 , pp. 1152-1154
    • New, J.P.1    Bakerly, N.D.2    Leather, D.3    Woodcock, A.4
  • 25
    • 33646698557 scopus 로고    scopus 로고
    • How many interviews are enough? An experiment with data saturation and variability
    • Guest G, Brunce A, Johnson L. How many interviews are enough? An experiment with data saturation and variability. Field Methods. 2006;18:59-82.
    • (2006) Field Methods. , vol.18 , pp. 59-82
    • Guest, G.1    Brunce, A.2    Johnson, L.3
  • 26
    • 69849083503 scopus 로고    scopus 로고
    • Analysis in Qualitative Research
    • Thousand Oaks: SAGE Publications Inc.
    • Boeije H. Analysis in Qualitative Research. Thousand Oaks: SAGE Publications Inc.; 2012.
    • (2012)
    • Boeije, H.1
  • 27
    • 36549063576 scopus 로고    scopus 로고
    • Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups
    • Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19(6):349-57.
    • (2007) Int J Qual Health Care , vol.19 , Issue.6 , pp. 349-357
    • Tong, A.1    Sainsbury, P.2    Craig, J.3
  • 29
    • 0023185342 scopus 로고
    • Equipoise and the ethics of clinical research
    • Freedman B. Equipoise and the ethics of clinical research. N Engl J Med. 1987;317:141-5.
    • (1987) N Engl J Med. , vol.317 , pp. 141-145
    • Freedman, B.1
  • 31
    • 84872422585 scopus 로고    scopus 로고
    • The research-treatment distinction: a problematic approach for determining which activities should have ethical oversight
    • Kass NE, Faden RR, Goodman SN, Pronovost P, Tunis S, Beauchamp TL. The research-treatment distinction: a problematic approach for determining which activities should have ethical oversight. Hastings Cent Rep. 2013;Spec No:S4-15.
    • (2013) Hastings Cent Rep , pp. S4-15
    • Kass, N.E.1    Faden, R.R.2    Goodman, S.N.3    Pronovost, P.4    Tunis, S.5    Beauchamp, T.L.6
  • 32
    • 84939961987 scopus 로고    scopus 로고
    • "Targeted" consent for pragmatic clinical trials
    • Wendler D. "Targeted" consent for pragmatic clinical trials. J Gen Intern Med. 2015;30(5):679-82.
    • (2015) J Gen Intern Med. , vol.30 , Issue.5 , pp. 679-682
    • Wendler, D.1
  • 33
    • 84925546337 scopus 로고    scopus 로고
    • HEAT-PPCI sheds light on consent in pragmatic trials
    • Shaw D. HEAT-PPCI sheds light on consent in pragmatic trials. Lancet. 2014;384(9957):1826-7.
    • (2014) Lancet , vol.384 , Issue.9957 , pp. 1826-1827
    • Shaw, D.1
  • 34
    • 84894178206 scopus 로고    scopus 로고
    • Informed consent for pragmatic trials-the integrated consent model
    • Kim SY, Miller FG. Informed consent for pragmatic trials-the integrated consent model. N Engl J Med. 2014;370(8):769-72.
    • (2014) N Engl J Med , vol.370 , Issue.8 , pp. 769-772
    • Kim, S.Y.1    Miller, F.G.2
  • 35
    • 84939195231 scopus 로고    scopus 로고
    • Stakeholders' views of alternatives to prospective informed consent for minimal-risk pragmatic comparative effectiveness trials
    • Whicher D, Kass N, Faden R. Stakeholders' views of alternatives to prospective informed consent for minimal-risk pragmatic comparative effectiveness trials. J Law Med Ethics. 2015;43(2):397-409.
    • (2015) J Law Med Ethics , vol.43 , Issue.2 , pp. 397-409
    • Whicher, D.1    Kass, N.2    Faden, R.3
  • 36
    • 84879871816 scopus 로고    scopus 로고
    • Ethics and informed consent for comparative effectiveness research with prospective electronic clinical data
    • Faden R, Kass N, Whicher D, Stewart W, Tunis S. Ethics and informed consent for comparative effectiveness research with prospective electronic clinical data. Med Care. 2013;51(8 Suppl 3):S53-7.
    • (2013) Med Care. , vol.51 , Issue.8 , pp. S53-S57
    • Faden, R.1    Kass, N.2    Whicher, D.3    Stewart, W.4    Tunis, S.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.