메뉴 건너뛰기




Volumn 89, Issue , 2017, Pages 181-187

Series: Pragmatic trials and real world evidence: Paper 4. Informed consent

Author keywords

Comparative effectiveness; Drug research; Informed consent; Pragmatic trials; Real world evidence; Research ethics

Indexed keywords

ACCESS TO INFORMATION; ARTICLE; BROADCAST CONSENT; HUMAN; INFORMED CONSENT; INTEGRATED CONSENT; MEDICAL INFORMATION; MORALITY; PATIENT DECISION MAKING; PATIENT RIGHT; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); TARGETED CONSENT; WAIVER OF CONSENT; STANDARDS;

EID: 85021651739     PISSN: 08954356     EISSN: 18785921     Source Type: Journal    
DOI: 10.1016/j.jclinepi.2017.03.019     Document Type: Article
Times cited : (32)

References (41)
  • 1
    • 0141684982 scopus 로고    scopus 로고
    • Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy
    • Tunis, S.R., Stryer, D.B., Clancy, C.M., Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. JAMA 290 (2003), 1624–1632.
    • (2003) JAMA , vol.290 , pp. 1624-1632
    • Tunis, S.R.1    Stryer, D.B.2    Clancy, C.M.3
  • 2
    • 84902602802 scopus 로고    scopus 로고
    • Ethics and regulatory complexities for pragmatic clinical trials
    • Sugarman, J., Califf, R.M., Ethics and regulatory complexities for pragmatic clinical trials. JAMA 311 (2014), 2381–2382.
    • (2014) JAMA , vol.311 , pp. 2381-2382
    • Sugarman, J.1    Califf, R.M.2
  • 4
    • 79960048069 scopus 로고    scopus 로고
    • Bridging the efficacy-effectiveness gap: a regulator's perspective on addressing variability of drug response
    • Eichler, H.G., Abadie, E., Breckenridge, A., Flamion, B., Gustafsson, L.L., Leufkens, H., et al. Bridging the efficacy-effectiveness gap: a regulator's perspective on addressing variability of drug response. Nat Rev Drug Discov 10 (2011), 495–506.
    • (2011) Nat Rev Drug Discov , vol.10 , pp. 495-506
    • Eichler, H.G.1    Abadie, E.2    Breckenridge, A.3    Flamion, B.4    Gustafsson, L.L.5    Leufkens, H.6
  • 5
    • 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 62 (2009), 499–505.
    • (2009) J Clin Epidemiol , vol.62 , pp. 499-505
    • Schwartz, D.1    Lellouch, J.2
  • 6
    • 84942932829 scopus 로고    scopus 로고
    • Exploring the ethical and regulatory issues in pragmatic clinical trials
    • Califf, R.M., Sugarman, J., Exploring the ethical and regulatory issues in pragmatic clinical trials. Clin Trials 12 (2015), 436–441.
    • (2015) Clin Trials , vol.12 , pp. 436-441
    • Califf, R.M.1    Sugarman, J.2
  • 7
    • 85032295432 scopus 로고    scopus 로고
    • Innovative Medicines Initiative (IMI) GetReal: new methods for real world evidence collection and synthesis. Available at Accessed October 12
    • Innovative Medicines Initiative (IMI) GetReal: new methods for real world evidence collection and synthesis. Available at https://www.imi-getreal.eu/. Accessed October 12, 2016.
    • (2016)
  • 8
    • 84904179088 scopus 로고    scopus 로고
    • The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials
    • van Staa, T.P., Dyson, L., McCann, G., Padmanabhan, S., Belatri, R., Goldacre, B., et al. The opportunities and challenges of pragmatic point-of-care randomised trials using routinely collected electronic records: evaluations of two exemplar trials. Health Technol Assess 18 (2014), 1–146.
    • (2014) Health Technol Assess , vol.18 , pp. 1-146
    • van Staa, T.P.1    Dyson, L.2    McCann, G.3    Padmanabhan, S.4    Belatri, R.5    Goldacre, B.6
  • 9
    • 84962050293 scopus 로고    scopus 로고
    • Pragmatic trials for noncommunicable diseases: relieving constraints
    • Patel, A., Webster, R., Pragmatic trials for noncommunicable diseases: relieving constraints. PLoS Med, 13, 2016, e1001986.
    • (2016) PLoS Med , vol.13 , pp. e1001986
    • Patel, A.1    Webster, R.2
  • 11
    • 84939961987 scopus 로고    scopus 로고
    • “Targeted” consent for pragmatic clinical trials
    • Wendler, D., “Targeted” consent for pragmatic clinical trials. J Gen Intern Med 30 (2015), 679–682.
    • (2015) J Gen Intern Med , vol.30 , pp. 679-682
    • Wendler, D.1
  • 12
    • 84899862013 scopus 로고    scopus 로고
    • Informed consent in randomized quality improvement trials: a critical barrier for learning health systems
    • Pletcher, M.J., Lo, B., Grady, D., Informed consent in randomized quality improvement trials: a critical barrier for learning health systems. JAMA Intern Med 174 (2014), 668–670.
    • (2014) JAMA Intern Med , vol.174 , pp. 668-670
    • Pletcher, M.J.1    Lo, B.2    Grady, D.3
  • 13
    • 84882986640 scopus 로고    scopus 로고
    • International ethical guidelines for biomedical research involving human subjects
    • CIOMS Geneva, Switzerland
    • Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for biomedical research involving human subjects. 2012, CIOMS, Geneva, Switzerland.
    • (2012)
  • 14
    • 84888610885 scopus 로고    scopus 로고
    • WMA Declaration of Helsinki: ethical principles for medical research involving human subjects
    • World Medical Association (WMA). WMA Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA 310 (2013), 2191–2194.
    • (2013) JAMA , vol.310 , pp. 2191-2194
  • 15
    • 85032307828 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice Guidelines E6 (R1)
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Good Clinical Practice Guidelines E6 (R1), (2002).
    • (2002)
  • 16
    • 85032297837 scopus 로고    scopus 로고
    • Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations, and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
    • Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations, and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, (2001).
    • (2001)
  • 17
    • 85032257951 scopus 로고    scopus 로고
    • Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
    • Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (2014).
    • (2014)
  • 18
    • 84870272275 scopus 로고    scopus 로고
    • The Ottawa statement on the ethical design and conduct of cluster randomized trials
    • Weijer, C., Grimshaw, J.M., Eccles, M.P., McRae, A.D., White, A., Brehaut, J.C., et al. The Ottawa statement on the ethical design and conduct of cluster randomized trials. PLoS Med, 9, 2012, e1001346.
    • (2012) PLoS Med , vol.9 , pp. e1001346
    • Weijer, C.1    Grimshaw, J.M.2    Eccles, M.P.3    McRae, A.D.4    White, A.5    Brehaut, J.C.6
  • 19
    • 84936847309 scopus 로고    scopus 로고
    • Pragmatic randomized trials in drug development pose new ethical questions: a systematic review
    • Kalkman, S., van Thiel, G.J., Grobbee, D.E., van Delden, J.J., Pragmatic randomized trials in drug development pose new ethical questions: a systematic review. Drug Discov Today 20 (2015), 856–862.
    • (2015) Drug Discov Today , vol.20 , pp. 856-862
    • Kalkman, S.1    van Thiel, G.J.2    Grobbee, D.E.3    van Delden, J.J.4
  • 20
    • 84983359390 scopus 로고    scopus 로고
    • Stakeholders’ views on the ethical challenges of pragmatic trials investigating pharmaceutical drugs
    • Kalkman, S., van Thiel, G.J., Grobbee, D.E., Meinecke, A.K., Zuidgeest, M.G., van Delden, J.J., et al. Stakeholders’ views on the ethical challenges of pragmatic trials investigating pharmaceutical drugs. Trials, 17, 2016, 419.
    • (2016) Trials , vol.17 , pp. 419
    • Kalkman, S.1    van Thiel, G.J.2    Grobbee, D.E.3    Meinecke, A.K.4    Zuidgeest, M.G.5    van Delden, J.J.6
  • 21
    • 84960112561 scopus 로고    scopus 로고
    • Waivers and alterations to consent in pragmatic clinical trials: respecting the principle of respect for persons
    • Kim, S.Y., Miller, F.G., Waivers and alterations to consent in pragmatic clinical trials: respecting the principle of respect for persons. IRB 38 (2016), 1–5.
    • (2016) IRB , vol.38 , pp. 1-5
    • Kim, S.Y.1    Miller, F.G.2
  • 22
    • 84960463558 scopus 로고    scopus 로고
    • When and why is research without consent permissible?
    • Gelinas, L., Wertheimer, A., Miller, F.G., When and why is research without consent permissible?. Hastings Cent Rep 46 (2016), 35–43.
    • (2016) Hastings Cent Rep , vol.46 , pp. 35-43
    • Gelinas, L.1    Wertheimer, A.2    Miller, F.G.3
  • 23
    • 0032717613 scopus 로고    scopus 로고
    • Barriers to participation in randomised controlled trials: a systematic review
    • Ross, S., Grant, A., Counsell, C., Gillespie, W., Russell, I., Prescott, R., Barriers to participation in randomised controlled trials: a systematic review. J Clin Epidemiol 52 (1999), 1143–1156.
    • (1999) J Clin Epidemiol , vol.52 , pp. 1143-1156
    • Ross, S.1    Grant, A.2    Counsell, C.3    Gillespie, W.4    Russell, I.5    Prescott, R.6
  • 24
    • 33744981438 scopus 로고    scopus 로고
    • What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies
    • McDonald, A.M., Knight, R.C., Campbell, M.K., Entwistle, V.A., Grant, A.M., Cook, J.A., et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials, 7, 2006, 9.
    • (2006) Trials , vol.7 , pp. 9
    • McDonald, A.M.1    Knight, R.C.2    Campbell, M.K.3    Entwistle, V.A.4    Grant, A.M.5    Cook, J.A.6
  • 25
    • 84859004974 scopus 로고    scopus 로고
    • Pragmatic randomised trials using routine electronic health records: putting them to the test
    • van Staa, T.P., Goldacre, B., Gulliford, M., Cassell, J., Pirmohamed, M., Taweel, A., et al. Pragmatic randomised trials using routine electronic health records: putting them to the test. BMJ, 344, 2012, e55.
    • (2012) BMJ , vol.344 , pp. e55
    • van Staa, T.P.1    Goldacre, B.2    Gulliford, M.3    Cassell, J.4    Pirmohamed, M.5    Taweel, A.6
  • 26
    • 0033807896 scopus 로고    scopus 로고
    • Attitudes towards and participation in randomised clinical trials in oncology: a review of the literature
    • Ellis, P.M., Attitudes towards and participation in randomised clinical trials in oncology: a review of the literature. Ann Oncol 11 (2000), 939–945.
    • (2000) Ann Oncol , vol.11 , pp. 939-945
    • Ellis, P.M.1
  • 27
    • 84894930266 scopus 로고    scopus 로고
    • In randomization we trust? There are overlooked problems in experimenting with people in behavioral intervention trials
    • McCambridge, J., Kypri, K., Elbourne, D., In randomization we trust? There are overlooked problems in experimenting with people in behavioral intervention trials. J Clin Epidemiol 67 (2014), 247–253.
    • (2014) J Clin Epidemiol , vol.67 , pp. 247-253
    • McCambridge, J.1    Kypri, K.2    Elbourne, D.3
  • 28
    • 84919709910 scopus 로고    scopus 로고
    • Obtaining real-world evidence: the Salford Lung study
    • New, J.P., Bakerly, N.D., Leather, D., Woodcock, A., Obtaining real-world evidence: the Salford Lung study. Thorax 69 (2014), 1152–1154.
    • (2014) Thorax , vol.69 , pp. 1152-1154
    • New, J.P.1    Bakerly, N.D.2    Leather, D.3    Woodcock, A.4
  • 29
    • 84962909302 scopus 로고    scopus 로고
    • PRECIS-2 in perspective: what is next for pragmatic trials?
    • Zuidgeest, M.G., Goetz, I., Grobbee, D.E., Work Package 3 of the GetReal Consortium. PRECIS-2 in perspective: what is next for pragmatic trials?. J Clin Epidemiol 84 (2017), 22–24.
    • (2017) J Clin Epidemiol , vol.84 , pp. 22-24
    • Zuidgeest, M.G.1    Goetz, I.2    Grobbee, D.E.3
  • 30
    • 84923794788 scopus 로고    scopus 로고
    • The concept of risk in comparative effectiveness research
    • Lantos, J.D., Spertus, J.A., The concept of risk in comparative effectiveness research. N Engl J Med, 372, 2015, 884.
    • (2015) N Engl J Med , vol.372 , pp. 884
    • Lantos, J.D.1    Spertus, J.A.2
  • 31
    • 84883385696 scopus 로고    scopus 로고
    • Risks (and benefits) in comparative effectiveness research trials
    • Feudtner, C., Schreiner, M., Lantos, J.D., Risks (and benefits) in comparative effectiveness research trials. N Engl J Med 369 (2013), 892–894.
    • (2013) N Engl J Med , vol.369 , pp. 892-894
    • Feudtner, C.1    Schreiner, M.2    Lantos, J.D.3
  • 32
    • 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 51 (2013), S53–S57.
    • (2013) Med Care , vol.51 , pp. S53-S57
    • Faden, R.1    Kass, N.2    Whicher, D.3    Stewart, W.4    Tunis, S.5
  • 33
    • 84894178206 scopus 로고    scopus 로고
    • Informed consent for pragmatic trials—the integrated consent model
    • Kim, S.Y., Miller, F.G., Informed consent for pragmatic trials—the integrated consent model. N Engl J Med 370 (2014), 769–772.
    • (2014) N Engl J Med , vol.370 , pp. 769-772
    • Kim, S.Y.1    Miller, F.G.2
  • 34
    • 84894120088 scopus 로고    scopus 로고
    • Informed consent, comparative effectiveness, and learning health care
    • Faden, R.R., Beauchamp, T.L., Kass, N.E., Informed consent, comparative effectiveness, and learning health care. N Engl J Med 370 (2014), 766–768.
    • (2014) N Engl J Med , vol.370 , pp. 766-768
    • Faden, R.R.1    Beauchamp, T.L.2    Kass, N.E.3
  • 35
    • 85032286077 scopus 로고    scopus 로고
    • Code of Federal regulations. Title 21 Part 50: Protection of human subjects.
    • United States Food and Drug Administration (FDA). Code of Federal regulations. Title 21 Part 50: Protection of human subjects.
  • 36
    • 85032266844 scopus 로고    scopus 로고
    • Code of Federal Regulations. 45CFR46. Available at Accessed October 13
    • United States Department of Health and Human Services. Code of Federal Regulations. 45CFR46. Available at http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html#. Accessed October 13, 2016.
    • (2016)
  • 37
    • 0033545528 scopus 로고    scopus 로고
    • Is informed consent always necessary for randomized, controlled trials?
    • Truog, R.D., Robinson, W., Randolph, A., Morris, A., Is informed consent always necessary for randomized, controlled trials?. N Engl J Med 340 (1999), 804–807.
    • (1999) N Engl J Med , vol.340 , pp. 804-807
    • Truog, R.D.1    Robinson, W.2    Randolph, A.3    Morris, A.4
  • 38
    • 85001022018 scopus 로고    scopus 로고
    • A framework for analysis of research risks and benefits to participants in standard of care pragmatic clinical trials
    • Chen, S.C., Kim, S.Y., A framework for analysis of research risks and benefits to participants in standard of care pragmatic clinical trials. Clin Trials 13 (2016), 605–611.
    • (2016) Clin Trials , vol.13 , pp. 605-611
    • Chen, S.C.1    Kim, S.Y.2
  • 39
    • 84872415114 scopus 로고    scopus 로고
    • An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics
    • Spec No:S16-27.
    • Faden, R.R., Kass, N.E., Goodman, S.N., Pronovost, P., Tunis, S., Beauchamp, T.L., An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics. Hastings Cent Rep, 2013 Spec No:S16-27. dx.doi.org/10.1002/hast.134.
    • (2013) Hastings Cent Rep
    • Faden, R.R.1    Kass, N.E.2    Goodman, S.N.3    Pronovost, P.4    Tunis, S.5    Beauchamp, T.L.6
  • 40
    • 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 43 (2015), 397–409.
    • (2015) J Law Med Ethics , vol.43 , pp. 397-409
    • Whicher, D.1    Kass, N.2    Faden, R.3
  • 41
    • 84940535251 scopus 로고    scopus 로고
    • Pragmatic randomized trials without standard informed consent?: a national survey
    • Nayak, R.K., Wendler, D., Miller, F.G., Kim, S.Y., Pragmatic randomized trials without standard informed consent?: a national survey. Ann Intern Med 163 (2015), 356–364.
    • (2015) Ann Intern Med , vol.163 , pp. 356-364
    • Nayak, R.K.1    Wendler, D.2    Miller, F.G.3    Kim, S.Y.4


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.