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A limited number of medicines pragmatic trials had potential for waived informed consent following the 2016 CIOMS ethical guidelines
Univ Autonoma Madrid, Fdn Jimenez Diaz Univ Hosp, Hlth Res Inst, Epidemiol Unit, Avda Reyes Catolicas 2, E-28049 Madrid 28040, Spain.
Puerta de Hierro Univ Hosp, Clin Pharmacol Serv, Manuel de Falla 1, E-28222 Madrid, Spain.
Univ Utrecht, Fac Sci, Utrecht Inst Pharmaceut Sci, Div Pharmacoepidemiol & Clin Pharmacol, POB 80082, NL-3508 TB Utrecht, Netherlands.
Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center. Uppsala Univ, Dept Med Sci, Dag Hammarskolds Vag 14B, SE-75237 Uppsala, Sweden;Uppsala Univ, Uppsala Clin Res Centel, Dag Hammarskolds Vag 14B, SE-75237 Uppsala, Sweden.ORCID iD: 0000-0003-4413-9736
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2019 (English)In: Journal of Clinical Epidemiology, ISSN 0895-4356, E-ISSN 1878-5921, Vol. 114, p. 60-71Article in journal (Refereed) Published
Abstract [en]

Objectives: European regulations do not allow modification or waiver of informed consent for medicines randomized controlled trials (RCTs) where the three 2016 Council for International Organizations of Medical Sciences (CIOMS) provisions are met (consent would be impractical or unfeasible, yet the trial would have high social value and pose no or minimal risk to participants). We aimed to identify whether any such trials of medicines were being conducted in Europe. Study Design and Setting: This is a survey of all phase 4 "ongoing" RCTs on the EU clinical trial register between July 1, 2016 and June 30, 2018, to identify those with potentially high levels of pragmatism. Trials that were excluded were as follows: those conducted on rare diseases; conducted on healthy volunteers (except those assessing vaccines); masked (single-, double-blind) trials; single-center trials; those where one could expect to lead patients to prefer one intervention over the other; and miscellaneous reasons. The degree of pragmatism of the RCTs was self-assessed by trials' investigators by means of the PRECIS-2 tool. Investigators of those trials considered to be highly pragmatic assessed the fulfillment of the three CIOMS provisions. Seven patients assessed the social value of the RCTs. Finally, 33 members of 11 research ethics committees (RECs) assessed the social value of the trials and whether they posed no more than minimal risk to participants. Investigators, patients, and REC members assessed the fulfillment of the CIOMS provisions as "yes," "not sure" or "no." Results: Of the 638 phase 4 trials, 420 were RCTs, and 21 of these (5%) were candidates to be pragmatic. Investigators of 15 of these 21 RCTs self-assessed their trial's degree of pragmatism: 14 were highly pragmatic. Of these 14, eight fulfilled the three CIOMS provisions. Assessments by patients and RECs were inconsistent for several trials. Conclusions: We found few low-risk participant-level pragmatic RCTs that could be suitable for modified or waived participants' informed consent. European regulators should consider amending the current regulation and encouraging the conduct of such trials. (C) 2019 Elsevier Inc. All rights reserved.

Place, publisher, year, edition, pages
ELSEVIER SCIENCE INC , 2019. Vol. 114, p. 60-71
Keywords [en]
Medicines, Phase 4 trials, Pragmatic clinical trial, EU-CTR, Informed consent, Waiver
National Category
Public Health, Global Health, Social Medicine and Epidemiology
Identifiers
URN: urn:nbn:se:uu:diva-395728DOI: 10.1016/j.jclinepi.2019.06.007ISI: 000488197900008PubMedID: 31212001OAI: oai:DiVA.org:uu-395728DiVA, id: diva2:1365253
Available from: 2019-10-24 Created: 2019-10-24 Last updated: 2019-10-24Bibliographically approved

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