Participants' written informed consent in low-risk pragmatic clinical trials with medicines.


:Introduction: An important gap within modern medicine is the lack of enough comparative effectiveness research of marketed medicines. Low-risk pragmatic randomized controlled trials (pRCTs) are those conducted resembling usual clinical practice that poses no or minimal incremental risk compared with normal clinical practice.Areas covered: This review addresses one important hurdle in the conduct of low-risk pRCTs: the need to seek participants' written informed consent.Expert opinion: The CIOMS ethical guidelines consider that any research that (a) would not be feasible or practicable to carry out without the waiver or modification, (b) has important social value, and (c) poses no more than minimal risks to participants, and that is approved by the relevant research ethics committee, could be conducted without participants' consent. It is clear that these provisions are applicable to some low-risk RCTs. Recently a research on the EU-CTR registry showed that only 2% of all ongoing phase 4 RCTs could have fulfilled the CIOMS provisions following the investigators' assessment. The EU clinical trial regulation - and that of other jurisdictions - should be debated on the suitableness of the conduct with an alteration or waiver of participants' consent of those low-risk pRCTs that fulfill the three CIOMS provisions.


Dal-Ré R




Has Abstract


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    journal_title:Expert review of clinical pharmacology

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    authors: Fallahi P,Ferrari SM,Elia G,Nasini F,Colaci M,Giuggioli D,Vita R,Benvenga S,Ferri C,Antonelli A

    更新日期:2016-06-01 00:00:00

  • Angiotensin-converting enzyme inhibitors and angiotensin receptor blockers in women of childbearing age: risks versus benefits.

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    authors: Pucci M,Sarween N,Knox E,Lipkin G,Martin U

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    journal_title:Expert review of clinical pharmacology

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    journal_title:Expert review of clinical pharmacology

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  • An update on repurposed medications for the treatment of drug-resistant tuberculosis.

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    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章


    authors: Mafukidze A,Harausz E,Furin J

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  • Hydrogen sulfide in the endocrine and reproductive systems.

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    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审


    authors: Zhu XY,Gu H,Ni X

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    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审


    authors: Jaleel T,Elmets C,Weinkle A,Kassira S,Elewski B

    更新日期:2016-01-01 00:00:00

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    journal_title:Expert review of clinical pharmacology

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    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审


    authors: Baron J,Wang ES

    更新日期:2018-06-01 00:00:00

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    authors: Ahmed SR,Petersen E,Patel R,Migden MR

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    authors: Reece PA

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    journal_title:Expert review of clinical pharmacology

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    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审


    authors: Bernardo M,Bioque M

    更新日期:2016-07-01 00:00:00

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    pub_type: 杂志文章,评审


    authors: Levêque D,Santucci R,Gourieux B,Herbrecht R

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    journal_title:Expert review of clinical pharmacology

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    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审


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    journal_title:Expert review of clinical pharmacology

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    journal_title:Expert review of clinical pharmacology

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    journal_title:Expert review of clinical pharmacology

    pub_type: 社论


    authors: Palmer P

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    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章


    authors: Simpson R,King A

    更新日期:2015-03-01 00:00:00

  • The pathophysiological and pharmacological basis of current drug treatment of migraine headache.

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    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审


    authors: Reddy DS

    更新日期:2013-05-01 00:00:00

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    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审


    authors: Felker D,Lynn A,Wang S,Johnson DE

    更新日期:2014-03-01 00:00:00

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    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审


    authors: Hamed SA

    更新日期:2015-01-01 00:00:00

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    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章


    authors: Megías-Vericat JE,Martínez-Cuadrón D,Sanz MÁ,Poveda JL,Montesinos P

    更新日期:2019-03-01 00:00:00

  • Levonorgestrel-releasing intrauterine system (LNG-IUS 12) for prevention of pregnancy for up to five years.

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    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审


    authors: Nelson AL

    更新日期:2017-08-01 00:00:00

  • Update and trends on pharmacokinetic studies in patients with impaired renal function: practical insight into application of the FDA and EMA guidelines.

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    journal_title:Expert review of clinical pharmacology

    pub_type: 杂志文章,评审


    authors: Paglialunga S,Offman E,Ichhpurani N,Marbury TC,Morimoto BH

    更新日期:2017-03-01 00:00:00