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

Participants' written informed consent in low-risk pragmatic clinical trials with medicines. Expert Rev Clin Pharmacol. 2020 Feb 19;: Authors: Dal-Ré R Abstract 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 pose 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 on-going 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 fulf...
Source: Expert Review of Clinical Pharmacology - Category: Drugs & Pharmacology Tags: Expert Rev Clin Pharmacol Source Type: research