Gaining informed consent for participants is a major challenge for the drug trials industry according to analysis suggesting such issues are the most common problem flagged by US FDA inspectors.
The analysis – published in the current edition of the Journal of Pharmacy & Pharmacognosy Research – looked at the US Food and Drug Administration's (FDA's) inspections and non-compliance actions taken against clinical research organizations (CROs) over a 13 years period, starting in 2010.
It revealed that - based on the analysis of publicly available inspection reports, warning letters and other documents issued by the agency - CROs often struggle with issues related to study protocols, data integrity, adverse event reporting, and adherence to good clinical practice (GCP) guidelines.
According to the results 12.9% of the warning issued by the FDA were related to failure to follow the study protocol with 12.5% being issued for failure to maintain accurate and complete records.
However, informed consent was by far the most common issue raised by FDA inspectors over the period analysed with some 14% of the documents relating to a “failure to obtain proper informed consent from study participants.”
The authors wrote “A retrospective analysis of USFDA inspections and non-compliance actions taken against clinical research organizations has shed light on a concerning issue: the failure to obtain proper informed consent from study participants.
“Through this analysis, it has become evident that this violation is one of the most frequent observations made during inspections.”
The authors also suggested potential solutions to the issue, even calling for CROs and sponsors to suspend programmes until such issues are resolved.
“It is important to take responsibility for the oversight and address it promptly. If the lack of informed consent undermines the integrity of the study or poses significant ethical concerns, it may be necessary to suspend or terminate the study until the issue is resolved.”