EMA releases good practice advice for clinical trials

Good practice advice has been released by the European Medicines Agency (EMA) for clinical trials using human samples, because of concerns some companies are simply following good laboratory practice (GLP).

EMA has not before released detailed guidance on this work for EU companies, and in a new paper it says that while some ‘aspects of GLP [are] applicable to clinical sample analysis’, its scope is for ‘non-clinical studies and consequently does not take into account issues that may impact on the safety and rights of clinical trial subjects’. As a result, the agency has released detailed advice on handling these issues, including ‘information on the organisation, conduct and monitoring of laboratory work’.

The paper’s scope is wide, including advice on personnel issues; contracts and agreements; trial conduct; requests for additional work; sub-contracting laboratory analysis; patient and subject safety; informed consent; sample labelling and storage; data recording and retention; equipment maintenance; information technology; blinding and un-blinding issues; and clinical kit preparation and distribution.

EMA has also released significant detail on quality assurance and control matters within the paper. For instance, on quality assurance, the agency ‘strongly recommends that facilities assess and document their approach…’. This includes ‘an assessment of the nature of the work performed, the number of trials conducted (or samples analysed) and the resources available to support the laboratory’s operations’. It adds that quality assurance programmes should always be designed to comply with EU ‘directives, associated guidance and the facility’s internal policies and SOPs [standard operating procedures]’.