Industry pushes forward with using interactive technology in clinical trials
EMA assesses several hundred responses to reflection paper on its use
The European Medicines Agency (EMA) has assessed several hundred responses from the pharmaceutical industry to a 'reflection paper on the use of interactive response technologies (interactive voice/web response systems or IRT) in clinical trials'.
EMA said the intention of the paper and the consultation was 'to provide the current thinking of the inspectors working groups on the use of interactive response technology systems, with particular mention of the removal of expiry dates from investigational medicinal product'. The exercise stems from increasing use of IRT through telephone or tone diallers and interactive web response systems (IWRS) using the Internet. These were originally developed to optimise drug availability at sites, however the practice has extended into other areas such as emergency unblinding (code-breaking), dose titration and expiry date updating.
If not handled appropriately this could pose an increased risk to the patient, said EMA, noting that sponsors had previously contacted regulatory agencies with requests to omit the expiry date on study medication in the case of IRT use 'and this raises concerns for regulatory authorities'.
Responses were received from 16 industry companies, associations and agencies, including AstraZeneca, Celgene and GlaxoSmithKline and the International Federation of Associations of Pharmaceutical Physicians (IFAPP), the Association of the European Self-Medication Industry (AESGP) and the European CRO (clinical research organisations) Federation (EUCROF).
Many of the observations involved wording and terminology. The EMA accepted many of these, indicating that the paper had been revised, although many were rejected. In many cases the agency said that the paper 'presents the current consensus'.
In conclusion, the Agency said 'it should be noted that this is a reflection paper and does not constitute guidance as outlined in European or national laws'.
The EMA published an ‘Overview of comments received’ in February.