Under the subtitle “Flying to 2020: Managing Turbulences of Innovation and Change” EUCROF together with ACRO-CZ were hosting a meeting of more than 200 attendees from 25 countries at the Prague Congress Centre.
The Day 1 was started by a Press Morning that was organized in a co-operation with the local Association of the Innovative Pharmaceutical Industry (AIFP).
The regulatory session included information on the new EU Clinical Trials Portal and ICH-GCP Addendum. It was interesting to hear that the Japanese delegation has not signed yet the revised ICG-GCP document (Step 4). This is expected to happen now, in November 2016. Implementation (Step 5), may be reached in mid 2017. The Single EU Portal should ensure that there is only one application dossier needed for each clinical trial or a modification to it, and a coordinated approach to clinical trial authorisation and supervision. An uniform procedure is to be implemented in EU both for single or multi-country clinical trials. There is to be one reporting member state and a common assessment by all concerned member states together. Clinical Trials Portal will also provide publicly available information. This system should go live in Oct 2018.
Internet of Things – and its strong impact on clincial research – this was the topic of one of the afternoon parallel sessions. Examples: Devices to measure, devices to monitor health- like various wearable devices ( e.g.bracelets). Devices reminding the patients of their medications or procedures. Devices alerting the caregivers or physicians. 3D printers for medications.
On Day 2 the most attractive session started right in the morning: Risk Based Monitoring. Traditional approach with 100% onsite SDV every 4-6 weeks used to be perceived to be the FDA’s preferred method. However, now the modern approach prevails, with the focus on critical study data and processes, flexible visit frequence following risk analysis, and combination of onsite and remote monitoring. New technologies, and avoiding issues rather than correcting issues. Despite the positive attitude of regulatory authorities we still also see reluctance of CRAs to change the approach to monitoring. In the last 2 years this has not changed, and surprisingly also the experience of CRAs with risk based monitoring has not been so widespread as it could have been expected.
The last session of the conference was dedicated to Patient-centric Approach. This approach is not focusing just on the clinical trial subject , but also e.g. on the role of so called „big data“ in healthcare. Healthcare systems produce an enormous amount of data that could be pooled, processed and used to be of a benefit for other patients – as a data bank of knowledge for physicians, as a tool to help diagnostic procedures, etc. On the other hand, patient-centric approach also includes educating representatives of patients and patient organizations to that they are able to be partners in clinical trial design and conduct.