Evaluation of the utility of Irish health and social care datasets for use in clinical trials

Clinical trials traditionally collect lots of data which are used to test whether a treatment works and is safe. Collecting the data is time consuming and expensive. Recently, clinical trials have started to move towards more efficient design, which can save time, effort and cost. One way to do this is to replace traditional data collection by accessing data that is already collected within the healthcare system. Several countries around the world
have used this approach very successfully, allowing trials to take place that would never have been possible with traditional methods of data collection. However, this approach relies not only on what variables are routinely collected in healthcare datasets, but also on the quality of the data, the ability to link different datasets and how quickly and easily the data can be accessed. It is known that healthcare datasets in Ireland are less well developed and more fragmented than in many other countries. We plan to use a tool – the HDRUK data utility framework – to objectively assess existing Irish healthcare datasets. We will apply the tool to the catalogue of routinely collected datasets managed by the Health Information and Quality Authority (HIQA) in Ireland. This will provide information on the current infrastructure in Ireland to support next generation clinical trials and will support individual researchers in understanding the potential of existing datasets to support planning of new trials.

The researcher will be available for contact with the PPI contributors involved at any stage during the project. This can happen via email, telephone, online or face to face meet ups outside of the regular PPI meetings, at the preference of the individual involved. A terms of reference will be co-created with those involved- this will be addressed in the terms of reference and a process that works for everybody will be developed.   The Galway PPI Ignite team will provide any supports they can to the PPI contributors, if other supports are required we will explore how best to provide these supports e.g. keeping an eye out on the calander of events for training opportunities, contacting other colleagues who may be able to provide the support. Each PPI panel meeting will be facilitated by two facilitators. The plan for managing conflict will be created with the PPI contributors involved and referred to in the Terms of Reference