Complex studies are those studies that are more difficult to develop and design, to recruit for and to evaluate once the clinical trial has completed. The subjects are from populations that are typically vulnerable because of the potentially complex interventions required, the lack of treatment options, the use of more novel compounds, the difficult choice of comparators/use of placeboor it could be that the outcomes are more difficult to measure. These types of studies include rare diseases/orphan indications, trials in paediatric populations and oncology studies.

Quality and innovation may not always go ‘hand in hand’, whilst they may be related they are not always complimentary. Innovation is today’s ‘buzz’ word but this needs to be carefully considered and systemically incorporated for it to be successful. Quality and quality improvement practices continue to play a significant role in clinical research ensuring subject safety and data integrity.

This EFGCP workshop will look at innovation whilst considering regulation by taking a look at current regulations and their impact in these types of studies; the use of big data and the impact of technological advances as well as gene profiling in oncology studies and finally requirements for laboratories who take part in clinical research. Quality management focuses on remote audits and their challenges as well as preparation and management of research units who will run complex studies.