Innovating clinical trials: a rich menu of options in which early dialogue will identify acceptable and feasible approaches
RSNN – Workshop 2019 – Key Takeaways
On 17 April 2019 the Regulatory Science Network Netherlands (RSNN) organized its fourth annual workshop. This edition focussed on “The future of clinical trials and evidence generation, and their use in regulatory decision making”. The multi-stakeholder event offered an opportunity to discuss and identify factors driving the need for innovation in clinical trials by exploring currently available and future options.
Given that the gold standard for clinical trials, the randomised controlled trial (RCT), does not work for some diseases and subsets of patients, and therefore cannot always be used to assess if a (innovative) medicine is safe and effective, there is a clear necessity for innovation in clinical trials. During the workshop, factors that drive the need to transform clinical trials were discussed, taking into consideration scientific innovation, societal changes and more strict regulations. Several options that can facilitate this transformation also passed the stage, such as academia helping with designing trials that answer a specific research question, using real-world data or evidence in pre- and post-marketing studies, and re-assessing the current rules and regulations to identify areas that allow for more regulatory flexibility. An early dialogue with all stakeholders is necessary to identify which study approaches are acceptable and feasible.
A short report of the workshop is published here. The RSNN will use the conclusions of this workshop to further explore this topic and to formulate new research questions. Outcomes will be published in relevant peer-reviewed journals.