09.00, Wednesday 23 January 2019
This FORUM workshop, held alongside the Medical Research Council, the Medicines and Healthcare products Regulatory Authority and the National Institute for Health and Care Excellence, examined the rapidly developing landscape of new clinical trial designs. New trial designs are emerging to tackle some of the challenges emerging in the clinical research environment, such as the high costs and often very lengthy timescales of traditional randomised controlled trials (RCTs), small population sizes such as in the case of rare diseases and stratified medicines, and the drive towards accelerating access to new therapies. Novel trial designs may also be needed to evaluate complex interventions or outcomes or mirror findings in real world conditions using adaptive models and new statistical techniques.
However, the acceptability of these new trials for regulators, health technology assessors and commissioners and, and where they might best be applied (as well as their limitations), needs further clarity.
Therefore this workshop explored the recent developments in novel trial design, determining how they might best be applied to research, and to discuss their acceptability across key stakeholders to better understand their expectations. In addition, it looked to identify potential future developments so that regulators and others can be prepared for these new designs.
This workshop took place on Wednesday 23 January 2019 and was invitation only. To discuss this workshop further please contact firstname.lastname@example.org.
The meeting report of this workshop has now been published and can be found on the right hand side of this page.