Do regulations and policies undermine the social value of independent academic research?

An article discussing the challenges and providing actionable recommendations regarding current legal and regulatory frameworks for clinical research has just been published in the European Journal of Cancer by Denis Lacombe, CEO of EORTC, and Fábio Borges, Research Fellow at EORTC. 

The authors highlight significant regulatory challenges encountered during the TOPGEAR trial, which was initiated by an independent Australasian research group and conducted under EORTC’s legal sponsorship in 20 centres across six European Union (EU) countries in accordance with the Clinical Trials Directive. These regulatory obstacles demonstrate the risk of Europe losing pace with other jurisdictions, potentially depriving European patients of timely access to transformative clinical trials and therapeutic advancements. Additionally, if the EU is unable to join global public health trials, the overall performance of these studies may suffer, leading to delays in the availability of critical results. 

Reflecting on over two years of experience with the EU Clinical Trials Regulation, the authors note increased difficulties in conducting academic and independent trials, particularly due to issues with risk-proportionality, which they argue lacks sufficient attention and adaptive procedures to facilitate pragmatic approaches. Moreover, discrepancies between Member States in the interpretation and implementation of the regulation add further complexity for study sponsors.  

They argue that research on treatment optimisation, especially studies addressing the efficacy-effectiveness gap and other pressing clinical questions, should be prioritised to support evidence-based decision-making in clinical practice, particularly in oncology, where overtreatment remains a significant concern. These challenges have also been highlighted by other initiatives. 

Click here to read the article.