Further harmonisation of clinical trial regulations to advance research on COVID-19

The need for safe and effective COVID-19 treatments requires the capacity to conduct multinational clinical trials to test and compare existing and new therapies and vaccines. In light of this, the OECD published a Policy Response on 4 August 2020: “Greater harmonisation of clinical trial regulations would help the fight against COVID-19”.

The nature of the COVID-19 pandemic has led to unprecedented changes on a global scale with most national and regional regulatory authorities fast-tracking clinical authorisations for COVID-19 clinical trials. However, the lack of harmonisation in the regulations across countries has led to delays in implementing large multinational clinical trials. The brief examines how the two large international trials, Solidarity and Discovery, have been able to overcome some barriers and what difficulties remain.

Furthermore, it highlights how existing national regulations and administrative requirements for the testing of new treatments and unknown risks to patients do not reflect the requirements for drug repurposing. The latter often attract less commercial interest and tend to be publicly funded, academic trials.

Difficulties in conducting multinational clinical trials are not new. The OECD 2012 Council Recommendation on the Governance of Clinical trials was developed with the objective of instating a new harmonised regulatory framework while promoting a risk-based governance. The Clinical Research Initiative for Global Health (CRIGH) was launched in 2016 by 40 international partners to address the bottlenecks in streamlining multinational clinical trials.