Impact on Trials in Europe after COVID-19?

On the eve of International Clinical Trials Day on May 20, a panel of European experts reflected on the impact so far of the COVID-19 outbreak on clinical trials-and, crucially, on what impact it may have on the future of clinical trials everywhere.

The new focus on promoting investigation to counter the pandemic is giving hopeful signs of some positive results, with European guidance assisting in speeding clinical trial authorizations. But at the same time negative impacts are also being felt on existing trials, with postponement, suspension, or premature termination in the face of the administrative and resource limitations, imposed by the ‘new normal’, despite parallel guidance aimed at minimizing or mitigating the downsides.

For Nicola Bedlington, a leading European spokesperson for patient interests, one of the evident impacts so far had been to generate anxiety and uncertainty among patients already on-or seeking participation in-trials for other conditions for which no alternative treatment exists. For them, trial suspension means treatment suspension, she pointed out, arguing for more and better information on a reversion to normal conditions.

This reversion to ‘normal conditions’ is-like COVID-19 itself-still a black box of mystery. EU member states, who retain most of the controlling levers on clinical trials in Europe, had to be persuaded by experts and agencies to agree on the temporary arrangements allowing new flexibilities, such as remote source data verification and administration of trial medications away from trial sites. But although the guidance is explicitly time-limited, there is at present no clear view of what point it will cease to apply.

European Commission official Kristof Bonnarens said the guidance had been adopted by consensus, and its terms provide for it to cease to apply by consensus when the COVID-19 crisis is over-but that is something that no-one is in a position to predict at this stage. Bonnarens said that it is likely the timing of the exit strategy from the temporary guidance would vary in line with the speed each member state decided it had the domestic situation sufficiently under control. But he expressed the hope that it would occur over a transitional period that would be broadly similar across the EU.

Meanwhile, he wished to assuage anxieties over any temporary prohibition of the start-up of trials in non-coronavirus indications: other clinical trials can still be initiated in serious indications where no other form of treatment is available.

The other aspect of ending the temporary regime that remains an open question is how far any of the flexibilities introduced-and which may have demonstrated their merits-will be retained on a permanent basis. Some of the temporary streamlining of regulatory processes that the guidance has allowed and even promoted could help to optimize research and development practice and clinical investigation in the post-pandemic era-notably in terms of novel clinical trials approaches, decentralized trial designs, greater reliance on real-word evidence, and digitalized data. 

As Cesar Hernandez Garcia of the Spanish medicines agency put it, the COVID-19 Fchallenge could lead to faster moves subsequently on discussions that are already underway on improving clinical trials.