Guest Blog | Will Covid-19 herald a new era for clinical trial research across Europe?
Clinical trials are an essential part of getting new treatments from lab to patient but during the COVID-19 pandemic, trials for treatments outside of COVID-19 had been heavily disrupted. However, in light of all this immediate disruption there have been claims that the swift action taken to produce a vaccine and the adoption of technology could set a positive precedent for the future of clinical trial research.
Impact of COVID-19 on ongoing clinical trials
Some of the problems encountered in ongoing clinical trials due to COVID-19 include greater difficulties in patient recruitment, tensions between stakeholders concerning payment (including CRO/sponsor), management of participating patients who test positive for COVID-19, an increase in protocol deviations, compliance with local government regulations related to COVID-19 (e.g. protective measures), and interruptions or terminations of clinical trials.
The response from authorities concerning ongoing clinical trials has been to issue specific recommendations at both the European and national level, with the goal of providing clarity and harmonisation. Regulatory flexibility has been increased although this is not meant to be continued permanently.
The pandemic has also led to the increased use of digital technologies, which can be used to meet reporting requirements. However, there is no certainty as to whether these elements will stay. In fact, many regulators have said they will be returning to usual protocol.
What about new clinical trials in the context of the current pandemic?
Under European guidance, it is still possible to open new clinical trials. However, these new trials should only be initiated if the sponsor has deemed it feasible, and if there is a need for the trial to be completed as soon as possible. Additional risks related to COVID-19 must of course be taken into account for participating patients (benefit/risk section of the protocol)
The future of clinical trials across Europe
Progress is being made to restart clinical trials that were paused or delayed due to the pandemic. Most of the issues that caused delays to trials were due to patient enrolment issues and availability of test sites, due to having to prioritise the pandemic. However, for those trials that were able to continue, we saw how technology was revolutionary in allowing them to progress. The use of digital technology, such as wearables, virtual inspections and apps meant that players involved from sponsors and clinicians to regulators were forced to embrace technology. But will this become the norm? Regulators across Europe have announced that they hope to return to normal from mid to late 2021 and also the Clinical Trial Regulation issued in 2014 is about to be enforced, despite the fact that it does not take into account the possibility of the brand new IT tools in the context of clinical trials, in particular during pandemics
Thus, it shows that there will still be a journey ahead for pharmaceutical companies and other businesses involved in the process to get technology firmly embedded into the clinical trials process.
Authors: Olivier Lantres, Co-head of life sciences at Fieldfisher
Alexandra Laure, associate, regulatory at Fieldfisher