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A look at the issues in Europe affecting ongoing trials including data management, measures being taken by sponsors, and more.
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.
Below, we focus on the implementation of clinical trials in Europe. We address the issues affecting ongoing trials; including data management, compliance with protocols, measures to be taken by sponsors, and the recommendations and regulations imposed by the authorities. We also look at the challenges surrounding the opening of new trials, including trials for COVID-19 treatments and vaccines.
Some of the problems encountered in ongoing clinical trials due to COVID-19 include:
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 harmonization. Regulatory flexibility has been increased although this is not meant to be continued permanently. The driving principle when adjusting the conduct of clinical trials is the implementation of a proportionate response, based on a risk-benefit assessment, where patient safety is always the first priority.
The pandemic has also led to the increased use of digital technologies, such as virtual inspections, 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.
Guidance issued by the European Medicines Agency (EMA), the Heads of Medicines Agency (HMA) and the European Commission1 has allowed sponsors to take relaxed measures to adapt the conduct of ongoing clinical trials to overcome Coronavirus-related challenges without always having to notify or request authorization from competent authorities.
As an overarching principle, sponsors should always strive to ensure compliance with the protocol to the highest level possible when setting up exceptional measures.
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)
Most competent authorities, in line with European guidance, have announced they would give priority to trials on treatment or prevention of COVID-19, or on serious diseases without satisfactory treatment options (unmet medical needs). It is true for example in France where the Ministry of Health has put pressure on Ethics Committees to deal quickly with COVID-19 trials.
In order to facilitate the launch of clinical trials relating to COVID-19, authorities have allowed enhanced communication with them, as well as expedited authorization procedures for initial assessment of authorization requests. Regulatory flexibility with regards the collection of patients' consent has also been allowed (e.g., oral consent with a witness, electronic signature, etc.).
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 prioritize 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.2 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.
Olivier Lantrès is the Co-Head of Life Sciences, and Alexandra Lauré is an Associate of Life Sciences; both of Fieldfisher