Changes in clinical trials during and after the Covid pandemic

clinical trials doctor

There are an increasing number of publications confirming that the Covid-19 pandemic has forever changed not only different areas of our everyday life, such as education, work or shopping, but clinical trials as well. It has shown us that there were several aspects of the practice of clinical trials where development was needed both in terms of speed and methodology, and this development could not be postponed any longer.

Let us examine the aspects that have most obviously changed.

Speed of execution and approval

It is obvious that in times of a rampaging pandemic, every delay needs to be eliminated in order to save as many lives as possible. The research and development of vaccines and drugs started in early 2020 at an unprecedented pace, and the first approvals took place in Western Europe and the United States in the very same year. This speed would have previously been unimaginable in the case of a “standard” clinical trial. There were three requirements for this transformation to occur: first of all, the research itself needed to be accelerated, secondly, the organization and execution of clinical trials had to be carried out more quickly, and thirdly, the approval procedures needed to be speeded up.

The American Food and Drug Administration (FDA), the European Medicines Agency (EMEA), and other national authorities have made tremendous efforts to make approvals happen as early as possible.

The question arises of whether there will be examples of such rapidly achieved projects for non Covid-related clinical trials too, or if this was only a one-off nudge for the industry and for the authorities involved, caused by the seriousness of the epidemic. Ideally, all the stakeholders would be able to employ the techniques that let them achieve such extraordinary speed in the future too.

New rules

As obvious as it may sound, the coronavirus has rewritten the rules of our lives – and those of clinical trials too.

For example, there has been a case in Hungary where a patient showing mild symptoms and participating in the clinical trial of a Covid drug was not able to attend an appointment prescribed in the study protocol as the patient was officially quarantined. Whoever put together the protocol could not have predicted this problem, because the possibility of a quarantine (or social distancing and other restrictions) had never been considered in any clinical trials before. In such cases, it is obvious that new rules have to be worked out. However, the question remains of whether the protocols need to be rewritten for similar circumstances, or if the restrictions should be eased for patients participating in trials.

In any case, it is clear that new considerations such as these are making their way into the planning and conducting of clinical trials. The above-mentioned case is just one of many new potential challenges that are reshaping the industry. Several 2020 publications and the new guidance of the FDA demonstrate that online visits and other remote solutions (e.g. electronically signed or photographed consent forms), that had previously faced opposition, could become necessary in both Covid-related and other types of studies.

As far as language services are concerned…

The speeding up of language services related to clinical trials is a self-evident necessity. If all researchers, those designing and carrying out clinical trials, and regulators are working at a superhuman pace, it would be nonsensical if the translation process slowed down the trial procedure. Both translation itself and linguistic validation (cognitive debriefing) had and still have to become quicker.

In the case of the latter, online interviews should be accepted too, so that all unnecessary human contact with the subjects who validate the text is avoided. And if it is possible to transfer linguistic validation from personal interviews to the online sphere, then this possibility should remain after the pandemic too.

To sum up, it can be stated that healthcare, the pharmaceutical industry, and clinical trials are all areas that have learned much about themselves and have introduced many long overdue innovations during the pandemic. We are hopeful that these lessons and positive changes will stay with us in the post-Covid world, and they will make the planning and conducting of clinical trials and the research of new drugs easier and faster. Humankind has been pushed forward many times by the need for a quick resolution to a crisis – let us hope that what we are witnessing today is just such a case.

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