The COVID-19 pandemic bears a burden to the clinical trials sector, which is not easy to manage and a negative impact on the trials themselves cannot be avoided. The effects of the pandemic must be taken into account by investigators, when they analyse and interpret their trial’s data, as study outcomes could be affected. On the bright side, measures to counteract the negative impact of the pandemic, made it possible for innovations to be introduced, which could have a profound role in advancing clinical research. After all, we had two waves of COVID-19 already and it is clear that this virus is not going away anytime soon. Adapting our life around it is the only option for the foreseeable future.
In both of the pandemic waves, most of the countries took measures to hinder the spread of the virus, with lockdown being the most notorious one. A proportion of the population might have opposed this measure, but in the absence of a suitable vaccine or therapy and taking into consideration the low adherence of the population to other measures of restraining the spread, this was a one-way option. A restriction, at best, came to the ability of the population to go to physicians’ offices, clinics or hospitals. The healthcare sector had to reduce the number of people seeking in-person consultations or receiving treatment on healthcare sites for a number of valid reasons. Some of them include the increased risk for patients, some of whom might belong to a vulnerable group, who visit healthcare infrastructures, the protection of healthcare professionals (HCPs) from unnecessary exposure to risk, the conservation of much-needed resources such as personal protective equipment (PPE) and of course making more HCPs available to deal with the strain COVID-19 imposes on the healthcare system.
The down side
As part of the above restrictions, clinical trial sites were also impacted. Staff might have been pulled out to support other departments, sites might have closed down due to a positive case among the staff or simply because it was not feasible to keep them open under all the restrictions. Of course there is always the patient side, as many cannot or are unwilling to travel to the clinical trial sites. Not to mention disruption in supply chains and availability of equipment and other support staff.
A research was conducted during the first pandemic wave and found that globally there was a 38% increase in the suspension of clinical trial sites. This peaked in June 2020 and after a short drop, it is on the rise again; at the moment more than 28,000 sites are closed. Another study identified 1,052 suspended trials during March and April 2020, of which 905 reported COVID-19 as the reason for their suspension.
Recruiting for clinical trials has been another important issue, as most sites are unable to do so due to the various restrictions imposed by the lockdowns. Moreover, there are not enough patients willing to commute to a clinical site during the pandemic, despite the fact that there are many out there willing to participate in a study. According to the first research mentioned earlier, recruitment between the two waves recovered to levels similar to those before the pandemic. It is notable that, despite some sites note reopening, and maybe they will never do so again, many new sites appeared, indicating the mobilisation of sponsors to mitigate the effect of COVID-19 on their studies. The need for those studies to move forward, perhaps has led to a selection of investigation sites that could be without adequate evaluation and systematic analysis. Current analysis of the clinical trials status will be reassessed, most probably towards the negative side, once contract research organisations (CROs) release their COVID-19 data.
Not all looks grim
On the bright side, COVID-19 impact coupled with the need for research and clinical trials to move forward, pressed for fundamental changes and made them possible. One notable example is how administrative procedures (i.e. preparation, review, approval) sped up from the usual “snail” pace, in order to meet current needs. Hopefully this will remain once this crisis is over, provided there is adequate quality and safety. Moreover, other processes, like contract creation, budget allocation, treatment initiation of enrolled patients, etc. have also been accelerated. Multidisciplinary teams monitor patients, not only in the clinical trial setting, but also at home. The need for such teams was becoming apparent for other diseases even before COVID-19 and now this looks like it is going to be the new normal for everyone, in the future.
Recruitment of patients seems to have found new ways to move forward, as more and more telemedicine and telemonitoring is being used in patients’ and HCPs’ everyday life and work. Physicians and investigators “visit” their patients virtually thanks to a variety of available platforms, both general and specialised for the healthcare community. Phones, emails and other electronic portals are also being used.
Self-testing and self-administration of treatment, or through a family member/caregiver, makes the uninterrupted participation in a trial a reality. Monitoring apps that can send real-time data to investigators are also on the rise and a great solution for the follow ups needed. Specialised services are being developed to deliver necessary resources to patients, while operating safely within a pandemic environment and retrieve samples or other monitoring logs from patients. Such services can drive clinical trials forward despite the circumstances and could remain after the pandemic is over.
A short article cannot be exhaustive on the impact of COVID-19 on clinical trials, as this is still an evolving situation and there are many aspects of this topic that one can look at. Addressing the urgent needs for COVID-19 research and at the same time maintaining adequate clinical research levels for other health conditions, is of paramount importance and a significant challenge.
Quality clinical research must be maintained at all costs, but this cannot be done without adequate patient participation. By implementing proactive measures and answering patients’ questions about clinical trials, it is possible to maintain their interest and engage with them in a clear and meaningful way. The modern era has seen many pandemics and disease outbreaks, even if most of them were not global, rather confined to regions or small areas. The experience, though, and know-how that the scientific community has earned from them, partnered with the evolution in technology, can help to introduce rapid, robust, durable and innovative responses that will carry clinical trials into the future. After all, the first virtual, indication-seeking clinical trial is already here (CHIEF-HF, invokana)!
#COVID19 #clinicaltrials #clinicalresearch
Sources
Impact of COVID-19 on clinical trials continuing, say researchers
Impact of the COVID-19 pandemic on clinical research