The COVID-19 pandemic has created tremendous challenges within the clinical research landscape. While hospitals and doctors' offices have become overloaded, strict hygiene and distancing rules have been implemented to limit the spread of the coronavirus. Even though clinical research might have suffered some level of disruption, clinical research organisations (CROs) are adjusting to the situation and rising to the challenges. Responsive players and early adapters are thus the ones managing the situation successfully.
At the beginning of the COVID-19 outbreak and to provide some clarity to all parties involved in clinical trials, the European and US authorities, EMA and FDA, provided guidance documents that contain recommendations for ongoing trials to guarantee the safety of study participants and staff. Suggested measures include stopping or discontinuing the trial, pausing recruitment of new subjects, adjusting trial sample size, and performing visits online or via telephone. However, these measures may result in longer running times for trials, in loss of data and/or subjects, which may impact data integrity.
In spring 2020, the situation was that ongoing trials (trials initiated before COVID-19) were required to implement protective measures for study staff and participants to proceed. Consequently, professional study centers, such as analyze & realize, immediately implemented the necessary adjustments to address the challenges and avoid trials being suspended or stopped. An essential element in clinical trials is a successful recruitment process. Here, the impact of the pandemic on the recruitment process might be manifold; on one hand, participants might be reluctant—due to a lockdown/infection—or unable to participate in a study, on the other hand, travel restrictions might affect their ability to keep scheduled visits as planned. One might even expect that, due to the current situation, participants would be hesitant to commit to a study at all. However, and based on practical experience, once safety is assured with regards to rules on hygiene and distancing, and with confidence in the operative adjustments, once these are credibly documented and executed, participants’ interest to take part in clinical trials remains high.
As the pandemic progressed, CROs began to implement a number of measures to guarantee that clinical trials can be conducted safely in these unprecedented times. For example, to reduce the necessity of on-site visits and thereby decrease frequency and duration of personal contact between staff and study participants, CROs are making use of telemedicine, i.e. remote visits via teleconference with electronically transferred data and digital devices for collecting study data at home wherever possible. In cases where blood samples, for example, are needed, a 'flying study nurse' is sent to the participant’s home. To reduce movement and direct contact, the investigational product is mailed directly to the subjects’ homes. As far as possible, monitoring is done remotely. Furthermore, instead of hospitals or local practitioners that might allow only critical visits or refuse to take part in trials during the pandemic, professional study sites (such as SMOs) may become even more relevant in the context of clinical research.
By implementing new measures to running clinical trials, it is essential to keep in mind that all modifications need to be adequately documented and major adaptations reviewed by the responsible bodies such as Ethics Committees. Furthermore, to address the possible COVID-19 impact on the collected data, the data should be assessed using appropriate statistical models, to ensure that scientific evidence remains valid despite the implemented workarounds or protocol deviations.
Even after vaccination options become available and mid-term measures to counteract the pandemic become increasingly fruitful, international clinical trials may still be partially impacted by individual countries’ or regions’ infection rate situations. To counteract this, studies will still need to be planned in a flexible way with contingency plans in place—for example to transfer recruitment for trials as an immediate response to less affected regions, which would then reduce any possible delays in overall timelines.
It is very likely that the implementation of remote setups of study designs due to the pandemic (by using TeleVisits, eDiary, eCRF etc.) will become more relevant and routinely employed and expanded in the future. Also, other remote methods will for sure be developed. Particularly in the area of consumer health research, hybrid approaches with initial on-site visits and off-site follow-up phases will continue to gain increasing popularity.
As in other industries, responsive players and early adaptors are the ones that typically come out of challenging situations successfully. At the current status of the pandemic, professional sponsors and CROs are most likely fully operational with the execution of their trial programs. In the case of a&r, all clinical trials currently conducted at the study site are continuing and appropriate safety measures are in place. Moreover, all new clinical trials have been initiated as planned so far, and as long as infection rates are kept under control, we foresee that professional centres will be prepared to cope with the described challenges in the same way.
Ultimately, the pandemic is leading to a fast-tracking digitalisation transformation in the clinical research space. There is an increased need for investment in related tools. Clinical units, CROs, and sponsors will thus have to continuously optimise and fine-tune their risk assessment and mitigation skills to successfully shape the consumer health clinical research of tomorrow.
Interestingly, an increasing demand for clinical research is being observed as a result of the pandemic. This is being driven by consumers’ demand for products that provide certain health benefits. Thus, clinical research is essential for the scientific substantiation of product claims as well as supporting consumers’ brand trust and education.
