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Virtual clinical trials and the impact of COVID-19

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Virtual clinical trials and the impact of COVID-19

COVID-19 has altered the way the medical research world operates as researchers strive to find innovative ways to deliver and assess novel treatment options safely.

The clinical trials sector is just one of the many sectors that has been forced to evolve quickly. For many vulnerable patients, leaving the safety of their home to receive treatment or for appointments is not an option given the virility and severity of COVID-19.

Established digital technologies have been able to facilitate virtual clinical trials, also known as decentralised trials, for a while now. However, COVID-19 has played a valuable role in bringing this method to the fore in clinical trial contingency plans during the pandemic lockdown. Patients now have the option to receive and be given instructions on their treatment remotely, and not be exposed to threats such as COVID-19 while on the way to the trial site or their doctor.

During this pandemic, there are trials that are finding the transition into the virtual format easy and efficient, while others are questioning the need for the trial to run remotely or even at all (Quenqua, 2020). In fact, many trials have been cancelled or put on hold during COVID-19.

As technology advances and virtual clinical trials become more feasible and attractive, there are still many questions about whether this digital method is beneficial or damaging in delivering results. This blog will explore some of the advantages and disadvantages of virtual trials.

Advantages of Virtual Clinical Trials

One of the most notable advantages of virtual clinical trials is its flexibility and adaptability. While traditional trials require those participating to make regular visits to the trial site or hospital, virtual trials do not. This opens up the possibility of creating a more diverse and a larger geographical reach.

With virtual clinical trials, researchers can recruit patients, obtain informed consent, administer treatment, monitor safety and assemble data without the patients ever leaving their home (Quenqua, 2020). By consequence of this advantage, these trials also become cost-effective and efficient as patients do not have the burden of travel and time demands. Individuals in regional and rural areas wishing to take part in a trial will no longer have the issue of distance, as they can participate in the trial from their home.

This cost-effectiveness is also derived from a shorter recruitment phase due to a larger pool of potential participants, improved data quality, and medicines becoming more personalised for patients (Smythe, 2019). Data quality is improved by the efficiency of data transfer from smartphones or other electronic devices, rather than depending on site staff to transfer data from source documents to databases (Smythe, 2019). While medicines are personalised through their delivery to the home, with informed decisions made by doctors from patient reports.

Also drop out rates are lower in virtual clinical trials compared to traditional trials, as time and travel is one of the main reasons for drop out (Ali et al., 2020). Dropouts can cause trials delays and added expense, which can be avoided by executing the trial virtually (Quenqua, 2020).

Disadvantages of Virtual Clinical Trials

The most obvious issue with virtual clinical trials is that not everyone has access to the necessary technology, such as a smartphone or a strong and stable internet connection (Moving Towards Virtual Clinical Studies, 2018). Sponsors and CROs running virtual trials will need to ensure each participant has access to the technology that they need before starting the trial to avoid unnecessary dropout and further expenses.

However, the main concern associated with virtual trials is the level of responsibility of the patient. Patients become in charge of their health and actions during the trial, having to know how to receive and take or enact the product or intervention, how to complete study assessments as well as being able to know how to troubleshoot any technical problems (Smythe, 2019). Although this is a significant disadvantage, it can be mitigated through participant training before the trial begins. However, this can then become time-consuming and costly.

Furthermore, there is also the issue of not being able to properly assess and monitor a participant’s quality of life (The National Academies of Sciences, Engineering, Medicine, 2019). Being able to physically interact and examine a patient is sometimes crucial to picking up small details that one may miss virtually. Although email, phone calls and live chat is available, a lack of in-person support could affect the choice of participation in a trial (Moving Towards Virtual Clinical Studies, 2018).

Additionally, one of the most common issues with conducting research online is maintaining the data privacy, security and protection of those involved, as large amounts of sensitive data are being shared online between those conducting the trial and those participating (Moving Towards Virtual Clinical Studies, 2018). Researchers need to ensure that patients are aware of the risks of data breaches during the process of obtaining consent (Smythe, 2019).

The Overall Evaluation

To conclude, there are numerous advantages to virtual trials from cost-efficiency to patient convenience to increased geographic and patient reach. But some challenges need to be addressed, including data security, patient responsibility and trial training, before virtual clinical trials can fulfil their promise and potential. Even though COVID-19 has accelerated the adoption of virtual trials, considering the overwhelming challenges, the traditional model is not expected to disappear anytime soon.

References.

Ali, Z., Anderson, K., Chiriac, A., Andersen, A., Isberg, A., Moreno, F., Eiken, A., Thomsen, S. and Zibert, J., 2020. High adherence and low dropout rate in a virtual clinical study of atopic dermatitis through weekly reward-based personalized genetic lifestyle reports. PLOS ONE, [online] 15(7), p.e0235500. Available at: [Accessed 17 July 2020].

Avigna Clinical Research Institute. 2018. Moving Towards Virtual Clinical Studies. [online] Available at: [Accessed 16 July 2020].

Quenqua, D., 2020. Virtual Clinical Trials Now Being Used To Fast-Track Drug Development During Coronavirus Crisis. [online] CNBC. Available at: [Accessed 16 July 2020].

Smythe, S., 2019. The Benefits And Challenges Of Siteless Clinical Trials. [online] Clinical Leader. Available at: [Accessed 16 July 2020].

The National Academies of Sciences, Engineering, Medicine. 2019. Virtual Clinical Trials: Challenges And Opportunities: Proceedings Of A Workshop. [ebook] Washington: The National Academies of Sciences, Engineering, Medicine., pp.1-4. Available at: [Accessed 16 July 2020].

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0235500