Virtual Clinical Trials (also known as Decentralised Trials and Siteless Trials) bring clinical trials directly into the participant’s home via a central and virtual coordinating site. Vital equipment like the Investigational Product, and wearables are delivered to the participant while support by study physicians and pharmacists is offered via video conferencing. Mobile health applications and telehealth technologies are used to collect medical data from participants and transmit it to the central study centre.
Virtual Clinical Trials have been getting more popular since the COVID-19 pandemic, in response to the adaptations and the contingency plans which have impacted every industry, including the medical and research one. As technological advances continue to be made, it is likely that Virtual Clinical Trials will continue to be utilized long after the COVID-19 pandemic has ended.
Virtual Clinical Trials provide unique opportunities and benefits which include:
Improved Participant Recruitment
Removing the need of a physical clinical trial site that participants have to travel to is a huge positive for patients who live in rural areas or who are unable to travel due to serious illness. Removing these barriers means that more people are able to be recruited, resulting in a more diverse patient population and increasing the quality of data collected.
Using higher quality data allows the clinical trial staff to have a better understanding of the type of patient populations that can be enrolled in clinical trials which can lead to a more realistic inclusion and exclusion criteria and improve participant recruitment and retention.
Materials Delivered to Particpant’s House
All the materials needed for the clinical trial including the Investigational Product, and wearables are delivered directly to the participant’s house meaning that in most Virtual Clinical Trials, participants don’t even need to leave their house to take part in a clinical trial.
Virtual Clinical Trials don’t need physical sites for study procedures, a full staff or storage facilities. Grant payment for Investigators also decreases considerably bringing down the overall cost of a clinical trial.
Higher Data Quality
The majority of the data is transferred directly from smartphones or wearables (Apple Watch and Fitbits, etc) to the clinical database, instead of having to rely on clinical trial staff to transfer the data from various documents to the clinical trial database where data could potentially be lost or accidentally edited.
Having a diverse range of participants also makes the data richer and of a higher quality.
Easier Communication with Clinical Trial Physician/Staff
Using technologies like smartphones and wearable devices allow participants to easily connect with the clinical trial physician in more ways than ever before. This communication improves healthcare and health outcomes of the clinical trial and makes patients feel secure while participating from home.
Participants Feel More Comfortable
Participants naturally feel more relaxed taking part in a clinical trial from the comfort of their own home. This boosts participant engagement and decreases the risk of participant withdrawal from the clinical trial.
The ongoing advancement of digital health technology which drives new discoveries and developments in the healthcare industry has also made the extension of healthcare beyond medical institutions and into homes possible. This technology will continue to transform the healthcare industry and improve the care of patients no matter where they are.
Despite Virtual Clinical Trials becoming more popular, there are still challenges that have to be navigated as the trial physicians and participants adjust to this new type of clinical trial. These challenges include:
The use of an Electronic Informed Consent (eConsent) form, (a digital consent process which clinical trial participants complete before their enrolment in the clinical trial), can be challenging as a participant can’t directly ask questions while filling out the eConsent form. When they aren’t interacting face-to-face, clinical trial staff can’t really be sure that participants have been fully informed.
Language and Cultural Barriers
Language and cultural barriers may cause some issues with virtual communication between participants and clinical trial physicians.
General Communication Barriers
It is harder to tell online if a participant is feeling confused, unwell or hesitant about certain aspects of the clinical trial.
Although virtual communication and technology has undoubtedly made our lives easier, it can’t fully replace the face-to-face communication and human interaction that is especially important in the medical industry.
Learning How to Use the Technology
Participants have to learn how to use the technology and software that is a vital part of Virtual Clinical Trials. This can be time-consuming and extra stressful, especially for elderly people and those who aren’t technologically savvy.
More Responsibility for Participants
Participants are solely responsible for receiving the Investigational Product, completing all the necessary study assessments and for learning how to use all the devices and software.
Participants have their personal medical data transmitted directly over the internet which has the risk of being hacked or accessed by unauthorised people. Sponsors need to inform all participants of this potential risk in the Informed Consent form.
If any of the data is breached, there needs to be a clear plan in place for dealing with the issue and notifying the participants and the Trial Sponsor.
Some clinical trials require tests and medical procedures which need to be carried out by a medical professional in a medical setting. Therefore, it isn’t possible for all clinical trials to be conducted virtually.
The rising popularity of Virtual Clinical Trials brings with it new opportunities and challenges that participants and clinical trial staff are facing and learning about together.
Having a hybrid approach to clinical trials might be the best way forward, as it will combine both the benefits of having a Virtual Clinical Trial and in-clinic ones. Participants have the opportunity to undertake medical tests/procedures and interact face-to-face with clinical trial staff, while still being able to largely participate in the trial from the comfort of their own home.