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Compared to traditional study models, the strength of the virtual trials concept is the ability to make it easier to include patients from diverse regions, rural areas and different socio-economic backgrounds in clinical trials.

Marko Niketic
Marko Niketic
Global Regulatory Affairs Specialist, Global Regulatory Clinical Services

By eliminating the need to travel certain distances and reducing the discomfort and cost associated with that, patients from rural areas and those coming from unfavourable socio-economic backgrounds will more likely participate in the trial. Being able to receive treatment in a comfortable space, a patient’s home, can make patient retention rates significantly higher.

As an example we can take rare diseases. These affect 1 person per 2.000, or less, and this can be a big challenge when it comes to clinical trials for many reasons. Reaching the required sample size when the patient population is so low is a huge challenge, and possibly having that population spread across a vast geo-political area just adds to complexity. Also, in certain cases treatment and/or site visits, need to be done abroad which poses a challenge not only from the logistical and financial points of view, but also from the bureaucracy and regulations associated with being treated abroad.

Another good example is COVID-19, which is something we have all experienced recently and clearly understand the difficulties and challenges it brings when it comes to clinical trials. COVID-19 pushed the concept of the decentralized trial into focus more than ever before due to the possibility to be able to overcome situations like this and ensure study continuity and patient safety no matter of the patient’s location and restrictions. We hope that in the near future this will become standard and the norm for our industry.

Using virtual channels (e.g. social platforms, targeted e-advertising, etc.) grants greater access to the wider population making it easier to reach out to target populations and can result in faster recruitment. This can be a challenge if the targeted population is elderly, and not that familiar and comfortable with technology, however in a world that is advancing in this field this should be less and less of a challenge and concern moving forward.

This new approach obviously requires strong technological support, but still it is estimated that overall costs are significantly lower showing this as another major benefit compared to traditional trials. Compared to traditional multi-site trials, virtual trials will have a reduced number of sites and study staff resulting in significantly lower operating costs. Recruitment in traditional models tends to be a lengthy phase of a study. The potential of virtual trials to significantly shorten the recruitment phase compared to traditional models can have a significant impact on all costs associated with trial duration.

In virtual trials data is gathered electronically and transferred remotely enabling the principal investigator and their team to have better oversight. Also, unlike within traditional models where data is collected during site visits, in virtual trials data is gathered constantly and transferred in real-time allowing a more holistic and objective analysis and conclusions. Dealing with high amounts of data, on the other hand can be challenging from the perspective of gathering, storing and analysing it.

The technology needed to support virtual trials should make the job simpler for researchers in terms of relieving them from administrative tasks and enabling them to be focused on patients. On the other hand patients need to be trained to use all these digital tools and be provided with support when needed, which can add burden to the study team. Underlying technology should enable easier communication between patients and trial staff, and within trial teams, but, with so many technologies involved it is also a challenge to ensure everything works as it should at any given moment in order to provide complete, reliable, meaningful and robust data.

PRA Readiness

PRA is already conducting virtual trials for our clients, currently counting over 40 virtual and hybrid trials globally, totalling over a million patients in over 30 countries. We at PRA developed the Mobile Health Platform - MHP (formerly known as Clinical6) as a multi-language multi-country end-to-end solution that leverages the power of mobile technology to increase the speed of research and provide paperless, near real-time, secure interactions. This allows clinical data to be collected, transmitted and reviewed in a validated and structured manner for all stakeholders in clinical trials. There is no another solution like this end-to-end solution out on the market.

MHP can be accessed by using any internet enabled device, and the intention is to transform traditional clinical trials into a fully virtual setup by enabling participants to qualify, consent, enrol and engage in a clinical trial by using this technology from anywhere in the world. Also, MHP enables all parties involved in a clinical trial, including participants, to collaborate by using this mobile platform. Specific workflows have been implemented within the platform in order to provide guidance to participants through important clinical processes and by doing so to improve retention, engagement and clinical outcomes. Try out our Mobile App Solution and Study Dashboard Solution Prototypes here.

In terms of pure virtual studies where a patient never engages with a physical site, the top challenges as observed by PRA are 1) the comfort of the industry in terms of data collection being handled by different means, 2) that certain assessments, procedures, examinations, etc. still have a component to them that require a physical interaction with a medical doctor, and finally 3) regulatory restrictions in certain countries that restrict the use of technology such as eSignature.

Here at PRA we continue working to improve the structure and platforms to be used in clinical trials, always with the objective of more easily involving patients in clinical research and ensuring their safety by working within established regulatory frameworks and, when necessary and applicable, collaborating In its development.

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