Clinical trials are vital as the basis of developing safe and effective drugs, but they can be slow and expensive. The patient burden can also be high - the time taken to travel to the site may be long (as many as 70% of patients may live two or more hours away from a clinical site), and this can be made worse when sites are not near public transport routes. The travel time, combined with the time spent at the clinic for visits, can result in absences from work or school, or issues with caring responsibilities. There are barriers that impact the access to a study for older people, neurodiverse people, people from the LGBTQIA+ community and people from ethnically minoritised groups. All of these can have an impact on recruitment and retention. [1-5]
One of the solutions to this could be the virtual clinical trial, also known as remote, digital, decentralised or siteless trials. These have potential to make the drug development process more efficient, more inclusive and more patient-centric, as well as widening the geographic area from which patients can be selected. [5, 6]
Virtual clinical trials are conducted remotely, with data collected from the patient wherever they are, rather than at a specific clinical trial site. The data is amassed in a variety of ways, including telemedicine platforms, and wearable devices and sensors. [1]
The benefits of virtual clinical trials
Virtual clinical trials are able to collect data at any chosen location. This can improve recruitment and retention by reducing the travel burden for patients, particularly for older people, people with mobility issues and people who live in a rural location, and avoiding time lost from work or education. Not having to travel away from home can also help neurodiverse people, people from the LGBTQIA+ community who fear discrimination, and people who feel that their race, culture or religion excludes them from studies. [2, 3, 7]
By removing access barriers, virtual clinical trials can allow researchers to access a broader and more diverse population. This creates a richer and more robust data set that more closely reflects the population that will receive the drug once it reaches the market. [6, 8]
Virtual clinical trials can reduce costs for the sponsors, by taking away the need for reimbursement of participant's travel expenses, cutting site and staffing costs, speeding up enrolment and expediting data collection. By improving recruitment and retention, they also reduce the risk that trials need to be repeated because of lack of participants. [6]
The challenges of virtual clinical trials
There are challenges to virtual trials, however, but with planning they can be overcome. Virtual clinical trials that require patients to use technology or internet access may exclude people who live in remote areas with poor signal, don't have mobile devices such as smartphones or tablets, or who have low technology literacy. The digital divide can be bridged by providing devices and internet services, either directly to patients or through partnerships with community centres or local libraries. The trial sponsor can provide the trial participants with education and training, and ensure that participants can access helpdesks to provide additional support. [7, 8]
There are data challenges associated with virtual clinical trials, and organisations entering this area need to be aware of these and ensure that they have suitably trained staff or external consultants. Virtual clinical trials produce data in large volumes, and this requires skills in data handling and analysis, as well as in standardising the data across the digital platforms and devices. [6]
Data quality cannot be controlled as closely as in an on-site clinical trial - for example, the patient may not wear the device correctly, or the data supply may be interrupted for charging or if it has to be removed for showering or bathing. Patients may also forget to pass on information about taking other medications. [6, 7] This must be taken into account in data analysis.
Data from clinical trials is highly sensitive, both from a business and an ethical...
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