Decentralising research: Virtual clinical trials

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 perspective. Companies using virtual clinical trials need to ensure that records are anonymised, and that regular security audits are carried out. Educating patients on data privacy and how their data is used will help to build trust. ^[8]

The lack of face-to-face interaction and requirements to input data or to wear sensors can make virtual clinical trials challenging for participants. The organisations running the trials need to remain aware of digital fatigue and work to maintain engagement. ^[6]

Because virtual clinical trials are still relatively new, some regulatory authorities may be reluctant to accept data from less traditional endpoints or sources. This is changing, however; for example, in December 2023 the US Food and Drug Administration (FDA) issued guidance on digital health technologies for remote data acquisition for industry and investigators. [9] Companies can help the process by focusing on guidelines and best practice. Working closely with regulatory authorities not only helps companies to keep on track, it also allows them to help to shape the future development of guidelines. ^[8]

Wearable devices and sensors

Wearable devices allow researchers to collect data over longer periods of time without patients having to attend a clinical trial site. Variables that can be measured include heart rate, sleep patterns, breathing rate, temperature, oxygen levels, blood pressure, blood glucose, and activity levels. They can also measure actions specific to particular clinical trials, for examples patients scratching in their sleep in an eczema study. ^{[7, 8, 10]}

Wearables, however, do run the risk of being used by someone other than the trial participant, but researchers can get around this by requiring continuously acquired data, or identifying users through biometric characteristics. ^[7]

Telemedicine platforms 

The COVID-19 pandemic triggered a broader uptake of telemedicine, which uses electronic information and communications technologies to support healthcare outside of a clinic or hospital setting. Telemedicine platforms allow clinical trial staff to check in with patients and carry out assessments remotely, for example overall appearance, breathing rate, cognitive changes and skin changes. ^{[11, 12]}

Hybrid trials

Some trials may be too complex for fully virtual trials, and may need regular clinic visits. It still be possible to make parts of the study virtual, in order to reduce the burden on patients while maintaining close contact with the trial site. ^[8]

While virtual clinical trials do have challenges, these can be outweighed by their benefits: lower cost, quicker results and easier recruitment, as well as greater convenience for patients. They will continue to evolve and change and will help companies to bring new treatments to patients more quickly while ensuring safety. 

References 

1. National Academies of Sciences, Engineering and Medicine, Health and Medicine Division, Board on Health Sciences Policy, and Forum on Drug Discovery, Development and Translation, Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop, ed. C. Shore, E. Khandekar, and J. Alper. 2019, Washington (DC).

2. Elvidge, S., Queering clinical research. The Peakwords blog: Writing about science, 27 March 2024. Available from: https://www.peakwords.com/the-blog-writing-about-science/queering-clinical-research.

3. Elvidge, S., Why Diverse Representation in Clinical Research Matters. Pharma Sources: An eye on the biopharma industry, 19 March 2024. Available from: https://www.pharmasources.com/industryinsights/why-diverse-representation-in-clinical-r-76347.html.

4. Adams, B., Sanofi launches new virtual trials offering with Science 37. Fierce Biotech, 2 March 2017. Available from: https://www.fiercebiotech.com/cro/sanofi-launches-new-virtual-trials-offering-science-37.

5. Ranganathan, P., R. Aggarwal, and C.S. Pramesh, Virtual clinical trials. Perspect Clin Re, 2023. 14(4): p. 203-206.

6. Statistical Consultancy Team, Everything You Need to Know About Virtual Clinical Trials. Quanticate blog, 12 April 2024. Available from: https://www.quanticate.com/blog/virtual-trials.

7. Mittermaier, M., K.P. Venkatesh, and J.C. Kvedar, Digital health technology in clinical trials. NPJ Digit Med, 2023. 6(1): p. 88.

8. Staff writer, How Virtual Clinical Trials are Revolutionizing Health Research. ObvioHealth blog, 13 July 2023. Available from: https://www.obviohealth.com/resources/how-virtual-clinical-trials-are-revolutionizing-health-research.

9. FDA, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations: Guidance for Industry, Investigators, and Other Stakeholders. U.S. Department of Health and Human Services; Food and Drug Administration; Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER); Center for Devices and Radiological Health (CDRH); Oncology Center of Excellence (OCE). 2023. Available from: https://www.fda.gov/media/155022/download.

10. Ilancheran, M., Use Of Wearable And Sensor Applications In Clinical Trials Is Booming. Clinical Leader, 26 October 2021. Available from: https://www.clinicalleader.com/doc/use-of-wearable-and-sensor-applications-in-clinical-trials-is-booming-0001.

11. Chiang, A. and R.S. Herbst, How Telemedicine Can Transform Clinical Research and Practice. The ASCO Post, 25 December 2022. Available from: https://ascopost.com/issues/december-25-2022/how-telemedicine-can-transform-clinical-research-and-practice/.

12. Institute of Medicine (US) Committee on Evaluating Clinical Applications of Telemedicine, Telemedicine: A Guide to Assessing Telecommunications in Health Care, ed. M.J. Field. 1996, Washington (DC).

About the Author:

Suzanne Elvidge

Based in the north of England, Suzanne Elvidge is a freelance medical writer with a 30-year experience in journalism, feature writing, publishing, communications and PR. She has written features and news for a range of publications, including BioPharma Dive, Pharmaceutical Journal, Nature Biotechnology, Nature BioPharma Dealmakers, Nature InsideView and other Nature publications, to name just a few. She has also written in-depth reports and ebooks on a range of industry and disease topics for FirstWord, PharmaSources, and FierceMarkets. Suzanne became a freelancer in 2006, and she writes about pharmaceuticals, consumer healthcare and medicine, and the healthcare, pharmaceutical and biotechnology industries, for industry, science, healthcare professional and patient audiences.