COVID-19 has created lasting impacts for clinical trials worldwide. Many pharmaceutical companies have had to rapidly implement innovative solutions to allow their clinical trials to continue, including adapting various aspects to be carried out in the safety of a patient’s home. Virtual and hybrid clinical trials have quickly become a necessity.

A host of benefits have arisen from the adoption of virtual clinical trials. The reduced number of site visits can decrease site burden, remove barriers to participation, and widen the pool of eligible patients. With these advantages, it is clear that decentralized clinical trials will continue to be a viable option beyond the pandemic. Although it is not realistic to assume all clinical trials can be made completely virtual, it may be suitable to implement aspects of virtual trials as a hybrid approach. Notably, dermatology trials can be particularly well-suited to a hybrid virtual trial design. Dermatology assessments are often less complex than other therapeutic areas, and the visual aspect of evaluating and identifying skin conditions is adaptable to virtual models.

Furthermore, as dermatology conditions are rarely life-threatening, patients are more likely to engage with trials if they can work around their other commitments, and virtual trials bring more convenience than traditional approaches.

Methods and tools to help adopt a virtual approach

Patient recruitment during and beyond a COVID-19 world

Adopting a virtual approach starts with enrollment. Currently, patient recruitment is the single biggest cause of delays in clinical trials, leading to lost revenue for pharmaceutical companies.¹ As we know, it is important for clinical trials in dermatology to have a digital recruitment presence. This is partly because more than 80% of internet users turn to the internet to find healthcare information, including millions of searches a month on eczema alone.¹ Now, with reduced face-to-face healthcare interactions as a result of the pandemic, it’s essential that digital patient recruitment strategies are carried through to virtual trials in order to widen the pool of potential participants. It is also important to share relevant information with potential participants, such as the study duration and procedures involved, which can be done virtually. Patients visiting web pages and recruitment ads can be redirected to nurse call centers where they can receive guidance on completing online pre-screening questionnaires and further information on the study. Following these calls, nurses can then refer the patient to study sites to determine their eligibility.

Patient data collection from the safety of patients’ homes

Initial screening assessments can often be done virtually, and throughout the clinical trial participants can continue to record clinical data from home. By using data collection tools, such as eDiaries, on patients’ own devices, data is captured in real time and can be sent straight to site staff. Not only is this more convenient for the patient, but it can increase data quality and allows study sponsors to instantly access study trends. This is important in dermatology studies as patient-reported quality of life data are generally used in combination with disease-specific instruments, such as the Psoriasis Area and Severity Index (PASI) and the Eczema Area and Severity Index (EASI). If adverse reactions do occur, participants can record this themselves more accurately than relying on recall in a face-to-face appointment. Photographic images can be sent to site study staff for evaluation, and advice can be given to the patient immediately.

Images can also be used in visual assessments and to help determine diagnostic endpoints, leading to utilization of central review options and reducing variability between sites.
The use of wearable technology is also gaining traction within clinical trials. Wearable devices, such as smart watches, can record vital signs in real time and send this data directly to site staff. This real-time data can provide regulators and payers with meaningful insights into the impacts of the study drug in the real world.²

Looking beyond technology, home visits allow blood samples to be collected without subjects having to leave their homes. Healthcare professionals can also bring the study treatment to a patient’s home, which is valuable where self-administration is difficult. This may help boost patient retention, considering some patients still prefer the human connection of face-to-face interactions with healthcare professionals. Alternatively, the study treatment may be shipped directly to the patient’s home, which has the added benefit of greater patient engagement.³

Continuing clinical trials with patients at the core

In the midst of enthusiasm around advancing clinical trials, the patient experience should remain the priority. Fortunately, adopting virtual elements in clinical trials can help improve the patient experience during the entire process. The implementation of digital study platforms allows patients to have 24/7 access to information about the trial, can be used to send reminders to take their study drug or complete questionnaires, and much more. The IQVIA Study Hub platform connects patients, investigators, and local providers on the same platform. The platform is accessible through an application, which can be used to schedule site visits, telehealth appointments, and to integrate smart watch data. As a result, patients have clear study information, regular support from healthcare staff, and shorter appointments, which can be scheduled outside of working hours.⁴ Consequently, there are advantages to all stakeholders, because improving the patient experience leads to greater adherence to the study protocol.⁵ Furthermore, as up to 40% of patients are estimated to drop out of clinical trials before the completion date,¹ it is beneficial to implement a patient engagement platform that keeps motivation high.

Virtual trials and technology are gaining acceptance among patients and sites, and patients are adjusting well throughout the pandemic. Greater acceptance has been seen among older adults as they are also becoming more comfortable using technology in their everyday lives.

Going virtual: what next?

Every clinical trial is different. An analysis of the protocol, followed by a tailored approach, is needed to establish which components of the trial could be made virtual, and what must happen on site. Ultimately, it is vital to find a partner who understands the custom and delicate balance of virtual versus traditional clinical trial components, based on the study population, severity of indication, the study endpoints, and more.

Challenging times call for innovative solutions. COVID-19 has helped facilitate new approaches to clinical trial conduct. Breathing new life into outdated clinical trial practices in the form of decentralization can help increase enrollment, patient retention and satisfaction, all while maintaining the highest data quality.

References:
1. Industry Standards Research. The expanding web of clinical trial patient recruitment. 2014. Available at: http://isrreports.com/wp-content/uploads/2014/04/ISR-The-Expanding-Web-of-Clinical-Trial-Patient-Recruitment-Whitepaper.pdf
2. Beckstrom K. Wearables in clinical trials: where we’re heading. 2019. Available at: https://www.ert.com/blog/wearables-in-clinical-trials-where-were-heading/
3. Taylor, A. Exploring the key considerations for direct-to-patient shipping. 2017. Available at: https://www.clinicaltrialsarena.com/news/exploring-the-key-considerations-for-direct-to-patient-shipping-5739643-2/
4. Henshall C, Narendran P, Andrews RC, Daley A, Stokes KA, Kennedy A, Greenfield S. Qualitative study of barriers to clinical trial retention in adults with recently diagnosed type 1 diabetes. BMJ Open. 2018;8(7). Available at: https://bmjopen.bmj.com/content/8/7/e022353.long
5. Pfammatter AF, Mitsos A, Wang S, Hood SH, Spring B. Evaluating and improving recruitment and retention in an mHealth clinical trial: an example of iterating methods during a trial. Mhealth. 2017;1;3:49. Available at: http://mhealth.amegroups.com/article/view/17200/17571

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Sonja VanWye has more than 30 years in the healthcare field including global pharmaceutical drug development with biopharmaceutical companies and CROs. She serves as Director of Dermatology Strategy for IQVIA Biotech with core responsibilities as a strategic consultant for study strategy and proposal development oversight. Her previous positions span a range of functions, including project management and quality assurance. With 17 years working with dermatology early and late phase trials, Sonja brings expertise on combining study conduct requirements with new and innovative technologies to deliver study strategies that support successful trial completion.