More and more companies are testing the idea of virtual clinical trials, albeit at a small scale. Yes, virtual trials offer the potential to reduce costs, improve efficiency, and reach new patient demographics. But the reality is that not all trials are suitable for a virtual approach, and not all patients benefit from it. To optimize today’s trials and make the most of current technologies – this blog discusses why a hybrid approach may be the best way forward for now.
What are virtual and hybrid trials?
Virtual trials operate on the premise of bringing the clinical trial experience to the patient’s home. They are sometimes called remote or site-less clinical trials because they can involve patient visits that are conducted in the home by qualified professionals. They can also be trials that are run via the collection of information remotely by the patient using a device or wearable which is then subsequently transferred for review.
One of the first virtual trials was carried out by AOBiome Therapeutics, which was a 12-week study of an experimental acne drug where patients received the drug or a placebo in the mail and used company-issued iPhones to take selfies of their acne to send to their physician.
While so many trials require tests like scans, biopsies, and other procedures that would need specialized equipment only available at the clinical site to carry out; numerous companies have been testing different models and incorporating virtual trial elements to their studies. At the same time, they are still carrying out some components of the trial that need to take place on-site. This mix of virtual and on-site is known as the hybrid option.
What are the implications of virtual and hybrid trials for clinical trial sites?
Being able to run some aspects of your study virtually brings a number of benefits, such as:
- Reducing the number of on-site visits, which results in time and cost savings for site and sponsor
- More accurate and timely data capture through devices, which when combined with security measures such as two-factor authentication can improve data integrity
- Increasing the reach of your trial - allowing patients the chance to participate in trials wherever they live can boost recruitment for rare diseases and can help sites reach recruitment targets
- Using technology to communicate with participants can improve compliance to the protocol and boost engagement and increase retention
What about the implications for patients?
One of the biggest benefits for patients is the reduced requirement to travel to study sites for clinical appointments. Patients on a traditional study may need to take a lot of time off work, drive long distances to the site, and then have long waiting times for their appointment. Reducing some of the clinical appointments with a hybrid study design could help to relieve some of this burden. And for some indications, such as conditions where the symptoms are incapacitating, not having to travel to and from the site can make the difference between being able to join a study or not.
Another advantage is that virtual trials can make use of technology that is often almost by the patient’s side – their smartphone. This familiar interface can make communicating with study staff and sticking to trial protocols much easier for patients and offer the possibility of real-time data capture from wearables and other devices. There are so many technologies now available that are improving trial processes – from eConsent to electronic data capture, particularly of patient-reported outcomes, to centralized trial platforms that help study teams and patients interact more efficiently and effectively.
In contrast to the clear benefits, some practical issues to a fully virtual model include the willingness of patients to have healthcare professionals conduct clinical appointments in their home, as not all patients may welcome this. For example, they may find at home visits to be intrusive, or feel pressurized to clean the house in advance – all additional factors that could end up increasing the burden on the patients. Recent feedback against virtual trials from patients include wanting their home to remain a sanctuary, and not having to undergo procedures while at home. Similarly, parents of paediatric patients have said that they would prefer to keep a clear line between the hospital or clinic setting, and the home for their child. It is important to them that their child feels safe and secure at home.
Additionally, trials that require biopsies, imaging, or complex treatment administration still require the specialist expertise of trial sites. International studies must comply with the many and varied regulations around direct supply of drugs to patients, which makes remote trials complex. For all these reasons and more, completely virtual models are not feasible for a majority of trials.
According to Ken Getz, a research associate professor at Tufts University School of Medicine, many patients also value, more than anything, the relationship that they establish with the study coordinator and with the investigator. It will be important to ensure we don’t throw the baby out with the bathwater and remove opportunities for face-to-face interaction when attempting to relieve the burden of clinic visits for patients.
Hybrid models allow sites to maintain the personal relationship with patients while using virtual touch points to reduce the overall number of site visits. Although virtual trials are an exciting but emerging area, hybrid options may offer the best approach at present to give patients the benefits associated with more traditional and virtual approaches.