Clinical Researcher—May 2019 (Volume 33, Issue 5)

SITE STRATEGIES

Mark Hanley

Virtual trials are gaining traction across the clinical research industry. With providers like VirTrial, IQVIA, Clinpal, THREAD, and Science 37 forming relationships with big pharmaceutical sponsors and contract research organizations (CROs), it won’t be long before your site is approached to participate in a virtual trial, if it hasn’t happened already. However, providers are taking various approaches on how they engage with sites, so make sure you understand the differences and align yourself with a provider that supports and values your site’s mission.

The core benefits of virtual trials revolve around their ability to streamline visits, add convenience for patients, and ultimately get new medications to market faster. It’s no secret that traditional clinical trials often exceed timelines originally proposed by pharma companies and CROs, with the most common challenges being recruitment, engagement, and retention of patients. A solution that helps alleviate these hurdles can be a big win for the industry.

Technology Simplifies the Process

Embracing technology in the clinical trial process can help alleviate several of the difficulties traditionally associated with the process. Two concepts in particular, Time Shifting and Place Shifting, provide numerous benefits.

Time Shifting

One of the key reasons patients drop out of clinical trials is because of the lengthy time commitment required. People have busy lives, and though they may genuinely want to join a trial, other commitments keep them from participating. The introduction of Time Shifting can greatly reduce the time required for participation. By using technology to conduct some of the visits remotely, patients can more easily fit the trial schedule into their daily lives.

Take for instance a working mother whose day is booked from 8 a.m. to 8 p.m. with taking children to school, working a full business day, picking the kids up, and heading home only to make dinner and help with homework. There’s little flexibility in her schedule during normal business hours to travel to a study site for a required visit. Technology can provide the option of a brief video chat during her lunch break from her personal cell phone, making the commitment possible.

Place Shifting

Traditionally, trials are run through networks of research sites selected by the sponsor or CRO. Participants are required to travel to those selected sites to participate. This requirement often creates challenges with recruitment, particularly for patients in remote geographies. Even for those who have a flexible schedule, the distance may be too great for them to travel for a trial they are participating in voluntarily.

With the use of virtual clinical trials, the distance barrier is greatly reduced. While patients will need to visit the site in person for some activities, the ability to conduct a portion of visits from their home or work makes the overall commitment more feasible. A virtual visit saves travel time and potential wait time onsite. The patient can simply attend the virtual visit from their personal mobile device from whatever location they choose.

Key Considerations for a Virtual Trial Platform

So we can see how virtual clinical trials can provide a welcome solution to some well-known challenges in clinical research; however, there are some considerations to keep in mind when incorporating virtual trials. If the overall goal is to improve recruitment, compliance, and retention, the key to rolling out a successful virtual solution is to make the trial process as patient- and site-centric as possible.

In addition to adding flexibility around time and place for visits, it’s critical to ensure the technology is easy to use—for both patients and sites. Seek to understand all aspects of a virtual trial provider before getting involved, including:

Mobile Device Agnostic—Some virtual trial providers require the use of vendor-provided devices and expect participants to carry the additional device around with them, as well as learn how to use it efficiently. This adds a new burden to participants rather than reducing it. Look for a solution that is device-agnostic and works on the personal devices that your participants already own and know how to use.
Multi-Language Translation—With an increased focus on adding diversity to trial populations, it may be necessary to communicate with patients in various languages. Find a virtual trial provider that offers translation services and medically certified translators. Ideally, you would want to have the ability for three- or four-way calling to include a caregiver or family member when needed.
Seamless Experience—Most clinical trials will require that some visits be conducted in person at a research site. To ensure a seamless experience for patients, and thorough and comprehensive trial data, it is critical to work with a virtual trial provider whose technology is available to any research site.
Some Sites or None?—Some providers work with only a limited network of sites or focus entirely on “site-less” clinical trials. For example, according to one provider’s website, its virtual trials involve no visits to physical trial sites at all.{1} So for your site’s sake, be sure to look for a virtual trial provider that understands the necessity for a hybrid approach for trials that require a combination of in-clinic and virtual visits.

Conclusion

Get up to speed on how virtual clinical trials enhance the research process so you’re familiar when the time comes to test one. Several providers offer free (and sometimes customized) demos on their websites. For additional information, you can look for educational resources about virtual trials from industry-related associations, such as the Association for Clinical Research Professionals.