Have you heard the latest media buzz? Apparently, all clinical trials are going “virtual.” Participants will never need to leave the comfort of their own homes, and researchers can manage the trial from hundreds of miles away. If the articles, tweets, and sound bites are to be believed, researchers “need to prepare now for this new reality!”
Well, the truth behind the headlines is that while some trials are indeed going completely “virtual,” they represent a very small fraction of overall clinical research. The practical reality is that for many drug and device trials, particularly those in early phases, participants must come to a medical facility. Regulatory agencies have issued guidance and support for virtual, or decentralized, trials; but for the most part, the traditional “come to the clinic” mode prevails in the vast majority of clinical research. Change is happening slowly.
Virtual study designs do exist and are currently being conducted successfully. Advarra’s IRB has reviewed a number of virtual clinical trials, where participants give informed consent remotely, and any sample collections or measurements are done at home by mobile medical technicians. Data capture is completed through wearables or participant-controlled devices, and the principal investigator is centrally located, with nurses sometimes visiting the participants’ homes.
However, the real trend is integrating virtual components into traditional trial designs to ease the burden on participants, thus boosting retention and enrollment. In this blog we will explore two of the more common, and maybe more viable, “virtual” options for research that we are seeing at Advarra and what they mean for your research.
In-Home or Remotely Facilitated “Clinic” Visits
How many potential research participants are missed because coming to the research clinic between 8 am and 5 pm weekdays is not convenient? Maybe someone can come for the initial visit, but he or she later finds that going across town every other week to have an hour-long exam and associated lab work is just not feasible. Incorporating mobile medical technicians or “teledocs” (doctors who see patients remotely) with evening and weekend in-home visits can ease this problem and increase enrollment and retention.
An increasing number of sponsors are incorporating in-home visits directly into the overall design of the protocol itself and specifically identifying some visits as “virtual.” Individual research sites are also more frequently incorporating remote clinic visits and teledoc-style services into their practices. If the visit can reasonably be done in-home (e.g., the visit does not involve the need for sophisticated monitoring or infusion equipment), then researchers can make the protocols they conduct more appealing by offering to come to the participant on his or her schedule and time frame. The additional cost of mobile med techs or teledocs can be offset by increased enrollment at the site. This approach has the added benefit of freeing up valuable clinic time and staff for studies requiring an in-clinic visit. Many sites have reported that sponsors view them favorably during site selection if they can offer in-home clinic visits.
From an IRB perspective, as long as adequate training, investigator oversight, and appropriate safety parameters are in place (e.g., trained phlebotomists), the IRB is likely to view a “virtual” in-home clinic visit approach favorably: it should not increase risk to participants and can also improve participant adherence to the protocol, reduce dropouts, and increase the diversity of potential participants. All of this in turn produces better quality research data.
Remote Participant Monitoring and Reporting (E.g., Wearables and Other Gadgets)
Probably the most rapid change toward enabling a virtual clinical trial paradigm has been the explosion of remote monitoring devices. With real-time monitoring data transmitted directly to researchers over a secure connection, a participant need not come into the clinic or interact with clinic staff. At Advarra we are seeing more clinical trials integrating some aspect of remote monitoring and/or wearables into their study designs.
With these new benefits also come new considerations and responsibilities unique to this type of research. For example, before sites embark on a protocol that incorporates wearables or other technologies, researchers need to be prepared with an appropriate staff training plan for user support. After all, the research staff will likely be fielding the calls when participants have a problem with their device or iPhone app. Who would have thought setting up a participant IT desk would be part of the clinical trial process?
However, these technologies remain somewhat limited in how appropriate they are for certain types of research. Unsurprisingly, adoption within the research community has not been as fast or robust as the media hype may suggest. While we have seen an increase in utilization of these technologies, the vast majority of clinical trials are not strapping wearables on participants or putting electronic diaries in their hands. Good old-fashioned written logs and periodic outcome measurements taken by a human medical technician are still the most common means of gathering data.
The progression towards making trials more “virtual” is inevitable and a welcome addition to the goal of enhancing the quality and reducing costs of conducting clinical research. However, completely virtual clinical trials are still along way from being the norm. Rather, based on our experience at Advarra, we anticipate seeing a slow and steady march on the part of sponsors and investigators to use technology smartly to improve the efficiency of clinical trials while at the same time easing the burden to participants.
As the world’s largest integrated IRB, Advarra has reviewed many virtual clinical trials. We understand the complexities and unique challenges which these trials represent. Incorporating virtual components into your next study? Contact us for support.