To a research site, the concept of running a clinical trial with no in-clinic visits seemed unrealistic only eight years ago. Today it is front-page news in many industries and mainstream publications. Disruptive technology is changing the industry in a big way and preparation for the impending changes is critical for sites to stay competitive. Those that don’t adapt will be in danger of being left behind.
Consider a quick example of how disruptive technology reshaped the home entertainment industry not so long ago. In the late 1990’s when Netflix incorporated, Blockbuster was not concerned. They had little belief, if any, that people would prefer to have movies delivered to their residence vs. shopping for them at a brick and mortar store. Because they failed to recognize the imminent change afoot, and didn’t shift their business model, they eventually fell prey to what is now the world’s leading internet entertainment service with over 148 million paid memberships in over 190 countries.
The Challenge of Traditional Trials
There are many factors that keep patients from participating in traditional trials, even when they want to participate. For instance, if they have a vacation scheduled during a trial, they would be eliminated from the pool of qualified candidates in a traditional trial.
There are other challenges that keep patients from participating such as the lack of availability for evening appointments, long wait times at the clinic, frequency of visits, traveling long distances to reach the site, the necessity for ambulatory travel, etc. Incorporating the option for virtual visits, via a hybrid virtual trial, makes these scenarios much less of an issue and gives patients more control.
Increase Your Sites’ Competitive Edge
When considering the adoption of technology for virtual trials, be sure to balance the benefits of the technology with the ease of use for patients. Just because a new technology is capable of streamlining trials doesn’t necessarily mean its the best solution. Unless the solution is intuitive and easy for patients to use, it’s not likely going to be adopted by them.
Some virtual trial providers promote 100% virtual trials. However, it’s been shown that attempting to run an entirely virtual trial has several challenges. It increases the burden on patients and removes the critical human connection. Additionally, less than one percent of trials can realistically be designed as 100% virtual. Because of these issues, despite fast enrollment, entirely virtual trials have demonstrated poor retention rates thus far. With an estimated cost of $37,000 for each day a trial is delayed1, trial costs can quickly climb well above the anticipated spend.
At VirTrial, our primary focus is to simplify and motivate patients to participate. Our hybrid virtual trial model works on patients’ personal devices rather than requiring them to carry and learn to use a secondary device. It supports a diverse population by allowing a greater geographic spread and by providing medically certified interpreters and translation for 20 languages for video chat and 183 for audio. Our recommendation is to replace only 25 – 40% of trial visits with virtual visits and maintain in-person visits for the remainder to facilitate the human connection.
Having first-hand experience at the site-level, we focus on ways to ease the process for site staff and support site sustainability. VirTrial works with any site globally and is a Global Impact Partner (GIP) of The Society for Clinical Research Sites (SCRS.) The VirTrial leadership team is working with large pharma companies to create protocols that includes a virtual component and operate under a hybrid model.
Tech Tools to Grow Your Business
Technology is much less intimidating for most people than it was even five years ago. In fact, Americans are now sending and receiving five times as many texts as calls per day2 and the average person checks their phone every 10 minutes3. Even the older generation is adopting technology at surprising rates. 94% of smartphone users age 70+ text message on a weekly basis4. For an industry trying to provide easier access to patients, this presents a great opportunity. Statistics show that 54% of potential patients would participate in a trial if it had virtual visits5.
Video check-ins can guide patients through the trial and promote patient-centered communication. In addition to interactive video chatting, video enables physicians to identify visual cues, see if patients are flush or pale, and to read body language vs. only hearing the patients’ verbal replies. Virtual visits are ideal for wellness check-ins, study med compliance, remote patient monitoring, or to provide educational emails regarding their disease state.
Hybrid Virtual Trial Example
One example of a hybrid virtual model is outlined below and demonstrates the value of incorporating both in-person and virtual visits.
- First visit – study eligibility, blood work, physical exam, dispense study medications, download app onto patient’s device and instruct on use, establish rapport
- Last visit – collect study medications, labs, brief PE, follow-up
- PRN – safety follow up, labs, PE, etc.
- All interim visits – safety check-ins, electronic questionnaires, medication compliance
- AE/Con medication monitoring
- Ensure compliance with e-diaries
- Maintain patient engagement
Watch the full webinar presented by Kim Kundert, VP of Operations at VirTrial and Amanda Rangel, VP of Business Development at VirTrial for additional details and links to research site resources for sustainability.
1Medical Marketing Insights, D. Stepmpel, January 2017.
2 Informate, PR news wire ‘”No time to talk,” 2015.
3 ”Three reasons why patient engagement is your secret weapon to study success,” Bracket Whitepaper, Oct. 2018.
4 Experian, Millennials Report, June 2014.
5 Pharmpro “Are Site-Less Trials the Future of Clinical Research?” May 2018.