Contributed Commentary By John Reites

November 24, 2020 | While there has been a lot of talk about how the COVID-19 pandemic has affected in-person physician visits and elective surgeries, sponsors and clinical research organizations (CROs) are facing their own challenges in the clinical trial space. In fact, according to an Accenture survey, 77% of patients worldwide had clinical trials they were participating in suspended or delayed because of the virus. These delays cause a multitude of problems for sponsors, CROs, clinical trial suppliers, and the participants they serve—not the least of which is expanding the timeline required to launch much-needed medications and treatments. Currently, there are more than 1,800 active Phase 3 clinical trials according to the U.S. National Institutes of Health. 

There is also the financial impact to consider. CenterWatch estimates that delays in clinical trials cost anywhere from $600,000 to $8 million per day. Those costs can add up quickly when delays occur over an extended period—amounting to a significant impact on drug development organizations.

One of the most common causes for delays is participants dropping out before the clinical trial is completed. In one pre-pandemic study, 38% of participants said they dropped out of traditional clinical trials because they found the site visits stressful. It follows that these dropout rates could increase slightly when considering the additional impacts of precautions such as social distancing and concerns by participants about attending clinical visits and/or having home health nurses visit. As we await a COVID-19 vaccine, the lack of engagement from now until then will continue to be a challenge for clinical trials as dropout rates are expected to increase above the typical 15% to 40% rate. 

During this complex time in our industry, some solutions are coming to the forefront to support and enable greater participant engagement. Virtual visits and remote patient monitoring (RPM) technology, which have seen increasing adoption by healthcare providers to help keep patients and staff safe and adherent during the pandemic, can also help keep clinical trials moving forward. 

While these technologies cannot fully replace in-person site visits for every study, they can support a more patient-centric, hybrid decentralized study model that minimizes the number of site visits required to complete the study. They can also enhance recruiting and participant engagement throughout the trial period, improving retention and timelines while reducing overall costs.

Here are some of the ways virtual visits and remote monitoring technologies can help sponsors, CROs,  and clinical trial suppliers keep clinical trials moving forward both during and beyond the pandemic. 

• Recruit candidates more efficiently. Qualifying participants is an activity that can easily take place over a video call. Removing the challenges of travel means appointments can be set up without candidates having to rearrange their entire schedules. If the recruiter is running behind on a particular day, it is also easier to reschedule, helping maintain more candidates at the top of the funnel.
• Minimize travel for participants. Getting to and from frequent research site visits can be challenging, especially for participants with complex conditions. Taking time off work, getting caregiver support and arranging childcare is difficult. If the site is more than an hour from the participant’s home or work, the challenges become even greater, leading to potential dropout concerns. Offering virtual visits and RPM can remove some of these barriers, encouraging participants to remain in the clinical trial throughout the entire study period.
• Expand the geographic footprint and be more inclusive. Connecting a wider range of participants in areas outside the clinic’s location can provide more options for matching participants to the right trials. Telehealth virtual visits and RPM technologies have the opportunity to decrease the number of site visits required, while increasing the overall participant pool and potential for greater diversity.
• Improve engagement. Infrequent clinic visits alone are often not enough to keep participants engaged throughout a clinical trial. Telehealth virtual visits enable those conducting the study to easily communicate and share information with participants and provide an opportunity to collect study data during a virtual visit from eCOA, CRFs, sensors, eDiaries and other assessments. Shorter, more frequent contacts also help participants build a strong personal relationship with their research site, further encouraging them to stay with the clinical trial.
• Make information and education manageable. Virtual visits enable researchers to deliver only the information that’s needed at that time to ensure better results. For example, if a participant needs to do X during week 1, Y during week 2, and Z during week 3, that information can be reported during the appropriate week, allowing for more timely and actionable data. Breaking up these visits and activities also makes it easier for participants to ask questions since they can focus on a single topic rather than having their attention split across several focus areas.
• Monitor progress and reactions more effectively. If data is only gathered during site visits, it may provide an incomplete picture of how participants are reacting to a medication or treatment. RPM enables researchers to obtain data daily, or even more frequently, so they can gain a better understanding of how a medication or treatment is affecting participants. Additionally, if a reaction is severe, or something unexpected occurs, they can react immediately from data review during a virtual visit to ensure safety is the top priority.
  

As the impacts of the pandemic continue to challenge clinical trial engagement and retention, we must provide ways to add resiliency to clinical trials. Virtual visits and RPM can help keep clinical trials on track in the short term while helping sponsors, CROs and clinical trial suppliers reduce costs and bring drugs to market on schedule. These technologies offer a valuable option in the quality and effectiveness of clinical trials. 

John Reites is president of THREAD, an innovative technology and service provider that enables decentralized clinical research. His career includes 17+ years leading global drug development and healthcare innovation. Named one of the Top 100 Influencers in Digital Health, Reites’ experience spans digital health strategy, remote patient research, virtual clinical trials, and Phase I - IV clinical research. He can be reached at john@threadresearch.com.