PCM Trials VP of In-Home Solutions Shares How Lessons Learned from the Pandemic Will Improve Clinical Trials Moving Forward
CenterWatch hosted a webinar featuring Ellen Weiss, vice president of in-home solutions for PCM Trials. As a leading provider of certified mobile research nurses to the clinical trials industry that has supported more than 300 protocols over 14 years and conducted more than 42,000 home visits, PCM Trials is in a unique position to share how the pandemic impacted the industry and what it means for CROs and sponsors now and moving forward.
Read some of the key take-aways below or click to watch the entire one-hour webinar. Feel free to submit any questions you may have for Ellen to [email protected].
Takeaways from CenterWatch Webinar: Applying the Lessons of the Pandemic to Your Upcoming Trial
How the pandemic changed the landscape
Decentralized clinical trials using mobile research nurses had already been around for about 17 years when the COVID-19 pandemic hit in 2020, but you wouldn’t have known it from the reaction of many sponsors and CROs. Those whose studies depended completely on site visits were at a loss for what to do as sites were forced to shut down virtually overnight, putting enormous investments of time and money in jeopardy.
To put this in perspective, prior to 2020, PCM Trials observed that studies fell into essentially three categories in terms of home nursing visits:
No home visits
These are trials that had no home visits in the protocol nor any alternative pathways around the site. These studies were most at risk and many were not able to continue during the pandemic disruption.
These are trials where home visits were included as an option but infrequently used, primarily as a contingency for a small fraction of the patient population for whom travel to a site would be especially burdensome or dangerous. Pre-2020, the bulk of PCM Trials’ patients fell into this category, including those living in rural areas with rare or orphan diseases, or the very young and very elderly.
PCM Trials was able to help “rescue” many studies in this category when the pandemic hit. As Ellen told webinar attendees:
“There were hundreds of study sponsors who came to us and said, for example, ‘OK, we had you down for only two of our 13 visits. And now that our sites are so disrupted and air travel is completely upside down and our patients are terrified to leave home, what can we do to expand from these two or three visits to maybe 11 of the 13?’ For these customers that had contingent-only plans, we were delighted when we could come back with an SOE review and say, ‘You know what? I know you’re experiencing all this challenge. What do you say we give it a try and move eight of these 10 activities that are possible with a registered nurse to a home visit? Can you see a way forward doing that? Is it better than suspending your trial?’ And for many of our customers, the answer was a happy ‘Yes.’”
Planned home visits
These are trials where home visits were “baked in” from the start, meaning written into the protocol, included in the Schedule of Events (SOE), accounted for in the Informed Consent Form (ICF), etc. The relatively small portion of studies in this category were able to continue without significant disruption and even meet their data locks.
PCM Trials served only a handful of studies in this third category of planned home visits pre-pandemic but year-to-date, this category makes up more than half of its studies, a sign that the industry is moving further toward decentralized clinical trials and utilization of home nurses is on the rise.
5 questions to see if home visits make sense for your trial
Given the lessons learned during this tumultuous period, sponsors and CROs are now reexamining their processes and approaches to avoid similar disruptions to future studies. While there’s no such thing as pandemic-proofing a study, building home visits into the study design may make sense. Here are five questions to ask. If the answer to any of them is “Yes,” home visits should be included.
- Are your endpoints derived from a heavy PK/PD schedule? As anyone involved in clinical trials knows, pharmacokinetics refers to the impact the body has on a drug, while pharmacodynamics refers to the effect that the drug has on the body. If a heavy PK/PD schedule is required, a home visit option can help ensure that patients don’t fall away or become lost to follow up.
- Is there an expectation of dose escalations in your protocol? PCM Trials has seen how this increases the amount of lab work needed to move those patients up, down or around in the escalation cycle. A home visit program can make that painless.
- What is the profile of your intent-to-treat pool? Is it inclusive of minorities, or people of varying ages living in far-flung geographies that you are not entirely confident you can serve? If so, a home visit program can help by removing many of the burdens on the patient and their families inherent in site-based trials.
- Is your trial competing against others for the same participants? This is becoming an increasing issue as site staffs become more pressured, making it more difficult to execute the SOE. Having an accommodation for the patient that removes the burden of, for example, a 10-hour PK, will make it easier for a patient to say “Yes” to your study over a site-based one.
- Are your sites prepared for future waves of the pandemic or other disruptions? While the world has begun to adapt to the COVID-19 pandemic and mitigate its negative impacts, no one believes that this will be the last pandemic or disruptive event we will ever see. Things are not going back to the way they were and organizations that recognize and prepare for that will be in the strongest position to survive and thrive, regardless of the challenges.