Should You Incorporate Home Nurses Into Your Next Clinical Trial?
Decentralized clinical trials (DCTs) involving home visits by mobile research nurses had already been around for about 17 years when the COVID-19 pandemic hit, but you wouldn’t have known it from the reaction of many sponsors and CROs. Certainly many had been tangentially aware of DCTs, but the incorporation of DCT methods into clinical studies was not the norm. As a result, those whose studies depended on participants being able to visit sites for all of their treatments and testing found themselves scrambling for solutions when sites were forced to shut down virtually overnight.
To put this in perspective, prior to 2020, PCM Trials, a leading provider of mobile research, observed that studies fell into essentially three categories in terms of home nursing visits: No home visits; contingency-only home visits, in which the potential for home visits was written into the protocol but used mostly as a last resort; and planned home visits, which specified precisely which visits would take place at the site and which would be done remotely. Prior to the pandemic, PCM Trials served only some studies with planned home visits, which generally were done to accommodate especially vulnerable patient populations with mobility or other constraints that would make travel to a site particularly difficult.
Currently, however, most of PCM Trials’ studies involve planned home visits. It’s a sign that the clinical trials industry is shifting even further toward the routine incorporation of home visits into their studies. Not only does decentralization provide a hedge against potential future site shutdowns, be they due to pandemics, natural disasters, or other disruptions, but they also are more convenient for participants, which can lead to easier recruitment, improved retention, and increased diversity. There also is emerging evidence that decentralized trials are less costly than their traditional site-based counterparts.
5 questions to see if home visits make sense for your trial
Given the experience of the past few years, more sponsors and CROs are incorporating DCT methods into their protocols while others are at least considering it, in part to benefit from the many advantages of DCTs as well as to avoid disruptions to future studies. While there’s no such thing as pandemic-proofing a study, building home visits into a study often is a smart choice.
Here are five questions to ask to see if home visits make sense for your trial.
- Are your endpoints derived from a heavy PK/PD schedule? A PK/PD study requires multiple blood draws over a period of time to see how a dose of a test drug affects the body, how soon those effects occur, and how long they last. The number of blood samples and the duration over which they must be collected varies by study, but the schedule can be particularly burdensome if it takes place over an extended period of time. For example, a 12-hour PK/PD schedule that requires the patient to first travel to the site and then wait for hours in between subsequent blood draws can make for a very long day. A home option can reduce this burden substantially and help ensure that patients don’t fall away or become lost to follow up.
- Is there an expectation of dose escalations in your protocol? A dose escalation study involves starting with a small amount of the test drug and gradually increasing the dose to discover the highest dose that does not cause harmful side effects. This requires multiple blood draws, often done over consecutive days. The requirement to drive to and from a site every day just to get a blood draw could prove to be more than a participant is willing or able to do. A home visit would remove that burden, making the patient less likely to drop out.
- What is the profile of your intent-to-treat pool? Does it include people of varying ages and ethnicities living in far-flung geographies that you are not entirely confident you can serve? Even patients living in an urban area within a reasonable distance of a site may still be unable to travel to the site for visits, be it due to lack of convenient public transportation, childcare, or the inability to take time off work. A home visit program can help increase the pool of participants and increase the overall diversity of clinical trials by removing many of the burdens for both patients and caregivers that are inherent in site-based trials.
- Is your trial competing against others for the same participants? Recruitment and retention of patients is becoming more challenging as studies become more nuanced. For example, as stated in the study Recruitment and retention of participants in clinical studies: Critical issues and challenges, “the straightforward study design to enroll all patients with Stage II breast cancers has been replaced by specific genetic biomarkers…with inclusion criteria [that] are more specific, stringent, and narrow.” Another constraint in recruitment is “stiff competition for potential patients with multiple studies simultaneously recruiting patients at the same center.”In addition, labor challenges have created pressure on site staffs, making it more difficult to execute the Schedule of Events and stay on schedule. As staff shortages create more delays in the waiting room, the patient burden is that much greater. Having an accommodation for the patient that removes the burden of, for example, a 10-hour PK, will make it easier for a given patient to say “Yes” to a home-based study over a less convenient 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.
To discuss how home visits may fit into your clinical development program, please contact PCM Trials at [email protected] or 303‐253‐7470.