The landscape for clinical trials has seemingly been turned upside down with the onset of the COVID-19 pandemic. However, there is one factor that has remained crucial, and that is “patient centricity.” This term- patient centricity,has been talked about for years within the industry, but now,due to today’s climate, it has come to the forefront of every clinical trial.
Patient centricity is a broad topic and constantly evolving, however, let’s take a step back to really look at the term and why this came to fruition in the first place.It’s because participants are the most important stakeholder in the trial process that, can either lead studies to success or failure. In the current climate, the industry really needs to understand, now more than ever, the needs of trial participants – whether it’s the burden a disease puts on participants and their families or the logistics to obtain access to a potential treatment for their disease.As the pandemic affects everyone, it can be especially distressing to individuals and their families participating in a clinical trial, as they may need the medications that offered in the study. In addition, most of these participants may have pre-existing conditions, making travel to sites or hospital even more of an issue due to potential exposure to COVID-19.
In today’s social distancing environment, the clinical trial industry is seeing a major shift to hybrid or virtual trials, where healthcare professionals are traveling to participants’ homes or cars are transporting medications or equipment directly to participants’ homes. Nevertheless, there are still going to be studies that cannot be fully decentralized and for those trials, we are already seeing an increased demand for transportation to the hospitals or research centers. A majority of participants in trials that cannot be virtualized will have specific and very personalized travel requirements because they are not well.
CROs and sponsors have already started to look at options to adapt their trials in such a way that participants remain engaged. As research centers start to adjust to this new normal, they must do so with a patient-centric lens, using tactics that might include:
Treating trial participants as team members, not patients
Let’s start to think about trial participants as part of the trial team, rather than patients. To attract trial participants to partake in a clinical study, we need to eliminate potential burdens before the trial even starts. Participants don’t want to have to think about how they are going to get to the research center– this should have already been planned out for them.Older participants may need to travel with caregivers, while some participants may need home care for children if the caregiver needs to leave the house.A good analogyis a company requiring employees to travel for conferences or other events where the company would arrange travel and accommodations for them. If we want to transform patients into participants, study teams need to be thinking about how to make the clinical trial process as convenient as possible for the participants and their families by removing any logistical barriers.
Understanding the burden of the disease on participants
A good patient-centric trial design must reflect an understanding of the participants themselves and the burden that a particular disease could place on them. From the beginning, sponsors and sites must keep in mind what a participant is going through and the added stress the disease and the pandemic are placing on him or her.This means having the participants at the forefront when you are designing the trial to understand how you can ease the trial journey for them.
Some good questions to ask when designing atrial in today’s environment:
- Do participants really need to leave the house for a visit/follow up visit, or through the use of technology, can we give them a portal where they can record their outcomes so they don’t have to come to the site every time?
- If participants really need to visit the site, how can we make that journey seamless for them?
Understanding the impact of the disease on the participant and the burden it brings is critical to both recruitment and retention.
Think of ways to better engage with patients
Since the onset of COVID-19, my company has seen a massive spike in interest from CROs and sponsors about patient convenience services in an effort to both reimburse patients for their participation and offer them travel services to get back and forth from a site.
To better understand participants,we need to find out what might help ease their minds whether that is the financial burden that has been placed on them due to the disease or the pandemic or the fear of leaving home or visiting a hospital using public transport. For example, easing a participant’s fears about cleanliness and safety may be paramount for any first-time users of car service and transportation. We simply cannot ignore that the biggest impact of COVID-19 is going to be on the participant.
Sponsors and CROs should be doing things now to prepare for when a sense of normalcy returns. While the industry has talked a lot about hybrid and virtual trials for the last few years,now is the time to take a closer look on how to integrate them into the clinical trial process to ease the burden on participants.
As a result of the pandemic, sites are starting to become more comfortable with running trials virtually. In addition, the regulatory authorities may also be more open to these types of trials because they can be assured studies can be conducted successfully virtually and certain drugs can be administered to the patients by themselves or at home. As we make more of an effort to make trials as patient centric as possible, we will find more and more opportunities to ease the entire clinical trial process to help optimize recruitment and retention.