This is part 1 of a 3-part series.
You can find part 2 here and part 3 here.
Series Overview
One primary barrier to getting new drugs to market is the inability for sponsors to enroll their clinical trial. With more than 70 investigational NASH drugs in development across more than 60 sponsors, the next 5 years* will see the need for at least 30,000 patients to enroll in clinical trials. The success (or failure) of your compound literally depends on meeting your enrollment milestones.
In this series, Continuum Clinical will pull from its more than 25 years of clinical trial enrollment experience to discuss the NASH patient journey, educational and awareness opportunities—including those specific to underrepresented patient populations—and other challenges associated with reaching and motivating this unique patient population. Ultimately, we will provide clear insights about what is necessary to help sponsors meet or beat their enrollment milestones for NASH clinical trials.
Part 1: Understanding the NASH Patient Journey
Understanding the patient journey and being in tune with the nuances of the patient voice – their fears, their struggles, their readiness to accept information—will elevate all patient communications and ultimately directly affect your ability to meet your clinical trial enrollment milestones. This is true across all conditions and therapeutic areas, but never as urgent as when a patient population is unaware of their condition. Add on the complications of the disease being chronic and potentially fatal, and the need to not only present the patient with the right message, but to present that message at the right time in their journey becomes absolutely critical.
We are often eager to get our information in the hands of a patient as quickly as possible – very early into their diagnosis, or even at the time of diagnosis. There are great reasons for this as it relates to clinical trial enrollment: sometimes we need to catch people before they begin standard of care treatment, sometimes it’s because they’re most engaged and hungry for options then, or because their diagnosing physician is also a referring physician or is likely located at a study site. But insights are critical to determining the right timing for introducing patients to options like clinical trials, and our insights have shown us one thing very clearly: a NASH patient is not ready to receive clinical trial information at the time of diagnosis.
But insights are critical to determining the right timing for introducing patients to options like clinical trials, and our insights have shown us one thing very clearly: a NASH patient is not ready to receive clinical trial information at the time of diagnosis.
A NASH diagnosis almost always comes out of the blue. Not only is NASH virtually unheard of despite its probable prevalence (with as many as 42 million adults likely having the condition—undiagnosed—in the US alone), it has no unique symptoms. It affects a patient population that may already feel marginalized by their obesity, diabetes, or other comorbidities. These patients are already stressed out, and they’ve just been dealt a devastating new diagnosis they weren’t expecting. In almost every case, they are blindsided. Consider, too, the social implications of having a liver disease—in the mind of the general population, it’s almost exclusively tied to lifestyle issues like excessive alcohol consumption and obesity. Admitting this diagnosis and discussing it with friends or family can be difficult for people, then, as it potentially carries with it an element of shame.
These diagnosis-related psychological effects cannot be undervalued in determining when to initiate with patients a discussion about treatment options including clinical trials. Patients must grieve this diagnosis—and it is a grief without resolution. Grief is usually thought of as in relation to single events: the death of a loved one, loss of a job, divorce or other emotional trauma. Single-event grief has a beginning, middle, and end. But with NASH (and other chronic, debilitation diseases that worsen over time), the grief process is ongoing because the patient will experience many losses throughout the course of their illness.
Ensuring your trial is positioned as an option, a choice—particularly when these patients have moved through a grieving period that likely included feelings of hopelessness due to a stark lack of options—will be the most empowering and motivating for patients.
The American Liver Foundation has amassed patient experience testimonies that underscore the shock newly-diagnosed NASH patients experience, with many patients lamenting having never heard of the condition and quickly understanding the stigmas around liver disease, particularly cirrhosis.
It is only when a grieving patient approaches acceptance that they are most open to receiving information about the next steps in their journey. This is marked by patients feeling more in control of their diagnosis, and to an extent, the disease itself. Likely many of the lifestyle changes a doctor will suggest are the same this patient population has heard before in relation to their comorbidities – particularly weight loss and diet change recommendations. These patients many not have been exposed to clinical research before, so it’s important that clinical trial options are presented alongside other educational materials. Ensuring your trial is positioned as an option, a choice—particularly when these patients have moved through a grieving period that likely included feelings of hopelessness due to a stark lack of options—will be the most empowering and motivating for patients.
It is not enough that clinical trial enrollment and patient recruitment messaging be empathetic (though that is also of huge importance). If you are not reaching the patient at precisely the right time in their journey, your message still may not be heard or understood, and you may have missed your opportunity to motivate that patient to enroll in your trial.
*at time of publication, from clinicaltrials.gov
