When I joined Shearwater Health in 2012, we operated a Clinical Trials company that administered low acuity trials at seven sites across Ohio and Tennessee. I was surprised by the administrative headache that went into the management of these trials. Administrative headaches always translate to a burden on patients, reducing participation, or worse, causing patient dropouts. I wondered, how could the patient experience become more central to the design so that there are better outcomes?
With recent clinical trial guidance from the FDA, the drug discovery process will accelerate, which reduces development costs. Importantly, it signals that the pharma industry is going through change.
And change is needed. According to recent data, 30% of trial participants dropout of the trial before completion. This is a significant waste to the industry with the cost burden to recruit and enroll patients, only to have them dropout.
So what needs to change?
There are several initiatives the pharma industry is considering, but one that resonates with me is changing the perception that a participant in a trial is a datapoint, to a human who feels welcomed and safe to participate in a trial.
Those conducting clinical trials need to move into a more patient centered, patient engaged model to drive improvements in enrollment and retention. This not only helps the participant but also reduces the time and costs associated with drug development. A recent Frost & Sullivan report concludes that the industry can save 15-20% of costs by moving to a more patient centered trial structure by leveraging a hybrid trial experience.
Imagine a scenario where a trial participant receives a welcome email and phone call from a clinical professional who welcomes them to the trial, outlines the trial overview, addresses any questions, and communicates with them throughout their journey.
The clinician can complete periodic wellness check-ins with the patient – discuss side effects, issues, questions, next steps, etc. and when necessary, escalate or log questions or concerns into the patient record for their next onsite visit. Essentially, the clinician is driving engagement and improving the overall experience for the participant.
Some of these aspects are already being completed, but not utilizing a protocol-trained clinician that understands all aspects of the trial and is a key member of the global study team.
The eyes of the world are on clinical trials right now which is driving change for the better. It is a great opportunity to continue brainstorming and strategizing ways to reduce the time and costs associated with drug development. I propose leveraging a patient-centric strategy is one key element.
CEO of Shearwater Health