Clinical trial sites are often set up in areas where the disease is most prevalent to maximize patient participation. While this strategy is helpful, this design inherently excludes those who cannot reach the trial site but are otherwise eligible to participate in the trial.
Patient participation usually means frequent trips to the trial site, which may be a deterrent for participation. Moreover, patients with ambulatory disabilities or certain diseases might have limited mobility. Proximity to the site plays a significant role in patient participation.
Last week, New York tech company, TrialSpark, announced the activation of its first clinical trial site using advanced patient recruitment strategies. The trial spawned from an ongoing collaboration with Novartis and is targeting patients with ankylosing spondylitis, a type of arthritis that affects the spine.
TrialSpark uses sophisticated web platforms and technologies such as “algorithmically-prioritized contact queues” to identify “hot spots” of patients who are at distant institutions or specialist centers that would otherwise not be included in trials. TrialSpark refers to their model as a “patient concierge,” boasting hotel-like service for patients.
“If you don’t live near an academic center or an existing trial site, you often will need to travel far distances to access clinical trials and leave your doctor to participate,” said Benjamine Liu, CEO and co-founder of TrialSpark. “Our model changes this, enabling patients to participate in clinical trials at their local doctor’s office.”
Making clinical trial designs more patient-centric can help improve patient recruitment and retention, however, some prospective trial participants think that a “person-centered” approach is more appropriate. Dr. Matthew Lariviere, a UKRI Innovation Fellow at the University of Sheffield, lives with severe hemophilia A, an X-linked disorder that causes patients to experience spontaneous bleeding or prolonged bleeding after an injury. He recently wrote an article for the BMJ explaining why he chose not to participate in a new drug trial.
“I [did not] participate in the trial [because of] unrealistic expectations to attend clinic for extended periods of time, participant information sheets with impenetrable jargon, routine follow-ups that impact my life,” Lariviere told Xtalks. “Participation in a trial should not be too burdensome… We need to think about participants in trials as people with full lives, commitments and obligations outside of the clinic – just like the clinical research team.”
By meeting the needs of patients, contract research organizations might achieve greater patient participation and retention, and potentially accelerate trial completion. With regards to the new clinical trial technology being employed by TrialSpark and Novartis, Dr. Lariviere has his reservations.
“Although recruitment is fundamental for a ‘successful’ trial, there are other facets of trial design, too. [TrialSpark’s] product may help with recruitment, but what about retention?”
Only time will tell if TrialSpark’s model will attract more participants – and keep them enrolled in a study – compared to a standard design. Until then, Dr. Lariviere emphasizes the need to translate clinical research into practice.
“The recent increase in process evaluations for clinical trials and the emergence of implementation science as a distinct field shows there is a disconnect between clinical research and practice,” said Lariviere. “A more pragmatic methodology may make implementation less costly and problematic for interventions which yield positive results. Understanding and involving people with the illness can help trialists co-design such research yet also maintain a robust and rigorous approach.”