The clinical research industry has been on an evolutionary journey, continually adapting and refining processes to optimize results. Central to these endeavors has been country and site feasibility—key factors in determining the odds of success of a clinical trial. However, despite the comprehensive nature of these traditional feasibility assessments, one critical element has remained relatively unaddressed: the understanding of patients. Even more precisely, finding a way to quantify that understanding in order to facilitate a successful and smart trial planning with the patient’s needs in mind.
Where Traditional Feasibility Falls Short.
Traditionally, feasibility processes have focused largely on site selection and country insights. They have depended on historical data, insights from KOLs, and sometimes even the intrinsic motivation of local investigators rather than concrete, patient-based evidence. The results? Clinical trials are delayed 85% of the time, with unsatisfied sponsors and a fragmented market for CROs. Why? Because of the limited understanding or misunderstanding of patients. The complexity of patient data, specifically its haotic nature, makes it further challenging to put together a digestible information that can be measured. Until now.
Introducing Patient Feasibility
Enter Patient Feasibility—the game-changer that the industry desperately needed, and now, can have. So, what sets patient feasibility apart from its predecessors?
At its core, Patient Feasibility is about comprehensively understanding the target patients, aka quantifying the patient burden. This means delving deep into:
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- The standard of care they receive, varying from country to country
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- Their unique journey from initial symptoms to treatment, the patient pathway
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- Unaddressed needs and predominant frustrations
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- Their demographic profile, cultural background, and lifestyle needs
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- The specific challenges posed by their disease
Such insights are instrumental in evaluating trial protocols objectively, amending them as needed, and selecting the most suitable countries for trials.
Is Patient Feasibility What You Need?
-> Removing Recruitment Barriers: Proper Patient Feasibility can help avoid common recruitment challenges, like expecting patients with mobility issues to travel long distances or asking patients averse to technology to adapt to eConsent and eDiaries.
-> Enhanced Protocol Design: With a deeper understanding of patients, trial designs can become more inclusive and patient-centric, ensuring better retention and adherence.
-> Efficient Resource Utilization: When the right patients are identified and understood from the outset, recruitment becomes more streamlined, reducing wastage of resources and time.
The Way Forward with Patient Feasibility
Addressing the challenges of the current feasibility model requires a comprehensive data-driven approach. Solutions like TrialHub are revolutionizing this space, offering a holistic view of the patient landscape. All essential data is housed in one place, from startup timelines to the standard of care, from competing trials to patient communities.
With tools and platforms geared toward genuine patient feasibility, we are inching closer to an era of truly patient-centric trials. The rewards will be manifold as the focus shifts: more successful trials, better patient outcomes, and, ultimately, more lives transformed.
