final dose Don Lazas
MD, ObjectiveHealth
Innovative integrated research models
How a new model for clinical research could benefit pharma manufacturers
The age of precision medicine is upon us, with significant growth expected in the coming years as more physicians begin customizing treatments based on patient-specific genetic, lifestyle and environmental factors. For pharma manufacturers, precision medicine represents a major opportunity to expand their market reach with specialized drugs and therapies that target populations of patients with specific genetic profiles. A flurry of new therapeutics, biologics and treatment options are already being introduced to treat cancer, neurological disorders, metabolic diseases and numerous other conditions. Over the past several years, precision medicine has led to an explosion in clinical research as advanced biomarker diagnostics narrow the scope of each trial. But the clinical trial industry is increasingly struggling to keep up with this increase in demand, due in part to an aging population of principal investigators, who oversee all aspects of trials. Yet, an emerging research model could present a solution that enables clinical research providers to continue keeping up with the output of pharma manufacturers. It expands clinical research from its traditional settings into more locations than ever before, while leveraging a previously untapped population of physicians who can fill the crucial role of principal investigators.
The promise of a new research model
Traditionally, clinical trials have almost universally taken place at academic institutions or independent community research facilities. In an academic setting, the principal investigator role is handled by physicians as a secondary responsibility, with their primary focus being research and education. In the community setting, clinical research takes place at standalone research centers that aren’t affiliated with medical practices. Though doctors may have an interest in research, working directly on a trial often seems unrealistic. Managing a trial is too much alongside regular patient-care duties. Clinicians who establish their own research programs typically struggle with continuity, sustainability, and scalability. But a new model of clinical research helps mitigate these concerns, broadening the scope of clinicians’ existing practices while effortlessly merging with their existing workflows. The upside for physicians is providing cutting-edge treatments for patients who would otherwise lack access, while expanding services that differentiate their practices as centers of excellence. Doctors can nurture patient confidence by being at the forefront of new drug discovery and emerging technologies for hard-totreat conditions.
The trust in doctor-patient relationships is crucial to this model’s effectiveness. Historically, patient retention in clinical research has been around 70%, driven by factors like losing interest when no improvement is seen or finding trial participation inconvenient. These challenges can be moderated by bringing clinical research to patients’ familiar medical care. Seeing research as an extension of their physician’s care, patients are more likely to complete trials. This model has achieved completion rates over 90%.
Facilitating the future of medicine
All of health care is becoming a research engine, with enrollment currently in progress for some 450,000 clinical trials. As the number of active investigators decreases, a new model of partnership between community practices and clinical research providers can benefit pharmaceutical manufacturers by providing a new source of qualified physicians to ensure that trials are run safely and meticulously. In addition, broadening into new community settings can deliver a level of patient diversity that is underrepresented in current research trials. With clinical research becoming more critical than ever for continued medical progress, all of these factors combine to make innovative integrated research models a highly promising avenue for the future of medicine.
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