The age of precision medicine is upon us. This emerging revolution in health care will, in the coming years, fundamentally reshape the experiences of not just patients and providers, but the clinical research community as well.
In contrast with the one-size-fits-all method that has long been employed by physicians to treat illness, precision medicine considers how patients’ genetic makeup, environments and even lifestyles can impact their susceptibility to certain medical conditions. Using improved diagnostic testing, physicians will increasingly be able to categorize patients into ever-narrower populations and find specific therapies, or combinations of therapies, that are the best and most effective for that population.
Many of us at this point know friends, family or acquaintances who have had double mastectomies or hysterectomies because they had a genetic mutation that elevated their risk profile for breast or ovarian cancers. In the decades since it became possible to observe those genetic mutations and take preventative steps early, our diagnostic tools have advanced, with blood- and stool-based DNA and RNA biomarkers now being commonly used for early detection of cancer, inflammatory disorders and neurologic conditions such as dementia.
Precision medicine meets clinical research
In many ways, the future of healthcare hinges on the convergence of research and clinical practice. As every disease gets sliced down into increasingly specific genotypic or phenotypic expressions, even common ailments will become rare in a sense.
One good example is a pervasive condition known as nonalcoholic fatty liver disease, which, according to the National Institutes of Health, affects 47 people per 1,000 globally, with higher rates among males than females. We now know, thanks to clinical research, that this disease has multiple versions with differing genomic footprints. Those different disease verticals are unique to certain populations and may require different therapeutic strategies.
As precision medicine takes hold, we’ll be able to categorize patients into subtypes based on certain genomic markers, with each subtype needing clinical research to identify which therapies are best for those populations. A clinical research trial typically involves one or two drugs, and every drug combination for every subtype will require its own series of trials — phase one, phase two and phase three.
It’s easy to see how this will lead to an exponential increase in the amount of research needed as precision medicine defines not only diagnosis, but subcategories of diagnosis based on genomic expression. According to recent data, an estimated 450,000 clinical research trials are currently in progress, and that number is only going to continue growing.
A new model of clinical research
While clinical research has traditionally taken place in hospital and academic settings, a new model is needed to find enough willing patients who provide enough genomic diversity to be suitable candidates for these highly specific trials. One logical solution is to go where the patients are — in the small and mid-sized community practices that are located in towns and cities across the country.
The company I co-founded, ObjectiveHealth, has pioneered a successful model in which we partner with these medical specialists and bring clinical research into existing practices, becoming an extension of the care they already provide to patients. This model for clinical research depends on the foundation of trust between patients and their physicians. In many cases, the practices we work with have been in their communities for decades and patients have long-standing relationships with the specialists. A recommendation from that physician to consider clinical research as a care solution goes a long way toward addressing any hesitations a patient might have about participation.
Taking part in a clinical trial offers patients access to next-generation diagnostics and treatments, as well as additional education and coaching around their disease state or their general health condition. In an age of too-brief patient interactions with their care providers, having a person who can take the time to sit with a patient and be advocates for their condition can be very meaningful.
Physicians, meanwhile, want to be on the cutting edge of what’s happening in their field, but they also don’t want to have additional administrative responsibilities added to their existing busy workload. By adding an embedded team of skilled research professionals backed by a central administrative support team who manage the trial opportunities with sponsors, regulatory matters, contracting and budgeting, and site staff management, research can become a premium care solution for patients and the practice. The physician acts as a principal investigator for the trial and confirms patient suitability for participation, maintaining their focus on clinical patient care while providing a valuable added service that benefits the practice and community.
At ObjectiveHealth, we developed proprietary technology for our research team that curates data from patients’ electronic health records using AI algorithms to rank disease severity and match patients to specific trials based on trial specific criteria. This allows our partnerships to identify the patients who can benefit the most from research as a care option.
Looking forward in clinical research
As we move in this era of precision medicine, there’s a bit of a two-edged sword in that clinical research will be needed to study and commercialize new diagnostic tests, pharmaceutical therapies and innovative medical devices, which will then be used to advance treatments for specific disease states. That means that there’s a lot of work ahead for clinical researchers. Adding an additional wrinkle is that the population of principal investigators for clinical trials is gradually aging out, and a new generation of clinical research professionals must be trained and educated to serve the growing need.
The key to meeting the coming demand lies in educating patients and physicians alike about the value of clinical research for them, as well as its importance in helping to diagnose medical conditions earlier and increase the probability of positive outcomes for patients.
Dr. Don Lazas
Dr. Don Lazas is chief medical officer and co-founder of ObjectiveHealth, a fully integrated multi-sided platform and ancillary care solution, partnering with premier community-based specialty practices to create clinical research centers-of-excellence. ObjectiveHealth’s proprietary technology finds and validates patients for pharma sponsors using AI disease and trial specific algorithms, delivering efficient clinical trial execution and more care access for patients.
