37AMGA.ORG OC TOBER 2019
The separation of clinical research and patient care has deep roots, but with an emphasis on decreasing cost and improving quality, both sides are reaching across the aisle to benefit patients and the overall health-care ecosystem. Through collaboration, patient participation
rates and patient diversity in clinical research can increase,
improving the cost, speed, and quality of trials, thereby bringing fast, effective treatments to market.
Physicians in the nonacademic community setting have
not typically been involved in clinical research because
of time and resource constraints, as well as the pharmaceutical industry’s lack of understanding of and access to
community-based practices. However, clinical research in
community physician practices may be just what the doctor
ordered to help cure what ails our systems of care.
Providers may be entering a world of value-based care that
focuses on quality outcomes, but for now, most are still
compensated in a volume-based model. Thus, merely having
the time to learn what clinical research studies are available,
as well as the reimbursement model and eligibility criteria, is
a challenge, never mind the time to complete the training and
tasks of a principal or sub-investigator.
For practices, the administrative and regulatory require-
ments of clinical research are often overwhelming, and even
referring patients to other research studies outside their
practice is challenging. Fifty-four percent of physicians don’t
feel they have the necessary information to refer patients, and
one-third don’t have the time to educate themselves or their
1 In addition, providers often feel that clinical research
hinders their ability to manage their patients because they do
not receive adequate information from trial investigators.
The costs to create and maintain a compliant, fully function-
ing research department (up to millions of dollars) are another
concern, especially when accompanied by an uncertain return
2 Nor has the pharmaceutical clinical research
industry been eager to recruit these community physicians,
who often lack the training, resources, and desire to follow
the highly regulated requirements of a clinical trial.
While these are valid issues, there are ways to build operational and communication processes to minimize disruption
and maximize benefits for physicians and patients who wish
to participate in clinical research. Despite the disconnect
of the past, “the pharmaceutical industry recognizes the
importance of the patient/physician relationship and now
understands that, when it comes to participation in clinical
trials, the way to a patient is through his or her own physician,”
says Mary Jo Lamberti, Ph.D., with the Tufts Center for the
Study of Drug Development. Furthermore, Dr. Lamberti says
that patients are more likely to be referred to a trial if their
physician has been an investigator.
The advancement of medicine is imperative, so we must
resolve this age-old disconnect between clinical research
and community physicians.
Care, Cost, and Cutting-Edge
First and foremost, safe and effective treatments help
everyone. For patients with diabetes, for example, life
expectancy and quality of life have improved dramatically
With Silos Benefits of incorporating clinical research into physician practice
By Alycia Rose James and Mary Costello