How Integrating Clinical Trials Into Private Practice Can Benefit Both Patients, Physicians

As a key part of the process of getting new medications and therapies to market, clinical trials offer clear benefits for society at large. However, there’s a growing body of evidence showing that there can be positive benefits for patients and physicians as well when studies are integrated into a patient’s regular care.

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Physician practices that add clinical trials open the door to increased interactions between physicians and patients, which often leads to additional opportunities for early detection of health issues. Additionally, having scheduled check-ins for an ongoing trial arguably helps patients feel more informed and in charge of their health.

The benefits are more than theoretical, yet only about 3% of physicians participate in the clinical trial process.¹ Reasons range from unfounded apprehension about the logistics of incorporating clinical research into a practice to concerns it may take away invaluable one-on-one time with patients.

As a physician specializing in the care of digestive diseases, I began offering clinical trials as a care option to my patients several years ago and have seen the advantages to them firsthand. I also witnessed how it enhanced the reputation of our practice.

Since then, an integrated research and technology platform company that I co-founded has documented evidence of both patients and physicians benefiting from clinical research into gastrointestinal (GI) disorders and liver diseases, which affect 2.6 billion and 1.5 billion people worldwide, respectively. In general, patients who participate in clinical trials experience not only improvement in liver health parameters, but enhanced blood glucose and cholesterol control, and weight loss, reflecting holistic improvements in the metabolic condition and reduced cardiovascular disease risk.

Here are 3 ways in which clinical research can have positive benefits both for patients and physicians:

1. Expanded access to preventative testing and care

Physicians who participate in a clinical trial provide an invaluable service to their patients by expanding access to preventative testing and care for life-threatening diseases and chronic illnesses. Preventative tests help identify at-risk patients whose health may be dramatically improved by a groundbreaking drug, treatment, or medical device.

As part of our research in liver disease, for example, we provide patients with free Fibroscans, a non-invasive, quick, and painless procedure to assess liver health and measure scarring or fibrosis. A Fibroscan was the initial test performed on patients to determine risk categories in a study we conducted that examined the prevalence of non-alcoholic fatty liver disease (NAFLD) and liver fibrosis.²

The goal of the study was to identify hemoglobin A1c (HbA1c) trends that could assist in determining thresholds for transient elastography (TE) screening protocols. The study found that both prediabetic as well as diabetic HbA1c values predicted higher TE measurements in ranges correlating with liver fibrosis.

The results could significantly impact which patients should be assessed for NAFLD risk and allow earlier treatment interventions to avoid end-stage liver disease. But even for the patients who don’t participate in research, the free Fibroscan they received helps provide a better understanding of their overall liver health.

2. Increased clinical trial patient retention rates

One of the most challenging hurdles in clinical research is retaining enough eligible patients throughout the study’s duration. For example, a study published in The Prevention and Treatment of Missing Data in Clinical Trials, estimated that patient dropout rates in phase 3 clinical trials often top 30%. However, when clinical research is integrated into an existing private practice, patients view their participation as a natural extension of the care being provided by their physicians and tend to remain in the study until its conclusion.

Another trial we performed focused on non-alcoholic steatohepatitis (NASH) liver disease.³ Previous NASH trials have shown that patient retention rates to second liver biopsy are not affected by factors such as the location of the practicing physician and patient follow-up appointments.⁴

Those studies, however, did not investigate the impact on retention rates when the clinical trial was integrated into a physician’s practice. The study’s goal was to determine whether retention rates could be increased by having a technology-enabled research team at the point of care.

Data from 113 patients was obtained from 13 randomized controlled NASH studies at 7 GI physician offices that had integrated clinical research into their practices. The average retention rate for the second liver biopsy was 89%. In comparison, data collected on 6695 patients in randomized controlled NASH trials had a retention rate of 82% for the second biopsy.

The results validate the thesis that retention rates can be improved when clinical research is embedded into a physician’s practice. The results also confirm the results our company achieves—90% retention rates versus an industry norm of 70%—when partnering with physicians to make clinical research a vital part of their practices.

3. Higher patient satisfaction scores

Trust is the foundation of the physician-patient relationship, but it also has been proven to be a key factor in positive health outcomes. One study found that patients who trusted their health care professional reported “more beneficial health behaviors, less symptoms and higher quality of life” and were “more satisfied with treatment” they received.⁵

When physicians integrate clinical trials into their practice, the physician-patient bond strengthens. Patients are more open to honest conversations about care options with a trusted physician who they have likely known for years. Although anecdotal, the increased patient retention in our research could very well be due to the continuity of care provided by their GI physician.

That strong bond may also explain why patients receiving a placebo saw their health improve. Researchers in a study of large phase 2b and phase 3 trials found that “22% of placebo-treated participants with fibrosis stage 2 or 3 NASH at baseline improved by at least 1 fibrosis stage with minimal net disease progression.”⁶

That finding is consistent with the results in our research partnership network. We believe the placebo response rate, in part, is related to the high level of trust and satisfaction that patients have in their physician when clinical trials have been integrated into the practice. Patients are more engaged with their physicians during the process. They spend more time having meaningful dialogue with their provider and become more educated about their care, and how they can embrace healthier lifestyle behaviors.

The United States leads the world in pharmaceutical and biotechnology research and development. We can build upon that leadership position by encouraging private practice physicians to bring clinical trials into their practices in a structured, integrated way that minimizes friction, and enhances care. Doing so will give more patients the opportunity to take part in clinical research as a natural extension of the comprehensive care they receive and, if needed, offer them better access to life-changing drugs and therapeutics.

About the Author

Don Lazas, MD, is the co-founder and chief medical officer for ObjectiveHealth, an integrated research and technology platform company based in Nashville, TN. A digestive disease specialist with more than 30 years of experience, he is a graduate of the George Washington University School of Medicine and received post-graduate and fellowship training at Walter Reed Army Medical Center. He is currently a Fellow of the American College of Physicians and a Fellow of the American Gastroenterological Association.

References

1. Paulson, J. Practice-Based Clinical Trials: Benefits and Barriers. https://physicians.dukehealth.org/articles/practice-based-clinical-trials-benefits-and-barriers#. Accessed April 13, 2023.

2. Lazas D, O'Rourke J, Pontes A, et al. Differences in liver elastography in non-diabetic, prediabetic, and known diabetic patients based on HbA1c levels in community-based gastroenterology practices. The American Journal of Gastroenterology. 2020; 115(): S533-S534.

3. Lazas D, O'Rourke J, Wallace M, et al. Improving patient retention in NASH trials with a technology-enabled research team in the GI practice. American Journal of Gastroenterology. 2021; 116():p S521.

4. Koutoukidis D, Morris E, Henry J, et al. What proportion of people have a follow-up biopsy in randomized trials of treatments for non-alcoholic steatohepatitis?: A systematic review and meta-analysis. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0250385. Accessed April 13, 2023.

5. Birkhäuer J, Gaab J, Kossowsky K, et al. Trust in the health care professional and health outcome: A meta-analysis https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0170988. Accessed April 13, 2023.

6. Rowe I, Parker R. The placebo response in randomized trials in nonalcoholic steatohepatitis simply explained. Clinical Gastroenterology and Hepatology. 2021; e564-e572.