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Using IROs can offer the opportunity for doctors to incorporate clinical research as a care option in their practices.
A clinical trial is one of the most essential steps in the pharmaceutical/biotechnology research and development process, yet one of the biggest stumbling blocks historically has been finding and retaining patients to participate in studies. The answer to that problem could lie in helping more physicians integrate clinical trials into their private community practices to make it a natural extension of the routine care they provide their patients.
For doctors, participating in potentially groundbreaking medical research certainly has its appeal. Unfortunately, only a small percentage take part in clinical trials. In my experience as a physician, their hesitancy often centers on unfounded anxiety about how the logistics of incorporating the trial into their practice could result in them having less time to devote to patients and potential administrative and regulatory ‘red tape’.
There are models that offer the opportunity for doctors to incorporate clinical research as a care option in their practices. By partnering with a separate team of dedicated clinical trial experts who reside in the practice and handle all of the logistics related to ongoing trials, doctors can keep their level of involvement at a manageable level that doesn’t interfere with their clinical duties.
As a physician specializing in the care of digestive diseases, I’ve seen the value of clinical research both for my own patients as well as for my practice. These observations led me to co-found an integrated research and technology platform company, ObjectiveHealth. And in our collaborations with doctors around the country, we have also seen clear benefits for physicians and their patients when clinical trials are integrated into a process of comprehensive patient care.
Here are five ways in which this model can benefit patients and physicians while streamlining the trial process itself:
1. Accelerating patient recruitment goals
As trusted healthcare providers, physicians play a crucial role in patient recruitment for clinical trials. Patients can be overwhelmed by a chronic disease diagnosis, and they rely on the advice and counsel of their doctor. Physicians who partner with clinical trial sponsors can offer potentially life-saving resources to treat, educate and guide patients during their journey toward personal health improvement.
A clinical trial team, working in partnership with a physician, can access patient health records in a compliant manner and analyze them using AI-driven technology to identify the most promising candidates for a clinical trial. The doctor is then able to suggest this option during a regularly scheduled patient appointment. Because of the trust the patient has in their physician, they often respond positively to this recommendation.
2. Increasing clinical trial patient retention
Patient drop-out rates in clinical trials generally average around 70%, but it doesn’t have to be that way.
One trial in which our company was involved focused on non-alcoholic steatohepatitis (NASH) liver disease and the willingness of patients to have a second liver biopsy.1 The study’s goal was to determine if retention rates could be increased by having a technology-enabled research team at the point of care.
Researchers analyzed data on 103 patients obtained from 13 randomized controlled NASH studies involving seven gastrointestinal physician offices that incorporated clinical research into their practices. The average retention rate for the second liver biopsy was 89% for participants in the study. In comparison, data collected on 6,695 patients in randomized controlled NASH trials showed an 82% retention rate for the second biopsy.
3. Improving health outcomes, strengthening patient relationships
Most patients facing life-threatening disease or illness are searching for treatment to improve their health. They also want to feel confident their physician is informed about life-changing drugs and therapeutics and, if necessary, providing access to cutting-edge therapies.
A meta-analysis2 that examined whether patients’ trust in the healthcare professional is associated with health outcomes, found that there is a connection between positive long-term health outcomes and patients who have a high level of trust in their doctor. The researchers concluded that patients reported “more beneficial health behaviors, less symptoms and higher quality of life” and were “more satisfied with treatment” when they had a high level of trust in their doctor.
In our experience at ObjectiveHealth, we have heard plenty of testimonials from physicians and patients about the stronger bond they forged during clinical trials. One of the reasons is that patients are more inclined to having an open, honest dialogue with a trusted physician who has been managing their care. And while anecdotal, the increased patient retention in the NASH study previously referenced in this article was likely influenced by the continuity of care provided by their GI physician.
4. Enhancing professional reputation
In today’s hyper-connected online world, it has become critical that physicians protect — and strive to enhance — their reputation in their communities. One of the key findings in the 2022 Healthcare Trends Report,3 for example, was that 72% of consumers read online reviews and ratings when choosing a new doctor.
Being involved with innovative research can enhance a physician’s reputation in the community. Increased patient referrals and positive word-of-mouth from influential community leaders also can increase when a physician’s practice offers novel medical therapies and treatments. A successful trial completion also helps connect physicians with experts at other centers of excellence, further enhancing the practice’s reputation among healthcare leaders.
5. Expanding access to healthcare to underserved and/or rural communities
Families and individuals in underserved and rural communities often find it difficult to receive life-changing care for chronic disease and illness. These communities, however, are essential to medical research because scientists and healthcare experts gain valuable clinical evidence about the impact of new drugs on diverse populations. When clinical trials are integrated into a private practice in these communities, patients have access to potential treatment plans that can lead to better health outcomes.
More money than ever is being invested in biotech/pharmaceutical R&D, but our industry needs a more cost-efficient, productive solution to improve the efficiency of clinical trials. The answer may be found in integrating clinical research into more community-based physician practices, which can be a win-win for patients and doctors alike.
Don Lazas, MD, is the co-founder and chief medical officer for ObjectiveHealth, an integrated research and technology platform company based in Nashville.
1. Lazas, Donald MD; O'Rourke, Josh MBA; et al., “Improving Patient Retention in NASH Trials With a Technology-Enabled Research Team in the GI Practice.” The American Journal of Gastroenterology, 116, October 2021, DOI: 10.14309/01.ajg.0000777952.00945.a0
2. Birkhäuer J, Gaab J., Kossowsky J, et al., “Trust in the health care professional and health outcome: A meta-analysis.” PLoS One, Published online 2017 Feb. DOI: 10.1371/journal.pone.0170988.
3. New Research Finds That Over 70% of Consumers Read Online Reviews When Considering a New Doctor, February 08, 2022, GlobalNewswire, Source: Reputation Inc.