In this feature of Ask ADAPTABLE, Dr. Schuyler Jones, an investigator with the Duke Clinical Research Institute Coordinating Center, discusses the role and importance of the clinician in the ADAPTABLE study.
Q: What is the role of the clinician in ADAPTABLE?
SJ: The role of the clinician in ADAPTABLE is that of support. Patients, especially older patients, like to hear about and discuss participation in clinical trials with their clinicians. We hope that clinicians will be able to answer questions, confirm eligibility, and validate that participating in ADAPTABLE may be of benefit to their patients. We expect that clinicians will be aware of ADAPTABLE and discuss the benefits and attributes of the study:
- Low-risk study for the participant
- Answers an important clinical question
- Defines an effective model for the conduct of clinical research
Watch this video to learn more about the role of clinicians in ADAPTABLE and how clinicians can be ADAPTABLE champions.
Q: What types of challenges do clinicians face in clinical research and how can studies like ADAPTABLE help?
SJ: Traditional clinical trials are costly, require a significant infrastructure for clinicians, and place the burden of collecting data on research staff. The goal of pragmatic trials like ADAPTABLE is to reduce the burden to clinicians and research staff by accessing and harnessing data that is already being collected in a patient’s medical record and other health information, such as emergency room and hospital visits from insurance claims. In ADAPTABLE, we are leveraging patient engagement to help with data collection by asking them to provide informed consent and report data directly through an online portal.
Q: Why is the ADAPTABLE study important to clinicians?
SJ: Results of ADAPTABLE will be important to patients with cardiovascular disease and their physicians. In ADAPTABLE, we are analyzing information recorded in medical records at office visits and information from health insurance claims—to answer a clinical question of what is the most effective dose (81 or 325 mg) of aspirin to prevent the occurrence of a heart attack, stroke, or death in people with cardiovascular disease. Currently, we don’t have sufficient evidence from clinical trials to answer this question so results of the ADAPTABLE study have the potential to make a significant impact on medical practice.
Often in medicine, physicians make recommendations based on their personal preference or what they think is best, rather than based on evidence. ADAPTABLE provides a new model to answer simple questions that will provide real-world evidence. Other questions regarding cardiovascular health that could be asked using this type of research model include:
- How much exercise is necessary?
- What is the best diet?
- What is the best time (morning or evening) to take medication?
In addition, studies like ADAPTABLE can provide academic value to clinicians. In ADAPTABLE, we posted the protocol in the public domain for clinicians and lay people to comment. We received more than 100 thoughtful and focused comments that we used to further define the eligibility criteria for ADAPTABLE. As the study progresses, we will continue to engage clinicians in manuscript development and dissemination of study results.
Q: What do we hope to learn from ADAPTABLE that will transform the conduct of clinical trials?
SJ: ADAPTABLE is the first demonstration study of the National Patient-Centered Clinical Research Network, an innovative initiative of the Patient-Centered Outcomes Research Institute (PCORI). It is designed to make it faster, easier, and less costly to conduct clinical research than is now possible by harnessing the power of large amounts of health data and establishing patient, clinician, and learning health system partnerships.
ADAPTABLE represents a new model of transforming the culture of clinical research from one directed by researchers to one driven by the needs of patients and those who care for them. We are engaging patients and clinicians in clinical research to design a new culture of clinical research and generate evidence to answer questions that matter most to patients and their clinicians.
In order for this model to work, we know that we must establish relationships and have buy-in from all stakeholders: patients, clinicians, and health system administrators. This is an exciting time in clinical research and we need all stakeholders to be effective champions of this new approach to conducting clinical trials.
Dr. Jones details further the importance of ADAPTABLE to clinicians in the below video.