The OneFlorida Clinical Data Research Network (CDRN) led by Principal Investigator, Carl Pepine will now be participating in ADAPTABLE and joining efforts with the other seven CDRNs to enroll 20,000 participants in this novel research study. Similar to the other CDRNs participating in ADAPTABLE, OneFlorida is a collaboration of researchers, clinicians, and patients who work together to conduct research to answer questions that matter most to patients and those who care for them.

Continue reading OneFlorida Clinical Data Research Network Joins the ADAPTABLE Study →

ADAPTABLE physician leaders Robert Harrington and Matthew Roe along with operations team leaders Lisa Berdan and Tyrus Rorick presented ADAPTABLE to the American College of Cardiology (ACC) Board of Governors (BOG) on April 1, 2016 during the annual ACC scientific sessions. The ACC BOG is the grassroots liaison organization that represents the local state ACC chapters within the ACC headquarters. Their presentation generated a thoughtful discussion about the goals and objectives of ADAPTABLE.  The BOG members expressed uniform support in communicating the importance of ADAPTABLE to local chapter leaders and local ACC state members and constituents to raise awareness of the trial among cardiologists across the United States. The ADAPTABLE team committed to providing the BOG with study updates, to connect local chapter leaders with the leaders of ADAPTABLE at the participating CDRNs and health care systems, and to work together with the BOG to facilitate the widespread dissemination of information about ADAPTABLE to the cardiology community.  

In CardioSource WorldNews, doctors Robert Harrington, Matthew Roe, and Adrian Hernandez discuss ADAPTABLE’s novel study design and the impact of the results for patients and their caregivers. 

“We are striving to answer an important clinical question that interests both patients and providers in a highly efficient way that takes advantage of data that is already being collected as part of routine care,” says Robert A. Harrington, MD, co-chair of ADAPTABLE. “It’s truly better integrating research into clinical practice and helping in the construct of the learning health care system.”

Another highlight of ADAPTABLE is that it includes patient involvement every step of the way.  According to Matthew Roe, MD, MHS, FACC, co-principal investigator for the trial, the trial includes targeted electronic outreach and electronic follow-up with patients in order to ultimately provide answers to questions like ‘How much aspirin should be taken each day to reduce risks of heart attack or stroke’ and/or ‘Do benefits and risks differ based on dose, health, age or other circumstance’?  Patient engagement is a key and defining aspect of this trial.

“We’re excited to be part of the first trial conducted through PCORnet which is a national research network that unites patients, clinicians, health systems and electronic health records to improve patient-centered outcomes,” said Adrian F. Hernandez, MD, MHS, FACC, director of outcomes and health services research at the Duke Clinical Research Institute and PCORnet’s Coordinating Center Principal Investigator. “Heart disease is the leading cause of death for men and women in the United States. The results of this study will help patients and those who care for them make better decisions about how aspirin therapy might be most helpful and ultimately could prevent as many as 88,000 death per year worldwide.”

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Another CDRN, Mid-South received full Intuitional Review Board (IRB) approval to conduct the ADAPTABLE study. Before a research study starts enrolling participants, the protocol (study plan) needs to be reviewed by someone not connected to the research to be sure it is ethical, provides potential benefits, and does not cause unnecessary harm to participants. This review is done by a IRB. An IRB is an independent group of professionals designated to review and approve the clinical protocol, informed consent forms, study advertisements, and patient brochures, to ensure that the study is safe and effective for human participation.

An article published in Circulation by a group of authors from the Duke Clinical Institute, some of whom are investigators and leaders in ADAPTABLE describes tensions between pragmatic clinical trial design and Good Clinical Practice (GCP) guidelines, which were established in 1996 to help ensure the safety of participants in clinical trials and the validity of trial findings. Pragmatic clinical trials (PCTs) such as ADAPTABLE are designed to test interventions in real-world settings and populations rather than under highly controlled conditions, and thus rely on simplified procedures, such as those used for screening, informed consent, and participant follow-up. Continue reading Adapting Good Clinical Practice Guidelines to Pragmatic Clinical Trials →