Category Archives: News

Novel New Study Could Finally Hold Answers to Questions about Aspirin Dosing

News, Pragmatic Research

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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Mid-South received full IRB approval today for the ADAPTABLE study.

News

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.

Adapting Good Clinical Practice Guidelines to Pragmatic Clinical Trials

News, Pragmatic Research

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 →

Challenging the Research Community to Think Differently about the Informed Consent Process

News, Patient Engagement, Pragmatic Research

A conversation with Laura M. Beskow, MPH, PhD, ADAPTABLE Co-Investigator, Duke University

A core aspiration of PCORnet is to redirect the culture of clinical research from researcher-directed to patient-driven. In this spirit, the Duke Clinical Research Institute’s Program for Empirical Bioethics, headed by Dr. Laura Beskow, developed a patient-centered informed consent process for the ADAPTABLE study. Her team is committed to ensuring that patients better understand the information presented in consent forms. Because ADAPTABLE’s informed consent process is web-based, it requires an innovative approach to promoting understanding. Continue reading Challenging the Research Community to Think Differently about the Informed Consent Process →

New editorial discusses the importance of ADAPTABLE

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Adrian Hernandez, MD, MHS, and his co-authors outline how the study has the potential to change how clinical trials are conducted.

An upcoming study comparing two doses of aspirin for secondary prevention of cardiovascular events in high-risk patients will answer an important clinical question while simultaneously testing a new approach to conducting pragmatic clinical trials. The authors of a commentary in Annals of Internal Medicine explain the significance of this effort.

The article was written by the DCRI’s Adrian Hernandez, MD, MHS; Rachael Fleurence, PhD, of the Patient-Centered Outcomes Research Institute (PCORI); and Russell Rothman, MD, MPP, of Vanderbilt University.

Known as ADAPTABLE (Aspirin Dosing: A Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness), the trial is the first to be facilitated by the National Patient-Centered Clinical Research Network (PCORnet). PCORnet is a “network of networks” created by PCORI to overcome the challenges that make medical research expensive, inefficient, and slow to provide results.

The mission of PCORnet is to support rapid and efficient randomized comparative effectiveness trials embedded in the delivery of usual care. In the ADAPTABLE trial, health record data collected during usual care will be used to identify, recruit, and follow up with research participants. Once the study is complete, researchers will have answers about aspirin and a better understanding of PCORnet’s capacity to accomplish its core mission.

“As ADAPTABLE progresses,” the authors write, “we believe it will illuminate PCORnet’s remarkable new approach to conducting pragmatic clinical trials and demonstrate how ‘big data’ can be leveraged to enhance the efficiency of clinical trials by facilitating the identification, recruitment, and follow-up of research participants.”

Sowing Seeds of Trust in Patient-Centered Research

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Trust is central to the relationship between patients and their clinicians. It’s also essential to the relationship between patients and researchers if patients are to fully engage in clinical research. As the healthcare industry becomes more patient-centered, clinical researchers will need to work closely with patients to assist them in finding answers to critical health questions.

Continue reading about ADAPTABLE’s commitment to engagement and transparency.