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  • ADAPTABLE: Answering an Important Clinical Question while Testing a New Approach to Conducting Pragmatic Clinical Trials

    Results of the ADAPTABLE study will directly impact the health care of millions of Americans and provide evidence to answer a simple question: Which dose of aspirin is more effective for preventing heart attacks and strokes in people with heart disease, a leading cause of morbidity and mortality in the U.S.? Moreover, daily aspirin therapy ...
  • PCORnet Announces Enrollment of First Participant in ADAPTABLE Aspirin Study

    “PCORnet is shifting the research paradigm through studies like ADAPTABLE by introducing a new genre of patient-centered research where patients are engaged to improve the science of clinical trial design,” said Adrian F. Hernandez, MD, MHS, director of outcomes and health services research at the Duke Clinical Research Institute (DCRI) and PCORnet’s Coordinating Center Co-Principal ...
  • ADAPTABLE Presented to the American College of Cardiology Board of Governors

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

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

    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 ...
  • Adapting Good Clinical Practice Guidelines to Pragmatic Clinical Trials

    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 ...
  • Major milestone today in pragmatic clinical trials

    Congratulations to the REACHnet team for receiving the first IRB approval for the ADAPTABLE Aspirin Study.
  • ADAPTABLE provides a new approach to consent form development

    February 2016 In this feature of Ask ADAPTABLE, we speak with Dr. Laura Beskow, ADAPTABLE Co-investigator who, along with her team, led the development of the ADAPTABLE consent form. Q: Why did ADAPTABLE need a new approach to consent form development? LB: My work has been devoted to studying ethical issues in research and informed consent raises many ...
  • Challenging the Research Community to Think Differently about the Informed Consent Process

    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. ...
  • Posting of the draft protocol for public review and comment

    Dr. Matthew Roe, co-principal investigator of the ADAPTABLE study, talks about the rationale and process involved in posting the ADAPTABLE draft protocol for public review and comment and how the feedback received impacted the final protocol.