• 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.
  • ADAPTABLE investigators, Dr. Matthew Roe and Dr. Schuyler Jones, Discuss ADAPTABLE The Aspirin Study

    In these videos, Dr. Matthew Roe and Dr. Schuyler Jones explore: The unique and Innovative Elements of ADAPTABLE Who is Involved with ADAPTABLE The Role of Open Science and the Impact of ADAPTABLE Clinician Engagement in ADAPTABLE The Importance of ADAPTABLE to Clinicians
  • Study Co-Director, Adrian Hernandez, Discusses the Promise of the PCORnet ADAPTABLE Aspirin Dosage Study

     Adrian Hernandez, MD, MHS, discusses the important questions to be answered by the ADAPTABLE aspirin dosage study and how it will be conducted faster and more efficiently using the data resources of PCORnet.
  • New editorial discusses the importance of ADAPTABLE

    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 ...
  • Sowing Seeds of Trust in Patient-Centered Research

    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 ...