Dr. Jacqueline Corrigan-Curay of the US Food and Drug Administration discusses recent trends in incorporating real-world data and real-world evidence in regulatory decisions.
Jaqueline Corrigan-Curay, JD, MD
Principal Deputy Center Director in FDA’s Center for Drug Evaluation and Research (CDER)
View the full Grand Rounds video: Real World Evidence: Contemporary Experience and Future Directions
Dr. Lesley Curtis describes the characteristics of a pragmatic clinical trial, which typically are large, efficient studies done in the real world that result in evidence for the adoption of an intervention into clinical practice.
Lesley Curtis, PhD
Professor of Population Health Sciences and Medicine, Duke University
Duke Clinical Research Institute
Collaboratory Steering Committee Chair
This Grand Rounds presentation was part of our special Grand Rounds series, Ethical & Regulatory Dimensions of Pragmatic Clinical Trials. Joe Ali, Tanya Matthews, and Leslie Crofford discuss what to do when data in a pragmatic clinical trial includes information that might signal physical, mental health or behavioral health risks to patient-subjects (e.g. substance use, depression, anxiety, suicidality).
Joseph Ali, JD
Assistant Professor, Dept. of International Health
Johns Hopkins Bloomberg School of Public Health
Core Faculty & Associate Director for Global Programs
Johns Hopkins Berman Institute of Bioethics
Tanya Matthews, PhD
HRPP Director
Kaiser Permanente Washington
Leslie J. Crofford, MD
Wilson Family Chair in Medicine
Professor of Medicine and Pathology, Microbiology & Immunology
Chief, Division of Rheumatology
Vanderbilt University Medical Center
Living Textbook: How Are PRO Measures Used?
In this Keynote Presentation, Dr. Clyde Yancy offers ways to ensure all populations have access to pragmatic clinical trials. The path forward includes expanding recruitment and training of coordinator and investigator research teams, incorporating novel information technology strategies, revision of the informed consent process to match literacy levels, and education at the societal level to advance overall "research IQ."
Clyde W. Yancy, MD, MSc, MACC, FAHA, MACP, FHFSA
Vice Dean, Diversity and Inclusion, Northwestern University, Feinberg School of Medicine
It's important to be thorough, informed, timely, and clear when discussing the research question for a PCT grant application. Dr. Wendy Weber provides an overview of strategies for success when writing PCT grant applications.
Wendy Weber, ND, PhD, MPH
Branch Chief, Clinical Research Branch
Division of Extramural Research
National Center for Complementary and Integrative Health (NCCIH)
What Are Common Pitfalls in Writing PCT Grant Applications?
Is It Important to Explain the Definition of Pragmatic to Grant Reviewers?
What Are the “Must Dos” of Writing PCT Grant Applications?
The Patient-Centered Outcomes Institute (PCORI) is an independent, non-profit research organization dedicated to funding real-world questions that will inform patients and other health care stakeholders. In this video, Dr. Anne Trontell, Associate Director of PCORI, shares the importance of early and continuous investment in engaging patients, stakeholders, and communities.
Anne Trontell, MD, MPH
Associate Director in the Clinical Effectiveness and Decision Science Program
Patient-Centered Outcomes Research Institute
Building Partnerships and Teams to Ensure a Successful Trial
In this interview, Dr. Stephen George discusses how complexity can change as you work in partnership with the people who will be implementing the intervention. The complexity of an intervention has to be simple enough to be feasible in the context of the research setting.
Steven George, PhD
Professor in Orthopaedic Surgery, Duke University
Living Textbook: Intervention Delivery and Complexity
Dr. Liz Turner discusses reasons to randomize clusters instead of individuals, making it logistically easier to implement the intervention your trial is studying.
Liz Turner, PhD
Associate Professor, Biostatistics and Bioinformatics and Global Health
Biostatistics and Study Design Core Co-Chair
What Is Outcome Clustering, and How Can It Affect a Trial?
What Is the Intraclass Correlation Coefficient?
Assessing data quality is a key step in research that uses data from the electronic health record. These data are a surrogate for clinical phenomena, meaning they represent an interpretation of clinical information about a patient instead of absolute truth. This video describes steps for assessing data quality, including identifying variation between populations at different sites and assessments of accuracy, completeness, and consistency.
Rachel Richesson, PhD 
Professor of Learning Health Sciences, University of Michigan Medical School
Electronic Health Records Core Co-chair
Dr. Liz Turner discusses the features of two types of cluster randomized trials, regular parallel arm and the stepped-wedge design. Turner discusses complete vs. incomplete versions of the stepped-wedge design and provides case examples of each type of design.
Liz Turner, PhD
Associate Professor, Biostatistics and Bioinformatics and Global Health
Biostatistics and Study Design Core Co-Chair
What Are the Arguments For and Against the Stepped-Wedge Design?
