DCRI Think Tanks Demonstrate What Is PossibleTackling today’s healthcare challenges requires collaboration from every stakeholder, including patients, academic investigators, site investigators, regulatory agencies, pharmaceutical and device industry leaders, payers, technology companies and more.
DCRI Think Tanks demonstrate what is possible when you bring smart people together to tackle the biggest challenges in clinical research. From cardiovascular diabetes to the Pediatric Rule to the Modern Data Monitoring Committee, these meetings are about creating pathways to useful, focused discussions across the healthcare continuum and then moving consensus to action.
Our mission—to address the most critical gaps in clinical research by convening leaders across the healthcare industry to map the way forward in designing, conducting, and implementing high-quality, evidence-based research.
July 31-August 1, 2019
Fast-tracking Research Results into Practice: Designing and Testing Effective Strategies for Implementing Evidence-Based Medicine
Health care organizations in public and private sectors spend more than $100 billion on research each year.
Yet, even when research evidence is available, stakeholders often do not have adequate information to make
decisions about the most effective treatments under particular circumstances or for particular patients. It often takes a long time to translate research results into clinical practice, particularly when health system and payor factors play a role beyond individual patient-clinician decision-making.
This Think Tank will focus on the question of how to sustain research-supported interventions at local health care institutions but also widely apply them beyond the initial systems under study. Healthcare environments around the world are increasingly driven by resource constraints and focused on maximizing health care value. Thus, descriptive studies of barrier/facilitators of implementation success are critical, but these need to link to rigorously controlled studies that evaluate the effectiveness of practice-based improvement initiatives. Implementation study outcomes impact both practice and the ability of interventions to be scaled.
Key questions of this DCRI Think Tank include:
- What are best practices in the design of implementation science studies?
- What do implementation science studies contribute to lifecycle management of a drug or device?
- What kind of real world evidence (RWE) do these implementation studies generate?
- How can complex health interventions be assembled to change clinician and patient behavior?
- How do you get patients involved and engaged meaningfully?
- How do you describe and adapt interventions to different health care settings?
- How can we best understand implementation science from a consumer perspective to help stakeholders interpret intervention benefit/value?
DCRI Think Tanks Publications
Heart Failure Preserved Ejection Fraction
Meeting: June 7-8, 2017
Advancing Care and Clinical Trials through Digital Health
Meeting: December 5-6, 2016
Issues in Pediatric Cardiovascular Drug Development
Meeting: September 8-9, 2016
Leveraging E.H.R. for Clinical Research Now!
Meeting: February 18-19, 2016
DCRI Think Tanks is partnered with the CardioVascular Clinical Trialists Forum (CVCT)—a unique experts-only forum aimed at discussing important and timely CV trials and trial science issues (design, methodology, interpretation, approval and implementation). Their emphasis on interaction among highly knowledgeable global experts from multiple backgrounds, including academy, industry R&D, regulatory agencies, major journal editors, NHLBI, payers (CMS, HTA organizations) and patient representatives makes them a key DCRI Think Tanks contributor.
DCRI Think Tank faculty lead Dr.Matthew Roe and Fred Cobb Distinguished Professor of Medicine Dr.Eric Peterson chaired a joint CVCT-Duke Think Tank session with Dr. Martin Cowie titled “eSolutions – Big Data – Smart Data and How These May Help with Clinical Evidence Generation” at the annual 2018 CVCT meeting on Friday, November 30, 2018.
Recent DCRI Think Tank
April 24-25, 2019
Accelerating Drug Development for Chronic Kidney Disease and End-Stage Renal Disease
Despite chronic kidney disease (CKD) and end-stage renal disease (ESRD) imposing substantial disease burden, reduced quality of life, increased mortality, and significant economic strain, the number of randomized clinical trials in Nephrology remains fewer than all other medicine specialties.
The unexpected successes of certain cardiometabolic therapies in the treatment of diabetic nephropathy have reinvigorated the push for clinical trials to improve outcomes for patients with CKD and ESRD. However, the regulatory pathways for development and approval of therapies to treat CKD and/or dialysis-dependent ESRD remain uncertain while several challenges exist for designing and executing clinical trials in these populations both in the United States and abroad. The lack of clear surrogate endpoints including a standardized definition for CKD progression, uncertainty regarding the need for a cardiovascular outcomes safety trial for therapies targeting patients with CKD and ESRD, operational challenges for conducting clinical trials among dialysis-dependent patients, and difficulties extrapolating and evaluating risk/benefit calculations in these high-risk patient populations present clear challenges for successful clinical trials in this population.
To address these shortcomings, this Think Tank focused on increasing the use of patient-centered and patient-reported outcomes, galvanizing key stakeholder groups to clarify development and regulatory pathways to accelerate the development of promising therapies for these conditions, developing effective and universal surrogate endpoints, improving interconnected site networks, and delineating novel research and operational methods to execute clinical trials in the evolving research data ecosystem with a special focus on leveraging real-world data sources.
Cardiovascular Outcomes and Diabetes Drugs: Lessons Learned and Path Forward
DCRI faculty joined a DCRI Research Forum panel on March 6, 2018 to share their perspectives on Cardiovascular Outcomes and Diabetes Drugs after attending a think tank meeting on the same topic.