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.
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 will focus 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.
Future DCRI Think Tanks
Facilitating Evidence Adoption into Practice – Delineating Best Approaches for Implementation Sciences
Meeting date: July 31 – August 1, 2019
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
January 29 – 30, 2019
Emerging Techniques for Monitoring and Analyzing Data from Pragmatic, Streamlined Trials
Evaluating novel statistical methods for monitoring and analyzing electronic health record and patient-reported data that underlie streamlined, pragmatic trials and understanding what amount of missing data will be acceptable for regulatory submissions for pragmatic vs. traditional clinical trials.
Health care stakeholders require access to high-quality scientific evidence for informed decision-making and for reimbursement coverage decisions. New technologies and innovative data sources are transforming how clinical trials are being conducted with expectations that most future clinical trial data will be collected directly from patients or from electronic health record sources without a clinical research coordinator at the interface of data retrieval and collection. Within this context, the definitions of data quality and completeness of data collected for clinical trials may need to be evaluated with different standards and expectations, particularly given the need to reduce the risings costs of clinical trials. Similarly, a recent Institute of Medicine report has clarified that there is no substitute for complete data, noting that in pragmatic clinical trials involving electronic health record data, the impact of missing data may be more profound.
This Think Tank examined the evolving regulatory standards for data quality and acceptability as well as methods for monitoring and analyzing data from pragmatic trials, taking into consideration multi-stakeholder perspectives including those from academic investigators, industry sponsors, regulatory authorities, payers, and patient representatives. This Think Tank also focused on the essential roles of biostatisticians, data scientists, and informatic experts as key team members for overseeing and leading the data collection, monitoring, and analyses that support the conduct of pragmatic trials.
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.