2024
Embracing Generative AI in Clinical Research and Beyond: Opportunities, Challenges and Solutions: January 24-25, 2024 | Directors: Chris Lindsell, PhD, DCRI, Peter J. Embí, MD, MS, Vanderbilt University, and Chuan Hong, PhD, Duke University; Meeting Fellow: Henry Foote, MD, Duke University | Read the Meeting Brief
The Power and Potential of Real-World Data in Randomized Clinical Trials: May 29-30, 2024 | Directors: Lisa Wruck, PhD, DCRI, and Stefan James, MD, PhD, Uppsala University; Meeting Fellow: Nina Nouhravesh, MD | Read the Meeting Brief
2023
An Ounce of Prevention, A Pound of Cure: January 25-26, 2023 | Directors: Clyde Yancy, MD, MSc, Northwestern University, and Christopher Granger, MD, DCRI; Meeting Fellow: Konstantin Krychtiuk, MD, DCRI
Developing Therapeutics for Rare Cardiovascular Diseases — Challenges and Opportunities: May 9-10, 2023 | Directors: Euan Ashley, MD, PhD, Stanford University, and Michael Felker, MD, MHS, DCRI; Meeting Fellow: Joseph Lerman, MD, DCRI
Misunderstanding Misinformation: A New Focus for the Next Health Offensive: July 26-27, 2023 | Directors: Emily O’Brien, PhD, DCRI, and Claire Wardle, PhD, Brown University
Realigning Incentive Structures to Accelerate Evidence Generation: October 25-26, 2023 | Directors: Scott Palmer, MD, MHS, DCRI, and Sir Martin Landray, FMedSci, University of Oxford; Meeting Fellow: Jeeyon Grace Rim, MD, DCRI | Read the Meeting Brief
2022
Consumerization and Digitization of Healthcare: Where Marketing Meets Clinical Trials: January 26-27, 2022 | Directors: Christoph Hornik, MD, MPH, PhD, DCRI, and Megan Ranney, MD, MPH, Brown University; Meeting Fellow: Rachel Randall, MD, DCRI | Read the Executive Summary
- Consumerization and Digitization of Healthcare: Where Marketing Meets Clinical Trials, Contemporary Clinical Trials, September 2023, Volume 132, Issue
Preparing for the Next Pandemic: From EUA to Beyond: May 11-12, 2022 | Directors: Susanna Naggie, MD, DCRI, and Rajesh Gandhi, MD, Harvard University; Meeting Fellow: Shanti Narayansamy, MD, Duke | Read the Executive Summary
- Lessons from COVID-19 for Pandemic Preparedness: Proceedings from a Multi-Stakeholder Think Tank Meeting, Clinical Infectious Diseases, July 2023, Volume 77, Issue 12
Drug Development for the Top Five Chronic Health Conditions: July 27-28, 2022 | Directors: Neha Pagidipati, MD, DCRI, and Richard Schilsky, MD, FACP, FSCT, FASCO, University of Chicago; Meeting Fellow: Konstantin Krychtiuk, MD, PhD, PD, FESC
- Drug development for major chronic health conditions—aligning with growing public health needs: Proceedings from a multistakeholder think tank, Am Heart J, April 2024, Volume 270
Clinically Integrated Trials: From Policy to Practical: October 19-20, 2022 | Directors: Schuyler Jones, MD, DCRI, and Pamela Tenaerts, MD, MBA, Medable ; Meeting Fellow: Anthony Peters, MD, DCRI
2021
Clinical Endpoint Classification and Adjudication – Consolidating Standards and Leveraging Technology: January 27-28, 2021 | Directors: Kenneth Mahaffey, MD, Renato Lopes, MD, PhD; Meeting Fellow: Vanessa Blumer, MD | Read the Executive Summary
Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change: April 28-29, 2021 | Directors: Gerald Bloomfield, Bray Patrick-Lake; Meeting Fellow: Michelle Kelsey, MD | Read the Executive Summary
- Inclusion and Diversity in Clinical Trials: Actionable Steps to Drive Lasting Change, Contemporary Clinical Trials, May 2022, Volume 116, 106740
Durable Innovations in Clinical Trials and Regulatory Oversights from COVID-19: Emergence of a New Normal: July 28-29, 2021 | Directors: Emily O'Brien, PhD, DCRI, Craig Lipset, Clinical Innovation Partners; Meeting Fellow: Josephine Harrington, MD, Duke University | Read the Executive Summary
Addressing Clinical Trial Deserts: October 6-7, 2021 | Directors: Charlene Wong, MD, DCRI; Harlan Krumholz, MD, SM, Yale University; Meeting Fellow: Andrew Vekstein, MD, DCRI | Read the Executive Summary
2020
Delineating Quality Standards for Real-World Data-Enabled Trials: October 14-15, 2020 | Directors: Erick Perakslis, PhD, Cynthia Senerchia, MD; Meeting Fellow: Vishal Rao, MD, MPH | Read the Executive Summary
Navigating Clinical Trials in the COVID-19 Era: An Accelerated Shift Towards Direct-to-Patient, Virtual and Hybrid Trials: July 29-30, 2020 | Directors: Lesley Curtis, PhD, Robert Harrington, MD; Meeting Fellow: Zach Wegermann, MD
Leveraging Artificial Intelligence and Machine Learning Methods and Approaches to Transform Clinical Trial Design, Planning, and Execution: January 29-30, 2020 | Directors: Erich Huang, MD, PhD, and Marzyeh Ghassemi, PhD, MSc; Meeting Fellow: E. Hope Weissler, MD
2019
Innovative Approaches to Accelerating New Drug Evaluation for Chronic Cardiometabolic Diseases - Leveraging Intermediate Non-Clinical Endpoints and Pragmatic Clinical Trials: October 2-3, 2019 | Directors: John Alexander, MD, and Michael Lincoff, MD
Fast-tracking Research Results into Practice: Designing and Testing Effective Strategies for Implementing Evidence-Based Medicine: July 31-August 1, 2019 | Directors: Tracy Wang, MD, and Amy Kilbourne PhD, MPH
Accelerating Drug Development for Chronic Kidney Disease and End-Stage Renal Disease: April 24–25, 2019 | Directors: Myles Wolf, MD, MMSc, Glenn Chertow, MD, MPH; Meeting Fellow: Daniel Edmonston, MD
- Drug Development in Kidney Disease: Proceedings From a Multistakeholder Conference, American Journal of Kidney Disease, December 2020, Volume 76, Issue 6
- NIH Collaboratory Grand Rounds Presentation, November 20, 2020
Emerging Techniques for Monitoring and Analyzing Data from Pragmatic, Streamlined Trials: January 29–30, 2019 | Directors: Lesley Curtis, PhD, and Susan Ellenberg, PhD; Meeting Fellow: Trevor Lentz, PT, PhD, MPH
- Designing, Conducting, Monitoring, and Analyzing Data from Pragmatic Randomized Clinical Trials: Proceedings from a Multi-stakeholder Think Tank Meeting, Therapeutic Innovation & Regulatory Science, June 8, 2020, Volume 54, Issue 4
- NIH Collaboratory Grand Rounds Presentation, August 28, 2019
2018
Technology-Enabled Clinical Trials: Innovations in Trial Design & Conduct: October 3-4, 2018 | Directors: Eric Peterson, MD, and Matthew Roe, MD
- Technology-Enabled Clinical Trials: Transforming Medical Evidence Generation, Circulation, October 22, 2019, Volume 140, Issue 17
Enabling Patient-Reported Outcomes: July 25-26, 2018 | Directors: Adrian Hernandez, MD, and Kevin Weinfurt, PhD
- Enabling Patient-Reported Outcome Measures in Clinical Trials, Exemplified by Cardiovascular Trials, Health and Quality of Life Outcomes, June 2021
Cardiovascular Outcomes for Diabetes Drugs: January 31-February 1, 2018 | Directors: Christopher Granger, MD, and John McMurray, MD
- Impact of Regulatory Guidance on Evaluating Cardiovascular Risk of New Glucose-Lowering Therapies to Treat Type 2 Diabetes Mellitus–Lessons Learned and Future Directions, NIH Collaboratory Grand Rounds Slides and Key Points, March 13, 2020
2017
Heart Failure Preserved Ejection Fraction: June 7-8, 2017 | Directors: Michael Felker, MD and Margaret Redfield, MD
- Heart Failure with Preserved Ejection Fraction Expert Panel Report: Current Controversies and Implications for Clinical Trials JACC Heart Failure, August 2018, Volume 6, Issue 8
2016
Advancing Care and Clinical Trials through Digital Health: December 5-6, 2016 | Directors: Eric Peterson, MD, MPH, Robert Harrington, MD, Mark McClellan, MD, PhD
- Using Digital Health Technology to Better Generate Evidence and Deliver Evidence-Based Care JACC Heart Failure, June 2018, Volume 71, Issue 23
Issues in Pediatric Cardiovascular Drug Development: September 8-9, 2016 | Directors: Jennifer Li, MD and Prince Kannankeril, MD
- Recommendations to Enhance Pediatric Cardiovascular Drug Development: Report of a Multi-Stakeholder Think Tank Journal of the American Heart Association, February 20, 2018, Volume 7, Issue 4
Stroke Prevention for AFib: Closing the Gap: June 2-3, 2016 | Directors: Bernard Gersh, MB, ChB and Christopher Granger, MD
Leveraging E.H.R. for Clinical Research Now!: February 18-19, 2016 | Directors: Lesley Curtis, PhD, Adrian Hernandez, MD, Eric Peterson, MD, MPH
- Leveraging electronic health records for clinical research Am Heart J, August 2018, Volume 202
2015
Data Monitoring Committee: June 4-5, 2015 | Directors: David DeMets, PhD, Thomas Fleming, PhD, Matthew Roe, MD
- Data monitoring committees: Promoting best practices to address emerging challenges. Clinical Trials, February 1, 2017, Volume 14, Issue 2
Medication Adherence: Solutions and Policy Implications: January 14-15, 2015 | Directors: Hayden Bosworth, PhD, Bradi Granger, PhD, Eric Peterson, MD
- Medication Adherence discussions began in July 2009 with the first meeting in 2010 and the last in January 2015. All papers from the Medication Adherence Think Tank are listed below:
- Medication adherence: A call for action, Am Heart J, September 2011, Volume 162, Issue 3
- Medication Adherence: Emerging Use of Technology, Current Opinion in Cardiology, July 2011, Volume 26 - Issue 4
- Ingredients of Successful Interventions to Improve Medication Adherence JAMA, December 23, 2013, Volume 310, Number 24 (Viewpoint)
- Medication adherence: process for implementation, Patient Preference and Adherence, July 28, 2014, Volume 2014:8
- Improving diabetes medication adherence: successful, scalable interventions Patient Preference and Adherence, January 23, 2015, Volume 2015; 9
- Health Information Technology: Meaningful Use and Next Steps to Improving Electronic Facilitation of Medication Adherence JMIR Medical Informatics, March 2016, Volume 4, Issue 1
- A renewed Medication Adherence Alliance call to action: harnessing momentum to address medication nonadherence in the United States. Patient Preference and Adherence, July 7, 2016, Volume 2016:10
- Medication adherence: A practical measurement selection guide using case studies. Patient Education and Counseling, July 2017, Volume 100, Issue 7
2014
Cardiovascular Drug Development: July 21-22, 2014 | Director: Robert Califf, MD
- Cardiovascular drug development: is it dead or just hibernating? JACCardiol, 2015; 65:1567-82.
2013
Transforming Professional Medical Education: December 9-10, 2013 | Directors: Robert Califf, Zubin Eapen, Eric Peterson and John Sundy
Resistant Hypertension: August 1-2, 2013 | Directors: Robert Califf, Manesh Patel, John Sundy
- Proceedings from Duke resistant hypertension think tank AM HEART J 2014; 167; 775-788
Medication Adherence Alliance: February 25, 2013 | Directors: Hayden Bosworth, PhD, Christopher Granger, MD, Bradi Granger, RN, MSN, PhD
- Refer to Medication Adherence, January 2015 above for list of papers.
Cancer and Thrombosis: February 3-4, 2013 | Directors: Gary Lyman and Robert Califf
Statin Intolerance: January 14-15, 2013 | Director: Robert M. Califf, MD
2012
Atrial Fibrillation: December 3-4, 2012 | Directors: Robert Califf, MD, Christopher Granger, MD, Ajay Kakkar, MD
2011
Rescuing Clinical Trials in the US and beyond: A Call for Action: October 5-6, 2011 | Directors: Robert Califf, MD, Christopher Granger, MD, Robert Harrington, MD, Eric Peterson, MD
- Rescuing clinical trials in the United States and beyond: a call for action. AM HEART J; 2013; 165; 837-847.
Disease-wide Consolidated Registries: A New Model for Capturing Rare Adverse Events in Juvenile Idiopathic Arthritis (JIA) and Pediatric Rheumatic Diseases: June 9-10, 2011 | Directors: Laura Schanberg, MD, Christy Sandborg, MD
- Using Registries to Identify Adverse Events in Rheumatic Diseases Peds 2013; 132:e1384-1394.
Developing an Action Plan for Patient Radiation Safety in Adult Cardiovascular Medicine: A DCRI/ACC/AHA Think Tank: February 27-28, 2011 | Director: Pamela Douglas, MD
- Action Plan for Patient Radiation Safety in Adult CV Medicine JACC, March 22, 2012
2010
The SCA Thought Leadership Alliance Think-Tank Meeting II: December 5-6, 2010 | Directors: Sana Al-Khatib, Eric Peterson, Gillian Sanders
- Quality of care for sudden cardiac arrest: Proposed steps to improve the translation of evidence into practice. AM HEART J 2011; 162:222-231.
Medication Adherence: What Do We Need To Do To Get People To Take Their Medications?: October 28-29, 2010 | Directors: Hayden Bosworth, Christopher Granger, Bradi Granger
- Medication adherence: a call for action AM HEART J 2011; 162:412-24.
Pharmacogenomics in CV Disease: Balancing Scientific Promise with Clinical Reality: August 2-3, 2010 | Directors: Robert Califf, MD and Christopher Granger, MD
2009
The SCA Thought Leadership Alliance Think-Tank Meeting: December 5-6, 2009 | Directors: Sana Al-Khatib, Eric Peterson, Gillian Sanders, Clyde Yancy
- Addressing disparities in sudden cardiac arrest care and the underutilization of effective therapies. AM HEART J 2010; 160:605-618
Venous Thromboembolism in High-Risk Groups: Role of Surrogate Outcomes: May 26-27, 2009 | Directors: John Eikelboom and Jack Hirsh
Race & Ethnicity in Cardiovascular Clinical Trials: Historical Disparities, Current Barriers and Future Opportunities: April 16-17, 2009 | Directors: Daniel Mark, George Mensah, Linda Davidson-Ray
2008
Implementation of Cell Therapy for Cardiovascular Disease: November 20-21, 2008 | Directors: Victor Dzau, James Willerson, Christopher Granger, Marc Jolicoeur
Globalization of CV Clinical Trials: August 29, 2008 | Directors: Paul Armstrong, Frans Van de Werf and Robert Harrington
Standardized Reporting of Bleeding Complications for Clinical Investigations in ACS: April 17-18, 2008 | Directors: Sunil Rao and John Eikelboom
2007
Preventing Tomorrow’s Sudden Cardiac Death Today: Dissemination of Effective Therapies for SCD Prevention: December 12-13, 2007 | Directors: Sana Al-Khatib and Gillian Sanders
- Preventing Tomorrow’s Sudden Cardiac Death Today: Dissemination of Effective Therapies for SCD Prevention AM HEART J 2008; 156:613-622.
Implementing Cardiovascular Imaging Quality: October 8-10, 2007 | Directors: Pamela Douglas, Greg Hundley, Fred Masoud
- Achieving Quality in Cardiovascular Imaging II: Proceedings From the Second American College of Cardiology–Duke University Medical Center Think Tank on Quality in Cardiovascular Imaging JACC. 2009; 231-240:2006 48:2141-51; Epub 2006 Nov 1
Regulatory Review of Drugs for Type 2 Diabetes and Cardiovascular Risk: Beyond HgbA1c?: June 13-15, 2007 | Directors: Darren McGuire, Robert Califf, Rury Holman, MD
Improving Quality of Care for Women with Heart Disease: March 8-9, 2007 | Directors: Pamela Douglas, M. Noel Bairey Merz, MD, Rita Redberg, MD
- Improving the quality of care for women with cardiovascular disease: report of a DCRI Think Tank Am Heart J 2008: 156:816-825
The Cardiovascular Clinical Research Enterprise: State of the Union: January 11-12, 2007 | Director: Robert Harrington, MD
2006
Chronic Advanced Coronary Artery Disease: December 3-5, 2006 | Directors: Magnus Ohman, MD, Christopher Granger, MD
- Clinical and Research Issues Regarding Chronic Advanced Coronary Artery Disease, Part I: Contemporary and Emerging Therapies Am Heart J. 2008 Mar; 155(3):418-34.
- Clinical and Research Issues Regarding Chronic Advanced Coronary Artery Disease, Part 2: Trial Design, Outcomes and Regulatory Issues AM HEART J December 2007.
Preventing Tomorrow's Sudden Cardiac Death Today: Part I: July 20-21, 2006 | Co-Directors: Gillian Sanders PhD and Sana Al-Khatib, MD, MHS
Current data on risk stratification for sudden cardiac death AM HEART J 2007; 153:941-50;
Preventing Tomorrow's Sudden Cardiac Death Today: Part II[JR1]
- Translating sudden cardiac death risk assessment strategies into practice & policy AM HEART J 2007; 153: 951-9
Dimensions of Cardiovascular Imaging Quality: January 30-February 1, 2006 | Directors: Pamela Douglas, MD, Ami Iskandrian, MD, Harlan Krumholz, MD | In conjunction with American College of Cardiology
- Achieving quality in cardiovascular imaging: proceedings from the American College of Cardiology-Duke University Medical Center Think Tank on Quality in Cardiovascular Imaging. JACC; 2006; 48:2141-51.
Bleeding and Transfusion in Cardiovascular Disease: January 15-17, 2006 | Director: Robert Califf, MD
- Bleeding and blood transfusion issues in patients with non-ST-segment elevation acute coronary syndromes European Heart Journal 2007: 28:1193-1204.
2005
Antithrombotic Development for Atrial Fibrillation: July 25-27, 2005 | Directors: Robert Califf, MD and Christopher Granger, MD
- Antithrombotic Drug Development for Atrial Fibrillation: Proceedings, Wash, DC, July 25-27, 2005. AM HEART J 2008:155:829-40.
Defining Risk in ACS: The Gateway to Enhancing Cardiovascular Care: June 2-4, 2005 | Directors: Paul Armstrong, MD, Christopher Granger, MD
ICD Cost Effectiveness: March 21-22, 2005 | Directors: Daniel Mark, MD, Gillian Sanders, MD
Clinical Events Endpoints Committees: Nuts and Bolts: January 20-22, 2005 | Directors: Kenneth Mahaffey, MD, Bernie Chaitman, MD, Marc Pfeffer, MD, Robert Califf, MD
2004
Combination Pills in Cardiovascular Disease: Update and Future Ideas: October 7-9, 2004 | Directors: Robert Califf, MD, George Bakris, MD
Child and Adolescent Psychopharmacology in the New Millennium: A Workshop for Academia, Industry and Government: September 23-25, 2004 | Directors: Joseph DeVeaugh-Geiss, MD, John March, MD, Barry Mangum, PharmD
- Child and Adolescent Psychopharmacology in the New Millennium: A Workshop for Academia, Industry and Government JAACAP 45:3 March 2006, 261-270.
ICD-CRT: August 23-24, 2004 | Directors: Robert Califf, MD, Sana Al-Khatib, MD, Gillian Sanders, PhD
- Implantable cardioverter defibrillators and cardiac resynchronization therapy in patients with left ventricular dysfunction: randomized trial evidence through 2004. Am Heart J 2005; 149:1020-34
Post-Market Evaluation of Breakthrough Technology Summit on Issues and Approaches (Case Study on DES Thrombosis & Allergy): February 16-18, 2004 | Directors: Robert Califf, MD, Mitch Krucoff, MD, Carl Pepine
Type 2 Diabetes, the Metabolic Syndrome and Adult Obesity: Evolving the Paradigms: January 29-31, 2004 | Directors: Scott Grundy, MD, Darren McGuire, MD
Heart Failure Trial Endpoints: Where are we heading?: January 22-24, 2004 | Directors: Christopher O’Connor, MD, Peter Carson, MD
2003
Genetics of Cardiovascular Disease II: September 12-13, 2003 | Directors: Christopher Granger, MD, Pascal Goldschmidt, MD, and Eric Topol, MD
Liability issues for data monitoring committee members: January 16-18, 2003 | Directors: David DeMets, PhD, Thomas Fleming, PhD
- Liability issues for data monitoring committee members. Clinical Trials 2004:1:525.
2002
Registration/approval/coverage/payment, Exploring Options for Improving Healthcare: December 8-9, 2002 | Directors: Kevin Schulman, MD, Daniel Mark, MD, Daniel Mendelson
- Exploring options for improving healthcare. Am Heart J. 2004 Jan; 147(1):23-30.
Challenges in Designing Trials of Drug-Eluting Stents: July 28-30, 2002 | Directors: Robert M. Califf, MD, Richard Kuntz, MD, James P. Zidar, MD
How to Develop Drug Combinations: July 19-21, 2002 | Director: Robert M. Califf, MD
Update on Key Issues in Phase III Cardiovascular Trial Design (Active Controls and Biomarker Surrogates): May 22-24, 2002 | Directors: Robert Califf, MD, David DeMets, PhD, Thomas Fleming, PhD, Magnus Ohman, MD
Uncontrolled Systolic Hypertension: April 26-27, 2002 | Directors: Robert M. Califf, MD, Henry Black, MD
- Results of expert meetings. Uncontrolled systolic hypertension Washington, DC, April 25-27, 2002 AM HEART J 2005, 149(5):768
- Systolic hypertension: An overview AM HEART J 2005, 149(5):769-75,
- Evaluation and management of patients with uncontrolled systolic hypertension: Is another new paradigm really needed? AM HEART J 2005, 149(5):776-84.
- Barriers to Hypertension control AM HEART J 2005, 149(5):785-794
- Improving blood pressure control by tailored feedback to patients and clinicians AM HEART J 2005, 149(5):795-803
- Diet and blood pressure: Applying the evidence to clinical practice AM HEART J 2005, 149(5):804-12
The Metabolic Syndrome of Cardiovascular Risk and Insulin Resistance: April 18-20, 2002 | Directors: John Guyton, MD, Ralph A. DeFronzo, MD, Robert M. Califf, MD
- Metabolic syndrome: definition, pathophysiology, and mechanisms. AM HEART J 2005, 149(1):33-45;
- Metabolic syndrome: evaluation of pathological and therapeutic outcomes. AM HEART J 2005, 149(1):20-32
"Back to our Future" How Government, Industry and Academia Can Work Together to Improve Pediatric Clinical Research: April 11-13, 2002 | Directors: Stephen Sanders, MD, Jennifer Li, MD, Robert M. Califf, MD
Depression and Cardiovascular Disease: January 24-26, 2002 | Directors: Christopher O’Connor, MD, Ranga Krishnan, MD, Alexander Glassman, MD, Robert M. Califf, MD
Depression and ischemic heart disease: what have we learned so far and what must we do in the future? AM HEART J 2005, 150:54-78
2001
Challenges in Ethically Designing Trials of Therapy for Peripheral Vascular Disease: November 29-December 1, 2001 | Directors: George J. Agich, PhD, Kenneth Ouriel, MD.
24–Hour Ambulatory Blood Pressure Monitoring: July 19–21, 2001 | Directors: Robert M. Califf, MD, Raymond Lipicky, MD
- 24-hour ambulatory blood pressure monitoring. AM HEART J 2006 May; 151(5):962-8
International Differences in Clinical Trials Conduct and Results: June 29 – 30, 2001 | Director: Robert M. Califf, MD
Practical Issues in the Non-ST Elevation ACS Guidelines: May 18-20, 2001 | Directors: Robert M. Califf, MD, Magnus Ohman, MD, FACC
Decompensated Heart Failure: Current Concepts and Future Directions: April 20-22, 2001 | Directors: Mihai Gheorghiade, MD, Robert M. Califf, MD, Christopher M. O’Connor, MD
- Abstract Am Heart J 2003; 145:S1-2
- Current medical treatment for the exacerbation of chronic heart failure resulting in hospitalization Am Heart J 2003; 145:S3-17
- The problem of decompensated heart failure: Nomenclature, classification, and risk stratification Am Heart J 2003; 145:S18-25
- Dyspnea as an endpoint in clinical trials of therapies for acute decompensated heart failure Am Heart J 2003; 145:S26-33
- B-Type natriuretic peptide: From bench to bedside Am Heart J 2003; 145:S34-46
- Design considerations and proposed template for clinical trials in hospitalized patients with decompensated chronic heart failure Am Heart J 2003; 145:S47-50
- Rationale and study design for a multicenter, randomized, double-blind, placebo-controlled study of the effects of tolvaptan on the acute and chronic outcomes of patients hospitalized with worsening congestive heart failure Am Heart J 2003; 145:S51-4
- Rationale and design of the pilot randomized study of nesiritide versus dobutamine in heart failure (PRESERVD-HF) Am Heart J 2003; 145:S55-7
- Tezosentan in patients with acute heart failure and acute coronary syndromes: Design of the fourth Randomized Intravenous Tezosentan Study (RITZ-4) Am Heart J 2003; 145:S58-9
- Rationale and design of the Initiation Management Predischarge: Process for Assessment of Carvedilol Therapy for Heart Failure (IMPACT-HF) study Am Heart J 2003; 145:S60-1
- Concomitant use of a positive inotropic agent to create a bridge to the successful initiation of β-blocker therapy in patients with heart failure: A proposal for a trial Am Heart J 2003; 145:S62-6
- Surrogate endpoints in heart failure trials Am Heart J 2003; 145:S67-70.
Reducing Costs of Phase III Clinical Trials: March 29-31, 2001 | Directors: Robert M. Califf, MD, Eric L. Eisenstein, DBA
- Reducing the costs of phase III cardiovascular clinical trials Am Heart J 2005; 149:482-8.
The Nexus of Cardiovascular and Renal Disease: February 23-25, 2001 | Directors: William F. Owen, Jr., MD, Robert M. Califf, MD, William F. Keane, MD
Changing Diagnosis of Acute Myocardial Infarctions – Implications for Practicing Clinical Investigations: January 25-27, 2001 | Directors: Magnus Ohman, MD, FACC, Joseph S. Alpert, MD
- Things ain't what they used to be: Impact of a new definition of myocardial infarction AM HEART J 2002, 144: S933-S937;
- Changing the diagnosis of acute myocardial infarction: Implications for practice and clinical investigations AM HEART J 2002, 144: S957-S980
- European Society of Cardiology and American College of Cardiology guidelines for the redefinition of myocardial infarction: How to use existing assays clinically and for clinical trials AM HEART J 2002, 144: S981-S986
2000
Risk Stratification and Interventions to Attenuate Progressive Diabetic Nephropathy: November 3-5, 2000 | Directors: William F. Owen, Jr., MD, George L. Bakris, MD
- Slowing the progression of diabetic nephropathy and its cardiovascular consequences AM HEART J 2004, 148(2):243-51
Cardiac Repolarization: Current knowledge, critical gaps, and new approaches to drug development and patient management: August 9-11, 2000 | Directors: Robert M. Califf, MD, Dan M. Roden, MDCM
- Cardiac repolarization: Current knowledge, critical gaps, and new approaches to drug development and patient management AM HEART J 2000:144:S769-S781
Institutional Review Boards & Data & Safety Monitoring Committees in the Monitoring of Clinical Trials: May 11-12, 2000 | Directors: Robert M. Califf, MD, Jeremy Sugarman, MD, Donald F. Fortin, MD
Cardiovascular Effects of Obesity & Obesity Treatment: March 24-26, 2000 | Director: Robert M. Califf, MD
- Introduction: Cardiologists should target obesity Am Heart J 2001; 142:1088-90.
- Obesity as a disease entity Am Heart J 2001; 142:1091-4.
- Obesity assessment Am Heart J 2001; 142:1095-101
- Obesity as a risk factor in coronary artery disease Am Heart J 2001; 142:1102-7.
- Obesity, the metabolic syndrome, and cardiovascular disease Am Heart J 2001; 142:1108-16.
Neuroprotection in Acute Cerebral Ischemia: February 25-27, 2000 | Directors: S. Clifford Schold, MD, James Grotta, MD
1999
Pediatric Cardiovascular Trials: December 11-12, 1999 | Directors: Stephen P. Sanders, MD, FACC, Robert M. Califf, MD
- Introduction Am Heart J 2001; 142: 218-223
- Pediatric issues and diseases Am Heart J 2001; 142: 224-228
- Endpoints for cardiovascular drug trials in pediatric patients Am Heart J 2001; 142: 228-232
- Ethical issues in pediatric trials Am Heart J 2001; 142: 232-236
International Differences in Treatment Effect: August 26, 1999 | Directors: Robert Califf, MD, Christopher Granger, MD Magnus Ohman, MD Robert Harrington, MD
- A tale of two countries: Insights from the differences in Canadian/American patterns of care for patients with acute coronary syndromes Am Heart J 2001; 142(July): 14-20
- Statistical issues relating to international differences in clinical trials Am Heart J 2001; 142(July): 21-28
Acute Coronary Syndromes Conference: August 6-8, 1999 | Director: Robert M. Califf, MD
Genetics of Cardiovascular Disease Conference: April 9-10, 1999 | Directors: Christopher Granger, MD, Robert Califf, MD, William E. Kraus, MD, Allen Roses, MD
- Introduction Am Heart J 2000; 140: S1-S2
- Recommendations for national and local regulatory authorities concerning research in genetic markers of disease Am Heart J 2000; 140: S1-S5
- Ethical and legal issues in genetic testing to predict risk of heart disease Am Heart J 2000; 140: S6-S10
- Genetics of coronary heart disease: Current knowledge and research principles Am Heart J 2000; 140: S11-S26
- Genetic approaches for the investigation of genes associated with coronary heart disease Am Heart J 2000; 140: S27-S35
- Genetic analysis for common complex disease Am Heart J 2000; 140: S35-S44
- Genetic susceptibility to cardiovascular diseases Am Heart J 2000; 140: S44-47
- Genetics, genomics, proteomics: What is a cardiologist to do? Am Heart J 2000; 140: S48-S50
Antithrombotic Therapy After Prosthetic Cardiac, Valve Implantation: January 8-9, 1999 | Director: Robert M. Califf, MD
1998
Data and Safety Monitoring: What are the rules?: October 8-10, 1998 | Directors: Robert Califf, MD, David L. DeMets, PhD
- Should all trials have a Data Safety and Monitoring Committee? Am Heart J 2001; 141:154-163;
- Procedures of Data and Safety Monitoring Committees Am Heart J 2001; 141:289-294
- Making changes in clinical trials Am Heart J 2001; 141:295-300
- Statistical approaches and policies for the operations of Data and Safety Monitoring Committees Am Heart J 2001; 141:295-300
- Regulatory issues for Data and Safety Monitoring Committees Am Heart J 2001; 141:536-541
- Terms of reference for Data and Safety Monitoring Committees Am Heart J 2001; 141:542-547
- The Data and Safety Monitoring Committee: Some final thoughts Am Heart J 2001; 141:547-549
Guidelines for Therapeutic Development in Heart Failure: September 8-10, 1998 | Director: Robert M. Califf, MD
Advanced Heart Disease: June 4-6, 1998 | Directors: Robert Califf, MD, Mike Gheorghiade, MD, Barry Uretsky, MD
- Hemodynamics as surrogate endpoints for survival in advanced heart failure: an analysis from FIRST AM HEART J 2001; 141:S154-S549
1997
What Is The Impact of Treating Type II Diabetes on Risk of Coronary Events?: November 21-22, 1997 | Director: Robert M. Califf, MD
- Paper – Introduction: Diabetes & Cardiovascular disease: Current Opinions & Future Directions - many papers in the Proceedings of a symposium: Am Heart J 1999; 138 (S327-S329 – Introduction; (S327-S416; 15 papers)
How Should We Design Phase II Trials in Cardiovascular Disease: October 2-5, 1997, Hilton Head, SC | Directors: Robert M. Califf, MD, Kerry L. Lee, PhD
- Introduction, Am Heart J 2000; 139 (April): S131-132
- Current definitions of phases of investigation and the role of the FDA in the conduct of clinical trials, Am Heart J 2000; 139 (April): S133-135
- Challenges in the conduct and interpretation of phase II (pilot) randomized trials, Am Heart J 2000; 139 (April):S136-S142
- The role of clinical nonfatal endpoints in cardiovascular phase II/III clinical trials, Am Heart J 2000; 139 (April):S143-S154, Christopher M. O'Connor, Wendy A. Gattis, Thomas J. Ryan
- Economic endpoints in phase II trials Am Heart J 2000; 139 (April):S155-S157, Daniel B. Mark, Tracey A. Simons
- Select-drop designs in clinical trials Am Heart J 2000; 139 (April):S158-S160, Susan S. Ellenberg
- Sample size and interim analysis issues for dose selection Am Heart J 2000; 139 (April):S161-S165, Kerry L. Lee
- Equivalence and noninferiority trials Am Heart J 2000; 139 (April):S166-S170, Jay P. Siegel
- Design and interpretation of equivalence trials Am Heart J 2000; 139 (April):S171-S176, Thomas R. Fleming
- Estimating the distribution of quality-adjusted life with censored data Am Heart J 2000; 139 (April):S177-S181, Anastasios A. Tsiatis
- Chronic ischemic heart disease Am Heart J 2000; 139 (April):S182-S188, Michael Gent, Robert M. Califf
- Acute ischemic heart disease Am Heart J 2000; 139 (April):S189-S192, Christopher B. Granger, Allan Skene
- Surrogate endpoints in cardiovascular disease trials Am Heart J 2000; 139 (April):S193-S196, Thomas R. Fleming
- An FDA perspective on antiarrhythmic drugs in phase II trials Am Heart J 2000; 139 (April):S197-S199, Raymond Lipicky
- The development of antiarrhythmic drugs Am Heart J 2000; 139 (April):S200-S201, Lloyd Fisher
- Current perspectives on the design of phase II trials of new drugs for the treatment of heart failure Am Heart J 2000; 139 (April):S202-S206, Milton Packer
- Design of phase II trials in congestive heart failure Am Heart J 2000; 139 (April): S207-S210, David L. DeMets
Economics and Cost-Effectiveness in Evaluating the Value of Cardiovascular Therapies: April 18-20, 1997, St. Petersburg, Florida | Directors: Robert M. Califf, MD, Daniel B. Mark, MD, MPH
- Evaluating the economic implications of cardiovascular therapeutics Am Heart J 1999; 137(May): S35-S144]
1996
Markers of Hemostasis and Platelet Activity in Acute Coronary Syndromes: Role in Drug Development and Patient Monitoring: December 7-9, 1996, Pinehurst, NC | Director: Robert M. Califf, MD
- Introduction Am Heart J 1998; 136 (October): S1-S6
- Coagulation markers and outcomes in acute coronary syndromes Am Heart J 1998; 136 (October): S7-S18
- Pathobiology of thrombin in acute coronary syndromes Am Heart J 1998; 136 (October): S19-S31
- Glycoprotein IIb/IIIa inhibitors in acute coronary syndromes: Pathophysiologic foundation and clinical findings Am Heart J 1998; 136 (October): S32-S42
- Relation between inhibition of platelet aggregation and clinical outcomes Am Heart J 1998; 136 (October): S43-S50
- Progress in point-of-care laboratory testing for assessing platelet function Am Heart J 1998; 136 (October): S50-S65
Management of Patients with Advanced Heart Failure II: October 18-19, 1996 | Directors: Mihai Gheorghiade, MD, Robert M. Califf, MD, Robert O. Bonow, MD
- Introduction Am Heart J 1998; 135 (June): S201-203
- Advanced congestive heart failure: What do patients want? Am Heart J 1998; 135 (June): S201-326
1995
Markers of Hemostasis and Platelet Activity in Acute Coronary Syndromes: Role in Drug Development and Patient Monitoring: December 7-9, 1996, Pinehurst, NC | Director: Robert M. Califf, MD
- Introduction Am Heart J 1998; 136 (October): S1-S6
- Coagulation markers and outcomes in acute coronary syndromes Am Heart J 1998; 136 (October): S7-S18
- Pathobiology of thrombin in acute coronary syndromes Am Heart J 1998; 136 (October): S19-S31
- Glycoprotein IIb/IIIa inhibitors in acute coronary syndromes: Pathophysiologic foundation and clinical findings Am Heart J 1998; 136 (October): S32-S42
- Relation between inhibition of platelet aggregation and clinical outcomes Am Heart J 1998; 136 (October): S43-S50
- Progress in point-of-care laboratory testing for assessing platelet function Am Heart J 1998; 136 (October): S50-S65
Management of Patients with Advanced Heart Failure II: October 18-19, 1996 | Directors: Mihai Gheorghiade, MD, Robert M. Califf, MD, Robert O. Bonow, MD
- Introduction Am Heart J 1998; 135 (June): S201-203
- Advanced congestive heart failure: What do patients want? Am Heart J 1998; 135 (June): S201-326