Conduct of Clinical Trials in the Era of COVID-19: JACC Scientific Expert Panel
The coronavirus disease-2019 (COVID-19) pandemic has profoundly changed clinical care and research, including the conduct of clinical trials, and the clinical research ecosystem will need to adapt to this transformed environment.
Heart Failure Collaboratory Statement on Remote Monitoring and Social Distancing in the Landscape of COVID-19
Patients with heart failure (HF) are extraordinarily vulnerable to the effects of COVID-19.
Utility of Restricted Mean Survival Time Analysis for Heart Failure Clinical Trial Evaluation and Interpretation
The study sought to demonstrate the statistical and utilitarian properties of restricted mean survival time (RMST) and restricted mean time lost (RMTL) for assessing treatments for heart failure (HF) with reduced ejection fraction.
Standardized Definitions for Evaluation of Heart Failure Therapies: Scientific Expert Panel from the Heart Failure Collaboratory and Academic Research Consortium (HF-ARC)
A series of meetings were convened to establish definitions and key concepts for the evaluation of HF therapies.
Challenges and Potential Improvements to Patient Access to Pharmaceuticals
Patient access to a drug after US regulator approval is controlled by complex interactions.
Representation of Women Authors in International Heart Failure Guidelines and Contemporary Clinical Trials
Gender disparities in authorship of heart failure (HF) guideline citations and clinical trials have not been examined.
Barriers to Clinical Trial Efficiency and Patient Access
Clinical trial inefficiency and lack of patient access to novel therapies have been identified as key barriers to successful heart failure innovation.
Clinical Trials in the Landscape of COVID-19
The HF Collaboratory Statement provides recommendations on HF clinical trials by outlining a number of guiding principles and possible trial conduct solutions for the COVID-19 pandemic.
Improving Heart Failure Therapeutics Development in the United States
Summarizes the discussions, challenges and opportunities, and makes recommendations to achieve improved efficiency in clinical trials and the development of effective heart failure therapies.
Changing the Research Culture in the United States
Dr O’Connor & Dr Bristow’s article further highlights the importance of what changes the HF Collaboratory are working towards.
Enrollment of Older Patients, Women, and Racial and Ethnic Minorities in Contemporary Heart Failure Clinical Trials
The article published in JAMA Cardiology discusses the under representation of these groups in clinical trials.
Design of a “Lean” Case Report Form for Heart Failure Therapeutic Development
The article published in JACC details the creation of a core CRF electronic form which is now freely available for use in clinical trials to improve clinical trial efficiency in HF drug and device development in the United States.
Heart Failure End Points in Cardiovascular Outcome Trials of Sodium Glucose Contransporter 2 Inhibitors in Patients
The white paper published in Circulation summarizes the discussions and key takeaway messages from the meeting on this topic at the FDA meeting on March 6, 2019.