Training the Next Generation of Data Monitoring Committee Members: An Initiative of the Heart Failure Collaboratory.
Thomas R FlemingJanet WittesMona FiuzatMichael R BristowFrank W RockholdJason T ConnorBenjamin R SavilleBrian ClaggettIsabella CavagnaWilliam T AbrahamThomas D CookJoAnn LindenfeldChristopher O'ConnorDavid L DeMetsnull nullPublished in: JACC. Heart failure (2024)
Clinical trials are vital for assessing therapeutic interventions. The associated data monitoring committees (DMCs) safeguard patient interests and enhance trial integrity, thus promoting timely, reliable evaluations of those interventions. We face an urgent need to recruit and train new DMC members. The HFC (Heart Failure Collaboratory), a multidisciplinary public-private consortium of academics, trialists, patients, industry representatives, and government agencies, is working to improve the clinical trial ecosystem. The HFC aims to improve clinical trial efficiency and quality by standardizing concepts, and to help meet the demand for experienced individuals on DMCs by creating a standardized approach to training new members. This paper discusses the HFC's training workshop, and an apprenticeship model for new DMC members. It describes opportunities and challenges DMCs face, along with common myths and best practices learned through previous experiences, with an emphasis on data confidentiality and need for quality independent statistical reporting groups.
Keyphrases
- clinical trial
- heart failure
- phase ii
- electronic health record
- healthcare
- phase iii
- quality improvement
- end stage renal disease
- study protocol
- big data
- open label
- mental health
- physical activity
- chronic kidney disease
- double blind
- newly diagnosed
- virtual reality
- primary care
- left ventricular
- prognostic factors
- ejection fraction
- climate change
- peritoneal dialysis
- randomized controlled trial
- adverse drug
- emergency department
- machine learning
- mass spectrometry
- case report