Clinical Trials & Evidence-Based Medicine: Introduction
1. Message from the Directors
We are excited to bring you the Clinical trials and evidence-based medicine section. Clinical evaluation of therapeutics in Medicine has evolved significantly in modern age worldwide, and randomized clinical trials and evidence-based methods have become the forefront of the physician’s decision‐making process for therapeutic interventions and subsequently the new standard of patient care.
The practice of evidence-based medicine is a process of lifelong learning process in which caring for one’s own patients creates the need for clinically important information about diagnosis, prognosis, therapy and other clinical and health care issues.
As both practicing clinical cardiologists and physician investigators, we hope to use this platform to provide important resource for not only starting a meaningful clinical trial and sharing clinical investigation resources, but also a forum for the critical interpretation of important clinical trials in cardiovascular disease for the purpose of higher quality of patient care.
Yan Liu, MD, PhD, RPVI, FACC
Xuming Dai, MD, PhD, FACC, FSCAI
2. How to start an investigator-initiated trial as a cardiology fellow or young clinical investigator?
Stepwise strategy of planning and conducting an Investigator-initiated trial– from Liu and Dai, JACC 66: 3, 2015, 324-327 https://doi.org/10.1016/j.jacc.2015.06.002
The 10 steps (please refer to original article for details)
Ask a clinically important and novel question.
Find a mentor.
Find collaborators, locally or through networking.
Institutional review board and clinical trial office process—appropriate expectation and planning.
Putting together a good team is essential.
Supporting environment and resources—improvisation and improvement.
Balancing between clinical duty and research—for now and for the future as a cardiologist.
Aim for meaningful publications—design, execution, and analysis.
Timing. it is never too early to start planning for your trial during fellowship or early career.
3. Major Cardiology Trial Forum
Odyssey trial ACC 18-03/2018
• Link to PDF file (see attached)
• Major Contribution of the trial: first trial showing that PCSK9i has mortality benefit in patients with recent ACS events
• Discussion topics
o Safety of PCSK9i – sufficient follow-up time? How low is not safe for LDL?
o Efficacy: RRR vs ARR
4. Sino-US clinical trial collaboration platform
Please email IntelliuHealth@gmail.com if you are seeking collaborations or new clinical trial sites in either US or China. We will post necessary information here and on CNAHA WeChat group to help facilitate potential collaborations
5. Useful Links:
a. Center for Evidence-Based Medicine https://www.cebm.net
b. ACC/AHA guidelines http://www.acc.org/guidelines