Premier Investigators Provide Insight to Transcatheter Cardiovascular Therapeutics Research

The multi-part session at the Transcatheter Cardiovascular Therapeutics (TCT) conference was moderated by Roxana Mehran, MD, professor of medicine at Icahn School of Medicine at Mount Sinai in New York, NY. Dr Mehran began by emphasizing the importance of clinical research in interventional cardiology. She then described the session’s speakers as premier investigators.

“Setting up a Thriving Clinical Research Program: The Basics and More” was delivered by David A. Cox, MD, chief of interventional cardiology research, Lehigh Valley Hospital, Bethlehem, PA. According to Dr Cox, the number of FDA-regulated, US-based investigators has declined 5.5% in the last decade, and many sites tend to under-enroll or fail to enroll. He described the basics of successful clinical research. The first “piece of the puzzle” is the principal investigator (PI), who must be passionate and humble, and keep referring physicians up-to-date. The second-most important piece is the research coordinators. “They are the key to your success,” he says. He then discussed subinvestigators—he stated that they often don’t know the protocol very well, which can lead to violations, among other problems. Dr Cox also addressed the importance of protocol choice. “Figure out which protocols work for you.”

Lauren Privitera, MPH, Columbia University Medical Center, New York, NY, presented “Guiding Principles in Clinical Research: The Cardinal Rules (GCP, IRB, Informed Consent, Quality Assurance).” Her first assertion was that clinical investigators must have public trust in order to get enrollment: “It is the cardinal rule of conducting research,” she stated. Ms Privitera then reviewed the roles of the FDA, IRB, study sponsors, and investigators. Her recommendations included instituting a plan for study supervision, having procedures in place for addressing errors and discrepancies, ensuring an adequate consent process, and implementing regular analysis of monitoring reports. She ended her presentation by emphasizing continuous quality improvement.

The third presentation of the session, “How to Be a Key Enroller in Clinical Trials: Bringing Your Colleagues Together,” was given by Nicholas Lembo, MD, medical director of the Interventional Cardiology Center of Excellence at Piedmont Heart Institute, Atlanta, GA. Dr Lembo is a top enroller for the EXCEL Trial, which is ongoing at 129 active centers worldwide and has 1655 patients enrolled to date. At his site, all interventional cardiologists and cardiothoracic surgeons were invited to be subinvestigators, and staff at every level were informed about the trial. In addition, referring physicians are involved in decision making; they are contacted to ask permission to approach a patient about the trial. According to Dr Lembo, keys for success are physician commitment to enroll, inclusion of all treating physicians as subinvestigators, making all staff aware of the study, and institutional commitment.

The final part of the session featured Timothy Henry, MD, director of cardiology, Cedars Sinai Heart Institute, Los Angeles, CA, who presented “The Informed Consent Process: More Complicated Than Informed!” According to Dr Henry, the consent process is one of the most commonly cited for clinical research sites. He reviewed key elements of a consent form and readability; while forms are required to be written at an eighth-grade education level, most forms are at a 10th-grade level. His recommendations for best practices included annual IRB approval, PI involvement at every level, education and training of staff, and version control (not getting confused by amendments). Quality clinical research “begins and ends with an excellent informed consent process,” according to Dr Henry. As did the other speakers, he reminded the audience that the PI is responsible for all aspects of the trial, including obtaining consent from subjects, even if the task has been delegated.