Clinical Research Workshop to review effective design, conduct, presentation of clinical trials


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2 minutes
Aditya Bardia, MD, MPH
Aditya Bardia, MD, MPH

Shepherding clinical research from study design to publication to scientific presentation is a long road full of many challenges.

The SABCS 2021 Clinical Research Workshop, From Study Design to Scientific Presentation, was designed to look closely at the different steps involved in this journey and provide guidance and advice, said Aditya Bardia, MD, MPH, Assistant Professor of Medicine, Harvard Medical School, and Director of Precision Medicine at the Massachusetts General Hospital Center for Breast Cancer, who will serve as moderator for the workshop on Tuesday, December 7, at 11:00 am CT.

“This session is particularly focused on clinical and translational research,” Dr. Bardia said. “We hope that attendees are able to get a better appreciation of what goes into the design, conduct, and presentation of clinical trials.”

The workshop will include presentations from a panel of experienced investigators and study design experts.

Justin Balko, PharmD, PhD, Associate Professor of Medicine and Pathology, Microbiology, and Immunology at Vanderbilt University Medical Center, will give a presentation on how to rationally select biomarkers.

“In the current era of precision medicine, biomarkers are an integral component of a clinical trial,” Dr. Bardia said. “Dr. Balko’s presentation will address components involved in biomarker selection, what are the analytical considerations, how to decide what cut off to use — all important considerations in a clinical trial setting.”

Valentina Nekljudova, PhD, Head Statistician at the German Breast Group in Neu-Isenburg, Germany, will discuss how to design an efficient clinical study. This includes consideration of the control arm, the intervention arm, randomization, the role of crossover, and other analytical considerations in trial design, Dr. Bardia said.

Patricia Spears, BS, Research Patient Advocate at the University of North Carolina-Chapel Hill, will talk about how to include patient advocates in clinical research.

“This talk will address considerations from the patient perspective and the key components that studies need to incorporate,” Dr. Bardia said.

George W. Sledge, Jr., MD, Professor of Medicine, Division of Oncology, at the Stanford University School of Medicine, will discuss how to effectively present clinical research results.

“This is an important skill to learn because there can be scenarios where an investigator might have great results, but if he or she cannot communicate the message effectively, it does not do justice to the research team and the scientific community in general,” Dr. Bardia said.

Dr. Bardia encourages anyone involved in clinical research to attend. That might include clinicians, patient advocates, investigators, members of the lab involved in translation work, and representatives of the pharmaceutical industry.

After the speaker presentations, Dr. Bardia hopes to have time for a discussion and questions from the audience.

“I am very excited about this session,” Dr. Bardia said. “We hope it will educate attendees on the essential tools needed to effectively design, conduct, and present clinical studies.”