Clinical Research Workshop will focus on drug development, adherence in clinical trials

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Aditya Bardia, MD, MPH
Aditya Bardia, MD, MPH

Beginning with this year’s Clinical Research Workshop, the SABCS 2022 program features a robust schedule of “can’t miss” sessions covering some of the most anticipated topics in clinical science, said Aditya Bardia, MD, MPH, Associate Professor of Medicine at Harvard Medical School and Attending Physician and Director of Breast Cancer Research at Massachusetts General Hospital in Boston.

“Each year at SABCS, the Clinical Research Workshop focuses on various key elements involved in clinical research and sets the stage for all of the important clinical research findings that will be presented and discussed over the course of the meeting,” said Dr. Bardia, who will serve as moderator for the workshop.

The Clinical Research Workshop will be held on Tuesday, December 6, at 8:00 am CT in Stars at Night Ballroom 1&2.

Among the topics to be addressed in this year’s workshop is how to improve drug adherence in adjuvant clinical trials, which will be discussed by Dawn L. Hershman, MD, MS, American Cancer Society Professor of Medicine and Epidemiology and Director of Breast Oncology, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center.

Dawn Hershman, MD, MS, FASCO
Dawn Hershman, MD, MS, FASCO

“The past decade has seen a dramatic increase in the number of FDA approvals of oral anti-cancer drugs (OACDs), some of which are commonly given along with endocrine therapy,” Dr. Hershman said. “For the treatment of breast cancer, endocrine therapies have remained a critical component of care for early stage and advanced disease. Despite the proven efficacy, adherence to therapy is suboptimal.”

Issues related to non-adherence are increasingly important, she said, as analyses from prospective randomized trials show compliance to endocrine therapy is associated with improved disease-free survival.

“It remains unclear how this increased oral medication burden on breast cancer survivors affects compliance with both endocrine therapy and other chronic medications,” Dr. Hershman said. “The reasons for non-adherence to hormonal therapy are multifactorial, but we need to understand how to measure adherence in clinical trials, the impact of adherence on outcome, the reasons for early discontinuation, and we need to develop strategies to improve adherence.”

The workshop will also include discussions on how the post-neoadjuvant/adjuvant setting can be leveraged to accelerate development of novel agents, statistical considerations related to the primary endpoint, and how to have a patient-centered approach in this setting.

“Patient benefit is the ultimate outcome, and the great thing about SABCS is that it reflects the entire journey in breast cancer research and care, from basic science breakthroughs all the way to the cutting-edge treatments and supportive care focused on improving outcomes and making a difference in the lives of patients with breast cancer,” Dr. Bardia said.