Conducting a three-country clinical trial during the COVID-19 pandemic: experience and future considerations

Sylvia Baedorf Kassis; Weidong Lu; Sarah A. White; Anita Giobbie-Hurder; Anna Tanasijevic; Hyun-Jung Jung; Xiping Zhang; Im Hee Shin; Sung Hwan Park; Young Ju Jeong; Chang Yao; Jennifer Ligibel; Barbara E. Bierer

doi:10.18203/2349-3259.ijct20231109

Authors

Sylvia Baedorf Kassis Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, Cambridge, MA, USA; Division of Global Health Equity, Department of Medicine, Brigham and Women’s Hospital, Boston, MA, USA
Weidong Lu Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA
Sarah A. White Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, Cambridge, MA, USA; Division of Global Health Equity, Department of Medicine, Brigham and Women’s Hospital, Boston, MA, USA
Anita Giobbie-Hurder Division of Biostatistics, Department of Data Science, Dana-Farber Cancer Institute, Boston, MA, USA
Anna Tanasijevic Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA
Hyun-Jung Jung Department of Diagnostics, College of Korean Medicine, Daegu Haany University, Daegu, Republic of Korea
Xiping Zhang Department of Oncology, Jiangsu Provincial Hospital of Traditional Chinese Medicine, Jiangsu Province, China
Im Hee Shin Department of Medical Statistics & Informatics, Daegu Catholic University, School of Medicine, Gyeongbuk, Republic of Korea
Sung Hwan Park Department of Surgery, Daegu Catholic University, School of Medicine, Gyeongbuk, Republic of Korea
Young Ju Jeong Department of Surgery, Daegu Catholic University, School of Medicine, Gyeongbuk, Republic of Korea
Chang Yao Department of Oncology, Jiangsu Provincial Hospital of Traditional Chinese Medicine, Jiangsu Province, China
Jennifer Ligibel Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA
Barbara E. Bierer 1Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, Cambridge, MA, USA; Division of Global Health Equity, Department of Medicine, Brigham and Women’s Hospital, Boston, MA, USA; Department of Medicine, Harvard Medical School, Boston, MA, USA

DOI:

https://doi.org/10.18203/2349-3259.ijct20231109

Keywords:

Clinical Trial, COVID-19 Pandemic, Acupuncture, Multinational Study, Preparedness, Study Completion

Abstract

The global SARS-COV-2 pandemic has significantly impacted the delivery of clinical care as well as the conduct of international clinical trials. A coordinated, multinational acupuncture study, consisting of three parallel randomized studies with a planned pooled analysis of individual patient data, was initiated in 2019 with the goal of assessing whether acupuncture relieved hot flash symptoms in hormone receptor-positive breast cancer patients prescribed adjuvant endocrine therapy. Eligibility included persistent hot flashes on endocrine therapy. Participants were randomly assigned to receive either immediate or delayed acupuncture in equal proportions; the primary endpoint was assessed at week 10, after completion of the immediate acupuncture treatments and before the delayed treatment sessions began. The trial was conducted in China, South Korea and United States of America (USA) and was in the midst of enrollment and study procedures when the COVID-19 pandemic began. Despite numerous challenges, the study was nonetheless completed successfully. We deployed a process evaluation method to describe each site’s experiences in conducting this multinational study during the pandemic. Using these observations, we offer measures for the planning and conduct of future studies, taking into account preparedness considerations in the event of exigent and demanding global circumstances.

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