This special series on “Challenges in Clinical Trials” is edited by Dr. Weiping Wen, Dr. Yanhong Deng, Dr. Qian Shi and Dr. Jun (Vivien) Yin. As with any industry, the challenges facing those working in clinical trials are numerous: from patient recruitment, adoption of technology, regulatory requirements, and spiraling costs. This series aims to provide some insight and overviews on the challenges in conducting clinical trials, including Eastern and Western perspectives.
Dr. Weiping Wen is the President of the Sixth Affiliated Hospital, Sun Yat-sen University (SYSU), the Vice-President, the First Affiliated Hospital, SYSU and the Chairman, Otorhinolaryngology of the First Affiliated Hospital, SYSU.
Dr. Wen is also chief of the clinic and professor at Otorhinolaryngology at the First and Sixth Affiliated Hospital, SYSU. Dr. Wen’s research interests include understanding the pathophysiology and immune mechanism of head & neck tumor and airway inflammation, including allergic rhinitis, nasal polyposis and chronic rhinosinusitis. His clinical expertise in endoscopic minimally invasive surgery and surgical treatment of head & neck tumor. As Director of Clinical Trials at the First Affiliated Hospital, SYSU, he has served as the site principal investigator for several important multicenter clinical trials and published “endoscopic surgery compared with intensity-modulated radiotherapy in resectable locally recurrent nasopharyngeal carcinoma: a multicentre, open-label, randomised, controlled, phase 3 trial” in Lancet Oncology. Dr. Wen has published more than 100 articles in the important academic journals and has authored 10 book chapters. He has presided over some major research tasks such as International Cooperation and Exchange Program of National Natural Science Foundation of China and the national 863- project. He is the vice chairman of the standing committee of otolaryngology-head and neck surgery branch of the Chinese Medical Association.
Dr. Yanhong Deng is a full Professor in Medical Oncology and Director of the Department of Medical Oncology in the Sixth Affiliated Hospital (Gastrointestinal Hospital), Sun Yat-sen University, Guangzhou, China. Her main research interests lie in colon cancer, cancer stem cell, biomarker validation and Clinical trial.
Dr. Deng obtained her PhD in Oncology in the Cancer Center, Sun Yatsen University in 2008. From Sep 2007 to Oct 2008, Dr. Deng served as a visiting scholar (Post doctorial training) in the Stem cell center, University of Washington, Seattle Cancer Care Alliance (Fred Hutchinson Cancer Research Center). Dr. Deng has published more than 60 scientific articles in high-impact journals, e.g. J Clin Oncol, JAMA, Lancet Oncology. She has held multiple scientific projects funded by the China National Natural Science Foundation (2019, 2014, 2011), China classification of Project (2019), Guangdong Natural Science Foundation (2019, 2009) and Guangzhou Scientific Plan (2018, 2014). Her work has got national and international recognition, including professional and institutional titles and awards (the provincial department of science and technology progress first prize in 2019 (ranked 4th), Chinese female doctor wuzhou women's science and technology award -- Innovation award of basic medical research in 2019, the Top young talents of Guangdong special branch plan for scientific and technological innovation in 2017, the China ministry of science and technology, Second prize of science and technology progress in 2016 (ranked 5th), the Guangdong provincial department of science and technology, First prize in 2012 (ranked 9th)).
Dr. Qian Shi is a member of Department of Quantitative Health Sciences and Professor of Biostatistics and Oncology at Mayo Clinic. Dr. Shi’s main research interests include statistical methodological research in surrogate endpoint evaluations, hierarchical Bayesian clinical trial design, biomarker-driven trial design, international large database sharing and research initiatives. She has been the lead statistician of both the Alliance for Clinical Trials in Oncology (Alliance, one of the National Cancer Institution [NCI] cooperative groups) and the Mayo Clinic Cancer Center Gastrointestinal Cancer disease-oriented groups. Dr. Shi has been collaborating extensively with oncologists, surgeons, radiologists, pathologist, basic science researchers on wild spectrum of medical research projects, especially oncology clinical trials. Dr. Shi has served as the primary statistician on > 20 Phase II or Phase III oncology clinical trials conducted nationally and internationally, sponsored by NCI and industry.Dr. Shi has been the Primary Investigator on multiple foundation or industry supported international large database research projects, as well as the Co-Investigator on multiple NCI grants including statistical methodology R01 grants. Dr. Shi was the Associate Director and Director for the Biostatistics of Alliance from 2015 to 2021. Currently, Dr. Shi is the Associate Director of Quantitative Science and Director of Biostatistical Share Resource of Mayo Clinic Cancer Center. Nationally, Dr. Shi has served on Evidence-Based Medicine Core Team and Lower Gastrointestinal Tract Expert Panel of American Joint Committee on Cancer (AJCC), NCI Gastrointestinal Steering Committee (GISC) and Taskforces, NIH Cancer Prevention Study Section, multiple institutional and industry Data and Safety Monitoring Boards, the editorial boards of high impact journals.
Dr. Jun (Vivien) Yin has collaborated with many outstanding experts in oncology, particularly, in the area of multi-institutional cancer clinical trial research, ranging from early phase to confirmatory trials. In her capacity as a lead statistician, she has designed and worked on > 20 clinical trials in cancer. Dr. Yin is currently the designated lead faculty statistician for the leukemia committee for the NCI Alliance for Clinical Trials in Oncology, and was the Mayo Consortium Statistician for the NCI Experimental Therapeutics Clinical Trial Network. Her career has been devoted to developing new statistical methods for clinical trials, many of which are motivated by her collaborations, for example, individualized dose-finding designs, biomarker-driven designs for basket and umbrella trials, and surrogate endpoints to expedite clinical trial conduct. Dr. Yin has national and international recognition for her work, with recognitions that include professional and institutional awards, Editorial Board for Contemporary Clinical Trial, and Clinical Trial Oversight Committee for the National Pediatric Cancer Foundation Sunshine Project.
- Challenges in rare disease trials (peds, ALL, neuro)
- Challenges in biomarker-driven trials
- Challenges in master protocols
- Challenges in N-of-1 Trials
- Challenges in multi-arm parallel-group randomized trials
- Challenges in real world study (AI, EHR)
- Challenges in phase II randomized controlled trials
- Challenges in non-inferiority and equivalence trials
- Challenges in pragmatic trials
- Challenges in phase I clinical trials
The series “Challenges in Clinical Trials” was commissioned by the editorial office, Annals of Translational Medicine without any sponsorship or funding. Dr. Weiping Wen, Dr. Yanhong Deng, Dr. Qian Shi and Dr. Jun (Vivien) Yin are serving as the unpaid Guest Editors for the series.