Hussein H Khachfe1,2,3, Joseph R Habib4, Ibrahim Nassour5,6, Hussein A Baydoun5, Elie M Ghabi7, Mohamad A Chahrour8, Ali H Hallal9, Faek R Jamali9. 1. Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA. khachfehh@upmc.edu. 2. Division of GI Surgical Oncology, UPMC Pancreatic Cancer Center, University of Pittsburgh Medical Center, UPMC Cancer Pavilion, Pittsburgh, PA, USA. khachfehh@upmc.edu. 3. Division of GI Surgical Oncology, Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA. khachfehh@upmc.edu. 4. Department of Surgery, University of Maryland, Baltimore, MD, USA. 5. Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA. 6. Division of GI Surgical Oncology, UPMC Pancreatic Cancer Center, University of Pittsburgh Medical Center, UPMC Cancer Pavilion, Pittsburgh, PA, USA. 7. Department of Surgery, Johns Hopkins University, Baltimore, MD, USA. 8. Department of Surgery, Henry Ford Health System, Detroit, MI, USA. 9. Department of Surgery, Sheikh Shakhbout Medical City, Abu Dhabi, United Arab Emirates.
Abstract
BACKGROUND: Hepatopancreaticobiliary (HPB) diseases carry high morbidity despite efforts aimed at their reduction. An assessment of their trial characteristics is paramount to determine trial design adequacy and highlight areas for improvement. As such, the aim of this study is to assess HPB surgery trial characteristics, summarize logistic, financial, and practical reasons behind early discontinuation, and propose potential interventions to prevent this in the future. METHODS: All clinical trials investigating HPB surgery registered on ClinicalTrials.gov from October 1st, 2007 (inclusive), to April 20th, 2021 (inclusive), were examined. Trial characteristics were collected including, but not limited to, study phase, duration, patient enrollment size, location, and study design. Peer-reviewed publications associated with the selected trials were also assessed to determine outcome reporting. RESULTS: A total of 1776 clinical trials conducted in 43 countries were identified, the majority of which were conducted in the USA. Of these trials, 32% were reported as "completed" whereas 12% were "discontinued." The most common cause of trial discontinuation was low accrual, which was reported in 37% of terminated studies. These resulted in 413 published studies. Most trials had multiple assignment, randomized, or open-label designs. Treatment was the most common study objective (73%) with pharmacological therapy being the most commonly studied intervention. CONCLUSIONS: The main reasons for early discontinuation of clinical trials in HPB surgery are poor patient recruitment and inadequate funding. Improved trial design, recruitment strategies and increased funding are needed to prevent trial discontinuation and increase publication rates of HPB surgery clinical trials.
BACKGROUND: Hepatopancreaticobiliary (HPB) diseases carry high morbidity despite efforts aimed at their reduction. An assessment of their trial characteristics is paramount to determine trial design adequacy and highlight areas for improvement. As such, the aim of this study is to assess HPB surgery trial characteristics, summarize logistic, financial, and practical reasons behind early discontinuation, and propose potential interventions to prevent this in the future. METHODS: All clinical trials investigating HPB surgery registered on ClinicalTrials.gov from October 1st, 2007 (inclusive), to April 20th, 2021 (inclusive), were examined. Trial characteristics were collected including, but not limited to, study phase, duration, patient enrollment size, location, and study design. Peer-reviewed publications associated with the selected trials were also assessed to determine outcome reporting. RESULTS: A total of 1776 clinical trials conducted in 43 countries were identified, the majority of which were conducted in the USA. Of these trials, 32% were reported as "completed" whereas 12% were "discontinued." The most common cause of trial discontinuation was low accrual, which was reported in 37% of terminated studies. These resulted in 413 published studies. Most trials had multiple assignment, randomized, or open-label designs. Treatment was the most common study objective (73%) with pharmacological therapy being the most commonly studied intervention. CONCLUSIONS: The main reasons for early discontinuation of clinical trials in HPB surgery are poor patient recruitment and inadequate funding. Improved trial design, recruitment strategies and increased funding are needed to prevent trial discontinuation and increase publication rates of HPB surgery clinical trials.
Authors: Robert R Shawhan; Quinton M Hatch; Jason R Bingham; Daniel W Nelson; Emile B Fitzpatrick; Robin McLeod; Eric K Johnson; Justin A Maykel; Scott R Steele Journal: Dis Colon Rectum Date: 2015-01 Impact factor: 4.585
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