Endoscopy 2023; 55(01): 36-41
DOI: 10.1055/a-1855-7870
Innovations and brief communications

Clinical trial transparency in gastrointestinal endoscopy research

Shashank Garg
1   Arkansas Gastroenterology, North Little Rock, Arkansas, United States
,
Anam Rizvi
2   Division of Gastroenterology, Long Island Jewish Medical Center, Zucker School of Medicine at Hofstra/Northwell, Northwell Health System, New Hyde Park, New York, United States
,
Diana Wee
2   Division of Gastroenterology, Long Island Jewish Medical Center, Zucker School of Medicine at Hofstra/Northwell, Northwell Health System, New Hyde Park, New York, United States
,
Youshaw Rizvi
3   Rutgers University, New Brunswick, New Jersey, United States
,
Fatima Rizvi
4   Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania, United States
,
Anza Rizvi
4   Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania, United States
,
Sheila Louise Thomas
5   Education and Research Services, UAMS Library, Little Rock, Arkansas, United States
,
Sumant Inamdar
6   Division of Gastroenterology, Department of Medicine, University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
,
2   Division of Gastroenterology, Long Island Jewish Medical Center, Zucker School of Medicine at Hofstra/Northwell, Northwell Health System, New Hyde Park, New York, United States
7   Institute of Health System Science, Feinstein Institutes for Medical Research, Manhasset, New York, United States
› Author Affiliations

Abstract

Background Under-reporting of clinical trial results can lead to negative consequences that include inhibiting propagation of knowledge, limiting the understanding of how devices work, affecting conclusions of meta-analyses, and failing to acknowledge patient participation. Therefore clinical trial transparency, through publication of trial results on ClinicalTrials.gov or in manuscript form, is important. We aimed to examine clinical trial transparency in endoscopic clinical trials.

Methods The ClinicalTrials.gov database was searched for endoscopy trials up to October 2019. Adherence to the reporting of results to the database or in publication form was recorded for each trial.

Results The final analysis included 923 trials, of which 801 were completed and 122 were either terminated or suspended. Results were available either on ClinicalTrials.gov or in publication for 751/923 trials (81.4 %). Other fields have reported a publication rate of 40 %–63 %. Results were available on ClinicalTrials.gov for 168 trials (18.2 %) and in the form of a publication for 720 trails (78.0 %).

Conclusions Compared with other fields in medicine, endoscopy clinical trials have a high rate of clinical trial transparency. However, there is room for improvements as close to one-fifth of trials fail to report results and 81.8 % do not report results to ClinicalTrials.gov.

Supplementary material



Publication History

Received: 17 February 2022

Accepted after revision: 18 May 2022

Accepted Manuscript online:
18 May 2022

Article published online:
20 July 2022

© 2022. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 
  • References

  • 1 Zarin DA, Tse T, Williams RJ. et al. The ClinicalTrials.gov results database – update and key issues. N Engl J Med 2011; 364: 852-860
  • 2 Saito H, Gill CJ. How frequently do the results from completed US clinical trials enter the public domain? A statistical analysis of the ClinicalTrials.gov database. PLoS One 2014; 9: 1-9
  • 3 Lassman SM, Shopshear OM, Jazic I. et al. Clinical trial transparency: a reassessment of industry compliance with clinical trial registration and reporting requirements in the United States. BMJ Open 2017; 7: e015110
  • 4 DeVito NJ, Bacon S, Goldacre B. Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study. Lancet 2020; 395: 361-369
  • 5 Prayle AP, Hurley MN, Smyth AR. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: cross sectional study. BMJ 2012; 344: 1-7
  • 6 Becker JE, Krumholz HM, Ben-Josef G. et al. Reporting of results in ClinicalTrials.gov and high-impact journals. JAMA 2014; 311: 1063-1065
  • 7 Ross JS, Mulvey GK, Hines EM. et al. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med 2009; 6: e1000144
  • 8 Ross JS, Tse T, Zarin DA. et al. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ 2012; 344: d7292
  • 9 Garg S, Rizvi A, Wee D. et al. Gastroenterology clinical trials transparency: an analysis of publication rates from the ClinicalTrials.gov database. Am J Gastroenterol 2022; 117: 180-183
  • 10 Psotka MA, Latta F, Cani D. et al. publication rates of heart failure clinical trials remain low. J Am Coll Cardiol 2020; 75: 3151-3161
  • 11 Miller JE, Korn D, Ross JS. Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012. BMJ Open 2015; 5: e009758