Challenges in the design, conduct, analysis, and reporting in randomized clinical trial studies

A systematic review

Fatemeh Varse, Leila Janani, Yousef Moradi, Masoud Solaymani-Dodaran, Hamid Reza Baradaran, Shahnaz Rimaz

Research output: Contribution to journalArticle

Abstract

Background: Randomized clinical trials have been considered as the gold standard for evaluating the effectiveness and safety of medical interventions; however, there are major barriers to their design, conduct, analysis, and reporting. They are multidisciplinary and involve different steps and face a variety of challenges that may vary from one country to another. The aim of this study was to provide a comprehensive presentation of the challenges of clinical trial studies in different steps including design, conducting, analysis, and reporting. Methods: In this study, all original articles conducted during 1991-2017 that reviewed the barriers to clinical trial studies at one of the steps of design, conducing, analysis, and reporting of the results in Medline (through PubMed), Embase, Web of Sciences, Scopus, and Google Scholar were considered. The searched keywords were as follow: challenges, barriers, and randomized clinical trial. Results: The following barriers in different steps of randomized clinical trials were identified: general barriers include insufficient knowledge and understanding of clinical research and research methodology, barriers to ethical and regulatory systems, and lack of funding. The investigator-initiated trials may face similar problems to those of sponsor-initiated trials, such as handling regulatory systems, administrative and financial issues, multiple languages, and different patient compensation approaches. The challenge related to design was poor planning. Other challenges were lack of manpower and financial resources, inappropriate statistical methods for analysis (analysis challenges), and challenges related to reporting which include selective reporting. Conclusion: Based on the results of this systematic review, the most important challenges were barriers related to handling ethical and regulatory systems, patient recruitment, and lack of budget and skilled staff for conducting clinical trials. Training to improve the quality of randomized clinical trial studies in different steps and levels was the most important recommendation in these studies.

Original languageEnglish
Article number37
JournalMedical Journal of the Islamic Republic of Iran
Volume33
DOIs
Publication statusPublished - 30 Apr 2019

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Randomized Controlled Trials
Clinical Trials
Budgets
PubMed
Patient Selection
Research Design
Language
Research Personnel
Safety
Clinical Studies
Research

Keywords

  • barriers
  • challenges
  • clinical trials
  • systematic review

Cite this

Challenges in the design, conduct, analysis, and reporting in randomized clinical trial studies : A systematic review. / Varse, Fatemeh; Janani, Leila; Moradi, Yousef; Solaymani-Dodaran, Masoud; Baradaran, Hamid Reza; Rimaz, Shahnaz.

In: Medical Journal of the Islamic Republic of Iran, Vol. 33, 37, 30.04.2019.

Research output: Contribution to journalArticle

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AU - Solaymani-Dodaran, Masoud

AU - Baradaran, Hamid Reza

AU - Rimaz, Shahnaz

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AB - Background: Randomized clinical trials have been considered as the gold standard for evaluating the effectiveness and safety of medical interventions; however, there are major barriers to their design, conduct, analysis, and reporting. They are multidisciplinary and involve different steps and face a variety of challenges that may vary from one country to another. The aim of this study was to provide a comprehensive presentation of the challenges of clinical trial studies in different steps including design, conducting, analysis, and reporting. Methods: In this study, all original articles conducted during 1991-2017 that reviewed the barriers to clinical trial studies at one of the steps of design, conducing, analysis, and reporting of the results in Medline (through PubMed), Embase, Web of Sciences, Scopus, and Google Scholar were considered. The searched keywords were as follow: challenges, barriers, and randomized clinical trial. Results: The following barriers in different steps of randomized clinical trials were identified: general barriers include insufficient knowledge and understanding of clinical research and research methodology, barriers to ethical and regulatory systems, and lack of funding. The investigator-initiated trials may face similar problems to those of sponsor-initiated trials, such as handling regulatory systems, administrative and financial issues, multiple languages, and different patient compensation approaches. The challenge related to design was poor planning. Other challenges were lack of manpower and financial resources, inappropriate statistical methods for analysis (analysis challenges), and challenges related to reporting which include selective reporting. Conclusion: Based on the results of this systematic review, the most important challenges were barriers related to handling ethical and regulatory systems, patient recruitment, and lack of budget and skilled staff for conducting clinical trials. Training to improve the quality of randomized clinical trial studies in different steps and levels was the most important recommendation in these studies.

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