Volume 15, Issue 1 (Vol.15, No.1 2019)
irje 2019, 15(1): 8-19 |
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Fakhri F, Eybpoosh S, Solaymani Dodaran M. Characteristics of Clinical Trials in Iran: A Sample of 5000 Trials Registered in Iranian Registry of Clinical Trials (IRCT). irje 2019; 15 (1) :8-19
URL: http://irje.tums.ac.ir/article-1-6277-en.html
URL: http://irje.tums.ac.ir/article-1-6277-en.html
1- Master of Epidemiology, Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Science, Tehran, Iran
2- Assistant Professor of Epidemiology, Department of Epidemiology and Biostatistics, Research Centre for Emerging and Reemerging Infectious Diseases, Pasteur Institute of Iran, Tehran, Iran
3- Professor of Epidemiology, Minimally Invasive Surgery Research Center, Hazrat-e-Rasool Hospital, Iran University of Medical Science, Tehran, Iran; Professor of Epidemiology, School of Public Health, Iran University of Medical Science, Tehran, Iran , msdodarsn@gmail.com
2- Assistant Professor of Epidemiology, Department of Epidemiology and Biostatistics, Research Centre for Emerging and Reemerging Infectious Diseases, Pasteur Institute of Iran, Tehran, Iran
3- Professor of Epidemiology, Minimally Invasive Surgery Research Center, Hazrat-e-Rasool Hospital, Iran University of Medical Science, Tehran, Iran; Professor of Epidemiology, School of Public Health, Iran University of Medical Science, Tehran, Iran , msdodarsn@gmail.com
Abstract: (3361 Views)
Background and Objectives: A considerable number of clinical trials are conducted in Iran each year. Not much is known about the characteristics of them, this study aimed to investigate key characteristics of Iranian clinical trials.
Methods: All clinical trial protocols registered in IRCT until November 2013 were selected. Text mining techniques were used to extract information from data that was mostly in the textual format. Stata software (v. 11) was used for both extraction and analysis.
Results: Totally 5049 trials where analyzed. Trials were in 40 different areas of medicine and their annual number was increasing. The sample size of registered trials was less than 70 in most trials and showed no significant improvement during the 5-year period (Median sample size= 64, inter quartile range (IQR) = 40-100). Phase III trials comprised 8.4% of the trials with a median sample size of 75 (IQR= 50-120). Of all phase III trials, 69% had a target sample size of less than 100. Most trials used randomization techniques (87.2%) but failed to use placebo (65.3%) and double/triple-blinding techniques (55.8%). The leading sponsors for 99.9% of trials were national bodies and 92.2% of the trials received public funds. Only 1% of the trials were exclusively sponsored by pharmaceutical companies.
Conclusion: The majority of clinical trials conducted in Iran are investigator-initiated and are funded by the public sector. The small sample size and failures in bias control observed in the majority of trials highlights the need for revising current policies of conducting trials in Iran.
Methods: All clinical trial protocols registered in IRCT until November 2013 were selected. Text mining techniques were used to extract information from data that was mostly in the textual format. Stata software (v. 11) was used for both extraction and analysis.
Results: Totally 5049 trials where analyzed. Trials were in 40 different areas of medicine and their annual number was increasing. The sample size of registered trials was less than 70 in most trials and showed no significant improvement during the 5-year period (Median sample size= 64, inter quartile range (IQR) = 40-100). Phase III trials comprised 8.4% of the trials with a median sample size of 75 (IQR= 50-120). Of all phase III trials, 69% had a target sample size of less than 100. Most trials used randomization techniques (87.2%) but failed to use placebo (65.3%) and double/triple-blinding techniques (55.8%). The leading sponsors for 99.9% of trials were national bodies and 92.2% of the trials received public funds. Only 1% of the trials were exclusively sponsored by pharmaceutical companies.
Conclusion: The majority of clinical trials conducted in Iran are investigator-initiated and are funded by the public sector. The small sample size and failures in bias control observed in the majority of trials highlights the need for revising current policies of conducting trials in Iran.
Type of Study: Research |
Subject:
Epidemiology
Received: 2019/08/5 | Accepted: 2019/08/5 | Published: 2019/08/5
Received: 2019/08/5 | Accepted: 2019/08/5 | Published: 2019/08/5
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