Challenges in the Design, Conduct, Analysis, and Reporting of Randomized Clinical Trial Studies in Iran: A Qualitative Study

Background and Objectives: Randomized clinical trials are the gold standard for evaluating the effectiveness and safety of medical interventions. Some unpredictable challenges may affect the results of these studies. Therefore, the aim of this study was to identify the challenges of clinical trial studies in different stages including design, conduct, analysis, and reporting. Methods: This study was a qualitative study using content analysis performed from 2017 to 2019. The study population included 13 clinical trial experts who were selected through purposeful sampling. Semi-structured interviews were conducted with all subjects. Data saturation was achieved after 13 interviews. Results: Among the 4 steps of design, conduct, analysis, and reporting, the majority of the challenges were related to conducing randomized clinical trials. Lack of knowledge of researchers, subjects, sponsors and physicians and supervisory and ethical challenges were the main challenges related to performing these studies. Poor design and lack of clinical equipoise were considered as the main challenges in the design step. Inappropriate analytical methods due to the absence of statistician in these studies were considered as the most common challenge related to analysis. Finally, lack of familiarity with international guidelines was the most important challenge in reporting. Conclusion: There are many challenges in different steps of clinical trial studies. Therefore, additional education sessions focusing on the related guidelines and standards as well as GCP workshops for researchers can be helpful.