Assessment of risk of bias in randomized controlled trials published in Indian journals pertaining to pharmacology.

Abstract

Context: Number of trials in India shows an increasing trend. As these trials will shape clinical practice, their quality is of utmost importance. Among many tools to assess the quality of randomized control trials (RCTs), risk of bias (RoB) is most robust.

Aims: To understand the quality of trials being carried out in India in terms of RoB.

Settings and design: We aimed to assess the RoB in a set of RCTs published in Indian pharmacology of randomized trials from journals pertaining to pharmacology.

Subjects and methods: We used published journal articles as source of information for randomized clinical trials and evaluated them using Cochrane RoB tool 2.0.

Statistical analysis used: Descriptive statistics were used.

Results: 158 trials published in seven journals were evaluated in six different domains. Overall evaluation for 97% (153) trials was "high risk," while 3% (5) were in "some concerns" category, with no trials categorized as "low risk. 74% articles showed a high risk of bias in the domain of 'selection of reported results. Nearly half articles scored "low risk" in domains of "missing data" and "deviations in assignment to intervention." The study results showed a slowly increasing trend of average RoB over the last 10 years.

Conclusions: The study shows concerning rise in RoB in various domains RCTs published in Pharmacology journals in India.