Clinical Research Quo Vadis? Trends in Reporting of Clinical Trials and Observational Study Designs Over Two Decades

BACKGROUND: Multiple classifications have been developed that classify the medical literature into different levels of evidence to facilitate the evaluation of study results and practice of evidence-based medicine. The suggested hierarchies of evidence are generally based on the type of study design; randomized, controlled clinical trials constitute the top level of evidence while case reports rank the lowest among epidemiologic study designs. However, little is known about the frequency with which different study designs appear in the medical literature overall. The purpose of this study was to describe trends in the frequency of reports of randomized control trials (RCTs) as compared to other study designs in the medical literature over two decades. METHODS: Data about the prevalence of various types of study designs in the medical literature over the last two decades (years 1990 - 2009) were abstracted from PubMed, validated and subjected to cross-sectional and longitudinal analysis. RESULTS: In the last 20 years, the annual rate of publication of journal articles has more than doubled. During this period, the percentage of observational studies increased from 29.9% to 40.5%, the percentage of reports of RCTs increased minimally, and there was a striking decline in the percentage of case reports (from 49.8% to 33.6%) in the medical literature overall. In contrast, in three selected, highly cited medical journals, the percentage of reports of RCTs increased by almost 10%. Surprisingly, the percentage of articles classified as case reports also increased (from 36.3% to 43.8%) in these three journals, while the percentage of reports of cohort and case-control studies decreased. CONCLUSION: Though the relative frequency of reports from RCTs has not changed substantially in the last 20 years, cohort studies and case-control studies have largely supplanted simple case reports. In contrast, in high impact journals, the representation of RCTs and case reports has increased, with corresponding declines in reports based on other study designs. Further research will be needed to determine whether those trends in publication have resulted in more robust evidence and faster advancement of medical knowledge.