Workshop Report 18 – Enhancement of the Scientific Process and Transparency of Observational Epidemiology Studies

Observational epidemiology studies have greatly contributed to the identification of causes of disease. The research methods applied in observational epidemiology studies have extensively described in textbooks and publications. However, the conduct of observational epidemiology studies in essence is not subject to agreed guidelines and there is no guarantee that study results are comprehensively disclosed in the form of scientific publications. Because of various reasons some study results, either positive or negative, may remain undisclosed which may introduce a distorted representation of study findings in the open scientific literature. Industry researchers may be accused of only publishing those results that are more favorable to industry. On the other hand, non industry researchers may be accused of only disclosing those results that are the most interesting to report and carry the most weight, these being the positive findings.

A more systematic and transparent process for the conduct of observational epidemiology studies, in line with the existing process for clinical trials, will improve the reliability and credibility of observational epidemiology.

The envisaged scientific process would include a register where study protocols are deposited prior to the actual conduct of the study, a more rigorous process for documenting and archiving collected data, and could lead to a "Cochrane Collaboration like" institution to coordinate the conduct of systematic reviews on observational epidemiology studies, and ideally a raw data repository.