Registration of observational studies: Is it time?

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Abstract
Much of the rationale for the prospective registration of clinical trials 9 applies to the registration of observational studies (Table 1). 7 For example, observational studies in which researchers acquire data directly from human participants entail ethical obligations to participants, even though such research generally involves less risk than interventional studies. 10 These obligations include oversight by ethical review boards, informed consent, and public release of the study findings to advance biomedical knowledge. As with clinical trials, incomplete reporting of observational studies has been documented. 3 Some researchers suggest that observational studies are also at increased risk for publication bias or other types of bias, including misrepresentation of prespecified analyses or phenotype definitions. 2,4 Such biases are a concern because they undermine the validity of observational studies, which are an important component of the medical evidence base in areas of public health, such as detection of rare adverse events. 1,16