Publication guidelines and study design:
mismatch or marriage?

Abstract of talk to be presented at the European Statistical Forum, Verona, 18 November 2010, by Andrea Rossi, Medical Writer, Eli Lilly Italy

When guidelines for reporting the results of randomised clinical trials on peer-reviewed journals were developed, their main scope was to increase consistency between different peer-reviewers, trying to improve the quality of published articles. Today, guidelines for disclosing the results of any type of research are available. All of them have a some indications to evaluate the quality of study design.

Even if they are not exhaustive, these guidelines should be a good reference for the researcher and the statistician to design their study. Some examples will be shared during the presentation, highlighting the role of the medical writer as highly professional contributor to protocol writing.