What Defines Good Quality in a Clinical Study Report?

Although clinical study reports (CSRs) are one of the central documents in clinical development, little attention has been paid to those features of such reports that determine their overall quality. While the ICH E3 guideline mentions a few quality attributes for CSRs, there are hardly any publications concerned with determining the key quality features of CSRs. This aspect is also often missing in medical writing textbooks. This study set out to identify the elements that contribute to the overall quality of clinical study reports using guided interactive introspection in a medical writing group (N = 28). All medical writers had a science background with a PhD; their professional experience ranged from 1 to 17 years (mean: 3.3 years). In total, 16 quality items were determined, which were grouped into 5 major areas: language, document structure, numerical information, audience focus, and company context. Ordered by decreasing importance, the 10 most important elements were: correctness, completeness, regulatory compliance, clarity of structure, conciseness, consistency, timeliness, appropriate language and style, adequate conclusion, and alignment with clinical project. The quality of clinical trial reports proved to be multifactorial and multidimensional; the overall quality cannot be represented by any single quality item. To achieve optimal quality, medical writers need to apply professional judgment to balance between those elements that were identified as contributing to overall document quality.