There are many parallels between reading a document for the first time and trying out a new restaurant. When you walk into a restaurant for the first time, your initial impressions are based on the cleanliness of the premises, the professionalism of the staff, the décor…in effect, first impressions are based on everything but the food. The chef may be excellent, the kitchen may run like a well-oiled machine, and the food may be first-rate. However, if this is not reflected in the first impressions, it may bias the overall experience.
Now consider the first time a reviewer reads a regulatory document. Obvious typographical and grammatical errors, lack of direction, or inconsistencies between text and tables may bias impressions regarding the quality of the analyses and may raise red flags regarding the overall quality of the research. In fact, a survey of FDA reviewers showed that the quality of documents can either facilitate or impede review [Boe et al, 2005].
Returning to the restaurant analogy, an enjoyable meal should be well composed, with a central focus, a balance of flavors and textures, and a reasonable portion size. The same criteria can be applied to regulatory documents. Documents should be concise, with highlighted key messages, logical flow, and emphasis on interpretation.
In a more recent survey, FDA reviewers were asked to evaluate submissions based on the quality of writing, organization, completeness of presented information, and adequacy of cross-referencing [Connelly, 2010]. The survey assessed CMC (chemistry, manufacturing and controls), nonclinical, and clinical sections separately. The survey uncovered areas for improvement, namely data that were presented with inadequate interpretation, too much redundancy (eg, repeating in the text what was presented in in-text tables), and overuse of scanned data/images (these cannot be searched, therefore slowing down review time). Some reviewers noted that the people writing clinical summaries had an inadequate understanding of the science.
Key messages should be defined early in the writing process in order to ensure that each document adequately addresses the intended question. This will ensure that the documents are focused. Writers should make more use of tables and figures to summarize data; then use text to describe trends or important changes. More time should be spent organizing the data into a cohesive story, with discussion of contradictory results and limitations of the data. Summaries should focus more on interpretation, with less emphasis on repeating data from the clinical study reports (think haute cuisine, not all-you-can-eat buffet).
Writers of regulatory documents should always bear in mind that the intended audience is the reviewer. A short, concise, well-written document with adequate cross-referencing using bookmarks and hyperlinks is easier to read. This will inevitably shorten the amount of time required to review the document…and not leave the reviewer feeling bloated. Food for thought?
References
Boe P, Kornacki DL, Lo K, Kelley MJ. Reports from Other Meetings: Drug Information Association (DIA) 41st Annual Meeting Review. AMWA Journal. 2005;20(3):136-138.
Connelly SM. CTD/eCTD Quality: FDA Survey Results. FDA Web site. June 20, 2010. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/FormsSubmissionRequirements/ElectronicSubmissions/UCM229656.pdf. Accessed May 23, 2013.
Disclaimer: These are my personal views and they do not reflect those of OptumInsight.