top of page

Regulatory and Medical Writing, A Consultant’s Perspective – Part 6 – Interpretation

Discussions or interpretations of the results should address questions such as:


·       What do the observations mean?

·       What conclusions can be drawn?

·       How do the results fit into a broader context?


Concentrate on the evidence presented in your results through reference and not repetition.  Did the study achieve the goal laid out in the introduction? 


Typing on keyboard

The function of the discussion section is to analyze the data and relate it to other studies.  Analyze, in this case, means to evaluate the meaning of the results in terms of the original question or hypothesis and to point out its significance.  So, the discussion should contain the relationship between the results and the original hypothesis, an integration of the results with those of previous studies and possible explanations for unexpected results and observations.  Trends that are not significant can be discussed but only if they are suggestive or interesting.


It is important to avoid redundancy between the results and discussion.  In many cases it is clearer to present both in a single narrative thereby allowing an integration of the results and conclusions with minimal repetition.


The final aspect of format is referencing.  This is by far the most important consideration in regulatory writing and impacts the credibility of all medical and scientific presentation.  In regulatory writing, citations and cross-referencing are provided to allow the reviewer to verify the data discussed.  There are, typically, hundreds of volumes in a regulatory submission.  Accuracy in referencing gives the location of specific information.  If incorrect the result can be hours of lost time spent by the reviewer.  Those hours lost are, inevitably, filled with annoyance and, to a degree, distrust.   My advice is to always check, recheck and check again all references and links. 


--


Regxia's senior team has over 90 years of combined industry experience. Learn more about our scientific and strategic consulting services here.


Betty Cory

Author: Betty Cory, President

Regxia Inc.

Comments


bottom of page