Why do we still organize clinical research reports by the IMRAD convention?

Here is Part 2 of the questions I posed in my previous blog post.

I have been thinking about this question for some time now. I remain curious as to why we still organize clinical research reports by the long-standing convention of Introduction, Objectives, Methods, Results, Discussion, and Conclusion? The IMRAD form of organization. The year 1665 is often cited as the origin of the platform commonly referred to as scientific papers. It was not until the second half of the 1800s that these documents moved in the direction of “theory – experiment – discussion.” Then starting in the early 1950s the IMRAD structure became the prominent norm for the structure of a scientific paper. 

The supposed reason for the IMRAD structure is that this organizational approach facilitates literature review, allowing readers to navigate articles more quickly to locate material relevant to their purpose. It has been suggested that the IMRAD structure effectively supports a reordering that eliminates unnecessary detail, and allow the reader to assess a well-ordered and noise free presentation of the relevant and significant information. I can see how this argument may apply to research manuscripts published in Journals, but it certainly does not apply to the kinds of study reports submitted to regulatory agency health authorities.  

Unfortunately, the supposedly neat order of the IMRAD arrayed report rarely corresponds to how regulatory readers consider using documents to help them make decisions. That is, decisions about how study results support or fail to support broad or narrowly defined questions/arguments. People are surprised to learn that health authority review agents rarely read study reports. They certainly engage with study reports and make use of the content. But read these documents? No, that is an approach not normally taken by the health authority review agent. 

Frankly, I cannot blame them. After all, the IMRAD form of organization does little to help them get answers to their questions or support their approach to making decisions.

Over the past 50 years, the idealized sequence of the IMRAD structure has on occasion been criticized for being too rigid and simplistic. Perhaps the most famous castigation was made by Peter Medawar in the early 60s. He criticized the IMRAD design for not giving a realistic representation of the thought processes of the writing scientist. And then in the mid 80s A. G. Gross wrote a paper titled: “The form of an experimental paper: A realization of the myth of induction” that challenged the notion of the IMRAD structure as well. 

I am right there too in questioning the merits of this approach. At least when it comes to study reports submitted to health authorities.

I believe the reason for rigid adherence to the IMRAD approach for research document organization is the precedence of the past. Not that it affords the most effective stucture for the reader to get what they want from a document.

As for me—I’d prefer a Question & Answer approach—something along the lines of organizing the report by study objectives with the study methods appropriately subordinated at the back of the report. Give me a report organized as follows: Objective—Results—Discussion—Assignment of Significance. Each section of the report deals with only one study objective and information is presented in the sequence I have suggested. Then the last section of the report would be Conclusions where you integrate and contextualize the study findings to answer the really big question of so what do all these findings mean?

So what do you think is the most effective form of organization for a regulatory clinical study report?