Thoughts on the Knowledge-managing Medical Writer

I have written from time to time here and elsewhere regarding my vision for what should constitute a good working definition of the regulatory medical writing profession in the 2000s. I thought I’d end the year by sharing a few more attributes that make up my working definition. I also want to contrast this vision with my observations of what I see as the most common mind-set for the medical writing profession. I place these considerations before you to see whether they resonate or perhaps play but a very flat note. Comments and counterarguments are always appreciated.

I argue that to succeed in 2013 and the years forward, a regulatory medical writer must see their role as a knowledge manager, not as a writer—that is, not as a scribe of clinical narratives or descriptive text in various types of documents. To play off the work of Metz Bemer in her article Technically It’s All Communication: Defining the Field of Technical Communication I too suggest that many aspects of knowledge management are indeed a sub-discipline of regulatory medical writing. So in this piece I will continually refer to the “knowledge-managing medical writer.”

My observations during the past 10-12 years of many medical writers in many organizations suggest few see or operate in a role beyond “a scribe of clinical narratives or descriptive text in various types of documents.” They do not act in the manner I assign to the knowledge-managing medical writer. This older vision of a medical writer worked in the past and may work in certain situations and with certain document genre today, but will fall to the edges of the road as we move forward in time.

Over the years I have become acquainted with some individuals who really do recognize the importance of knowledge management and representing greater value than “just a scribe.” I do not use this term “scribe” derisively, but in the context of how many clinical development or regulatory submission teams and organizations treat medical writing resources—they are just an afterthought brought in late in the development or strategy life cycles to attend to the matters of writing up the details. Writers may be wrongly characterized to such a model, but then again many are correctly cast. I see the situation as similar to what played out in the Irish monasteries of the 10th century—monastic scribes working in the background arduously producing manuscripts.

I argue that as part of knowledge management, regulatory medical writers at a minimum have a role in advising teams on the effective design of documents for the highly selective professional reader at regulatory agencies. I know there are some reading this piece who fully understand the implications of what reading research shows—and shows with ample evidence I might add—that successful research reports and submission dossiers are predicated on more than just good study results and an adequate template (though this does make the task of writing significantly easier.) A brief digression here: I do not consider whether a submission package is or is not approved as the only parameter of success, but I am not going to describe my working definition of “successful documents” in this piece.

Okay, back to the point—most reading this piece will likely agree that successful documents routinely require more than just someone sitting at the computer who has an advanced degree in the life sciences, great attention to detail, good analytical skills, above average MS Word skills, and good command of the English language prevalent in medical writing (by-the-way: I suggest these attributes make for a reasonable working definition of a scribe.) My observations suggest that not many writers take on the role of advising their teams on effective document design. A role that I fully associate with the knowledge-managing medical writer.

I suggest “successful” clinical research reports require close, carefully orchestrated and well-articulated design intentions and regulatory submission documents demand significantly more consideration of such intentions within and across the “corpus” of various Module 2 submission documents. Therefore, I argue that medical writers need to carry the “knowledge torch” regarding how to consider and then act out various design intentions in regulatory submission documents.

Now please keep in mind, by “design” I do not mean making a document look pretty or to comply with a template. These are mechanical attributes of a document. By design, I mean how one builds and shapes arguments and how one creates division and hierarchy to convey meaning to the busy professional reader in complex, technically demanding sets of data and information. These are among the semantical attributes of a document.

My observations suggest many writers retreat from such tasks. They are very comfortable staying in the background operating in the manner of the monastic scribe versus the manner of the knowledge‑managing regulatory medical writer. They are most comfortable working to the model of “tell me what you want and I’ll write it” and the dictate of “here—write your document just like this one because it was approved by senior management.” I suggest this is an authoring approach that would appear quite comforting to an 11^th century Irish monk writing manuscripts in the monastery at Le Mont Saint-Michel.

So looking towards 2013 and years forward, I suggest that some of the things really good knowledge-managing regulatory medical writers will do are as follows.

• These writers understand that the mantra of “well this is how we have always done it” is not a meaningful metric—especially since regulatory agents in public forums and private sessions talk about how they sometimes gasp and choke their way through data and documents in submission packages. Good regulatory medical writers clearly understand that they are writing for a decision-making reader and look to get their teams to understand the implication of errant document design decisions for this type of reader. These writers understand how to design documents to satisfy the question-based inquiry of the decision-making reader of regulatory submission documents.

• Knowledge-managing regulatory medical writers truly understand the working definition of the term “concise” and look to influence their teams to recognize not only the importance of concise writing but the hallmarks as well. These writers know that writing style must vary by document genre and that you cannot simply take a “one shoe will fit all feet” approach to both style and level of detail as you move across various document genres. Their writing is marked by brevity of statement and is free from low-value elaboration and superfluous detail.

• Knowledge-managing medical writers recognize there is marked difference between descriptive text and expository text and assiduously avoid redundant representation of data in a textual form. These writers understand that much of descriptive text at best adds bulk and at worst adds noise to a document. They look to educate their teams to recognize much of traditional scientific writing style brings no added value to the domain of regulatory documentation, but will consume considerable amounts of time and energy to produce and manage within their documents.

I end this piece with a working definition that I feel is a good fit for the knowledge-managing medical writer—“the knowledge managing writer utilizes a range of strategies and practices with a team to identify, create, represent, and enable adoption of insights and experiences to foster effective work practices to create high-quality document products.”

Need a New Mental Model for Regulatory Documents

Wow……I have been away from this blog a whole lot longer than intended. Those competing interests….like you all understand….are the bane of my existence.

For the past couple months I have been looking closely at how people think about the “vehicles” used to communicate with regulatory health agencies. I am using the word vehicle here because I am trying to divorce myself from the notion of document, in particular, the notion of “a document.” In the modern times of on-screen reading and linked files, what is a document anyhow? To me it is the entire corpus somebody may be able to access, not just one slice of that body.

In my consulting/training interactions at McCulley/Cuppan, I find that the majority of people I interface with in the client setting operate within the mind set of individual documents (some have even smaller boundaries and operate by document sections) that are stand alone with well defined boundaries (pages and page counts.)

I want to argue that the vehicle of communication for regulatory submissions is not a document. It is the full and complete dossier submitted by the sponsor. Documents are just placeholders where I go to get a piece or pieces of information that help answer my questions. I want to argue that the regulatory reader does not see a dossier as a set of documents. Rather they see a dossier as a corpus of information that they will use to answer question and make decisions. The contents are just vehicles they peruse to get what they want.

Applying my working model means you stop seeing documents as “stand alone” and stop saying “this document has to tell a story.” I’d also like you to stop using the word document. That word has baggage I am trying to jettison. Instead I want people to view their work at least as “modules” and preferably as vehicles that help a user to answer very specific questions. Bottom line, a research report is just a part of the constellation that tells the stories. Note the plural form as we have many stories to tell in a dossier, not just one.

Applying my working model means you stop seeing your work as being like a novella—something to be read from page 1 to page n. Applying my working model means you see your body of work as something that is read in a coordinate manner that is defined by very narrowly defined aspect rules of inclusion/exclusion. Applying my model means you stop seeing pages and sections and you start seeing concepts and topics.

My argument is that the selective professional reader at regulatory health agencies cares little about documents, sections, pages, and data tables. I am suggesting such readers care solely about making informed decisions and where in the submission dossier they find vehicles that can get answers to their concept and topic questions.

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?

Importance of language and writing style in a clinical study report

How important is language and writing style in a clinical study report?  I was recently asked this question by a medical writer working for one of my McCulley/Cuppan clients. The writer is dealing with a team that seems to obsess over every word in every draft and the writer is looking for some help in how to address the situation.


Here is my response to the question:


You are asking about lexical and syntactical elements of writing (the third element of writing is grammatical.) 


Lexical pertains to the words (vocabulary) of a language. In the context of clinical research we need to talk about several applied lexicons of scientific phraseology that apply broadly to science and then narrowly to a specific therapeutic area. The admittedly most distinctive feature of any clinical study report is the application of specific scientific and technical prose. So, language is very important in a CSR to avoid lexical ambiguity (why I so love statisticians and their demands for careful use of language when describing statistical observations) in order to allow the reader to derive the intended meaning.


My experience suggests that many people in Pharma think attention to syntactical elements (style) means they are either eliminating ambiguity or improving clarity of message. Rarely is this the case.


You have heard me say before that style does not matter in the type of writing represented in clinical study reports submitted to regulatory authorities in the US and elsewhere.

My position is supported by current discourse theory. Discourse theory states that, as a rule in scientific writing, meaning is largely derived from the precise use of key scientific words, not how these words are strung together. It is the key words that create the meta-level knowledge of the report. Varying style does little to aid or impede comprehension.


What happens is people often chase and play around with the style of document. Largely they are looking to manipulate an advanced set of discourse markers specific for clinical science writing or some subset specific to a therapeutic discipline. Discourse markers are the word elements that string together the key scientific words and help signal transitions within and across sentences. These discourse markers are the elements that provide for style. There are macro markers (those indicating overall organization) and micro markers (functioning as fillers, indicating links between sentences, etc.) Comprehension studies show that manipulating discourse markers--that is, messing with style--in most instances does not influence reader comprehension. It is worth noting that manipulation of macro markers appears to have some impact on comprehension for non-native speakers of English (why it is worth using textual advanced organizers to help with document readability.)


So the net-net is: there is little fruit to be picked from messing with style in a clinical study report. Put review focus on the use and placement of key terms.


This is a bit of a non-sequitur to the question, but a concept I’d like to share. To derive meaning from scientific text, readers will rely on their prior knowledge, and cues provided by the key terms and data they encounter or fail to find in a sentence, paragraph, table, or section of a clinical study report. So what I’d really prefer to get people thinking about is the semantical elements of their documents. Semantics is fundamentally about encoding knowledge and how you as an author enable the reader to process your representation of knowledge in a meaningful way. Semantics is about how much interpretive space you provide to the reader in a document by what you say and equally important, by what you do not say. Of course you cannot get to the point of thinking about semantics unless you see clinical study reports as something more than just a warehouse for data.

The importance of understanding the reader and the need to be informed by reading theory

In thinking about the ExLPharma conference where I spoke two weeks ago on review, I talked for some time about the importance of reviewers understanding their readers and the need to be informed by reading theory so as to become a truly good reviewer. My comments were largely well received by the group attending the conference and, for most of the points I raised regarding reading theory, were truly novel for them. I came away from the conference with the notion that few people actively engaged in creating business documents have invested time in thinking about what regulatory readers actually “do” with their documents and how they actually read these mission-critical documents.

Given that most people inspect a document for accuracy tells me that the prevalent view regarding reading is “if we get the numbers and the words right, then we are good to go and surely everyone will understand what we mean.”

I remain perplexed as to why this view is so uniformly applied. I am even more perplexed why some people I cross paths with in my client settings struggle to accept the notion that readers construct a meaning that they personally create from a text, so that "what a text means" can differ from reader to reader. Readers construct meaning based not only on the visual cues in the text (the words and format of the page itself) but also based on the knowledge readers already have stored in their memory. This pre-existing knowledge readers bring with them as they encounter a text is very potent and not much appreciated by many I work with across the life sciences.


Originally published on our Knowledge Management blog

Designing Documents for the Regulatory Reader

Over the years I have heard numerous presentations or read articles by regulators at FDA that suggest the documents submitted by pharmaceutical and medical device companies are not designed to support the reader tasks of the regulatory reviewer. When considering these comments, I’d suggest the core problem is that these documents are written from the perspective of the writers, with little consideration given over to what a reader is trying “to do” with these documents.

Here are some generalizations about regulatory readers and corresponding document design actions:

1. Regulatory readers work under a spotlight, in agencies subject to governmental scrutiny, with high levels of public criticism. Therefore it is important to write discussions to bring in focus the troublesome study issues of the development program. Highlight the issues as questions the regulators are likely to ask and provide responses to the questions, appropriate rationales for the responses, and then explicitly point to the corresponding data that underlies or supports your response.
   
   
2. Regulatory readers may be in the same broad field as the industry scientists who developed the drug or device, but they likely will not have the same level of specialization. Therefore, explain key decisions regarding development programs, study designs and methods of analysis. It is important to provide scientific and regulatory context to help support scientific expectations and reasoning.
   
   
3. Each regulatory reader brings specialized expertise to a team evaluation, where multiple reviewers work with different sections of the marketing request application for a drug or a device and arrive at various perspectives on the filing. Therefore authors must assume global use of their documents with multiple readers taking multiple perspectives. Authors must provide entry context at the beginning of main sections. That is, orient readers with purpose and main messages at the beginning of sections.
   
   
4. Regulatory readers are swimming in a sea of documentation. Make it easy for them to navigate your document. Carefully consider how discussions will be sequenced within sections and across sections of the reports as well as summary documents. Assume your regulatory reader applies a coordinate review to your document. Design pages for easy skimming and scanning. Use informative headers and deep subsection structuring.
   
   
5. Each regulatory reader has individual ways of working—individualized practices, work habits, and standards that have evolved as they have become expert reviewers. A common point is that they all read “against the text” by looking for weaknesses in the conduct of science, logic of arguments, and unsupported positions. This means authors must be aware that the regulatory reader is largely looking for what is not there in the document. It is therefore important to design documents assuming multiple points of entry for the reader. Critical information may need to be summarized in several locations to ensure the reader does not miss critical arguments. Repetition of information must be carefully managed so as not to become redundant.

Originally published on our Knowledge Management blog