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.”

Difficulties Assessing the Value-Added of Professional Communicators

Here is a post originally published in 2008, but the topic is worth repeating.

As mentioned in previous installments of this discussion, we at McCulley/Cuppan believe that the role of the professional communicator can add considerable value to the research and development process. But we recognize that in order to justify the need (and the added expense) for this expanded role, managers have the daunting task of trying to quantify the value added of such professionals to the organization.

The professional communicator must add value to a company’s information processes and products in order to justify their presence within the pharmaceutical organization. Mead (1998) defines the concept of value quite simply: “Value can be defined as the benefit of an activity minus its cost.” However, to apply that concept of value to the role of a communicator or science writer is not so simple. The value of the communicator in the life science research enterprise is not easy to determine for one principal reason: what value does one place upon a timely, efficient, and effective regulatory submission documents?

The problem is that communication in the life science industries does not lend itself to easy analysis against the traditional measures of professionalism that are routinely applied in other aspects of research or in other writing settings for that matter.

To measure the benefits of the professional communicator’s activity within the life science research organization, and in particular within a research project team, it is necessary to turn to the existing body of research illustrating the ways in which communicators provide project teams with valuable input and experience that enhance the overall quality, timeliness, and labor allocation to the tasks of research and reporting research. Quantitative and qualitative research methods, including case studies and surveys, offer data to demonstrate the significant effect professional communicators have on both organizational processes and products. However, little research and few publications directly address the roles and value of the professional writer within the life science research industries.

It is thus necessary for savvy managers to cast a wide net and look to other fields for relevance to the context of life science research. Managers should consider the task of writing in the work of engineering, aerospace, and computer industries, industries that share an intense document development environment similar to what we see in the life science research environment. These industries are similar to the life sciences in that the document product is used by regulators or buyers to create an informed opinion of the company’s proposed product or service. The caveat we must offer is that there is a thin volume of literature assessing the value added by communicators to these organizations, so the existing body of case studies may not be sufficient. Managers may need to seek out others in their organization or industry that have made use of communicators on their project teams.

Professional communicators can contribute to the understanding of the value added by documenting their work and comparing their tasks and targets with company benchmarks. Communicators must document their tasks over the life of the project because it is not possible to assess value added simply by looking at the documents that writers produce. Jong (1997) points out the problems in the “inspection model of quality control,” a model that when applied to documentation, focuses merely on the cost of writing and occassionaly the cost of review. This model is “inherently vulnerable to error,” as significant costs and errors may be missed. Jong claims, “The best way to improve the quality of the output is to improve the quality of the input” (40). Improving quality of input suggests that researchers carefully consider how they present the logic of their interpretations, how they design information to satisfy readers’ needs, and how they represent the resolution of issues within the framework of their document or sets of documents. Communicators can facilitate this consideration and ensure that the documents are logical, complete, and meet readers’ needs. One way to demonstrate these skills to managers is by comparing “before-and-after” documents that show how the communicator improved the logic and readability of initial drafts or how a communicator involved from the beginning of a project can better convey the resolution of issues than a writer brought in at the end of the project.

The variety of roles for writing in the life science research environment makes it difficult to employ a simple model for calculating the value added of writing specialists where the principal output is an informational product. As Fisher (1998) states, “The profession of technical communication is difficult to define in scope” (186). Within the pharmaceutical and life science research industries, writers and communicators have very different roles in various enterprises. Some are primarily writers, others function principally as editors, some coordinate the compiling of documents for registration filings, some facilitate team-based document development, and some concentrate on knowledge management. The challenge is to understand how professional communicators can contribute to efficiently and effectively producing the desired outcome: a high quality document product that helps in the conveyance of knowledge or the advancement of work on drugs and medical devices. Professional communicators must be able to defend their roles to management. By providing “before-and-after” versions of the documents and recording their tasks and timelines (thus enabling managers to compare those with previous projects), professional communicators may be able to reverse the current trend of having writing as a wholly separate task from research and may be able to start a new trend of utilizing professional communicators.

Works Cited

Fisher, J. “Defining the Role of a Technical Communicator in the Development of Information 

Systems.” IEEE Transactions on Professional Communication 41 (1998): 186-199.

Jong, S. “The Quality Revolution and Technical Communication.” Intercom 44 (1997): 39-41.

Mead, J. “Measuring the Value Added by Technical Documentation: A Review of Research and Practice.” Technical Communication, Third Quarter (1998): 353-379.


Originally published on our Knowledge Management blog

Minimal Time and Effort Should be Applied to the Creation of the Clinical Study Report Synopsis

How much time and effort to apply to the creation of the clinical study report synopsis?


This is another question I am asked on a regular basis and a line of discussion that repeatedly comes up when I am working with clients to help streamline work practices. I usually draw slack jaws accompanied by an incredulous stare as I give my answer: 


"The amount of time should be minimal, involve no more than three people, the level of effort better be next to nothing, and the time should be no more than an hour to create and a whole lot less time to review."


My reasoning is very simple and straightforward.........."You apply time and effort to the development of a product in relationship to the product's strategic value. The value of the CSR Synopsis to the regulatory reader is virtually zero."


Think about it. The CSR Synopsis affords little utility to what the reviewers are looking to accomplish when they choose to enter the framework (that is, the document) of an individual clinical study. If a regulatory reviewer wants a “snapshot” of a study, they will likely take a contextualized snapshot at a higher level of a drug submission dossier. That is, the documents in Module 2. They do not enter the framework of the study report to get generalized or summarized information. They are at the Module 5 level and embedding themselves in a clinical study report because they are seeking answers to narrowly defined questions.


At McCulley/Cuppan we have queried regulatory reviewers about how they "use" a study report synopsis. Their responses support the premise I have laid out for you in the above paragraph.


So this gets us back to the question on time and effort. Why generate a study report synopsis with every draft? Why allow the full team to look at the document? Talk about wasting time and energy. 


In our assessment of review practices at pharmaceutical and medical device companies we see the same review pattern played out time and time again. The study report synopsis is generated with the first draft and in the review process it consistently garners the attention of the full review team (many of whom never make it all the way through the results sections during the course of their reviews.) Same thing happens on each subsequent draft.


Given the synopsis is but a summary of the body of work presented in the study report, it should not be generated until that body of work is completed and signed off as "good to go." The synopsis does not even warrant review. It should be critiqued. Critique is a comparative read. A reading to ensure that the synopsis accurately and appropriately portrays the sum total of key details of the study. The critique process requires at best two people and certainly no more than three. All being subject matter experts drawn from the key clinical disciplines represented in the research study.

More On Why Do So Many Feel Complex Language Is Needed To Have Good Scientific Writing

I made post a few weeks back addressing the topic of why some authors in the life sciences feel compelled to construct documents that are dense and difficult to read. Here's a link to that post.  The post generated quite a bit of discussion in a medical writing discussion group I belong to on LinkedIn.  The discussion there has motivated me to do some further investigation on this topic. I want to share with you some interesting pieces of information that I hope impacts how you think about what constitutes "good writing."

I came across a series of papers by J. Scott Armstrong, who is at the Wharton School of Business at the University of Pennsylvania. In these papers, Armstrong considers the broad question that academic communications should enhance knowledge and, therefore, researchers should invest energy in developing understandable ways to present their findings.

In his paper, Unintelligible Management Research and Academic Prestige, Armstrong explores the notion that if the goal of successful communication is to share information with others and, if science places a premium on successful communication, then, all other things being equal, journals should prefer articles that are clearly written to those that are not. Armstrong concluded from the studies presented in this paper that clear communication of one's research is not the norm in the prestigious journals he examined, nor is it widely appreciated in his small test of the academic community at three universities.

In a another paper, Research on Scientific Journals:Implications for Editors and Authors Armstrong states the following: "A review of editorial policies of leading journals and of research relevant to scientific journals revealed conflicts between 'science' and 'scientists'. Owing to these conflicts, papers are often weak on objectivity and replicability. Furthermore, papers often fall short on importance, competence, intelligibility, or efficiency."

In yet another paper, Barriers to Scientific Contributions: The Author’s Formula, published in the journal Behavioral and Brain Sciences, Armstrong, with tongue in cheek, describes a set of rules that authors can use to increase the likelihood and speed of acceptance of their manuscripts. Authors should: (1) not pick an important problem, (2) not challenge existing beliefs, (3) not obtain surprising results, (4) not use simple methods, (5) not provide full disclosure, and (6) not write clearly.


Originally published on our Knowledge Management blog

Improved Document Quality Does Pay

Quality control and improvement in document content and design can provide a significant financial benefit to  pharmaceutical and medical device organizations. It is our observation that companies must learn that writing is a process open to continuous improvement.

However, I find in my consulting work that many people working in the life sciences question the merits of attempts to improve the communication quality of their technical and scientific documents.  Quite a few of these people subscribe to the notion that as long as I get the study design right or have the correct data, then that is good enough. This may be the case for a small subset of documents, but the assumption clearly does not apply to the vast majority of documents produced in the life sciences. It is our observation that an effort to improve document quality generally does pay off for the individual and the organization. Though these pay-offs may not be easily seen unless there is an attempt to capture data regarding the impact of better document quality.

Here's a few examples where organizations instituted quality control programs and measured change in selected outcomes in order to answer questions about their document products and processes. These organizations found document quality by design does pay.

The Motorola Corporation substantially improved its operation after instituting a document quality program. The company made changes in R&D and Finance operation guides. These changes were focused on providing clearer directions and rationales in the guides and an easy-to-use format. These changes have helped streamline processes, and reduced delays from review and rework. The company calculated savings at US$ 20,000,000 per year. Source – Business Week Oct. 25, 1992
The United Kingdom Department of Health and Social Security spent the equivalent of US$ 50,000 to develop and test a series of new forms. They have reported annual savings of over US$ 2.9 million in reduced staff time from the forms being properly completed the first time.
Source – Plain Language Principles and Practice by Erwin R. Steinberg

The United Kingdom Department of Customs and Excise cut a 55% error rate to 3% by revising lost-baggage claim forms used by airline passengers.  Source – American Institutes for Research
An  aerospace contractor lost 15 consecutive contract proposals over a three year time period before a quality proposal writing group was called in to review the quality of the proposals and to help the proposal development teams institute new work practices and improve writing skills for developing large proposals. After instituting changes in documentation work practices and processes, the contractor “won” 11 of 12 proposals.
Source – Shipley Associates private communication


Originally published on our Knowledge Management blog

The McCulley/Cuppan Standards Development Process We Use with Our Clients

As I mentioned in a previous post, in our McCulley/Cuppan consulting work we find the prevalent standards used to determine the “success” of a document are largely driven by simple measures of accuracy and then a passel of “home brewed” concepts for characteristics of document that are largely idiosyncratic ideas about what matters to the reader.

When you have 10 people reviewing a document you will end up with at least 12 opinions about the quality of the document (incongruous number is intentional as sometimes you have a reviewer offering more than one opinion that often conflict) and ways of describing quality that are all over the map. People use different terms to describe quality and if they actually use the same term, then it is highly unlikely that they will use the same definition for the term. So the first problem faced in the review process is the vocabulary used to describe quality attributes in a document.

When writers and reviewers compose or edit text, they continually make decisions that concern semantics—the meaning their words convey—and syntax—the way the words are arranged and other structural elements of the document. However, writers and reviewers often base these decisions on assumptions that have not been tested with technically-oriented adult readers or complex, data-rich, technical documents. Worse yet is many assumptions have never been tested to determine validity. Thus, there are actions ordered by writers and reviewers that may not in fact have the expected effects on a readers' performance (we know this is certainly true with one very important reading audience for pharmaceutical and medical device companies—the regulatory agency, like FDA). So the second problem faced in the review process is to understand what document elements have a meaningful impact on semantics and where to focus time and attention on the syntactical elements of a document.

The first thing we do with a client is an examination of the terms used formally (such as in guidance documents) and informally (such as review comments in documents) to describe quality. This will give us a sense of how the organization views quality and how sophisticated they may be in trying to create a common platform that describes document quality for the organization.

The second thing we do is to provide clients with the terms McCulley/Cuppan uses to describe document quality and why the concepts underlying these terms are extremely important to help determine document communication quality. A very important consideration is that the terms should speak the user’s language, with words, phrases and concepts familiar to the user, rather than system-oriented terms.

We spend a huge amount of time talking about semantics. The term "semantics" refers to the study of how language conveys meaning. Using a broad definition of semantics, we help our clients learn how to focus on different features of a document. Features like word choice, the position of information in document sections, paragraphs and in documents as a whole, idea importance, and the visual representation of data.

Then we work with a client team to create and vet working definitions for the various quality standards.

We then roll out the standards in a workshop setting and show people how the standards are applied to the types of documents they have and will produce.


Originally published on our Knowledge Management blog

How Do You Measure Communication Quality?

One of the truisms we see in our McCulley/Cuppan consulting work is that rounds of document review tend to go until the point when the document must be sent somewhere. That's why we say that in the pharmaceutical industry, the opportunities for making changes to a document are virtually limitless. The problem driving this situation is most people involved with authoring and reviewing process do not have good markers to inform them of the overall communication quality of a document.  So without good markers they are left to utilize really poor markers to help them measure document quality. Markers like: grammatical soundness; how many people have reviewed the document; how many rounds of review; and how many comments leveled on the text and data in the document. Unfortunately, these markers have little correlation in the case of grammatical soundness and, for the other three, no correlation whatsoever to the communication quality of a document.

To paraphrase Steve Jong in his paper (you can read it here)  You Get What You Measure—So Measure Quality: "if you don't measure it, you'll never get it."  This is so true with document communication quality.  In order to measure communication quality you have to employ meaningful markers. We find our clients typically employ only two markers that are useful: accuracy and compliance. Unfortunately, neither of these do much to measure the quality of argument, soundness of logic, or overall usability of a document for the end-user. There are some useful markers to consider for measuring these document attributes. More on these markers in my next post.


Originally published on our Knowledge Management blog