Something to consider: using intranets as Knowledge Management tool to support collaborative pre-writing planning

Jakob Nielsen is a name some of you may recognize. He is a self-appointed guru on all matters regarding usability of web sites and web-mediated work tools. You can find much of his work summarized on his web site titled Useit.

Last week Nielsen came out with his list of Top 10 designed business Intranets for 2011. Here's the link.

I noted with interest Nielsen's comment "If there's anything that has been overused, abused, and hyped beyond the level of cliché, it's "knowledge management." Thus, it might be better to say that many of this year's winners were strong in "managing knowledge" on their intranets." 

Managing knowledge. This is a concept where I see drug and medical device teams struggle all the time. One reason for the struggle is the slow uptake of tools that can help foster an effective work environment and change deeply ingrained cultural practices.

I believe intranets, such as WIKIs are great tools that should be deployed at the project team level. These platforms become incredibly valuable from the moment a clinical development plan is written until well after a dossier is submitted to the regulatory authorities. 

While it is true that knowledge management is not a technology issue, effort must still be spent in providing a suitable environment to facilitate knowledge capture and sharing. 

I am suggesting the use of team specific intranets as a way to promote cultural change in an organization, at the level of knowledge-sharing activities and also for shaping broader work behaviors. In most companies where I train or consult, little has really changed since the 1960s in how people approach the planning and authoring of documents.  Using intranets, like a WIKI, can quickly get a team applying best practices in terms of pre-writing planning.

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.

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.