Notes on Managing Reviews Presentation and Discussions at DIA Clinical Forum

We had an interesting set of presentations and discussions yesterday at the DIA (Drug Information Association) Clinical Forum in Basel, Switzerland related to managing reviews. Here are my summary notes on the session.

I spoke along with Barry Drees from Trilogy Medical Writing and Rhys Stoneman from GlaxoSmithKline. We each covered aspects of improving review outcomes for clinical research documentation.

I addressed the topic that to affect change you must look at the root causes of poor review outcomes not merely the symptoms of poor outcomes. Barry and Rhys talked about how their organizations--a contract writing house  and a large multinational pharmaceutical company, respectively--look to improve review outcomes.

I talked about the underlying root cause of most poor review outcomes fit into two boxes

1. No formal training in review methods
2. Poor reviewer discipline

Note: Jessica will get my presentation slide set posted to the M/C web site.

I stressed that without training most people are left to inspect and edit documents and generally are not sensitive to how rhetorical situations vary with audience and document genre.  I talked about reviewer discipline is difficult to modify without  making process changes and applying performance mandates.

Barry  talked about methods he uses to influence behavior of review teams. He had a great line on one of his slides addressing lengthy review cycles: "We do not have enough time or money to do it right, but there is always time and money to do it over."

Rhys talked about the steps taken to transform work practices and belief systems related to the authorship and review of clinical documents. We did a lot of support and training work at GSK on this project, so I have seen firsthand the changes. It is fair to use the descriptor, dramatic, to characterize how they have reformed work practices and outcomes.

Not surprisingly, the topic of greatest interest to the audience was issues related to reviewer discipline and what can be done to modify or blunt the impact of bad behavior.

Regulatory Writing Must Be "Fit for Function" Not Perfect

Documents for the medical regulatory audience do not have to be perfect. Rather, they have to be "fit for the intended function."

I suggest to you that the majority of people associated with drug and device development do not either understand or appreciate this concept. I also suggest to you that the majority do not understand that you apply different document designs to different document genres. Which in turn means you have different standards for different genre. Fit for function means you do not work to one standard.

Fit for function means a document is built and judged by standards that are determined by audience and the task or role the document will take when in the hands or on the computer screen of the specified audience.

A few weeks back I was working with a development team that judges all of their work by one standard. No matter what they are writing, the team judges their handiwork by their personal standards for a research manuscript. This one standard is applied to clinical study reports, protocols, and investigator brochures. I know this to be the case because review comments are often predicated with statements like: "Well, when I was writing manuscripts we always did.............in the Discussion Section. We need to do that in this report." or "I think the reviewers at the agency would find this very interesting to read. So let's expand the discussion here." and "You have a hyphen break at the end of the line in this paragraph. We cannot have mistakes like this in our documents."

Fit for function places focus squarely on the elements that matter, that is, the underlying logic of what the document is to convey or enable the reader to do. So in the world of drug and device development, this means authoring teams have to move away from the notions that when creating documents for regulatory readers, they are either simply reporting data or writing for an audience interested in knowledge acquisition. Working to either of those standards guarantees that your documents will not be fit for function. Rather, documents must be built following the underlying logic of what the reader is trying to do with the document.

More on how we characterize the logic of document genres in my next post.