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.