I was at a conference in Philadelphia yesterday on the eCTD and CTD – these are new standards for the submission of drug and other life sciences applications to regulatory authorities. Pharmaceutical and other life sciences companies cannot test new candidate drugs on humans or market tested drugs without the permission of government regulatory authorities such as the Food and Drug Administration (FDA) in the United States, or Health Canada’s Therapeutic Products Directorate (TPD). The Common Technical Document (CTD) and its electronic equivalent (eCTD) is a global quasi-standard format for such submissions. Maybe in a future posting I’ll describe this more, but for the moment I thought I’d focus on an element of the talk that I gave – I can’t remember the last time I went to a conference as an attendee – either I’m a speaker or I man a company booth.
Most of the speakers were from pharmaceutical companies and so talked about aspects of implementing the CTD or eCTD. As a member of a software company that sells a solution to help such companies prepare eCTD submissions (i.e. Livelink for Collaborative Submissions), I wanted to talk about software. Now no one at these conferences wants to hear a commercial from a software company, so I decided to give a talk entitled, “Applying the eCTD Standard to Internal Business Processes.” The talk was well received and I was asked by a number of people for copies. One aspect of the talk was how people confound the potential benefits of an electronic system.
As a first example, I talked about the steps involved in the review of a document:
In the paper world, a request for an action (e.g. a draft report for review) by a user takes time to arrive by internal mail. When that user has completed their review, then it takes time to hand-off or mail to the originator or next person required to act. In theory, with electronic content, distribution at the beginning and end is essentially instantaneous. But in the real world, the expected time savings are often not achieved. While the worker may have been notified that they have to perform an action, they may not be ready to do so. Consider the scenario were the worker has decided that on Fridays he/she will perform all their reviews for that week. A request that arrives electronically on Monday will be addressed on Friday, just like a request that took until Wednesday to arrive by internal mail. So the actual time involved is longer:
But it gets worse. Very often people prefer to review on paper – if they receive a request for review of a paper document, they can begin work immediately. If the request is electronic, they have to ‘find time’ to print it out, before beginning their review, and then at the end they have an extra step transferring their comments back to electronic form:
Another potential benefit of electronic systems is that they can allow multiple workers to perform tasks on the same material at the same time (i.e. in parallel). Technologies exist for people to be adding comments to a document and in real-time see the comments added by their colleagues – each worker is seeing the latest version of a document. In the paper world, serial processes are much more common – only one copy circulates and one person at time makes comments:
But frequently, as electronic systems are adopted, a pre-existing paper process is mapped unchanged to the electronic system, reducing the potential time saving benefits. And then ‘people factors’ enter the equation again – we may find that a final manager is less motivated to perform the his task because he got the request sooner – he doesn’t think it is so urgent!:
Simple examples from personal experience, but I’ve found they resonate well