Work Pressure

On our internal work website, today there was an article about a new drug application being submitted just 21 days after data unblinding.  That is an impressive turnaround, but I think it was a mistake to publicize it because it raises the expectation of us being able to complete this kind of turnaround on all future submissions.  What is worse is that my specific function – statistical programming – was featured heavily in the article, and we are the group that is probably put under most pressure to achieve this quick a turnaround.  We are the ones that have to produce submission-ready datasets, tables, listings and figures, validate all these things, and then provide all the accompanying documentation, using the final data at unblinding.  To deliver the outputs in 10 days, as stated in the article,  towards a submission that probably involves several studies, given the amount of data involved, I would suggest is just not feasible.  Yes, we can do a certain amount of programming in advance, but to really understand the data, identify data issues, and achieve a level of quality to your work needs more time.  As many team members naively think outside of our function, we do not just press a button which magically provides all the output – it takes a lot of programs, a lot of resource, a lot of time, a certain level of detail and scrutiny, and is complex – which is why we get paid good money to do our job.  I’m thankful to not be part of the team that worked on this submission – I bet those 10 days between unblinding and delivering the output were absolutely horrendous and stressful for all those involved, and they probably had zero opportunity to actually look at the data.  No wonder the retention rate in our department is so poor, and this is exactly the kind of pressure that was the reason I left this job before.