They are all sharks, every single one of them

The growing competitiveness of clinical research is mind boggling to me. I understand that in pharmaceutical development, maybe more so than in other industries, time really is money. Countless reports have been done identifying how much money a year of development costs, how much money regulatory delays cost, and most importantly for us: how much money enrollment delays cost.
Unfortunately for sites it seems that most of the time lines are based on prompt, efficient enrollment at the site level in clinical trials. This means that sponsors are increasingly pushy to meet deadlines and it raises the stress level at the site significantly. Sites can no longer afford to take their time searching for the "perfect" subject, getting start up documents in to the IRB and sponsor, entering data with no mistakes, and recruiting when it is convenient for themselves. Sponsors can and will pull the plug on a site if enrollment is not proceeding as planned and they will strongly consider not using that site for future studies for that very reason. For this reason, the types of sites where clinical research originated (places where doctors were just plain interested in research) are being pushed out of the business by large scale, research factories.
Now on many levels this is not a bad thing because such research only sites are designed to very quickly carry out trials while at the same time maintaining high standards of quality research. Most small practices do not have the time or training resources to both do good research as well as meet the pressured time lines of the sponsor, so I would anticipate most, if all studies going to big research sites in the future. This doesn't have anything to do with the quality of the work, it's just that they can't keep up with all the demands.
There are two problems with this scenario. The first is that the FDA likes diversity in clinical trials, but large research sites are typically based in larger metropolitan areas and they will be recruiting from the same population for all studies. As more and more trials over the years are given to those sites the diversity decreases greatly. The other issue is that every site knows that in order to come out in the black, they need to enroll as many subjects as fast as they can. This puts much pressure on the site staff to work long hours meeting sometimes unrealistic time lines. Unfortunately this can be a recipe for disaster with inaccurate safety reporting, sloppy data entry, and worst of all: weakened subject relationships. So much of clinical trial success is based on good rapport with trial participants and in my mind, the last thing we want is to come across as telemarketers pushing cattle through a processing plant.
Unfortunately I can't foresee a simple solution to the problem because sponsors need their numbers and sites need their payments, so I suppose they will have to keep dancing around each other until something changes.

in other news, check this story out about H1N1 vaccines for everyone!
http://www.biohealthinvestor.com/2009/07/fighting-swine-flu-the-wal-mart-way-wmt-azn-gsk-novn-sny.html