Creo Quality has a good post up about expectations and a list of unrealistic ones:
From a regulatory and clinical perspective, there were other expectations, including:
- A pre-IDE meeting with the FDA would happen before the close of 2007.
- Animal testing would be simple and straight-forward to adequately demonstrate product safety.
- An IDE submission should be ready for FDA submission in early February 2008.
- An IDE clinical trial should only require a single site with limited # of patients.
- The clinical site IRB and enrollment process should be quick and easy.
I’ve known all along that every one of these expectations were not and are not realistic.
I can't comment on the expected schedule items, but I agree with the rest. I'll detail some of my experience below.
Animal testing would be simple and straight-forward to adequately demonstrate product safety.
I worked at a company that thought this at one time too, the product performance testing on animals and bench was all wrapped up, from this we had some safety data, but nothing clean, so additional safety tests had to be performed. Eight months and an unfortunate number of pigs later it was finally locked down. Some of the difficulties were due to differences in anatomy, to get to the femoral vein in a pig you have to do a cut down through muscles and fat, while most humans you don't. Also, you can expect a critically ill patient to lie relatively still for 5 days, the same can't be said for a healthy pig. Another major problem was we didn't realize that a 100 ml blood loss was an adverse event until very late in the game, it was never a problem in animal tests where losing the blood isn't going to matter to a healthy pig. Surgeons are much more concerned about the blood loss than large animal vets. All of these issues required significant amounts of time and money to work through, it is difficult to anticipate all problems with a new test.
An IDE clinical trial should only require a single site with limited # of patients.
We actually asked for and got this at my company, but it was to our detriment. A single site with a 10 patient safety study required, after the 10 patients a review to see if a larger study was needed. The single site was a killer, the surgeon involved was a champion for our device, but other hospital personnel involved with patient sign up for clinical trails were much more cautious and frequently and strongly voiced doubts to the people that the surgeon had convinced to sign up. We thought the surgeon was on board so it was all good, we didn't find out what was really happening for a year- a year with no patients. There was also limited patient population at the hospital our surgeon could approach due to some internal hospital politics that we weren't told about when we started. We had previously amended our request to the FDA and were granted additional sites, but thinking we could do it at one was a mistake that cost us a lot of time.
The clinical site IRB and enrollment process should be quick and easy.
The hospital Internal Revue Board (IRB) meetings I've been part of (all of two), or ordered to produce something as a result of, have been tough, but fair. I don't think that most people not in the industry know this, but IRBs can be tougher to get past than the FDA and can require extra testing as well. The ones I've dealt with met once a month and generally set the meeting agenda the previous month, so it required 3 months to get approval, one month to get on the agenda for the next, the initial discussion of the device and request for more information, and the third month was approval after discussion of the requested information.
I don't think you can ever say patient enrollment will be quick and easy. Its amazing that you can spend so much time on selection criteria and then someone always shows up with something unexpected.
Anyway, I hope it all turns out well for Creo's client companies!