Great summary! And yet, for all their problems, CROs are sometimes still the fastest alternative. We did a clinical trial for a software platform a few years ago, and hoped to partner with a prestigious hospital system to run the trial.
The hospital partner was 100% on board—our protocol just had to pass their internal review board (IRB). IRB is a black box, and they could only give us a vague estimate of how long this would take. We had a huge team, and every week we sat around waiting cost about $200k.
Finally the client couldn't take the uncertainty and burn rate anymore, and they reached out to a CRO they had used in the past. The CRO's IRB had a fixed timeline (2 weeks?), and we were onboarding patients a short time later.
Yeah the lesson with getting IRB approval if you want it done in less than 6 months is to always use an external IRB (if possible). Institutional IRBs are sloooooowwww.
Any particular issues? I am most opposed to the rigid 30-day cycles and the need to spend one just to get on the agenda. But in terms of the questions asked and the due diligence required, I have not found our IRBs to be onerous
We did keep working on the platform, but from the perspective of the client, we already had the MVP for the trial. So to them we were working on “nice to haves” for 200k/wk
The hospital partner was 100% on board—our protocol just had to pass their internal review board (IRB). IRB is a black box, and they could only give us a vague estimate of how long this would take. We had a huge team, and every week we sat around waiting cost about $200k.
Finally the client couldn't take the uncertainty and burn rate anymore, and they reached out to a CRO they had used in the past. The CRO's IRB had a fixed timeline (2 weeks?), and we were onboarding patients a short time later.