Conference Call Summary, page-194

My 2c worth of what went wrong with data quality in this trial?

The trial fell between the cracks. This is because non-interventional clinical trials (as this trial was) are rare.

In a standard clinical trial something (mostly a new drug) is tested. An independent data and safety monitoring board is created. The DSMB is independent of the CRO and trial sponsor. It is unfettered with respect to blinding.

The DSMB monitors safety and trial integrity. A nose dive in data quality should be picked up by statisticians reporting to the DSMB. The DSMB will jump on the threat to trial integrity and take corrective action.

But in this clinical trial there is no drug being tested. The safety risk to participants is trivial; provided nothing comes between the child and receiving prompt treatment.

So you don’t think you need a DSMB. The sponsor (RAP) thinks they can’t monitor data quality in a double blinded trial. The CRO trains staff and thinks they have done their job. No-one spots the implementation going skew-wiff of both the protocol and the statistical analysis plan.

Unusable recordings are taken because of TVs. No-one realises. The mother coughs first and no-one twigs the statistical analysis plan requires the first five coughs to be analysed.

The lack of the key central monitoring group that sits on top and monitors that all the moving parts are moving in synch is missing.

A year later ... RAP wake up to a very nasty surprise.