Dianthus Medical Blog Archive

DIA clinical forum, day 2

We're now on our second day at the DIA clinical forum. I've been to quite a variety of talks: one session on clinical study reports, another on validation of computerised systems, and most recently on statistical analysis of bioequivalence trials, where there was much discussion of whether it's acceptable to widen the acceptance criteria for bioequivalence if drugs have highly variable Cmax. It will be interesting to see what the new guideline on this says when it's published, supposedly later this year.

But the most interesting session was on clinical study reports, particularly on metrics for writing them. One fascinating talk was about looking at the specific metric of time taken from availability of data to having the final report signed off. One company that had looked at this had made significant savings in time by investigating the factors leading to delays in report sign off.

There are many variables affecting how long a report takes, of course. Interestingly, they had simply used the phase of the study as the predictor of how long the report should take. One could certainly imagine making this a bit more sophisticated, for example by looking at the number of endpoints in the study.

I would love to do these kinds of analyses at Dianthus Medical, but I fear that it might be a lot harder for us than it was for the speaker, who came from a pharmaceutical company. By far and away the biggest predictor of how long a report takes is not the phase of the study or the number of endpoints, but how streamlined the review process is for reports. Within a single company, that review process is probably broadly similar from one study to the next. However, we work with a wide variety of clients, with an even wider range of review processes. Some of our clients have extremely well streamlined processes, and with those clients we have been known to get from a draft report to a final report in less than a month. Other clients have less streamlined processes, which can lead to the final sign off being delayed by many months. Those processes are largely outside our control, so I'm not sure how useful studying these kinds of metrics will be to us. Having said that, they might provide useful information for our clients, so perhaps I'll start looking at analysing these data when I'm back in the office.

But just in case you thought the conference was all work, work, work, I'm happy to report that we found time after the conference yesterday to go out for a very splendid dinner. Sitting by the harbour in Nice eating soupe de poissons and seafood paella was a great way to unwind after a hard day at the conference.

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