Don’t let this happen to your company

I want to apologize for slamming your posts. But — it is disturbing to see misinformation like this used to sell eClinical products and services. Let’s start with your statement “ I have no personal knowledge of this drug trial.” That being the case — you probably shouldn’t conjecture that the price drop had anything at all to do with bad or missing data — as you seem to want to imply.

I was curious about what caused this price gap and it appears that, contrary to what you imply, the FDA refused to file because the submission “ wasn’t complete enough to permit a substantive review of the drug by the regulator.”

There are many reasons other than those you imply why PTC could have gotten the refuse-to-file. Based on the close FDA scrutiny of the competitive drugs it appears the FDA is not inclined to approve any of the class.

I honestly don’t think you need to push the idea that direct data capture could save time. Intellectually and pragmatically we know that and have accepted that. But in the real world — our clients (the sponsors) live in dread of what happened to PTC happening to them with no way of recovering possible additional data that could be used to support a more robust submission. So they still use paper and EDC and they still collect “supporting” not for analysis data elements — “just in case”.

Finally, your recommendation that “ Once in the database, run real-time analytics and find out how the trial is going” seems naive. I am not a statistician but I don’t think you can do this in a blinded trial. In fact, any interim analysis, let alone a continuous analysis, has the potential to “burn the alpha” and bias the study and must be included in the calculation of p-values and sample size prior to study start.

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