Bioequivalence and Bioavailability Forum

I think addressing this topic is not new for most of you, but what is new is the increasing frequency of discovery of many cases of fraud in the clinical trials & BE in the past few years, starting with GVK (copied ECG), Semler (Subjects samples substituted & diluted) and similarly used methods with Panecexell & Synchron (Samples switch & dilution), by the way, Anders Fuglsang will hold a presentation about the smart techniques he's developed (Buster routines ‘trends’)+ SaToWIB routines ‘Profile similarity’) to detect such type of manipulation on Jordan, on the 4th MENA Conference on the 19th and 20th of September, looking forward to learning more from this genius.

Here, I don’t want to discuss the reasons that led to this, as some of them are clearly known to us, including those related to regulatory bodies (strict Guidelines (GL) + lack of expertise on both sides), by the way, those series of frauds will make the GL more strict, (ICH 10 asked now for 100% chromatograms) which led to the elongated registration process and decrease the profit margin for pharmaceutical companies due to the high cost of those studies and some on the other hand related to the companies, and that brings me to a real story I have heard that the sponsor refused to pay the remaining amount to the CRO because the BE study was failed!!

As we all know, COI could cause biased trial results and create the risk of misconduct (Manipulation) and COI interest arise when clinical investigators have relationships with the company that manufactures the drug that is the subject of the investigation.

Obviously, This COI will of course definitely increase the cases of fraud in clinical trials especially when the CRO belongs to the pharmaceutical company.

Recently, we discussed the matter of accepting BE studies that are performed in CRO belonging to the pharmaceutical companies if this contradicts the principles of COI and therefore the files of these studies should not be received or accepted.

Unfortunately, there is nothing clear in any Guidelines that regulates (allowing or denying) this matter, therefore the opinions of colleagues are very important in setting the right direction.