Australian company, Hyperion, was recently forced to halt development of its type 1 diabetes drug following serious breach of Good Clinical Practice rules.
Development of DiaPep277 has been halted with “no viable regulatory path forward” after serious breaches of GCP rendered the trials unviable. DiaPep277 is a heat shock protein peptide intended to prevent the destruction of insulin-producing cells in patients with type 1 diabetes.
According to Hyperion, it discovered that employees of its recently purchased subsidiary, Andromeda Biotech, had allowed a separate biostatistics company to receive unblinded study data and manipulate trial analyses for at least two studies on the drug.
The alleged data manipulation to give a positive result underlines just how essential it is that trials are conducted properly. Whitehall Training’s ICH GCP course highlights the importance of blinding…
“Most trials compare two or more treatments or interventions. To prevent bias, comparative trials usually use randomisation, a scientifically approved method of allocating subjects to a particular treatment. The most common forms of randomisation are blinded. In this way, the investigator is unaware, at the time she selects the subject for the trial, what treatment the subject will receive.
Those trials of the highest scientific quality maintain the blind throughout the lifetime of the trial. This means either the subject (single blind) or both the subject AND the investigator (double blind) do not know what treatment the subject is on. By these means bias is avoided. The randomisation method will be in the protocol and the investigator should be familiar with it and ensure that it is adhered to. [ICH guidelines, section 4.7]”
The course also makes it clear that a key role of the sponsor is to ensure that blinding is preserved to ensure that commercial interests cannot distort the trial findings.
Ending the development programme will cost the firm a one-off charge of between $25 million to $55 million – not to mention potential lost revenues had the drug been successfully launched. They are also being charged Euro 8.7 million in compensation by German biotech firm, Evotec, for ending the programme.
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