;   Medical Translation Insight: Lessons learned from a clinical study gone bad - ForeignExchange Translations

Lessons learned from a clinical study gone badToday's news that J&J must pay $130 million to Basilea for botching a pair of clinical trials is a good reminder of the business risks involved in clinical translation work.

Five years ago, Johnson & Johnson and Basilea signed a licensing deal for an anti-MRSA antibiotic that Basilea had been developing. Together with ICON Clinical Research, J&J then attempted to run clinical trials. I say "attempted" because both ICON and J&J had their knuckles rapped by FDA in the form of separate warning letters (if you are interested, here is the J&J warning letter and here is the ICON warning letter).

The warning letters listed lots and lots of GCP issues. For instance, FDA said that J&J violated the protocols of its own study, by failing to ensure that patients were storing the drug properly when using it at home, not documenting some doses given to patients, not conducting thorough examinations of all patients, enrolling patients who should not have been eligible for the study, and hiring unqualified investigators.

So now that J&J has to pay Basilea, J&J is likely to want to pass the buck. ICON could be forced to compensate J&J. Others could be dragged into the fight as well.

It's easy to see how medical translation providers could get involved in these kinds of situations as well. FDA's warning letter to J&J specifically mentions translations a couple of times:

"Based on the source documents for Subject #140107, and translations of those documents that you provided..."
"This study monitor also recommended that this site not be used because the site declined use of Spanish Informed Consent Forms when demographics of the region indicated a large population with native and preferred language of Spanish."
Translations aren't at issue in this dispute but they certainly could be. At ForeignExchange, we maintain ample professional liability ("E&O") insurance but it would be an unhappy morning when a regulatory agency or global pharma company calls and says "We seem to have a little issue with one of your translations..."

(As an aside, to be properly prepared when FDA comes calling for a GCP audit, be sure to attend our audio conference Preparing for FDA GCP Inspections – Essentials for Sponsors and Clinical Sites.)

Find out more about ForeignExchange's specialized medical translation services for international clinical trials.

1 Comment:

  1. cgtradmed said...
    Not surprised at all. Some protocols are a real mess and a non-sense, and the way some studies are conducted is all but professional and rigourous. The often biased results are not worth mentioning.
    When I'm translating such protocols/study results, I find all this frightening and check even more carefully than usual my translation.

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