Thermo Fisher Scientific has pledged to correct a glitch in software used to analyze data from clinical drug trials within "four to eight weeks", after independent experts highlighted a potential for errors.
As Reuters reported exclusively last month, a problem with the U.S. company's Kinetica software package triggered concerns about the reliability of tests used to win approval for some drugs, particularly generic copies of original medicines.
Now Thermo Fisher has written a letter to Kinetica users confirming that its software would produce inaccurate results under certain circumstances.
"We are currently implementing a software update and will be performing rigorous testing to ensure that this issue is resolved," Sanjay Khunger, vice president and general manager of Thermo Fisher Scientific Informatics, wrote in the letter.
"We expect to complete the software update within four to eight weeks and will notify you as soon as it becomes available."
A copy of the letter, dated Oct. 29, was provided to Reuters.
The issue surrounding the reliability of Kinetica was first raised in a highly technical paper in the journal of the American Association of Pharmaceutical Scientists (AAPS).
The issue was also flagged to European regulators and was discussed at an expert meeting at the European Medicines Agency (EMA) on Oct. 21-22.
An EMA spokeswoman said its experts had concluded there was no need for "immediate regulatory action". She declined to give further details.
Kinetica is one of the most widely used statistical software packages for analyzing so-called bioequivalence in clinical trials.
Proving bioequivalence, which means two drugs with the same active ingredient are absorbed equally when taken into the body, is a prerequisite for winning approval for cheap, generic versions of medicines after patents on the originals expire.
Generics account for around 80 percent of such bioequivalence studies, although innovative pharmaceutical companies also use them for testing drug-drug interactions, food effects and formulation changes.
The problem could, in theory, mean that some drugs have been approved on incorrect data. Others may have been rejected or never submitted, even though they might have been good enough for use.
In practice, Thermo Fisher said the impact of the Kinetica glitch was likely to be limited in most cases.
"Although individual cases may differ, our preliminary assessment suggests that in most cases this error would result in only a small difference in the overall results," its letter to users said.
The problem arises when there are more clinical trial subjects in one sequence of treatment than another. Such imbalance is common as patients can drop out of clinical studies for various reasons.
A spokesman for Thermo Fisher declined to comment on the situation beyond the content of the letter to customers.
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