Last week a former Aptuit employee was found guilty of tampering with preclinical data used to support clinical trial applications in a case prompted by the discovery of irregularities in study results dating back to 2001.
The Medicines and Healthcare products Regulatory Agency (MHRA) told Outsourcing-pharma.com the fraud had involved changing the results of various analytical methods – including calibration curves – modifying injection times and manipulating chromatograms. It added that while the precise scale of the deception is hard to estimate its repercussions were wide-ranging.
“It is not possible to say exactly how many but his actions led to the review of many hundreds of safety studies in order to assess the impact that the manipulation of the results had on the interpretation of the data.”
One positive to emerge from the investigation is that unlike other high profile cases of data manipulation that required research to be repeated – notably the debacle involving Cetero – trials do not need to be re-done.
The MHRA told us that investigators “carried out a full assessment which concluded that the data integrity issues did not invalidate the outcomes of subsequent clinical trials.”
Regulations sufficient
The MHRA rejected the suggestion that a regulatory clampdown is needed to prevent similar fraud, explaining that: “The current regulations are sufficient. This is a very rare incident. Many thousands of studies are conducted in the UK every year with no problems.”
The UK regulatory agency also advised that pharmaceutical companies and contract services firms should ensure that robust procedures are in place to ensure employees follow good laboratory practices (GLP) rules.
In a press statement, Aptuit said it had promptly notified the MHRA after detecting the irregularities in studies conducted at its site in Riccarton, Scotland and reiterated the agency’s conclusion that the fraud was “the independent actions of individual employees.”
The firm also said that – although the Riccarton site was subsequently closed for unrelated business reasons – it had implemented a corrective action/preventative action programme to address and correct the situation.
“All impacted customers were engaged in the process to ensure minimal impact to their ongoing projects. The CAPA program included the development and institution of new or updated SOPs and quality programs, as well as additional training for all staff.”