Managing risk in clinical outsourcing

By Kirsty Barnes

- Last updated on GMT

Related tags: Clinical trial, Pharmacology

Sponsors need to ensure they are managing the risk involved in
clinical outsourcing, particularly when dealing with multiple

This was a warning contained in Ernst & Young's global 'Pharma Report - Progressions 2007', released today. Leading contract research organisations (CROs) managed nearly 23,000 Phase I-IV studies from 152,000 clinical sites worldwide in 2004, the most recent year for which data are available, according to the Tufts Center for the Study of Drug Development. This reliance on CROs has only increased since then, both in clinical and pipeline drug development, and manufacturers need to make sure they remain vigilant and involved in any outsourced R&D because ultimately, the responsibility for the ongoing safety evaluation of the investigational products and for reporting any information that could adversely affect the safety of trial subjects, lies on the sponsor's shoulders, stated the report, citing section 5.2 of the International Conference on Harmonisation's (ICH) Guideline for Good Clinical Practice​. "Monitoring CRO performance and compliance is crucial to mitigating the potential risks that manufacturers face in any third-party collaboration, from R&D to manufacturing, distribution, and advertising. For CROs, this includes reviewing patient records and medical charts",​ said the authors of a chapter of the Ernst & Young report titled 'contract research: criteria to live by'. The more complex the outsourced task, the greater the risk and this potential for risk may also increase when clinical protocols are developed by several physician-investigators and involve multiple investigational sites and other third parties. As a general rule, "as more people and systems are involved, additional prudence may be needed",​ the report indicated. To try and put the extent of these clinical outsourcing relationships into perspective, the report contained a graph giving a snapshot of the ten big pharmaceutical companies who are engaging in this activity the most, using data gathered from searching a Centerwatch database, based on the number of "research centres" claiming a previous client relationship with the pharma firms. Pfizer was associated with the most relationships, with 340, while Novartis and Merck followed closely behind with 318 and 317 respectively. Trailing the top ten list were Sanofi-Aventis on 119 and Amgen on 115. "This data is meant to be indicative of the scale that outsourcing is now being done by pharmaceutical companies and raises the question of how the firms that are or have been involved with so many third party companies are making sure they are managing the risk that comes with having so many of these relationships,"​ Andrew Jones, Pharmaceutical analyst from Ernst & Young told Meanwhile, the authors also pointed out that in addition to monitoring ongoing third party activities, sponsors also need to establish a "strong foundation for CRO compliance and integrity",​ citing again, the ICH guideline, which states that any trial-related duty that is transferred from sponsor to CRO should be specified in writing. The importance of this is highlighted by the high-profile Phase I drug trial disaster last year in which six volunteer subjects ended up in intensive care, where Parexel was hired to conduct the trial by German developer of the drug TeGenero. Although clearing Parexel from contributing to the drug trial disaster, a final UK Medicines and Healthcare products Regulatory Agency (MHRA) report slammed the US firm for failing to follow correct procedures and for making errors over contracts and patient records. According to the report, Parexel did not adhere to documentation procedures during the trial. "Parexel failed to complete the full medical background of a trial subject in writing - one principal investigator did not update the medical history file in writing following a verbal consultation with one of the volunteers,"​ said the report. Alarmingly, there was also no contract in existence for the bank-screening physician at the time they were employed (although one was subsequently issued). Parexel's principal investigator failed to authorise in their log the full work remit for the bank-screening physician at the start of their employment, the investigation found. "Having interviewed the bank-screening physician as part of their inspection we were also not satisfied that the individual had adequate training and experience for their role,"​ said the MHRA Inspectors. At the time of the drama, the MHRA also found that Parexel was non-compliant with the unblinding procedure, meaning that the placebo volunteers were allowed to leave the trial before appropriate checks were taken to confirm that they were the two subjects that had received the placebo. Surprisingly, prior to beginning the trial there was also no contract in place between TeGenero and Parexel, although again, one was subsequently issued, and there was only a draft contract in existence between Parexel and the private laboratory they had engaged. In addition, Parexel had failed to review TeGenero's insurance policy to ensure that one was in place and that there were no exclusion categories within it that might impact upon their volunteers. There was also no formal system in place to provide 24-hour medical cover, the report stated. Parexel was required to provide a response to the MHRA with evidence of appropriate corrective action.

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