Accountability for CROs is weak

Further Reading

Few companies report having robust measures to ensure clinical trials conducted by contractors are safe and ethical, with the majority providing no evidence of exerting real influence over the way their contractors conduct trials.

Only four companies provide evidence that they use disciplinary measures to enforce codes of conduct in relation to the Contract Research Organisations (CROs) they employ to conduct clinical trials on their behalf in developing countries. Without adequate due diligence in selecting contractors, monitoring of their conduct, or enforced disciplinary action, patients are left vulnerable to clinical malpractice with little recourse to justice. While many companies have codes of conduct consistent with the basic minimum standard of the Helsinki Declaration, more than three quarters of them have not provided evidence of enforcement. Furthermore, in general, companies do not provide information about the CROs they hire, making it impossible for interested parties to monitor their behaviours. Current industry performance in the area of accountability for CRO behaviour is far from meeting Index expectations for clinical trial participant well-being in developing countries.

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