UK Medicines and Healthcare products Regulatory Agency (MHRA) inspections are, for some, a constructive experience, but many others raised concerns. Unprofessional, intimidating behaviour and a lack of constructive responses are among the criticisms of some MHRA inspections.
These concerns were published in a Government commissioned Academy of Medical Sciences report into UK health research regulation and governance. Commercial and non-commercial respondents alike were critical of MHRA good clinical practice (GCP) inspections.
“Given the concerns around the clinical trial functions of MHRA, we gave serious consideration to transferring these functions to the Health Research Agency (HRA)”, says the report. Some felt moving GCP inspections to HRA was the only way change the culture and address the problems.
However, the report decided it would be unwise to disrupt UK policy interface with the European Commission (EC) at a critical stage in discussions about the European Clinical Trials Directive. Furthermore, respondents said the MHRA authorises clinical trials in a timely manner.
In a statement to Outsourcing-Pharma an MHRA spokesperson said: “The MHRA welcomes the early publication of this report which we will be keen to study in depth.
“We will also be working with Department of Health in drawing up a Government response to the report overall in due course.”
To remedy these concerns the report recommends the MHRA improves “the training of their GCP inspectors as a matter of urgency”. Also, the MHRA should ensure inspectors: are professional and objective; work constructively with sponsors; and are consistent across inspections.
In 2009 the MHRA began introducing a formal ‘risk-based’ inspection programme designed to maximise patient protection while cutting administrative burden. The report says the impact of the initiative is still unclear but ACRO has already expressed concerns about the programme.
“The application of the risk approach meant that most CROs would now be inspected every 18 months, rather than every 3 years, effectively doubling their costs in this regard”, said Douglas Peddicord, executive director of ACRO, in a statement to the Academy of Medical Sciences.
UK concerns & remedies
“UK approvals take longer, the investigator grant is higher, the data quality is poorer, and the yield of patients is lower than the mean and median values across the EU”, said Peddicord. These factors increase costs for sponsors and make the UK an unattractive location for trials.
The report makes three main recommendations. Firstly, the MHRA should, without delay, adopt a more proportional approach to clinical trial regulation. This entails implementing recommendations on risk stratification and developing GCP audit alternatives.
Also, the UK government, supported by the MHRA, should work with the EC to simplify adverse event reporting and reduce the scope of the Clinical Trials Directive. Finally, the MHRA should increase the quality, timeliness and consistency of its clinical trials advice.