Increasing bureaucracy in clinical research in the UK is posing a threat to the industry, according to a report published in the British Medical Journal.
The report says that the regulatory process in the UK has caused it to slip from being one of the most attractive places to conduct clinical trials, to one of the least.
European legislation was introduced in 2001 that was intended to simplify the regulatory process and create a harmonised system across the European Union.
However this is criticised by the reports authors, Professors Morris Brown and Paul Stewart, who say the EU legislation is: "poorly coordinated, lacks consistency at all levels, and at times is completely illogical."
The report is critical of the fact it can take up to 40 hours to complete the paperwork needed for the regulatory process. In addition the review process is described as inconsistent and prone to delays, with ethical approval also said to be unclear.
Overseeing these processes is the Medicines and Healthcare Products Regulatory Agency (MHRA), which is branded as ineffective in the report. In particular the authors say that applications are too complex, cannot be submitted online and are sometimes lost by the MHRA.
The MHRA’s brief was extended to include the approval of clinical trials but the report says this has created an “extra tier of bureaucracy”, without bringing any discernible benefits.
Not only has it not improved the regulatory process but the report claims it has failed to improve patient safety, citing the TeGenero disaster at Northwick Park as evidence of this.
Trimming the fat
The report goes on to give recommendations on how the current system can be streamlined and simplified, to improve the process for patients and those conducting clinical trials.
By initiating a “bureaucracy busting” mission the National Institute of Health Research (NIHR) has already started the process. However, the authors make some further, specific recommendations.
These include removing the need to complete a different form for every funding and governance organisation by implementing a single and simple online application, covering all clinical trials.
A national ethical review process is also recommended to stop the “postcode lottery” that currently occurs, according to the report. They also believe that an automatic grading system should be implemented, with the intention of making patient safety “self-evident”.
The authors do not believe these initiatives should be put into action by MHRA, which they feel should focus on its initial remit of ensuring medicines are safe and effective.