The National Institute for Health and Clinical Excellence and the Medicines and Healthcare products Regulatory Agency have kicked off a pilot scheme under which pharmaceutical firms are offered joint scientific advice on trials.

Currently, both groups individually provide separate scientific advice to firms to help them better design clinical trial programmes for drug candidates, essentially to ensure that they will be able to provide the information needed for regulatory and cost-effectiveness approval.

More specifically, the MHRA advises companies on which tests are most appropriate to help cut back on costly delays and objections that could hold back a marketing authorisation application, while NICE offers product-specific scientific advice on products already in development, as well as guidance on producing evidence that is relevant to a cost appraisal.

In order to simplify this process, NICE and the MHRA are mulling over the possibility of providing voluntary parallel scientific advice in relation to clinical trial programmes, and as such have agreed to pilot a scheme under which companies will be able to attend a joint meeting with both organisations and then receive subsequent parallel scientific advice.

“Since only one meeting is required this may be more efficient for companies, [and] it will also enable them to compare and contrast the different Health Technology Assessment and regulatory perspective,” a spokeswoman for the MHRA spokeswoman explained to PharmaTimes UK News.

There is no set time limit on the pilot scheme, however, it will initially allow for the provision of scientific advice for approximately four to six applications, and after each application the MHRA and NICE will set aside "time for reflection to allow for modifications to the process as appropriate", she confirmed.