Before a clinical study can begin, an application must be made to address trial protocol, safety and reliability of the proposed study. The MHRA (Medicines and Healthcare products Regulation Agency) must then issue authorisation for the study and it must be approved by the Ethics Committee.
The new amendments aim to simplify and streamline the approval for medical trials whilst maintaining robust oversight of the safety of participants. Amongst the new changes, pilot regulatory and ethics reviews will be introduced, greatly reducing the time it takes to get approval for a study.
The MHRA also aims to introduce a timeline for completion of the application process of 30 days from the point the application is acknowledged to the point of approval. Furthermore, a 10 day maximum time limit will be introduced for the time taken to grant a decision once the regulator has all the information required.
The overhaul is also hoped to increase general transparency of the clinical trial process as a whole, with a new legal requirement to register any medical trial in the World Health Organisation public register. In addition, the results of clinical studies must be published within 12 months of completion. With a focus on participant involvement, there will also be a legislative obligation to share clinical findings with participants within an appropriate and prompt timeframe.
The aim is to move away from a 'one size fits all' approach and introduce measures which incorporate proportionality. Flexibility will be integrated in terms of regulatory requirements for different kinds of trials. For example, a 'notification scheme' will allow low-risk trials to be approved without the need for regulatory review (however approval from the Ethics Committee will still be required).
The consent process will also be simplified for low risk trials, establishing a clear informed consent process. There were mixed responses during consultation regarding the proposed change to the consent process, with concern expressed as flexible consent provisions may mean participants are unaware of what exactly is being investigated. It was concluded that flexible consent approaches will be available where the trial is classed as low risk, whilst also providing assurance on safety.
The current requirement to include information regarding all serious adverse events and reactions in annual safety reports will be removed and instead replaced with an appropriate discussion of risks involved.
Chief Science and Innovation Officer at MHRA, Marc Bailey, stated, "This will make the UK one of the best countries in the world to conduct clinical research and, get innovative medicines to the people who need them faster. We will now work collaboratively with patients and the research community to ensure these changes are implemented as quickly as possible.”
HRA’s Chief Executive, Matt Westmore, added, "The consultation responses show we are all committed to enabling the highest quality health research which can benefit the whole UK population, and that we are all working towards making it easy to do research that people can trust".
The consultation involved responses from members of the public, patients, carers, researchers and health care professionals. A strong opinion emerged that safety of participants should remain at the heart of the new proposed amendments. In a bid to address safety concerns, MHRA emphasised the requirement for both regulators and researchers to be continuously aware of potential risks posed. However, it is important to consider that full informed consent remains a critical factor in medical trials.
Fundamentally, the new measures are intended to signal a move towards a more flexible, proportionate and transparent approach to clinical studies, encouraging development of innovative medicine.
The Government response to the consultation can be found here. Guidance will also be issued to accompany the legislation.
Written by Olivia McGuigan, Trainee Solicitor (Insurance, Belfast)