Preparing for the trial
First of all, the team will apply for funding. The CTU will help the team put together a strong case for funding by bringing their knowledge of adhering to clinical trial and ethical regulations and recruitment experience.
If they are successful in securing funding, the CTU then helps the scientists and clinicians to set up their trial. The most important and time consuming element of this is developing a ‘protocol’ and other documentation for regulators. In the UK, the following regulatory bodies ensure each trial meets stringent ethical and safety regulations:
- Health Research Authority (HRA/Research Ethics Service) – the HRA assesses the governance and legal compliance of trials with the Research Ethics Committees checking each trial will be conducted in an ethical manner. For instance, they want to ensure patients aren’t going to be burdened by excessive tests, like too many blood samples or x-rays.
- MHRA (Medicines and Healthcare products Regulatory Agency) – this is a government body which checks that medicinal products, such as drugs and devices, are safe to use. For instance, they ask how much medicine you will give to patients, how will you monitor their safety, and how will you manage any negative reactions.
Alongside liaising with regulators, the CTU has to design a database to collect information about participants and how they are responding to the treatment throughout the trial. The database has to be ready for the start of the trial, so it is tested and peer reviewed by the trial team, clinicians and research nurses.
The CTU also carries out a Site Initiation Visit at each of their trial sites. This involves training all the healthcare professionals at the site on how to conduct the trial and how they assess patients and enter data into the database. Relatedly, the CTU also has to write a strategy on how they will manage and monitor sites throughout the trial.
‘Oversight Committees’ to independently check the CTU and the trial team are acting responsibly/doing things right (proves to funders and regulators that people are doing it right).
After all of this preparation (and much more besides!), the CTU has to get the ‘Green Light’ from their Sponsor. A sponsor is the organisation that takes on responsibility for the initiation, management and financing of the trial. Our Sponsor is NUTH: Newcastle-upon-Tyne Hospitals NHS Foundation Trust. Once CTU has ticked off all the things that need to be in place before the trial starts, the Sponsor then gives the green light to go ahead.