Who Works on Trials

Most of the trials we run take place in the NHS. Healthcare professionals like doctors and nurses are responsible for conducting the trial where they work on a day-to-day basis. For example, they introduce the trial to patients and answer any questions or concerns that people may have. They follow the instructions described in the trial protocol, to make sure that everyone in the trial is treated in the same way and make sure people are safe.

Trial management staff are responsible for the logistics of running of the trial. They will identify which sites are suitable to take part and get all of the contracts and approvals in place for them to join the trial. They make sure that all of the correct approvals are in place, supply chains for drugs and devices are in place, and that all the trial staff understand the trial and have everything they need. They’re also responsible for getting in touch with the sites that patients are recruited from- this might be hospitals, care homes, GP surgeries or specialist centres. They may also develop letters and communications for patients too.

Data management (DM) staff are responsible for making sure the data that is collected for the trial is useful, accurate and secure. This includes data entry clerks, who enter the data onto our secure system, data management assistants, who check that the data is correct, and trial coordinators and data managers who design the databases and forms that are used.

DM staff work with the rest of the team to decide what data should be collected in order to answer the research questions. They then figure out the best ways to collect that data, and how it can be checked for accuracy. Once that’s been decided they design forms and databases to collect the data, and write instructions on how to use them. Researchers and participants then start to send data in using those forms, and DM staff check it to make sure it all makes sense and is answering the questions we’re interested in. At the end of the trial, DM staff will do a final check of the data, find any missing pieces of data, and work with the statisticians to make sure the data is ready to be analysed.

Statisticians are involved from the very start of a trial. They help to decide how many people are needed on the trial (called the sample size) and how the trial will answer its research question by deciding what information the trial should collect. At the end of the trial, they look at all the information collected on the trial and summarise it to find the answer to the research question (this is called data analysis). They also help to share the results of the trial by writing information for newsletters, journal articles and conferences.

Clinical trials require a lot of information, information systems staff make sure that this information is stored in a secure way which can be accessed and used by those who need it. For example, they work with trial teams to design databases which can be used by healthcare professionals to return data, which can then be used by the statistician in their analysis. Information system staff also help to develop public facing materials like websites in order to publicise ongoing trials and share trial results.

The Business Management team work closely with trial managers to make sure the trials run smoothly. For example, they help with budgets, contracts, admin support, insurance and publicity. They also play an important role in recruiting and supporting staff across the CTRU.

The Quality Assurance (QA) team work closely with all other staff members who work in a clinical trials unit. They make sure that staff members know about and follow the laws and guidance that exist to keep trial participants safe and trial results reliable. They also make sure all staff are well trained and have clear processes to follow.

“Monitoring” in clinical trials means all the work we do to ensure that patients who agree to take part in a trial are kept safe and that the trial results are reliable. Clinical trial monitors work with NHS hospitals to ensure that all the work they do on the trial is conducted to a high standard. They are a point of communication between research centres and the trial teams at the clinical trials unit. Clinical trial monitors can review any issues or concerns that might be impact the quality of the research quality. If they find any issues they aim to resolve them swiftly and efficiently.

Patients and members of the public are often part of our research teams. Their input is sometimes called Patient and Public Involvement (PPI). PPI means working with patients and the public to plan and carry out research. This helps us to ensure that we are researching topics which are relevant to patients, that the information that we provide is clear, and that we are doing our research in a respectful way.

“I’ve gone down lots of blind alleys with different treatments and at times it felt as though my condition wasn’t being treated seriously. That’s why I’ve been delighted to work on this trial proving patient input to the study. It’s a privilege to work with a team that take my condition seriously and want to use their expertise to develop better treatments” – Public contributor on the ATLANTIS study