"It doesn't rest on me anymore" – Cindy Cooper's contribution to clinical trials

"After completing my PhD, I worked at Sheffield and West Yorkshire Health Authorities, where I supported research and audits. I wanted to be surrounded by people who could advise me, but instead, I was the only advisor and methodologist. So I applied for anything at ScHARR as soon as it was established, as I really wanted to work there."

Cooper joined the School of Health and Related Research (ScHARR) in 1996 to establish the North Trent Research Office, where she supported chief executives at local NHS organisations in developing a Sheffield-wide research strategy and increasing their research income.

"I enjoyed it, but I wanted to do research, not just work with chief executives at hospitals. So I started asking investigators at ScHARR if I could help them with their research grants."

Glenys Parry, a professor of mental health research and a clinical psychologist, supported Cooper, and they started writing and submitting grant applications together.

"We put in a grant application on the quality of life for gypsy travellers, and then a trial of Cognitive Behavioural Therapy in people with asthma."

I started working on a grant-to-grant basis as a study manager for Glenys. It was enjoyable but very insecure. In the first few years, I had about 16 contracts, and I couldn't see where the next grant was going to come from unless I wrote my own. So I did. With Glenys' help, I submitted a grant application for a pilot trial looking at online Cognitive Behavioural Therapy for depression."

They ended up not recruiting anyone to lead the Trials Unit, so I decided to apply.

Funding became available for setting up clinical trials units across England, and two professors, Mike Campbell and Jon Nicholl, wanted to establish one at ScHARR. Cooper promised to support them with the process. However, no one was recruited to lead the Unit, and Cooper decided to apply.

"And I got it! I had two reasons for applying: I wanted more job security, and I wanted to be an expert in a specific methodology. I felt like I was going from one type of study to another - from a survey to qualitative research to a trial. I liked the concreteness of trials. You get a definitive answer. So I decided it was what I wanted to do."

In addition to Glenys Parry, Cooper says she received a lot of support from other experienced investigators such as Steve Goodacre, Liddy Goyder, Mike Campbell, Steven Julious, and Stephen Walters, as well as experts in health economics.

It literally started with just me and a data manager, and we now have more than 70 people.

"At the same time that I started as the director of the CTRU in 2006, my grant application for a pilot trial of online Cognitive Behavioural Therapy for depression was successful, which was very helpful, as there was no funding to set up the Trials Unit apart from my role and a part-time data manager."

"As we won more grants, we could expand. Karen Beck, Tim Chater, and Dan Hind were among the first staff members who set up the CTRU with me, largely thanks to research funding. I used to think, "When we get the next member of staff, it will quieten down." This obviously didn't happen as everyone worked hard and brought in more projects. It literally started with just me and a data manager, and we now have more than 70 people."

Now, you could take me away, and it would all stand up. I don't feel it rests on me anymore, and that's what I wanted.

Cooper states that nowadays, in practice, it has become a requirement to utilise a clinical trials unit or another experienced unit to conduct clinical trials. Before, a large portion of funded trials failed to recruit participants because there wasn't experienced staff to run them. Establishing specialised units has secured the continuity of the staff and work.

"When I was running the asthma trial, I wasn't very experienced. I was trying to work out everything from scratch by myself. I thought it was ridiculous, as many people have run clinical trials! One of the first things I wanted to do at the CTRU was to establish standardised ways of doing things so that new staff could refer to the procedures. We need to share our experiences, not keep reinventing the wheel."

Cooper wanted to ensure that the Unit could fully function and that all relevant information would be shared when she was unavailable.

"The CTRU management group knows the issues across a wide range of specialisations, and if they don't know, they know who to ask. You could take me away, and it would all stand up. I don't feel it rests on me anymore, and that is what I wanted. One person can fall ill or can disappear overnight, and you need to be able to keep functioning."

"This model gets hopefully repeated down the line so that everyone can be both independent and well-supported by others. Staff work on their specific studies and within their specialised teams, so that they always have two channels to share knowledge and experience. When the study ends, rather than losing all that expertise, the people will be transferred to a new study, and they will bring their knowledge to the new team."

Cooper has enjoyed seeing staff progress within the Trials Unit, move elsewhere within academia, or utilise the CTRU as a stepping stone to move to other places where they can apply their project management skills gained in trials.

"I like that people can move around and find their niche. For example, one member of staff has progressed through the CTRU from being a clerical officer to a portfolio lead and senior research fellow, which has been brilliant to watch. And, a clinical investigator who was one of the first investigators through the door when the CTRU began with not much research experience, has now become a professor and has a large NIHR Programme Grant starting in September."

"Other clinical investigators I worked with on their early grants, now have large portfolios of trials and support more junior investigators across Sheffield. When you look at the scale and complexity of  trials and programmes today, it's hard to imagine how clinical trials could run without a trials unit and its specialised roles."

Alice Flanagan