Clinical trials are a way for doctors and scientists to work out if new tests and treatments are safe, and if they’re better than what’s already available.
Trials couldn’t happen without patients selflessly volunteering to take part. That’s why today, on International Clinical Trials Day 2017, we’re celebrating the heroes who take part in clinical trials.
But patients aren’t the only heroes involved in clinical trials. Behind the scenes, there’s a team of people working tirelessly to make trials happen.
To find out more, we spoke to 4 people involved in different aspects of our National Lung Matrix Trial.
And over the next 4 days, we’ll feature their stories to learn more about what they do and how clinical trials couldn’t happen without them.
First up, Professor Cindy Billingham, Director of Statistics at the Cancer Research UK Clinical Trials Unit at the University of Birmingham and lead statistician on the National Lung Matrix trial.
Turning ideas into clinical trials
I’ve been a medical statistician for almost 30 years. After studying maths at university I did a Master’s degree in applied statistics and then a PhD in medical statistics.
While I was working in my first job at a health authority I saw a job advertised at the Cancer Research UK Clinical Trials Unit at Birmingham. I applied straight away and was thrilled when I got the job and have been here ever since. I feel so fortunate to be working here and feel particularly privileged to work on the National Lung Matrix trial.
As a medical statistician, I take the ideas that doctors come up with and mould them into research questions that we can answer through clinical trials. We nail down the specifics of what is often quite a general idea and turn it into something more concrete.
For example, a doctor might come to me and say: ‘I think combining drug X and drug Y will be better for patients.’ It’s my job to figure out what ‘better’ means – for example, does it mean fewer side effects, or extending survival and if so for how long? And what’s it better than?
Once we know what question(s) we’re trying to answer, we can design the trial to answer it.
The statistics involved in setting up a clinical trial depend on the phase. Phase I clinical trials, which are used to find the safest dose of a treatment, require very specific types of statistical methods so people usually specialise in this area. I’m more involved in designing phase II and phase III trials.
One of the main roles a statistician plays in designing a trial is determining the number of patients who need to take part. We also identify the population of patients needed – what type and stage of cancer should patients have, what age should they be, have they had treatment before, that sort of thing.
The type of patient needs to be carefully selected because the results of any trial can only be applied to the population of patients that were involved. So if we do a trial involving 40-70 year olds with bowel cancer for example, the results of this trial won’t apply to people with any other type of cancer or people outside of this age range.
There are so many good points to the job that they just out-weigh any of the negatives.
– Professor Cindy Bellingham
And we determine things like how many different parts – or treatment arms – a trial should have, how treatments will be assigned to patients and how many times patients need to have scans or biopsies in order to assess how they’re doing.
Another key part of my job is analysing the trial data to see what the results are. As lead statistician, I’m in the privileged position of being able to look at the data from the trial as it’s generated – no one else, not even the doctor running the trial, gets to see it at that stage.
When the trial is finished, we analyse all the data and help the doctors write up the results, which then get published as a paper in an academic journal. And hopefully, they help change how patients are treated for the better.
So you see, statisticians play an important role in clinical trials, and it’s fair to say that if we weren’t involved, while trials could still happen, they may be done in a way that wouldn’t produce useful results.
More good than bad
There are tough parts to the job, mainly managing my time and all the different people who need my help and input.
But there are so many good points to the job that they just out-weigh any of the negatives. Every single day I learn something new and I’m involved in the way cancer clinical trials are changing and evolving. I play a role in something that could change clinical practice and help more patients survive cancer now and in the future.
It really is a privilege and an honour to be able to do what I do – and work with amazing people in such a brilliant place.
Interview conducted by Áine McCarthy