Spotlight on: Clinical Trials

The Biologist Vol 61(3) p30-32

Why is it important?

Failure to fully investigate the safety of promising drugs has had devastating consequences throughout history. Most memorably thalidomide was once widely prescribed to alleviate morning sickness in pregnant women, but caused abnormal limb formation in thousands of their children. Clinical trials can take years to report and cost many millions of pounds, but ultimately they give us confidence that the medicines we take will improve our health, safely.

What careers are available?

Clinical trials are usually conducted by government health agencies or pharmaceutical, biotechnology or medical device companies, but also by independent research organisations, hospitals or academic research units. A multitude of public bodies – such as the Medicines and Healthcare Products Regulatory Agency and the National Institute for Health and Care Excellence (NICE) in the UK – regulate clinical trials and the use of approved drugs.

Careers are available at all stages of the drug approval process, from lab-based research roles in small, early phase pilot studies, to the design of huge trials involving real patients in institutions spread across many countries. Trial managers are required to organise these complex trials (see opposite) while teams of statisticians analyse and interpret trial data. Other opportunities around the world are dependent on how healthcare is administered. In the UK, for example, NICE helps interpret data from a range of sources, including clinical trials, to advise the NHS on what therapies are most cost-effective.

Where can I get more information?

■ The Medical Research Council’s website has a section on careers and training in research roles and information on studentships, fellowships and funding. 
■ The UK Clinical Research Collaboration’s Clinical Trials Network provides information for researchers and funders.
■ The UK clinical trials gateway provides information on all trials running in the UK as well as useful links to organisations that run trials. 
■ Clinicaltrials.gov currently holds information on 164,703 studies in 185 countries around the world.

What does a typical day involve?

In our unit we design, develop and analyse clinical trials for cancer treatments. When clinicians have a concept for a trial, we advise on the statistical design and develop the complex logistics for its delivery. We then oversee the conduct of the trial, collect data from the participating hospitals and analyse the results.

I work with lab scientists, clinicians and statisticians – locally and nationally – as well as funders and regulators. There’s lots of liaising to make sure that the trials are of the highest scientific quality and safety standards. I also work with various lobby groups to ensure EU legislation on clinical trials is not overly bureaucratic and does not delay novel treatments unnecessarily. Much of the trial management role is logistics: how do we get samples from 100 hospitals to one centre for analysis? A trial concept may be scientifically very interesting but logistically challenging to fit within the typical care pathways in the NHS.

How did you come to work in clinical trials?

I did a degree in zoology, then a master’s in ecology, and didn’t really know what to do. I took a research assistant’s job at The University of Manchester, which is when I first worked on clinical trials. I then worked on clinical trials in industry and moved back to academia, working for Imperial College London before coming to the Institute.

People are aware of drug research in the pharmaceutical industry, but don’t know there is an equivalent  academic career path available. A lot of scientists get to a certain point and think they don’t want to spend the rest of their life working in a lab. Clinical trials allow you to stay in  biomedical research, but much of it is office-based, with visits to hospitals, labs and research facilities in the UK and abroad. We are looking to promote clinical trials in university settings as a career option.

Is it a rewarding job?

Working on a huge experiment for the benefit of cancer patients is rewarding. Clinical trials can take a long time to report, not all are successful and it can be very bureaucratic – but you can see them making a difference.

Has there been a trial you’ve worked on that had a positive outcome?

Yes, patients with hormone sensitive breast cancer were typically treated with tamoxifen to stop it coming back. It is an effective drug, but doesn’t work for everyone. We trialled treatment that involved switching to aromatase inhibitors, after two to three years of treatment. It improved disease free survival and went on to influence how breast cancer in postmenopausal women is treated.

As drug screening technology improves, will the nature of the trials change?

Pre-clinical trials may change greatly, but you will always need to put treatments into a patient population.