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JUST around the corner from Euston Square tube station in London is an organisation called the CTU. While those initials would make most people think of Jack Bauer fighting bloodthirsty terrorists, what reality delivers here is the Medical Research Council鈥檚 Clinical Trials Unit, the venue for a very unusual clinical trial which began this year. 鈥淚t鈥檚 unlikely that anybody else in the world would be able to do this,鈥� says Richard Stephens, the project leader.

He is referring to QUARTZ (Quality of Life After Radiotherapy and Steroids), a study of people with cancer that has spread from the lung to the brain. Normally, such patients are offered supportive care and radiotherapy. However, two small-scale studies have raised doubts as to whether radiotherapy actually does any good: the unpleasant side effects may outweigh any increase in life expectancy.

Clinical trials are usually conducted by pharmaceutical companies or contract research organisations (CROs) on their behalf. As an independent organisation, the CTU is in a position to mount studies such as QUARTZ, in which patients are selected to receive supportive care alone. In other words, the CTU can test the impact of removing a treatment 鈥� something that a pharmaceutical company would rarely, if ever, investigate.

鈥淗istorically, people have been assuming that we鈥檙e doing the right thing by giving whole-brain radiotherapy,鈥� says Paula Mulvenna, chief investigator for QUARTZ and consultant clinical oncologist at the Northern Centre for Cancer Treatment in Newcastle upon Tyne. 鈥淲e have to be brave, step back and ask whether we鈥檝e got it right.鈥�

鈥淎n idea like QUARTZ probably started out on the back of an envelope,鈥� says Stephens. Whereas organisations like Cancer Research pick and choose from proposals for trials submitted by external researchers, Stephens says that at the CTU staff have the freedom to suggest ideas from within the organisation, or from round-table discussions with clinicians. 鈥淭hose first couple of meetings where sparks intersect and you go away with a possible design [for a trial] are really exciting. It鈥檚 the best part of the job,鈥� says Matt Sydes, a project leader at the CTU.

Starting the puzzle

Getting a clinical trial up and running is often a slow process. 鈥淚t can take more than two years to go from an idea to opening the study,鈥� says Sydes. This is because careful planning is essential, particularly since the TeGenero debacle two years ago, in which six healthy young men were left fighting for their lives after volunteering for a clinical trial of TGN1412, a drug targeted at leukaemia and chronic inflammatory conditions. Since then, safety regulations have been tightened and the industry has learned some tough lessons. Although the CTU does not conduct 鈥渇irst in human鈥� trials like that involving TGN1412, the incident has helped to improve the public鈥檚 awareness of their clinical trials, says Stephens.

As project leader, Stephens took charge of planning QUARTZ, working with the trial manager and the various teams of clinical researchers involved in the trial. Once approved by scientific and ethical regulators, a trial generally settles into a routine, he says. The project leader, who may have up to a dozen trials to deal with at one time, then takes more of a back seat, and the day-to-day management falls to the trial manager.

Trial managers deal with regulatory authorities and help to secure funding for the trial. They also become the first point of contact for the clinicians treating the volunteers, and ensure that the various sites involved in the trial work to the same protocol. The job requires a degree in science but not necessarily a postgraduate qualification, says Cheryl Pugh, QUARTZ鈥檚 trial manager. 鈥淐ommunication skills are also very important as there鈥檚 a lot of liaison work,鈥� she adds.

As well as designing a good experiment, QUARTZ鈥檚 research team must work out how to store and analyse the resulting data. This task falls to the data manager and data programmer. The data manager鈥檚 main responsibility is to make sure that information is collected and processed quickly and consistently throughout the trial. Data managers get involved from the very beginning, helping to draft data entry forms and ensuring that the data will be usable. Once the results come in, they spend a lot of time fielding queries from medical staff on processing the data and sorting out mistakes. 鈥淚t鈥檚 more of a skill set than a qualification,鈥� says Nancy Tappenden, QUARTZ鈥檚 data manager, 鈥渂ut it helps to have a background in science to deal with the clinicians鈥� questions.鈥�

Meanwhile, data programmers create a database for the trial. This has to be in place before the trial opens and may need fine-tuning once it is up and running. Either a computing degree or equivalent work experience is required to become a data programmer, and at the CTU you have to be flexible because you give input throughout the whole trial, says Mary Rauchenberger, a senior data programmer at the CTU. 鈥淚f all you want to do is code, this [role] isn鈥檛 necessarily for you.鈥� The job has its rewards too, of course: being involved with different stages of the trial gives you 鈥渁 real feel-good factor鈥�, according to Nadine Van-Looy, the data programmer for QUARTZ.

As patients are recruited and the trial gets under way, results begin to arrive and statisticians are brought into the team. Throughout the trial, they produce reports for its independent data monitoring committee, who regularly inspect results to ensure that the study is not posing any undue risk to the volunteers. 鈥淎n MSc in statistics is essential for this area of clinical research,鈥� says Matt Nankivell, QUARTZ鈥檚 statistician. He previously worked for a CRO, but prefers the variety that his current work at the CTU offers. His colleague Rachel Morgan agrees: 鈥淵ou get a sense of the big picture 鈥� that鈥檚 really encouraged at the CTU.鈥�

Although most clinical researchers have a background in science, it is possible to enter the profession with other expertise. Cheryl Courtney, whose background is in business studies, joined the CTU in an administrative capacity as a trial assistant, the most junior position among trial staff and a common entry point. However, she says it is getting harder to progress from that role unless you have scientific training, and to move on you must prove yourself. 鈥淵ou have to take on as much as you can,鈥� advises Courtney, who was recently promoted to data manager. 鈥淭o move up the ladder, you have to make people aware that you鈥檙e willing.鈥�

鈥淲orking in trials is like doing a massive jigsaw, where you鈥檝e been given a huge pile of pieces and someone鈥檚 stolen the box,鈥� says Sydes. 鈥淓ventually you鈥檒l find bits and pieces that fit together and occasionally you鈥檒l see clumps, but you have to be here five, maybe 10 years to see the whole picture.鈥� The best part of the job is finishing that jigsaw or even just putting two pieces together, says Stephens. 鈥淚f you get satisfaction out of problem-solving, this is a job you can really enjoy.鈥�

聯It鈥檚 like doing a massive jigsaw where someone has stolen the box聰

When QUARTZ draws to a close, the project leader will return to a much more hands-on role, writing papers and presenting the findings at conferences. For now, the first few patients are being recruited and the team are looking forward to the preliminary results. 鈥淚f we get it right then we鈥檙e actually going to help a lot of people,鈥� says Stephens. 鈥淚n the end, that鈥檚 really what drives us.鈥�

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