Developing a drug can take more than two decades. Health Correspondent Alison Dayani investigates part of the process carried out at a clinical research centre in Birmingham.

Medical research has never been so advanced and being able to pop a pill to relieve most ailments is something most of us take for granted.

But each and every tablet or injection is the result of decades of scientific sweat and tears – and the strictest of regulations.

The unassuming office where Synexus clinical trials company is based at the Midlands Clinical Research Centre, off Vincent Drive in Edgbaston, belies the vital work being played out with human guinea pigs behind its doors.

With four stages to every human drug trial, Synexus handles the late stages, when drugs are on the threshold of being placed into the market.

Synexus site director Mike Chevins said: “The first phase is to test if a drug is safe to use on fit and healthy subjects, often students being paid who are looked after in intensive care conditions,” said Mr Chevins.

“They are given a weak part of the dose and the point is to see if the drug is safe, rather than if it will do what it says on the tin. There are only a few very specialised phase one units.

“Stage two is looking at safety and effectiveness by giving a mild dose to around 30 patients.

“Stage three is when we often get involved, when hundreds of patients get a stronger dose in the hope of making their condition better.

“Then stage four is when large numbers of patients trial a drug. By this point, the safety elements are dealt with and we are focusing on effectiveness. We are seeing if the drug will do what it claims before doctors prescribe it.

“From when someone comes up with the concept of a drug to getting it in a pharmacy can be 20 years.

By the time it reaches us, it is 15 years down the line.

“There are ten to 20,000 ideas for drugs, but only a handful ever get as far as us.”

At any given time, Synexus is carrying out around 20 different trials for most of the main pharmaceutical companies for everything from pioneering treatments for asthma and prostate cancer to flu jabs, insomnia and Alzheimer’s disease.

Synexus has even started working with Heartlands Hospital on an insomnia study that looks at people’s sleeping patterns.

“Most drugs we trial get as far as going on to the market,” explained father-of-four Mr Chevins.

“Some studies last 12 weeks, others are up to five years, but they are all ‘double blinded’.”

Double-blinded studies involve administering drugs and placebos where neither the patient or trial doctors know which is which, so as not to bias the results.

Boxes of drugs arrive from a pharmaceutical company with only a code.

“We don’t even know if the packet we are giving a patient is a placebo or the drug,” the site director says.

“A number is allocated for each participant and it is just a box. It can be frustrating because we go through a four-year study and at end of it, won’t know whether the drug has worked or not.

“It is only once all the data from different test sites has been analysed that the pharmaceutical company ‘unblinds’ us and tells us which drug or placebo a patient was on and we can then tell the patient.”

That can be a hard secret for doctors at the unit to keep, especially when during a trial they start to detect improvements.

One recent trial for an osteoporosis medication involved closely monitoring patients’ bone density, but doctors were not allowed to tell the patient if they were spotting any changes.

The only time they can “code break” is in a medical emergency if a volunteer is suddenly taken ill and hospital doctors need to know what drugs they are taking.

Every participant carries a card that medics can activate to break the system to reveal exactly what they are taking, but voids them from the trial in the process.

Despite the uncertainties involved with being among the first people to test a new drug, Synexus has no shortage of volunteers. In 2010 alone, more than 35,000 people showed an interest in taking part in the company’s trials worldwide.

Many are referred by their GPs within a 50-mile radius for specific trials relating to their illness while others respond to adverts, even though they are not paid to take part.

“You may wonder why patients want to try a drug in the testing phase, but a lot of people are desperate for something to help them,” said Mr Chevins.

“It might be they get terrible migraines every month and have tried every product on the market and they are not helping, or someone who has suffered with insomnia for 20 years.