What are clinical trials?

Around the world doctors and scientists are involved in research aimed at the holy grail of a universal cure for pancreatic cancer. The development of a new treatment starts within a laboratory, with experiments studying how cancer cells can be damaged by new drugs. Should these initial studies show promise, after further laboratory studies, the drug may be taken forward into a trial context.

Phase I studies: The first duty of a doctor is to “do no harm” and consequently the initial phase of clinical drug development is an assessment of how well patients may tolerate the drug. Whilst extensive pre-clinical testing will have been carried out, it is not until the drug is first tried in humans that accurate information on what side effects may occur at various dose levels can be obtained. This is what a phase I study is – usually small groups of 3-4 patients given a dose and if that is well tolerated, a higher dose is given to the next group etc. There is usually no assessment of how effective the drug is in damaging the tumour.

Phase II studies: Having established the optimum dose (Phase I), the next stage is an assessment of the potential a drug has to arrest the progression of a cancer. This usually involves the study drug or treatment being given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

Phase III studies: Having shown some potential tumour activity and a good safety profile in Phase II, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, and importantly to compare it to the current gold standard treatment.

Although clinical trials may pose some risks, researchers take very careful steps to protect their patients.

We would encourage participation if approached to take part as it is through these trials that progress in treating pancreatic cancer will be forthcoming.

Current UK clinical trials can be found on the Cancer Help database or on the UK Clinical Research Network (UKCRN) study portfolio pages.

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