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Clinical Trials are being offered to patients to provide high quality care locally here in Yeovil and enable patients to have access to new and novel treatments and drug therapies.
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One of the first clinical trials was in 1875 when James Lind planned a comparative trial of the most promising treatments for scurvy. This was a six arm study performed on 12 patients.
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Clinical trials involving patients only begin after preliminary studies in the laboratory and with animals showing promising results. This costs millions of £s and can take 7 to 10 years to develop. Only 1 in 10,000 compounds succeed.
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There are three phases of trials. Phase I trials are the first studies performed in man, usually normal healthy volunteers, usually male (due to female pregnancy etc) aged 18 to 45. They are performed in specialised units and focus on looking for side effects, dose finding and route (i.e. oral or intravenous).
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Phase II trials are the first studies in patients performed in small numbers and focus on looking for safety and efficacy of the drug and the minimum effective dose.
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Phase III trials (done at Yeovil) are the large studies which are performed internationally in multiple centres. They focus on safety and efficacy, evaluation of treatment, and are compared with a placebo or gold standard alternative treatment.
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A lot of trials focus on the use of Monoclonal Antibodies (mAbs). Examples of these are Bevacizumab, Pertizamab, Panitumumab and Cetuximab. These all need careful monitoring, are very expensive and are currently data promising.
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An example of a colorectal trial is the MRC Classic Trial. This was for patients who had a diagnosis of colorectal cancer and were randomised to either open or laparoscopic resection. They then had a 5 year follow up (focusing on Quality of Life and Health Evaluation data).
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Another trial was EnROL. This looked at conventional (open) surgery versus laparoscopic (keyhole) surgery within an enhanced recovery programme for colorectal cancer. This was a 10 year research programme and looked at the key features of enhanced recovery – pre-
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Another trial of interest QUASAR II is a mobile phone project with an aim to develop a reliable and fully tested system to assist patients with the management of symptoms associated with chemotherapy for colon cancer. Yeovil is one of four centres in the UK to pilot this project. The patient response is positive. Patients are randomised to use either a paper diary or a mobile phone. The mobile phone is specially designed to input temperature, nausea and vomiting. This is then sent to a clinician via an Internet server and they are alerted accordingly with any problems.
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