This article, in affiliation with the Christie Hospital in Manchester, explains the safety process for bringing new cancer drugs to patients..
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Introduction to clinical trials
Clinical trial treatments aim to discover if a drug is safe, has side effects, and works better than established treatments. They offer important opportunities for patients to access the most innovative treatments for cancer, giving them the best possible chance of survival or extended life, and they are an essential part of developing the cancer treatments of the future.
There are three phases of clinical trials, however the infrastructure needed for phase 1 trials is such that there are very few places in the world set-up to undertake these.
The Christie is recognised as one of the leading centres in the world for phase 1 clinical trials. The research undertaken here is underpinned by science and we work with the Paterson Institute for Cancer Research and Wolfson Medical Imaging Centre, which are part of The University of Manchester and both based on our site, as well as Cancer Research UK. The Paterson undertakes laboratory research and analysis and we work closely together on translational research, bridging laboratory research to cancer patients (for treatments) – drug discovery - before a trial is first undertaken with humans.
The Christie specialises in personalised targeted treatments where the choice of cancer treatment is based on the patients’ own genetic profile. Through using a combination of family history information, clinical data, gene testing, scanning and laboratory testing it is now possible to develop targeted personalised medicines for patients.
The top three centres in Europe undertaking this kind of experimental cancer research are regarded as NKI Cancer Institute in Amsterdam, the Royal Marsden and the Christie. At the Christie we will have about 200 drug trials on going at any one time, treating 2,400 patients a year. Our trials are funded by Cancer Research UK, biotechnology and pharmaceutical companies, health authorities and the Medical Research Council. It can take 5–10 years for a new treatment to make it through all the stages of development and to become widely available.
Phase 1
The first time drugs are tested in humans is called a phase 1 trial. It checks if a treatment is safe and identifies side effects. The average phase 1 trial has about 40 patients and patients are on trial for about two months. All patients on a phase 1 trial have exhausted all conventional treatment.
About one third of our clinical trial work in the new clinical trials unit will be phase 1.
Examples of world-first phase I trials undertaken at the Christie include:
- Stilboestrol for breast cancer in 1944
- Tamoxifen for breast cancer in 1969
- Iressa for lung cancer in 2002
The Christie undertook the world’s first trials with Tamoxifen and this drug has been given much of the credit for the sharp drop in breast cancer deaths. The drug is cheap, taken in pill form and blocks the female sex hormone oestrogen to help prevent the cancer coming back after the initial surgery to remove a tumour. Iressa is a targeted treatment for terminal lung cancer which carries a specific gene mutation. This form of the disease is very hard to treat, but accounts for 80% of lung cancers in Britain; about 30,000 cases a year. The Christie treated the first patients in the world in 1996 with this drug. Iressa subsequently received its European license in 2009.
Phase 2 and 3
Phase 2 trials involve larger numbers of patients and look at how well treatment works with different cancers.
Phase 3 trials involve even larger numbers of patients, involving many hospitals, and will compare the new drug will the current drug.
In recent years the percentage of phase 3 clinical trials carried out in the UK has dropped as companies have increasingly carried out trials in Asia and Eastern Europe where it is cheaper. The cost of doing trials in the UK is one of the highest in Europe.
Trials taking place in new clinical trials unit when it opens
Ten new phase I and phase 2 trials will start in the new clinical trials unit over the next few months. Christie cancer patients are currently being recruited for these trials. These 10 new trials will be for the follow cancers: gynaecology (eg: cervical, ovarian), breast, gastro-intestinal (eg: bowel, stomach), genito-urinary (eg: bladder, kidney), lymphoma, haematology (leukaemia & lymphoma), lung, sarcoma (soft tissue) and melanoma (skin) – as well as some studies that will involve a mix of cancer patients.
The new clinical trials unit will also be running around 40 phase I and 2 trials which started in the old Christie trials unit and will be transferred. In the chemotherapy section of the new patient treatment centre, patients will also be participating in around 30 national and international phase 3 trials.
Anyone seeking more information from the Christie on clinical trials can click here.
