Clinical trials are designed to test whether new drugs or treatment strategies are more effective than current treatments. They asses the side effects and impact of new treatments on patients day to day life as well as the beneficial effects on their symptoms. This often includes monitoring mental health in addition to physical health.
Clinical trials can also be designed to investigate ways of preventing cancer to reduce the number of people who develop it, by testing preventative measures. There are also clinical trials designed to look at new diagnostic techniques and tests. This can lead to new, more accurate, and less invasive diagnostic tools for clinicians to use, and improved screening programmes to detect cancer earlier.
Cancer patients across Yorkshire will soon have better access to pioneering treatments following the funding of a new Centre for Early Phase Clinical Trials by Yorkshire Cancer Research. The centre has been formed in partnership with the Clinical Trials Research Unit at the University of Leeds and clinicians and scientists at the universities of Leeds, Sheffield, York, Hull, and Bradford.
In light of this new development in the region, some details of clinical trials are explained below.
Trials usually examine how well a new treatment compares to the existing treatment (if there is one). Trials are usually split into an “experimental group” (which gets the new drug) and a “control group” (which gets the existing treatment). This allows researchers to compare the new treatment directly with existing drugs in order to assess whether it is better. Several measures are used to ensure that the clinical trial is a fair test. Trials are often “blinded” meaning the patients and doctors are not told which treatment each individual patient is given until after the trial is over. Trials can also be “randomised”, this means that patients are put in either the control or experimental group at random, rather than letting the researchers choose. These measures ensure that the treatments get a fair test and no bias is introduced.
The design of a trial is very important to ensure that we can trust the results from it, and that we can detect any differences between a new drug and the existing treatment. A trial is well planned before any patients become involved and several experts in both the design of clinical trials and statisticians are involved to ensure the work will be of the highest standard. The YCR Early Phase Clinical Trials Unit will offer scientists support in the planning and design of their trials to ensure the results from them are the best possible.
Phases of Clinical Trials
New drugs and treatments have to go through several stages of testing before they are fully released on the market. Once a drug has shown promise in the lab, using tests with cells in a dish or in animals, the drugs are tested in human volunteers. These next stages of testing are called “Phases” and are designed to test different aspects of the new treatment.
- Phase 0 – The first tests in humans. These are used to find out if a drug behaves in the way researchers expect it to based on their thorough studies in the lab. Very small doses are given, which are not enough for the patient to benefit, but are too low to cause side effects. The researchers aim to find out where the drug travels to in the body and how cancer cells in the body respond to the new treatment
- Phase 1 – Small trials with a few dozen patients to test how useful a new drug is and to understand how large a dose is needed. These take several groups of people, steadily giving them higher and higher doses to test how effective the drug is and assessing the level of side effects. This involves taking blood tests and close monitoring of the patient’s condition.
- Phase 2 – Larger trial with perhaps 100 patients. Once an appropriate dose is known from a Phase 1 trial researchers can test the drug on a larger group to help identify which cancers will respond best to treatment and identify positive effects and side effects.
- Phase 3 – Much larger trial, with thousands of patients often across several hospitals and countries. This type of trial compares the effect of the new treatment with the current treatment, in order to identify whether the newly developed drug is a better option. These trials are more thorough, last longer, and can identify any rare side effects. After this stage has been completed, regulatory approval can be sought to enable hospitals to buy the drug for their patients.
- Phase 4 – After a treatment has successfully moved into hospitals as a standard treatment Phase 4 trials are carried out to examine how effective it is over the long term and any side effects.
The YCR Early Phase Clinical Trials Unit will focus on undertaking Phase 0, 1 and 2 trials to provide the early data that can be taken forward to larger trials.
Recently Funded Projects
More information about the programme we have funded is shown below. For further information about other projects we have funded, use the links in the sidebar to the right.
Yorkshire Cancer Research Centre for Early Phase Clinical Trials
We are establishing a Yorkshire-wide early clinical trials network to support development of new treatments for cancer patients in Yorkshire. These trials will assess the feasibility and promise of potential new therapeutic strategies, especially those arising out of discoveries within cancer research laboratories in Yorkshire or where we have specific expertise to determine the potential value and safety of a new treatment before definitive testing in larger clinical trials. Provision of this infrastructure funding will make Yorkshire a more attractive place for industry to invest in development of new cancer treatments and ensure our cancer research remains internationally competitive.
No matter how successful and detailed laboratory studies may be, clinical trials in real cancer patients are the only way to test whether new cancer treatments work. Our proposal will establish a network of experienced scientists and clinicians in Yorkshire, which should improve the links between laboratory findings and the patient, making it easier for new treatments to enter clinical trials. The multidisciplinary network will assess the promise of potential new treatments, as well as many genetic and other factors that determine how patients respond differently to selected treatments, ultimately tailoring treatments to individual patients in Yorkshire.
This programme is designed to enable collaboration between laboratory researchers and clinical researchers to ensure that new findings from the lab make it to the clinic as soon as possible. This research will incorporate: use of biomarkers that distinguish different types of cancers, investigating particular groups such as the elderly or ethnic minorities, and also provide development opportunities for younger scientists who can be guided by the experts at the unit. The unit will help guide the planning and execution of trials, and also provide advice for new applications to bring further funding into Yorkshire. Yorkshire has a population of 5 million, with around 500,000 non-white people and a diverse range of social groups; we have tens of thousands of cancer patients who can benefit from earlier access to novel therapies and help develop the drugs of the future.
- Prof Julia Brown, Dr Sarah Brown, Prof Robert Coleman, Dr Fiona Collinson, Prof Michael Lind, Prof Norman Maitland, Prof David Sebag-Montefiore, Prof Chris Twelves, Prof Penella Woll
- Leeds University, Clinical Trials Research Unit
- Awarded: £724,339 (Programme Award)
- Dates: 1 June 2014 to 31 July 2019
- Last updated: 24/06/2016
- View more in: Research