Every year, more than half a million people help the NHS improve healthcare and develop life-saving treatments by taking part in clinical trials.
All new drugs need to be vigorously tested to ensure they are safe and effective before they are licensed for use. Testing is conducted in the laboratory and in the clinic. Drugs are tested in the laboratory to ensure they are pharmacologically safe for human use. They are then tested in the clinic by administration to humans in clinical trials. The data collected during laboratory testing and clinical trials are compiled by the pharmaceutical company into a product license application. This application is submitted to the regulatory authority in each individual country to obtain a license to allow the pharmaceutical company to market and sell the drug.
You can find a list of clinical trials currently running for kidney cancer by using the search engine above.
What are clinical trials?
When doctors are uncertain about whether one type of cancer therapy is better than another, or if a new treatment or drug is likely to work or have side-effects, they try to answer this by involving patients in clinical trials. Most of the information that doctors have about how well different drugs work is obtained in this way. During a clinical trial, detailed information is collected about each patient, drug side-effects and how well the treatment has worked. When this information is collected and compared from all the patients in a trial, it should become clear how good the treatment is. Without clinical trials it would be very difficult to know which cancer drug works best.
- You will receive high-quality health care provided by leading doctors in the field of cancer research.
- You will have access to new drugs and interventions before they are widely available.
- Your health care will be closely monitored, along with any side effects related to the treatment.
- You will play a more active role in your own health care.
- If the approach being studied is found to be helpful, you may be among the first to benefit.
- The trial will provide an opportunity for you to make a valuable contribution to cancer research.
- New drugs and procedures may have side effects or risks unknown to the doctors.
- New drugs and procedures may be ineffective or may be less effective than current approaches.
- Even if a new approach has benefits, it may not work for you.
- The fact that you have kidney cancer doesn’t make you automatically eligible for a specific clinical trial. You will have to fit certain requirements of the trial eligibility criteria.
Are clinical trials safe?
All clinical trials have been passed by a committee of doctors and members of the public before they begin. Involvement in a clinical trial is completely voluntary. If patients decide that they want to stop being involved in a trial then they simply have to tell their doctor. This will not affect their chances of future treatment if other options are available.
Where do clinical trials take place?
Trials take place in a variety of locations including cancer centres and district hospitals. If patients are interested in discussing clinical trials then they should ask their cancer doctor for further information on what trials are available in their area.
Are there different types of clinical trial?
Yes, Clinical trials are divided into different stages, called phases. The earliest phase trials may look at whether a drug is safe or the side effects it causes. A later phase trial aims to test whether a new treatment is better than existing treatments.
There are 3 main phases of clinical trials – phases 1 to 3. But some trials have an earlier stage called phase 0, and there are some phase 4 trials done after a drug has been licensed.
Phase 1 trials
Phase 1 is sometimes written as phase I. They are usually small trials, recruiting only a few patients. The trial may be open to people with any type of cancer.
When laboratory testing shows that a new treatment might help treat cancer, phase 1 trials are done to find out
- How much of the drug is safe to give
- What the side effects are
- How the body copes with the drug
- If the treatment shrinks the cancer
Patients are recruited very slowly onto phase 1 trials. So although they don’t recruit many patients they can take a long time to complete. The first few patients to take part (called a cohort or group) are given a very small dose of the drug. If all goes well, the next group have a slightly higher dose. The dose is gradually increased with each group. The researchers monitor the effect of the drug until they find the best dose to give. This is called a dose escalation study.
In a phase 1 trial you may have lots of blood tests because the researchers look at how the drug affects you. They also look at how your body copes with, and gets rid of the drug. They record any side effects.
People taking part in phase 1 trials often have advanced cancer. They have usually had all the treatment available to them. They may benefit from the new treatment in the trial but many won’t. Phase 1 trials aim to look at doses and side effects. This work has to be done first, before we can test the potential new treatment to see if it works.
Phase 2 trials
Not all treatments tested in a phase 1 trial make it to a phase 2 trial. Phase 2 is sometimes written as phase II. These trials may be for people who all have the same type of cancer or for people who have different types of cancer.
Phase 2 trials aim to find out
- If the new treatment works well enough to test in a larger phase 3 trial
- Which types of cancer the treatment works for
- More about side effects and how to manage them
- More about the best dose to use
Although these treatments have been tested in phase 1 trials, you may still have side effects that the doctors don’t know about. Drugs can affect people in different ways.
Phase 2 trials are often larger than phase 1. There may be up to 100 or so people taking part. Sometimes in a phase 2 trial, a new treatment is compared with another treatment already in use, or with a dummy drug (placebo). If the results of phase 2 trials show that a new treatment may be as good as existing treatment, or better, it then moves into phase 3.
Some phase 2 trials are randomised. This means the researchers put the people taking part into treatment groups at random.
Phase 3 trials
These trials compare new treatments with the best currently available treatment (the standard treatment). Phase 3 is sometimes written as phase III. Phase 3 trials usually involve many more patients than phase 1 or 2. This is because differences in success rates may be small. So, the trial needs many patients to be able to show the difference.
Sometimes phase 3 trials involve thousands of patients in many different hospitals and even different countries. Most phase 3 trials are randomised. This means the researchers put the people taking part into treatment groups at random.
You must be prepared to be allocated into groups which will influence which treatment you receive.
Phase 4 trials
Phase 4 trials are done after a drug has been shown to work and has been granted a licence. Phase 4 is sometimes written as phase IV. The main reasons for running phase 4 trials are to find out
- More about the side effects and safety of the drug
- What the long term risks and benefits are
- How well the drug works when it’s used more widely
How do drugs get approved for use on the NHS?
A drug is given a license by the European Medicines Agency (EMA) and then a UK license by the Medicines and Healthcare products Regulatory Agency (MHRA) once it is deemed safe to use in a certain group of patients, and has shown to be of some benefit.
Drug manufacturers generally submit applications for licenses once the results of clinical trials are published. This process can take up to a year.
Once a drug is licensed, the National Institute of Health and Care Excellence (NICE) and the Scottish Medicines Consortium will, if asked, assess whether the drug should be used by the NHS.
They look at the clinical and cost effectiveness of the drug. In other words, does the drug in question work better than standard treatments offered (either for all patients, or for a particular group of patients)? Is the price to the NHS acceptable for the amount of benefit seen?
This process can take some considerable time, and countries within the UK may reach different conclusions.
This means it can take up to two years, or more, from results of trials being announced to the drugs being approved for use on the NHS.
You can also visit the UK Clinical Trials Gateway website which provides information about clinical trials running in the UK and is designed to enable you and your clinician to locate and contact trials of interest to you.
- UKCCCR (UK Coordinating Committee for Cancer Research)
This link provides information about the Medical Research council Clinical trials unit trials. These trials are hosted by 5 locations in the UK and can be searched for here: http://www.ctu.mrc.ac.uk/our_research/studies/