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About clinical trials

About clinical trials

Clinical trials are vital to ensure new treatments are available to blood cancer patients.

Sometimes as part of their treatment, patients may be asked to take part in a clinical trial. Patients can also ask to be included on a trial.

You can now download a copy of our new leaflet for blood cancer patients, 'Taking Part in a Clinical Trial'

What are clinical trials?
Types of clinical trial
How do clinical trials work?
How are clinical trials regulated?
What are the benefits to me?
Should I be worried?
Finding a clinical trial
How to enter a clinical trial
Clinical trials for children
Working with other charities

What are clinical trials?

Clinical trials test new drugs or combinations of drugs in patients. This is really important because this is the only way to improve treatments for all patients in the future.

Trials can run for several years over which time scientists are able to see whether the new treatments are better than existing ones. This is essential in order to translate scientific breakthroughs discovered in the laboratory into treatments available to every patient who needs them.

Clinical trials are also important for developing better ways of diagnosing the different blood cancers. Trials may also be used to develop treatments that prevent and relieve the symptoms of blood cancer, as well as manage side effects associated with different treatments.

Types of clinical trial

Some clinical trials are designed to test the effectiveness of new treatments and others are designed to establish the best way of using these, or current treatments. This might mean changing the doses or combining multiple drugs.

Clinical trials are also used to test if new drugs are safe, and the safest dosage for each patient.

There are three types of clinical trial:

Phase I trials test the safety of new drugs or treatments and establish the appropriate dosage.
Phase II trials confirm the optimum dosage of new drugs and identify any side effects.
Phase III trials compare new drugs or treatments with the best currently available treatments.

Phase I and II trials normally involve small numbers of patients, whereas phase III trials usually involve several hundred sometimes even thousands, of patients. This is important as the more patients recruited onto a trial, the more confident scientists can be in its results.

Leukaemia & Lymphoma Research tend to invest in early phase clinical trials as these give the promising ideas for new treatments the best chance of ultimately benefiting patients.

How do clinical trials work?

Clinical trials are designed by doctors and researchers who want to improve treatments for patients with blood cancers.

All clinical trials are designed with at least two treatment groups. One group of patients will receive the new treatment, or treatment combination, and the other group will receive the best currently available treatment.

Patients are randomly selected to enter each treatment group. This means that not all patients will receive the new treatment.

It is important to understand that the new treatment will not always prove to be better than existing treatments. More usually trials find small differences in the outcome of the treatment groups. But this information is still extremely valuable in terms of improving treatments in the future.

When planning a new clinical trial, scientists are required to write detailed plans about the study. This is called a protocol, and includes an explanation of why the trial is necessary, how many patients will be recruited, details of the planned treatments as well as the tests and examinations each patient will receive during the trial.

Trials will often be run at more than one hospital but everyone involved in the trial will follow exactly the same protocol. However, doctors will still use their own judgement and can modify treatments for individual patients if necessary.

How are clinical trials regulated?

Every new protocol is passed before the Medical and Health Regulatory Agency (MHRA) as well as the Research Ethics Committee (REC) who make sure the trial is ethically sound and the drugs are suitable for use in patients.

Once a trial is up and running, it is monitored by a committee called the Data Monitoring Committee (DMC). The DMC are a group of scientists put in place to monitor the safety of patients entered onto trials and ensure that it is being run according to the approved protocol. The DMC scientists are not involved in running the trial itself, so their judgement is unbiased.

If any serious or unexpected side effects are reported, the trial may be stopped immediately or the protocol amended.

What are the benefits to me?

Patients entered onto trials have access to the latest treatments that may only be available as part of a clinical trial. Patients can enter a trial regardless of where in the country they live.

But it is important to be aware that not everyone taking part in a clinical trial will receive the new treatment.

Phase I and phase II trials are not normally expected to offer any direct benefit to patients taking part in them. Although, this does occasionally happen, patients should not expect it to be the case.

However, everyone taking part in clinical trials is helping to improve treatments for patients in the future.

Should I be worried?

Doctors will not recommend patients for a clinical trial if they think that conventional treatments are more suitable.

Clinical trials are very carefully regulated to protect the safety and privacy of the participants. Blood cancer trials never use placebos, or ineffective drugs, as a basis for comparing the effectiveness of new drugs. Instead patients are either given new treatments or the best available current treatment.

Before agreeing to enter a clinical trial patients should be given sufficient information. If you are considering taking part it is advisable to discuss every aspect and all concerns with your doctor before deciding to enter a clinical trial.

And it is never too late to change your mind. Even after treatment has begun it is okay to refuse to continue on the trial. However, if you are in real doubt about entering a trial, it is better to say no at the very beginning.

Finding a clinical trial

Patients are usually informed about relevant clinical trials by their doctor.

However, there are a number of databases available online that anyone can use to search for and find information about all current cancer trials.

For information about all UK cancer trials visit the UK Clinical Research Network Study Portfolio:

http://public.ukcrn.org.uk/Search/Portfolio.aspx

For information about all international clinical trials visit:

www.controlled-trials.com

It is important to read all the information carefully, as most clinical trials have very strict guidelines. Your doctor will be able to advise you as to whether you are eligible to enter a particular trial.

How to enter a clinical trial

If a suitable clinical trial is found, the patient’s doctor will pass their details onto the researcher running that particular trial.

Following this, the patient and their doctor will meet with the researcher along with other health professionals involved in running the trial, such as research nurses, to discuss the trial in more detail.

Once patients are happy that they have received all the information they need, they can make a decision as to whether or not to enter the trial.

Clinical trials for children

Most children in the UK with the most common form of leukaemia (acute lymphoblastic leukaemia, ALL) are entered into a large national clinical trial as a standard part of their treatment.

It is mainly because of clinical trials that fantastic progress has been made in the treatment, and survival, of children with leukaemia in the last 50 years.

The latest clinical trial for childhood ALL, which opened in August 2012, is called UKALL2011. This trial is recruiting children and young adults up to the age of 25 from across the UK.

The previous clinical trial for childhood ALL introduced the minimal residual disease (MRD) test, which was pioneered and funded by Leukaemia & Lymphoma Research, to help doctors guide children’s treatment. The MRD test proved to be so successful that the NHS is now paying for every child with ALL to be given this test as a standard part of their treatment.

Working with other charities

Leukaemia & Lymphoma Research work with other UK charities to invest in clinical trials that improve treatments for adults and children with blood cancers.

All children’s cancer trials in the UK are organised by the Children’s Cancer and Leukaemia Group (CCLG), an independent body who receive funding and support from many children’s cancer charities.

The latest clinical trial for children with ALL, UKALL2011 is being supported by Leukaemia & Lymphoma Research, Cancer Research UK and Children with Cancer UK.

Leukaemia & Lymphoma Research are also part of the National Cancer Research Institute (NCRI). NCRI is a UK wide partnership between the government and charities that aims to deliver the best new cancer treatments to patients. This includes organising clinical trials, encouraging collaboration between charities to fund good trials and identifying gaps in research that should be explored to the benefit of patients.

Clinical trials

Research open day

Leukaemia & Lymphoma Research currently have more than £7 million invested in clinical trials which are improving treatments for patients with blood cancers across the UK.