Brain tumour clinical trials

Below, find information on what clinical trials are, how they are designed to run, how you might join a trial and what some of the benefits and risks might be.

What is a clinical trial?

A clinical trial is a research study, which involves people. People test treatments for an illness or approaches to prevention or diagnosis. This tells us whether the new approaches are safe and effective. A typical trial might research:

  • Whether a new drug is as effective as an existing one
  • Whether a combination of treatments (e.g. radiotherapy and chemotherapy) work better if used at the same time
  • Whether giving a drug in a different way can be more effective.

Cancer clinical trials will research drugs, screening, diagnosis, treatments and controlling symptoms.

We need clinical trials so that we can continue to develop better healthcare. They provide evidence so that doctors know which treatments work best.

Follow brainstrust’s clinical trials video series which covers all the basics of clinical trials:

Find brain tumour support on your doorstep, and current brain tumour trials at www.braintumourhub.org.uk

How do they work?

Clinical trials are designed by specialists with input from a wide range of people, which can include patients. A lot of work has to be done before a trial can start; this is the design phase. During this phase it is decided what questions need to be answered by the trial and the results of previous trials are studied (this is called a systematic review). The outcome of this phase will be a design and this forms the trial protocol.

The trial protocol will include guidelines about who can take part. These are called eligibility criteria. This makes sure that the sort of people who may benefit from the trial are included and that people are not being exposed to avoidable risks.

The trial protocol is then sent to an ethics committee. This is an independent group of people who will decide whether the trial should go ahead. They will discuss the potential benefits, whether the information is clear, whether the way in which people are asked to participate in the trial is appropriate.

Once the trial protocol has permission to go ahead it happens in stages:

  • Phase 1 trials look at whether a trial treatment is safe or has any harmful effects. The research team will also find out the best dose (if relevant) to use. This usually involves a small group of people.
  • Phase 2 trials look at how well a treatment works. Researchers will know more about the treatment by now. This phase involves a larger group of people. Only a treatment that has got through these 2 phases goes into phase 3 testing.
  • Phase 3 trials test a new treatment against the existing standard treatment. If it gives better results, it may become the new standard treatment. This phase is large and will involve more people than phase 2.
  • Phase 4 trials are carried out after a treatment has been shown to work and has been licensed. In this phase researchers collect information about side effects, safety and the long term risks and benefits of a treatment.

Terms you might hear

Controlled trials: a control is a standard against which experimental observations may be evaluated. In clinical trials, one group of participants is given an experimental drug, while another group (i.e., the control group) is given either a standard treatment for the disease or a placebo.

Placebo: a placebo treatment looks like the treatment being tested, but it is inactive. By comparing people’s responses to the placebo and to the treatment being tested, researchers can tell whether the treatment is having any real benefit.

Blind trial: A blind trial is a trial where the people taking part do not know which treatment they are getting. They could be getting the new treatment. Or they could be getting standard treatment or a placebo, depending on the design of the trial.

Double-blind trial: In the double-blind trial neither the patient nor the researchers giving the treatment know who is being treated and who is in the placebo control group.

Randomised trial: this means that people are picked at random to the treatment groups in a trial. So you can get double blind, randomised trials!

Where can I find a brain tumour clinical trial?

The simple answer for brain cancer is on our Brain Tumour Hub. Click here to visit the hub at www.braintumourhub.org.uk. This resource has been carefully researched, is kept up to date and is currently the most complete database of UK brain tumour clinical trials. Please note that currently it only covers trials recruiting patients in the UK.

For more information on clinical trials in the UK and abroad, have a look at these websites:

The UK Clinical Trials Gateway provides easy to understand information about clinical research trials running in the UK, and gives you and others access to a large range of information about these trials. Be careful though because some of the brain tumour trials listed are more generic; they are trials based on the broader picture and are not brain tumour specific.

Visit NIHR website

This is the Cancer Research UK site. It provides information about closed, as well as open trials, and past trial results:

Visit Cancer Research clinical trials page

A US site, specifically focused on brain cancer:

Visit www.virtualtrials.com

Health Talk Online is a patient centred website. Whilst generic, it has some good background information about clinical trials which is easily accessible:

Visit the Health Talk Online website

Brain tumour support is driven by your support. We know. Click here to help us do even more for people living with a brain tumour in your area.

What should I think about before participating in a trial?

You need to know as much as possible about the clinical trial and feel comfortable asking questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for you to discuss with your doctor.

  • What is the purpose of the trial?
  • Who is going to be in the trial?
  • Why do researchers believe the experimental treatment being tested may be effective? Has it been tested before?
  • What kinds of tests and experimental treatments are involved?
  • How do the possible risks, side effects, and benefits in the study compare with my current treatment?
  • How might this trial affect my daily life?
  • Will taking part in a clinical trial stop me from receiving any other treatment that might be recommended by my healthcare team?
  • How long will the trial last?
  • Will I need to stay in hospital?
  • Who will pay for the experimental treatment?
  • Will I be reimbursed for other expenses?
  • What type of long-term follow up care is part of this study?
  • How will I know that the experimental treatment is working? Will results of the trials be provided to me?
  • Who will be in charge of my care?

What are the benefits and risks of participating in a clinical trial?

Benefits

Clinical trials that are well-designed and well-executed are the best approach for you to:

  • Play an active role in your own health care.
  • Gain access to new research treatments before they are widely available.
  • Obtain expert medical care at leading health care facilities during the trial.
  • Help others by contributing to medical research.

Risks

There are risks to clinical trials:

  • There may be unpleasant, serious or even life-threatening side effects.
  • The experimental treatment may not be effective.
  • More of your time and attention might be needed than an existing standard treatment, such as trips to the research centre, more treatments, hospital stays or complex dosage requirements.

This information has been sourced and adapted from Understanding Clinical Trials, version 2, October 2010, published by the National Institute for Health Research. The source material is available to download as a pdf at: http://www.crncc.nihr.ac.uk/

Did this information make you feel more resourced, more confident or more in control?

Date published: 17-05-2009
Last edited: 31-08-2017
Due for review: 31-08-2020

sidebar brainbox

Introduction

The Brain Tumour Data Dashboard lets you explore up -to-date, population level data about the brain tumours diagnosed in England between 2013 and 2015. Using the drop down menus on the left you can select different groups of patients to view in the charts below. In these charts the number of patients for every 100 diagnoses is displayed as images of people. Patients have been grouped by date of diagnosis, type of tumour, age, gender, and region in England.

For each group of patients you can explore the different routes to diagnosis, the proportion of those who received chemotherapy or radiotherapy, as well as the survival of the patients within each group. For more information about what these metrics mean please see the glossary.

How to use

  1. Select the year of diagnosis using the drop down menu.
  2. Select your patient group of interest from the four drop down menus in the following order:
    1. Tumour group
    2. Age at diagnosis
    3. Region of England
    4. Gender of patient
  3. To view a second chart to compare different groups of patients, click the ‘compare’ button.The second chart will appear below the first chart.

*Note that the tool is best used on a laptop or tablet rather than a mobile phone*

Unavailable data

Some of the data in these charts is not available.There are two main reasons for this:

  1. How the data has been grouped

If you cannot select a patient group from the drop down menus, the data is unavailable because of how the data has been organised.

Public Health England has grouped the data like a branching tree. The bottom of the tree contains all the patients with brain tumours, and then each branch divides the data by a certain characteristics, like age, or location of tumour. But the data is divided in an order, starting with location of the tumour (endocrine or brain), then by age, region, and gender. Age is at the start because it makes a bigger difference to survival rates and treatment rates than gender or region. Sometimes, after the data has been split by type of tumour and age, there is not enough data to be split again. This is because to protect patient confidentiality groups cannot contain less than 100 patients. Because some groups cannot be split further, you cannot create ‘totals’ for everyone by region or gender. For example, you cannot see results for all ages by region, or all brain tumours by gender. If these totals were calculated and released, it might be possible to identify patients, which is why Public Health England cannot release this data.

  1. Statistical reasons and data availability

If you can select a patient group from the chart menus, but the chart does not display, the data is unavailable for one of several reasons:

  1. Data is not yet available for the selected year from Public Health England.
  2. Data is not available because the data quality is too poor to release this statistic.
  3. Data is not available as the statistic is not appropriate for this group.
  4. Data is not available because the standard error of the estimate was greater than 20% and so the estimate has been supressed.

Up to date brain tumour data

Brain tumour data may influence the decisions you make about your care. Data also helps you understand the bigger picture, or landscape, in which you find yourself.

Brain tumour data and statistics influence the focus, and work of organisations like brainstrust. The information helps us to understand the scale and impact of the problems we are setting out to solve.

This tool helps you understand the landscape in which you find yourself having been diagnosed with a brain tumour. This landscape can be particularly tricky to navigate as there are many different types of brain tumour, all of which have a different impact.

The information you see represents the most up-to-date, official, population level brain tumour data available for England. Over time we will be adding to the brain tumour data available and publishing reports, with recommendations, as a result of what we learn from this data.

The data behind this content has come from Public Health England’s National Cancer Registration and Analysis Service (NCRAS) and is a direct result of the ‘Get Data Out’ project.

This project provides anonymised population level brain tumour data for public use in the form of standard output tables, accessible here: http://cancerdata.nhs.uk/standardoutput

Incidence

The number or rate (per head of population) of new cases of a disease diagnosed in a given population during a specified time period (usually a calendar year). The crude rate is the total number of cases divided by the mid-year population, usually expressed per 100,000 population.

Malignant

Malignant tumours which grow by invasion into surrounding tissues and have the ability to metastasise to distant sites

Mortality

The number or rate (per head of population) of deaths in a given population during a specified time period (usually a calendar year). The crude rate is the total number of deaths divided by the mid-year population, usually expressed per 100,000 population.

Non-malignant

Not cancerousNon-malignant tumours may grow larger but do not spread to other parts of the body.

Survival

The length of time from the date of diagnosis for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the survival is one way to see how well a new treatment works. Also called ‘overall survival’ or ‘OS’.

Routes to Diagnosis

Under the ‘Routes to Diagnosis’ tab in the Brain Tumour Data Dashboard, you can explore the ways patients have been diagnosed with brain tumours. There are many ways, or routes, for cancers to be diagnosed in the NHS. A ‘route to diagnosis’ is the series of events between a patient and the healthcare system that leads to a diagnosis of cancer. The routes include:

  1. Two Week Wait

Patients are urgently referred by their GP for suspected cancer via the Two Week Wait system and are seen by a specialist within 2 weeks where they are diagnosed.

  1. GP referral

Diagnosis via a GP referral includes routine and urgent referrals where the patient was not referred under the Two Week Wait system.

  1. Emergency Presentation

Cancers can be diagnosed via emergency situations such as via A&E, emergency GP referral, emergency transfer or emergency admission.

  1. Outpatient

Outpatient cancer diagnoses include diagnoses via an elective route which started with an outpatient appointment that is either a self-referral or consultant to consultant referral. (It does not include those under the Two Week Wait referral system).

  1. Inpatient elective

Diagnosis via an inpatient elective route is where diagnosis occurs after the patient has been admitted into secondary care from a waiting list, or where the admission is booked or planned.

  1. Death Certificate Only

Diagnoses made by Death Certificate Only are made where there is no more information about the cancer diagnosis other than the cancer related death notifications. The date of diagnosis is the same as that of the date of death.

  1. Unknown

For some patients with a cancer diagnosis, there is no relevant data available to understand the route to diagnosis.

 

More information

If any of the statistical terms in this section of the brainstrust website are hard to understand, we recommend looking them up here:

Cancer Research UK’s Cancer Statistics Explained

http://www.cancerresearchuk.org/health-professional/cancer-statistics/cancer-stats-explained/statistics-terminology-explained#heading-Seven

If you are looking for help understanding terms relating specifically to brain tumours, and treatment, then the brainstrust glossary is available here:

https://www.brainstrust.org.uk/advice-glossary.php