Trials database pro forma

We often alter the wording to make it more ‘patient friendly’. We include any acronyms to make it easier to identify specific trials.

This is an introduction to the trial, and includes

• Some information about the usual treatment or tests for that type of cancer (if relevant)
• A brief description of the new treatment or test and how it works
• The rationale for the trial
• The aims of the trial - whether it is finding the best dose or comparing a new treatment to existing standard treatment, for example
• If the trial is supported by Cancer Research UK

While containing all the relevant information detailed above, the summary should be as brief as possible and not duplicate information in other fields.

We can also make it clear (either here or in the trial design section below) if patients cannot volunteer for or be referred to take part in the trial (in other words, if people have to be invited to take part).

We include the date recruitment started, and an estimate of when recruitment will end. This needs to be in “dd/mm/yyyy” format. This is very important as we can’t enter the trial onto the database without these dates.

The end date is a guide only. We use it as a prompt to check if the trial is still recruiting or not, and can easily edit this field at any time if need be. We aim for a conservative estimate so we can try to avoid trials closing before we check them.

This could be phase 1, 1/2, 2, 2/3, 3, or 4, pilot study, or ‘other’ if it is a non treatment trial.

We take this information directly from the protocol. We generally include all inclusion and exclusion criteria, although we may group some together. For example, we may group specific blood tests together as ‘satisfactory blood test results’.

We include

• Stage and grade of cancer
• Other factors, such as cancer spread to the brain or bone (metastases)
• Past or current treatments
• Other medical conditions
• Age and general health (performance status)

This is a summary of the design of the trial, and includes

• How many people will take part
• How many trial groups there are and what the treatment is for each group, or if all patients have the same treatment
• If the trial is randomised
• How many times (and how often) people have treatment
• If it is a dose escalation trial
• If it includes a quality of life questionnaire
• If there are any substudies, or parts of the trial that are optional (for example, the collection of tissue samples)

In this section we outline what the trial will involve from the patients’ perspective. This helps them to get an idea of the impact it will have on their day to day lives. We include information such as

• How often people in the trial have to attend hospital, and what for
• What tests they have before, during and after treatment
• If they have treatment as an in patient or out patient
• How long they will stay in hospital for
• How often they see the doctors for follow up appointments, and what happens at these visits

We include information about the known (or possible) side effects of all treatments given in the trial.

We include links to pages of CancerHelp UK for more information about existing treatments and how to cope with specific side effects such as sickness or hair loss, for example.

If the trial is looking at a new and experimental treatment, we say what the possible side effects are, but explain that there may be others we don’t know about yet.

When results are available, a plain English summary of the main findings is added to this field.  At this point, the following fields are no longer visible on the site: trial design, hospital visits, side effects & location.

We list the name of the towns, cities, counties or regions where open trials have participating centres. This gives people an idea of whether there is a centre taking part near them or not, but stops people contacting the hospital directly and inappropriately.

If agreed by the trial team, we also keep a list of specific hospitals and doctors in our internal secure database. If the Cancer Information Nurses have an enquiry from a patient who may be able to take part, they can give them the name of their nearest centre, so they can tell their own doctor who they need to be referred to.

Once a trial is closed to recruitment, the location field is marked ‘CLOSED’ and the list of centres is deleted from our internal database.

We include the contact details for the Cancer Research UK Information Nurse team as an impartial source of information on each trial summary.

The information nurses are a team of very experienced cancer nurses. They are not directly involved with the trials on the database and cannot recruit patients - we make this clear on the database. But they are happy to talk to people about taking part in a trial, and help explain the trial if need be. If the patient is interested and appears to be eligible, the nurses advise them to take a print out of the trial information to their own doctor.

We include the name of the chief investigator in the UK.

This is an optional field. We can list any additional information, such as the Cancer Research UK trial number (if applicable). We can also provide links to additional, appropriate information about the trial.

Here we list the organisations that are funding, supporting or managing the trial. They are not necessarily the legal ‘sponsor’ of the trial, although the list will include the sponsor.

The database includes trials funded by a variety of organisations, not just those run by Cancer Research UK. This includes other charities, research organisations, pharmaceutical companies and Government organisations.

This template will be reviewed by October 2013.