Newcastle Biomedicine Clinical Research Platforms

 

Northern Centre for Cancer Care

Medical research and clinical trials

Contact: (0191) 213 8441 - Dr J Charlton or Sister F Chapman

As part of your care and treatment, you may be approached about taking part in a clinical trial or research study. This section aims to provide some basic information about clinical trials, including what they are, why they are important, how they are organised and what a trial involves. It also explains some of the more unfamiliar terms you may hear from your doctor or research staff.


How are new treatments developed and tested?Show [+]Hide [-]

Each new treatment goes through strict testing before it can be offered to patients as an established treatment. First, it is tested in the laboratory. If the tests show good results, then the new treatment is normally developed in further phases of testing, as shown below.

The three phases of clinical trials and what testing is done at each phase :

Phase I Trials  Establish safe dosage   

    ⇒   Phase II Trials  Establish how well the treatment works   

           ⇒   Phase III Trials Compare a new treatment with an established treatment   

                    Treatment enters into routine medical practice

These phases involve the treatment of patients in clinical trials before doctors are allowed to offer it as an established treatment. This kind of testing can take many years and during each phase, checks are made for any unwanted effects.

What would a trial involve?Show [+]Hide [-]

Trials usually have guidelines as to who can be involved (known as eligibility criteria). These guidelines are important in helping to ensure the welfare of patients taking part in the trial, and also to make sure that patients who are likely to feel more ill by the treatments they are given are not put at risk. For instance, patients at a particular stage of their illness may not be able to cope with the effects of certain drugs. If you are not chosen for a trial, you will still continue to get the best latest treatment available.

 

If you are asked to take part in a trial you will have the chance to talk with the doctors or research team about the details of the trial. You will get to know about the kind of treatment you will be given, the possible benefits or unwanted effects you might get, and what extra tests you may be asked to do as part of the trial.

 

Once all of the details have been explained and any questions answered, you will then be given written information to take home with you. You then have some time to think it over and to talk about the trial with your family, friends or GP before deciding what to do. Taking part in any clinical trial is entirely your own free will and you are under no obligations.

Informed consentShow [+]Hide [-]

If you do decide to take part in a trial you will be asked to sign a form saying you understand that you are agreeing to take part in a clinical trial. This is called informed consent.  This form is for your protection.

 

The form will clearly say that you are allowed to leave the trial at any time if you wish to do so. You do not have to give a reason why you want to leave.

 

It is usual to give you the name of a person to contact should you have any problems and your GP may also be told about you taking part in a trial.

 

All patients, whether in a trial or not, will continue to get the best care available from their healthcare workers.

What are the possible benefits and drawbacks of being in a clinical trial?Show [+]Hide [-]

Benefits - If you take part in a trial you…

  • can be among the first ones to benefit from a new treatment (should you be included in the treatment arm of the study).
  • may feel better in yourself because you are taking extra action regarding your treatment.
  • can sometimes feel that, by helping to improve treatments, you could be helping others who might have the same illness in the future.
  • will be seen by the research team, which may mean that you feel more reassured and will receive more medical monitoring than patients who are not in a trial.

Drawbacks - If you take part in a trial you…

  • may not know which treatment you are receiving
  • might find that the new treatment is no better than the established treatment
  • may find that there might be some unexpected unwanted effects from having the new treatment
  • may discover that the new treatment works well with some other patients, but not with you
  • may be asked to make extra hospital visits at the local hospital or at another hospital that might not be convenient

What questions might I ask about the trial?Show [+]Hide [-]

A checklist of questions to ask the research team

 

The following questions deal with many of the areas that should be covered in the informed consent form.  However, to double check that you have all the information that you need, this checklist of questions (and why it may be important to ask them) might be helpful.

 

 

Question to ask Why ask this question?
What is the purpose of the trial? This will help you decide why the trial is important
Who will sponsor the trial?

You may wish to know if the research is sponsored by industry, a charity, or a University.

Who has reviewed and approved the trial?

How are the trial results and the safety of the patients taking part being checked?

How have my views and considerations been taken into account when planning the trial?

These will help you understand how the trial was developed and if your point of view was considered.
How long will the trial last?  This will help you get clear in your mind how long your involvement in the trial will be, and how long the trial itself will run
What will my responsibilities be if I decide to take part? This will give you an idea of what will be expected of you.
If more information is required, who can be approached during and after the trial? If you are taking part in a trial you should have a named person you can contact if you want any further information at any stage.
Who can I see to find out the trial results? You may want to know the results of the trial. However, some trials may take many years to complete.
What steps will be taken to protect my privacy and the confidentiality of my medical records? You may wish to know exactly how your anonymity is to be protected.
 Are there any alternatives to the trial treatment? This may give you a better idea of the full range of treatments available. 

 

What questions should I ask about the possible benefits and risks?Show [+]Hide [-]

  

Questions to ask Why ask these questions?
What are the possible short-term and long-term benefits?

What are the possible short-term risks (such as unwanted effects) and long-term risks?

These will help you reach a decision about how the trial might possibly affect you.

 

 
 

What questions should I ask about the personal impact the treatments may have on me?Show [+]Hide [-]

 

Questions to ask Why ask these questions?
What kind of therapies, procedures and/or tests will I have during the trial?

Will they hurt and if so, for how long?

How do the tests in the trial compare to those I would have outside of the trial?

If I take part, will I still be able to take my regular medications?

These questions will help give you an idea of the personal impact the treatments given during the trial may have on you.
 

 

What questions should I ask about where the trial takes place and who is responsible?Show [+]Hide [-]

 

Questions to ask 

Why ask these questions?

How could being in the trial affect my daily life?

Where will the trial care take place?

Will taking part in the trial mean staying away from home?

If yes, where will I have to travel?

How will I get there?

How often will I have to go?

How long will I have to stay?
 

These will help you in deciding whether the location where the trial care will be given is acceptable.

Who will be in charge of trial care?

This will make clear to you who is responsible for your trial care whilst you are taking part in the trial.


 

What questions should I ask about what the personal and cost issues are of being in a trial?Show [+]Hide [-]

 

Question to ask  Why ask this question?

Can I talk to other patients taking part in the trial?

You may feel that it would be beneficial to hear about other patients’ experiences.
Will there be any travel or childcare costs that I may need to consider while I am in the trial? This will help you to fully consider any further costs that may be involved.

 

Some useful termsShow [+]Hide [-]

If you are approached about taking part in the clinical trial or research of any kind, the doctors, nurses, and other professionals will sometimes use unfamiliar words and terms in order to describe the research. They are comfortable with these words as they use them every day in their jobs. However, it is possible you may not have heard them or understand what they mean. To help with this, some of these terms have been described below.

Control group (arm)

Patients in this group will receive the established or conventional treatment (See also Randomisation and Treatment Group).

Double blind

In some trials, so that they do not accidentally favour any one treatment, neither the patient nor the doctor/research team knows which treatment the patient is having (in fact, nobody knows this until the end of the trial unless, on very rare occasions, a doctor needs to find out for medical reasons).

Single blind

In some trials, so that they do not accidentally favour any one treatment, the patient is not told whether he or she is taking the new treatment being tested or the established treatment. Only the doctor/research team knows (see double blind).

Ethical Control

All research studies, including clinical trials, when funded by commercial drug companies are subject to the same strict codes of practice.

Ethics

All research studies, including clinical trials, are considered ethical only if the patient’s interests are put before anything else.

Open Label

In this kind of trial, both the patient and doctor know the treatment that a patient is having.

Placebo

A placebo is a type of treatment that looks exactly like the treatment being tested, but it does not actually contain any part of that treatment. Some studies compare a new treatment against a placebo to test if the effect of the new treatment is a true one or not.

Randomisation

Trials split patients into groups (also called “arms”) to look at the effects of different treatments. This means that patients who take part in a trial don’t have any choice in which kind of treatment they will be having (neither do the doctor/research team). The choice is usually made randomly by computer so the trial does not accidentally favour any one treatment – this is like tossing a coin.

Side effects

Preferred by some patients to be called ‘unwanted effects’ or known by researchers as ‘adverse events’. The treatments given by doctors in normal practice, as well as in clinical trials, may give unwelcome symptoms that might make you feel ill or perhaps interfere with your usual activities for a while.

Sponsor

Clinical trials are very expensive to run and often the funding comes from different sources, such as the Government, commercial drug companies and charities.

Treatment(s)

Treatments are what are given to patients, whether they are in a trial or not. Not all clinical trials use drugs as treatments. Some trials, for instance, look at different methods or surgery or the effects of different ways of giving  radiotherapy.

Treatment group (arm)

Patients in this group will receive the new treatment being tested.

Control Group

If a trial is comparing the standard treatment with new treatment the people receiving the standard treatment are known as the control group.

Research teamShow [+]Hide [-]

Investigator

Anybody who is involved as part of the research team. The Lead Investigator (or Principal Investigator) is the person who has overall responsibility for patient care as part of the research project.

Research Nurse

This qualified nurse supports patients throughout their involvement in a piece of research. The Research Nurse is normally the first point of contact if patients and/or carers have any queries about the study.

Research Radiographer

This qualified radiographer supports patients throughout their involvement in a piece of research. The Research Radiographer is normally the first point of contact if patients and/or carers have any queries about the study.

Clinical Trials Officer

The CTO is a member of staff who may be a health care professional or science graduate. The CTO is there to give you information about your trial, answer questions and organise your treatment, follow up and collect any information needed during the study.

Other Team Members

Other team members may include:

  • Dieticians
  • Occupational Therapists
  • Pharmacists
  • Physiotherapists
  • Psychologists
  • Radiographers
  • Social Scientists

Further informationShow [+]Hide [-]

This information has been developed in partnership between patient representative groups and health care professionals.

If you would like any further information on any aspect of our Clinical Trials Unit, all correspondence should be addressed to:

Clinical Trials Unit
Northern Centre for Cancer Care 
Freeman Hospital, High Heaton
Newcastle upon Tyne
NE7 7DN

Sister F Chapman
Telephone:   (0191) 213 8441

We would like to thank the Clinical Trials Project, Sheffield for giving us permission to reproduce and revise this information.

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