Patients FAQ's

Frequently asked questions

Who organises clinical trials?
Clinical trials are usually organised and paid for by pharmaceutical companies, hospitals or charities.  However, the clinical trials are carried out by doctors and nurses at hospitals, specialist clinics or GP clinics.  Sometimes a type of company known as a ‘Contract Research Organisation’ can be asked by the pharmaceutical company to help organize and run all, or part of, the clinical trial on their behalf.

What procedures do the researchers have to follow?
The researchers planning the clinical trial must abide by certain written international rules.  There are ‘ethical’ guidelines (a moral code of conduct which puts the patient’s interests before anything else) and ‘Good Clinical Practice’ guidelines (how clinical trials should be performed).  Together these ensure that clinical trials are scientifically sound (so that they produce accurate and reliable results) and that the volunteers and patients taking part are properly cared for.  Before the clinical trial can start, the plans must be approved by committees of independent reviewers who will check that they comply with the guidelines mentioned above.  The independent review is performed by a local ‘ethics committee’ and also by the national regulatory authority (which reviews all clinical trials in the country).  These committees consist of medically qualified and non-medical people.

Why should I take part in a clinical trial?
There are several reasons for wanting to take part in a clinical trial.

• You may receive a new treatment that may be better than those currently available (note that in some trials you may be given a ‘Placebo’ which is an inactive or ‘dummy’ treatment; this is explained in more detail later).
• Your progress is often more closely monitored by specialist doctors and nurses than it might otherwise be in normal practice.
• You are helping others who have the same illness by increasing medical knowledge and assisting in the development of new and improved medicines for the future.  If you are taking any medicines now it is likely that you are benefitting from the clinical trials performed on patients in the past.

What are the risks and drawbacks?

• The new medicine may not work better than the best current treatment.
• You may not know which treatment you are receiving until the end of the trial.
• There may be unexpected side-effects.
• You may have to make more trips to the clinic, which will take up your time.

Why have I been chosen?
Your doctor or nurse will contact you if they think you may be able to participate in a clinical trial based on what they know about your age, sex, medical history and current condition. 

What does a clinical trial involve?
You may be invited to attend the clinic so the doctor or nurse can tell you more about the trial.  The information they give will include what the new medicine is, what the trial is trying to find out, what the likely side-effects are, what tests and procedures are involved, how long the trial will last and the number of trips to the clinic.  For each clinical trial there will be specific instructions for the doctor about who can be involved. For example, the age they should be, the state of their general health and other medicines they can or cannot take.  This is because the people taking part must be as similar as possible and the doctor must avoid including people who may be put at risk by the procedures and treatments involved in the trial.  Your doctor or nurse will tell you whether you are able to participate. If you agree to participate you will be required to attend the clinic on certain dates. It is important that you understand how many times you are required to attend the clinic and over what period of time.  At these visits the appropriate tests and procedures will be performed; these often include blood tests and physical examinations.  Other tests and procedures may include x-rays or questionnaires, for example.  It is important to understand what the tests and procedures actually involve and how many times they will be done.  You may be given a dose of the new medicine whilst you are at the clinic or you may be given a pack to take home and use (depending on the condition being studied).  You may be asked to complete a diary card between visits if specific information is required by the trial, for example daily temperature, and you can also record the details of any side-effects or other medicines taken.  The final visit in a trial is often just a check-up to make sure that you are well before you leave the trial.

How long does a clinical trial last?
The trial may last just a few days involving perhaps only two or three trips to the clinic whilst other trials may last years involving several trips to the clinic.  At each visit the appropriate trial procedures will be performed.

What is Informed Consent?
This is your freely given agreement to participate in the trial, based on an understanding of the information which has been given to you.  The doctor or nurse will tell you about the trial and answer any questions you may have.  You will also be given written information about the trial to take home with you (often called a ‘Subject Information Sheet’).  You will have the opportunity to think it over and talk about the trial to family, friends or your GP before deciding what to do.   Participation in a study is entirely voluntary.  If you do decide to participate in a clinical trial you will be asked to sign an ‘Informed Consent Form’.  By signing this form you are confirming that you have understood all the written and verbal information that has been given to you and that you agree (consent) to participate in the trial.  It does not affect your legal rights.  You will be able to keep a copy of the Informed Consent Form and you can continue to ask your doctor or nurse any questions that occur throughout the trial. 

Can I change mind?
You are allowed to leave the trial at any time if you no longer wish to continue, without having to give a reason.  This will not affect the quality of care you receive afterwards.

Will my doctor be paid for my participation in the clinical trial?
A payment is usually made to the hospital or the department research fund for your participation.  Part of this payment is to cover the cost of procedures that must be performed (for example, blood tests), the staff required to run the clinical trial and any administrative work. Your doctor should tell you they are to receive any such payment. This should not influence why they have asked you if you would like to participate, or your decision.