Read more about why we need clinical studies in the UK, who organises them, whether to participate and the confidentiality of your personal information.
About clinical studies
Organisation
Participation
About clinical studies
- What is a clinical study?
Clinical studies are studies performed with human subjects to test new drugs or combinations of drugs, new approaches to surgery or radiotherapy or procedures to improve the diagnosis of disease and the quality of life of the patient.
Most hospitals and many doctor surgeries take part in clinical study, which are only begun after laboratory studies have outlined the potential safety of a new treatment or procedure and that it has the potential to work better than existing methods.
- Why do we need clinical studies?
None of the existing treatments result in a cure of all patients, nor are they without side effects, and doctors continue looking for better ways to treat the disease. It is also important that we study the safety of our treatments in special populations such as children, the elderly and those with liver or kidney disease.
What information do we get from clinical studies?
Any new treatment or procedure will be investigated using a whole series of clinical studies, each one designed to answer a specific set of questions.Clinical studies are also organised into different phases of research, in order to build up a greater understanding of the new treatment, before it is approved or recommended for routine use.
Phase I - the first studies in humans are Phase I studies. They are performed with small numbers of patients or healthy volunteers and are used to answer questions such as what dose of the drug is likely to be effective and what side effects might occur.
Phase II - these studies continue this process with larger numbers of patients.They have a greater focus on how well the treatment or procedure works, perhaps in particular situations or groups of patients.
Phase III - these studies enrol large numbers of patients and are used to compare the effectiveness and safety of the new treatment with that of the standard existing treatment. Information obtained from large Phase III studies that demonstrates the benefits a new drug over the existing treatments is sometimes presented to regulatory authorities in order to obtain a licence to market and sell the drug.
Organisation
- Who organises and runs clinical studies?
A number of different organisations, agencies and companies may be involved in a single clinical study. For example, the study may be guided by a team of researchers and funded by resources from a public health agency, a research organisation and/or a pharmaceutical company.
The clinical study is managed by a principal investigator (a medical doctor with considerable experience in research) who leads a research team, composed of other doctors, scientists, nurses, psychologists and other medical and research professionals. A wide range of specialists contribute to the clinical study design and to the analysis, interpretation and presentation of the results.
If you should decide to participate in a clinical study, before enrolling, you should request a clear explanation of the purpose of the study and the role of each sponsor.
Before a clinical study can start the doctors concerned have to explain and justify what they wish to study and how they wish to study it to a supervisory board of other doctors (a so-called Review Board or Ethical Committee). Part of this review body’s job is to ensure that your rights are protected, and that the highest standards of clinical practice will be observed.
Participation
- Should I participate in a clinical study?
There are advantages and disadvantages to taking part in a clinical study.
Advantages - you will be cared for by doctors who are familiar with the latest information about treatment and you will be monitored very closely. If the treatment being tested is beneficial you could be one of the first to benefit from it. Particularly if you are not responding well to the current therapies, a clinical study might give you access to an alternative that will work better. In addition, you will be personally contributing to a better understanding of the disease as the study will provide valuable knowledge about the disease area and the effectiveness and the safety of the treatment for the benefit of the whole community
Disadvantages - new drugs and procedures can have unexpected side effects or prove to be less effective than the existing procedures, and even if the procedure works well for many patients, it may not work well for you. The careful monitoring required in a study can mean more visits to the hospital and more testing than would be necessary outside of a study, and this may prove disruptive to your life.
As with all issues regarding health and medical care, the decision to take part in a clinical study should be reviewed carefully and discussed in detail with your doctor. It is important to learn as much as possible about the specific treatments under investigation and how appropriate these are to your particular case. You should be prepared to ask your doctor about the possible risks and the possible benefits that you may get from the treatments being offered in the study.
It should be remembered that in most studies the different treatments are allocated randomly to the patients who enrol and neither you nor your doctor can choose which one you receive. Furthermore, most studies are also conducted ‘blind’ and neither you nor your doctor will know which of the treatments you are receiving until the end of the study. In addition some studies include a “control” or placebo group of patients, who are given “dummy” medication that does not contain the medicine which is being studied.
If, at the end of the study one treatment is found to be better than another, the opportunity to move onto the better treatment may be discussed with you, if it was not the treatment that you were receiving during the study.
- Can I change my mind after I have enrolled in a clinical study?
You will never be enrolled in a clinical study without being asked first and also having given written consent to take part. However, you can, for any reason, decide not to continue to take part in the study and your doctor will then offer you the existing treatment for your particular condition.
You can withdraw from a clinical study, without explanation, at any time.
- Will the information about me from the study remain confidential?
The information from the study, including your personal case notes, will need to be checked by the people running the study. They, in addition to the doctors at your hospital, may include a number of other specialists, people from the pharmaceutical company who produce the test treatment, and possibly people from the national drug regulatory organisations.
However, all your personal details will be kept strictly confidential and you will be identified in the study only by a code number and not your name.
Date of preparation: 28th January 2008
C14230
