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For public and patients

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What is clinical research?

It is essential to improve our understanding of how new medicines and technologies can be developed to help in the fight against diseases such as cancer, heart disease, arthritis and diabetes. Scientists in laboratories across the world are tirelessly working to unlock the key to fighting disease by studying the basic mechanisms underpinning life and by doing this are able to create new medicines and techniques. However, these need to be tested in real people to make sure they are effective and any side effects are kept to a minimum. This is called clinical research.

Clinical research seeks to address two fundamental questions:

  • Does a new treatment work in people living with a particular disease? Is the new treatment more effective than existing treatments? Does it have fewer side effects than existing treatments? Is the new treatment a step forward in the treatment of the disease?

  • Is a new treatment safe? This is a vital aspect of research. If a new treatment is effective against a disease, it must also be safe to use in people. Assessments of safety represent a very significant component of clinical research.

Without clinical trials new treatments cannot be developed.

Below is a list of frequently asked questions which should help you learn more about clinical research and its benefits. Please don’t hesitate to contact us if you require further information.

Is research safe?

All trials are governed by strict, legally enforced regulations. Before they go ahead they undergo close scrutiny by an ethics committee. All research staff receives dedicated training about clinical research called Good Clinical Practise. In this way patients’ safety, wellbeing and rights are consistently maintained.

Medical professionals only include patients in studies who meet detailed criteria for being included on the study (see below) and continuously monitor their safety throughout.

Through these channels, risk to patients is kept to a minimum.

How do I benefit from being in a trial?

If you enter a trial, there is a possibility that you will receive the latest treatment and this treatment might prove to be more effective than the ‘standard’ care. However, if the trial is testing a new treatment it is often necessary for the doctors to compare the treatment with the ‘standard’ care, and this means you might not receive the new treatment. You should note that you cannot choose which treatment to receive. Whichever treatment you are given, in research you will receive a high level of attention from our clinical staff, and many patients find this attention to be reassuring.

How is a trial managed?

Before a trial can recruit volunteers and start it must have in place a detailed blueprint known as a ‘protocol’. The protocol is compiled by many leading experts in the field and is carefully scrutinised by an independent Ethics Committee to ensure the safety, rights and wellbeing of study participants come first and are protected at all times. This protocol will let you know the healthcare professionals responsible for the various study activities; the number and medical status of participants required at the outset; the precise treatment you will receive; medical tests and assessments.

Can I get paid for being in a trial?

Patients who participate in certain studies receive reasonable travel expenses and refreshments.

What if I change my mind and decide to withdraw from a trial?

Participation in clinical research is entirely voluntary. Anyone taking part in a study can withdraw at any time without giving a reason. Withdrawing from a study or a decision not to take part in a study will not affect the quality of care you will receive.

What sort of questions should I ask when I consider joining a trial?

You will have a hospital appointment where we will determine your suitability to join a trial and will provide you with enough information to decide whether joining the study is the right choice for you. This information will include written material which you can study at leisure. You will be told about any possible risks as well as potential side effects. You will also be given the opportunity to ask any questions you have about the trial. Some issues you might like to raise are:

  • what is the purpose of the study?
  • why am I being considered and approached for the study?
  • how many other people have undergone this new type of treatment so far?
  • how long will the study last?
  • who can I talk to if I have any questions?
  • how many appointments will I have at the hospital?
  • what restrictions are there on what I can do while in the study?
  • what will happen to any of my samples or information collected during the study?
  • what happens if my illness becomes worse?
  • what happens if something goes wrong?

Will my information be kept confidential?

A clinical trial could involve the activities of a range of medical professionals which means that more people than just your doctor will need to see your medical information. However, your confidentiality is assured by the Data Protection Act. On some occasions your data will need to be shared with other hospital sites, and in this instance steps are taken to anonymise your details. And, of course, when doctors publish the findings of a trial they are not allowed to include your name unless they have specifically obtained ethical approval for this purpose and you have given explicit consent.

What does participation mean?

Your involvement and the time that each study takes will vary depending upon what is being researched and what tests or measurements are needed. The researcher will give you further information about the estimated length of the proposed study and what to expect if you agree to take part. To get a feel for what might be involved, you can visit the NHS website.

Is profit the main motive for trials controlled by drug companies?

Although it is true that drug companies need to recompense shareholders, they re-invest billions of pounds of their income into the medical research process, some of which spills into clinical trials located in hospitals around the country. In this way drug companies have become leading players in making cutting edge discoveries in medical care.

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