Frequently Asked Questions

What will happen to me if I take part?

You will usually visit our clinic quite often. You (and your carer if appropriate) can claim back your travel expenses for getting to and from the clinic (please keep your receipts or tickets, and show them to the study doctor or nurse). You may be given medication and we will ensure that that you fully understand how to take any medication. Your blood pressure and pulse will usually be monitored at every visit, and blood samples may be taken for safety measurements regularly during the study. A physical examination will usually be performed at the beginning and end of the study.

What are the possible benefits of taking part?

We hope that the treatment given to you in a study will help with your condition but this cannot be guaranteed. The information we get from this study may help us develop new treatments for the condition, which may benefit you and other patients in the future.

What are the possible side effects and risks of taking part?

It is possible that you may experience some side effects while taking the study medication. Our doctors are always available to talk to for any symptoms.

Will I have any side effects to procedures or tests?

Some people feel faint when they have blood taken, and there may be some pain and bruising where the needle goes in. Some people feel weak and dizzy after fasting or blood and glucose tests. If you are affected, you should not drive to the clinic, and you should ask someone to accompany you on your journey.

What if new information becomes available during the study?

Sometimes, during the course of a research project, new information becomes available about the treatment that is being studied. If this happens, your study doctor will tell you about it, and discuss with you whether you want to continue in the study. If you decide to stop taking part in the study, your doctor will advise on the most suitable treatment for you. If you decide to continue in the study, you will be asked to sign a new Consent Form. Also, on receiving new information, your study doctor might consider it best to take you out of the study. He/she will explain the reasons and arrange for your care to continue. If the study is stopped for any other reason, you will be told why and your continuing care will be arranged.

What if something goes wrong?

If you are not happy with the general care and treatment you receive during the study, please speak first to your study doctor or nurse, who will try to resolve the problem. He/she should also tell you about the clinic's standard complaints procedure in case you wish to take the matter further. You can get a copy of the guidelines from the clinic, or write to: The Director of the Prescription Medicines Code of Practice Authority, 7th Floor, Southside, 105 Victoria Street, London SW1E 6QT, telephone 020-7747 8880, facsimile 020-7747 8881, email [email protected]

What happens at the end of the study?

About 12 months after the study ends your doctor will then be able to tell you which of the treatments you were taking. You can be given a copy of the results once they are publicly available, if you want a copy. Any report that is published about the study will not identify you or any other patient taking part.

Will my taking part in this study be kept confidential?

Your data will be coded and collected on a paper record/electronically and it will be kept confidential. To make sure the information collected in the study is accurate, it will need to be checked by researchers and authorised persons working on behalf of the pharmaceutical company and for government health departments. You are asked to give permission for these authorised people to see your medical records. They will keep the information confidential. Information from this study may be passed on to government health departments and subsidiary companies in countries within and outside Europe (the European Economic Area), for administering this study and for possible further scientific study. In some of these countries, the data protection laws are not as strict as those within the European Economic Area. The information passed on this way will never include your name. You have the right to check the accuracy of the data held and correct any errors. You are asked to give permission for us to let your GP know that you are taking part in a study (unless the study is arranged through your own GP). It is also possible that we will need to contact your GP for more information about you. If so, you will be told; and you will be given a copy of any correspondence. Please see our Privacy Promise for more information.

Are studies approved or checked by anyone?

Yes. A Research Ethics Committee must review and approve any research study. The Research Ethics Committee includes healthcare professionals as well as non-medical people. All members of the committee are completely independent from anyone organising the study. If you have more questions about a study, you can contact the study doctor at the clinic.

What will happen if I don't want to carry on with a study?

You are free to withdraw from a study at any time, without giving any reason, and without your medical care or legal rights being affected. All data up until the date of your withdrawal will be used. You retain the right to decide whether data from any post-withdrawal assessments can be used. If you withdraw from the study, researchers, authorised persons from the medical company and the regulatory authorities will still require access to your medical notes to verify the data collected up to the date of your withdrawal.

Do I get paid?

An ethics committee must approve all payments to patients, including reimbursements of travel expenses. It is usual for all reasonable travel expenses to be paid. Normally patients are not paid for their participation in trials where they may receive some medical benefit.

 

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