A clinical trial is a medical research study that tests a medicine or treatment to see if it is safe and if it works. Before you participate in a study, you must be given complete information including possible side effects, risks and benefits. You must sign an patient information sheet before participating in the study. You may leave the study at any time. For more information, please visit http://www.sarahcannonresearch.co.uk.

A clinical trial is also known as a medical research study. It is a carefully-designed test of medicines and treatment options under the supervision of a doctor. These studies rely on people, referred to as study participants, to try the new medicine or treatment. Any participation is voluntary. The medicine or treatment may be described as “investigational”, which means it is being tested to determine how well it works and/or what side effects it may cause. For this reason, every study participant is closely monitored with medical tests and examinations before, during and after the clinical trial. In some clinical trials, the medicine being studied is already used by doctors but is in a clinical trial to test it for a new disease, new dose or in new combinations. Clinical trials must follow strict rules set by the Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health. Each trial must be approved by an Ethics Committee (EC) in the UK. An EC is an independent committee of healthcare professionals and non-medical members. Before the study goes ahead, the EC makes sure that it is ethical and that the highest standards of safety will be maintained.

Individuals participate in clinical trials for a variety of reasons including access to new treatments before they are widely available, advancement of science or improved medical care. Study participants can benefit greatly from clinical trials by receiving access to the most promising investigational cancer treatments available. This helps in the possible development of a new medicine or treatment that may offer better care or a cure for life-threatening and chronic diseases. Whatever your reason for participating, you can be sure you will receive quality cancer care while on a clinical trial.

Before you enrol in a study, a detailed description of the study as well as any possible risks and benefits of participating will be discussed with you by your consultant or research nurse. All this information will be provided in writing in what is called a “patient information sheet”. When you sign this form you agree to participate in the study. You will be given a copy of your informed consent for your own personal reference. You may be given a physical examination and your medical history will be reviewed. Once you are enrolled in the study, you should feel free to discuss your medical care with the doctor or any research staff at any time during the course of the trial. It is important that you take all the medication as prescribed and keep all scheduled visits. It is also important for you to answer questions regarding how you feel or whether you have been taking the medication at the scheduled times. Your study doctor needs to record any symptoms, no matter how minor they may seem. If you miss a dose of the medication or do not take it on schedule, tell your doctor or research staff. As a study participant, you have the right to withdrawal from the study.

The patient information sheet will list the side effects of the study medicine. Because some of the medications being tested are new, some side effects may still be unknown. Some medications being tested can have serious side effects.

Data collected during a clinical trial may eventually lead to a new medicine being approved by the MHRA and may help develop medications that are safer, more effective and work better than current medicines.

After the study treatment is complete, some participants will be followed up with via a phone call or letter every few months. All of the information collected is analysed to help determine the study drug’s safety, effectiveness and side effects. MHRA medical advisors and specialists closely review this data before considering any new drug for approval. After a drug has been approved by the MHRA, studies continue to compare the new drug with other drugs already on the market. Other studies may research whether it can be administered to children or special populations, its long-term effectiveness and impact on the quality of life.

The information below should help you to understand the types of visits you may have with us and how to prepare for them.

You may be referred to us through either your oncologist or general practitioner; all referrals must come through a medical practitioner. If you have heard about a trial we are conducting that may be suitable for your cancer type you can ask your GP or oncologist to refer you.

We are open from 8am to 8pm, Monday to Friday. Once you have been referred to us one of our team will get in touch with you by email or telephone to arrange your appointment in advance and we will be ready for you in reception when you arrive to accompany you to meet your consultant.

At this consultation appointment you can discuss with the doctor whether you may be an appropriate candidate to participate in a clinical trial. To help decide if a trial may be suitable for you we may have to perform some simple tests, such as a full blood count and an ECG, these will be done during your visit. We will also discuss with you what is involved in participating in a clinical trial and answer any questions you have.

The research team needs to have an accurate record of the medication you are taking to ensure that the medication does not interfere with the research treatment so please can you bring all your medication with you or provide a complete list of:

Any medicine that you are taking prescribed by your doctor, bought from a pharmacy, supermarket or via the internet including: homeopathic medicines, herbal preparations and indigestion remedies. This includes capsules, creams, inhalers, liquids, patches and tablets.

Following your first clinic appointment, if the doctor thinks that you may be a suitable candidate for a trial, they will take your case summary to our weekly 'Patient Allocation Meeting.' This meeting is a multidisciplinary, meeting to allocate patients to open trials. The purpose of this meeting is to make sure that patients are selected in order of suitability and that decision needs to be made by a group of research professionals working in partnership with our research team at SCRUK e.g. Radiologists, Pathologists and other Oncologists.

If you are allocated to a trial you will be informed immediately and we will send you the patient information sheet relating to the specific trial so that you have time to consider in more detail what is involved. When you next visit us we will confirm whether you want to participate and if you do we ask you to sign a consent form. Only after you have consented to take part will we begin the screening tests specifically related to the trial treatment you are going to receive.

You will be given more information about the steps involved in participating in a trial by your doctor, including the consent process.

You will be given a schedule in advance of all your appointment dates. The length and type of appointment will vary for each trial, for more information please discuss this with a member of the research team. It is likely that you will be with us for a full morning or full afternoon, or sometimes all day, so you may wish to bring a book, personal stereo or similar form of entertainment to pass the time. Alternatively computer and satellite television channels are provided here. We recommend that you wear loose comfortable clothes.

The process at the end of each trial will also vary, however you will always have an in depth consultation with your doctor to discuss the next steps involved in management of your disease. Throughout your treatment we work in close collaboration with your referring doctor, and update them with your results and treatment plans.

We also conduct an end of trial interview with our patients to ask them about the experience of participating in a trial at SCRUK and ask patients to fill in a questionnaire relating to this.

You may decide at any stage before or once treatment has started that you no longer want to participate. You do not need to give us a reason why, although we are always happy to discuss the matter with you.

Sometimes patients referred to us are not suitable for trial, this may be for a number of reasons. Our research team will discuss this with you and you will usually be referred back to your GP or oncologist.