Clinical Trials are a necessary exercise if new ways of providing information and treatment for patients are to be made available. They are vital to push out frontiers of knowledge in medicine, improving our understanding, improving treatment, improving quality of life for you. In the Clinical Trials Unit we benefit from facilities and expertise second to none, but despite this without people who are willing to participate in studies, there simply would not be a functioning Clinical Trials Unit. You are as much a part of the Unit as we are and we would like to take this opportunity to thank you for trusting us and being willing to put your self forward for studies. Working together, we are making new in-roads into the knowledge and treatment of disease.

So - Who are we?

For those of you who are currently taking part in a study, or have taken part in one in the past, you will know who we are, where we are and, to some extent, what’s involved. For those of you who have given your name for the database but have not gone further in the system, here’s a little bit of information to try to answer some of the more common questions.

There are a team of us working on Clinical Trials. Caroline Wright is the Manager, Rachel Thompson and Jenny Jackson are Research Associates. The Unit is part of the Respiratory ‘arm’ of the Division of Academic Medicine at Castle Hill Hospital, headed by Professor Alyn Morice. The Department includes a team of doctors: Dr Mulrennan, Dr Everett and Dr Hogg. We all work for the University of Hull or the Hull & East Yorkshire NHS Trust.

I'm not sure if I should get involved?

Sometimes people are worried that agreeing to take part in a clinical trial is leaving them wide open to be used as ‘guinea pig fodder’, upsetting their treatment and ‘dabbling’ with the unknown. We’d like to reassure you that we don’t do that sort of work here. All our studies gain Ethics Committee approval before commencement, which means that this auspicious group is happy that the study is safe, and that your health and well being are our priority. Moreover, should Professor Morice judge that it is not in your interest to take part in a study you would not actually be allowed to, whether willing or still deciding.

‘I don’t want to upset my doctor’

Some of our volunteers are worried that their consultant or GP or other health care provider might disapprove of their participation. Should you be suitable for entry into a study, the standard procedure is to consult whoever is looking after your treatment, giving them full information and opportunity to voice any concerns that they may have. Also, we provide you with information for your doctor and your progression through a study is documented.

What do you mean, ‘suitable for a study’?

It sounds rather ungracious doesn’t it, but basically when conducting research, it’s very important that the results actually mean something. Each study will have a set of inclusion and exclusion criteria, for example age, what medication is being taken, smoking history, allergies, symptom history, etc. They are designed to ensure that, as far as possible, all participating volunteers are as similar to each other as we can obtain. We can then talk with more certainty about the effectiveness of a new treatment.

What happens when you first visit the website?

If, from the information you have given us, it appears that you may be a suitable candidate for a particular study you will be given detailed information about the study and you will have an opportunity to email us any questions. One of us will reply, usually within 24 hours. If you are still happy to take part, we will ask you to electronically sign a consent form. This is not a contract binding you to us for life! It is simply to show that you understand what the study is about and that you are happy to take part. You are free to withdraw from a study if you decide to change your mind.

Depending on the study we will ask for details of your symptoms, your past medical history and medication. The study may call for more specific questions, for example, what is your blood pressure? Once we have the answers to these questions we will contact you to let you know if you are suitable for the study.

What then?

Well, assuming the results are OK, you would be enrolled onto the study. Usually, you would receive a recommendation of your diagnosis and a suggestion as to the best management suggested by the National guidelines. Sometimes you will be able to try treatment available over the counter. At other times the best recommended treatment may be prescribed by your doctor. Whatever the choice we will give you a letter to print off to explain the process and recommendation to your doctor. We will subsequently email you to find out how you are getting on.

Thankyou!