Research is carried out within the diabetes department. The research can be for new drugs or insulins; new regimens of insulin therapy, new devices to be used or how current practice can be improved.
All the research that is done has to be approved by the hospital’s local research ethical committee and the research and development committee. These ensure that the research being done is ethical and safe and that the person taking part will not have to do anything that is not considered to be unnecessary or harmful.
The drug trials that are done are also governed by two other guidelines.
GCP – Good clinical practice – this is an international ethical and scientific quality standard for designing, conducting, recording and reporting of trials that involve human subjects.
ICH – international conference on harmonisation – this provides a standard for the European Union, Japan and the United States, so that the regulatory bodies in these countries can mutually accept clinical data.
Each trial looks for a specific type of patient and only certain people will fit the criteria.
If you fit the criteria you may be asked if you would like to take part in a trial. There is no obligation to take part. All participation in the trials is entirely voluntary and at any time during the trial the person can change their minds and this will not affect their routine medical care.
The nurse will explain briefly on the phone the main points about the trial; you will then be sent a detailed information sheet in the post. You will have time to read this and ask any questions before agreeing to take part.
Trials vary in length from a few months to several years. The number of visits to the hospital can range from weekly to once every two to three months. There is no set pattern and each trial needs to be looked at individually.
You will see one of the consultants and a research nurse at the first visit. On most of the subsequent visits you will see the research nurse, who is dedicated to work on that trial.
This depends on the trial. If you are interested in taking part you need to know what the trial asks you to do before you start. The following is some of the things people have been asked to do; it will vary:
Your GP will be informed that you are on the trial and will be sent an information sheet to inform him or her more about the trial. Your GP is free to ring the consultant to discuss this in more detail.
If you have been on a new drug that is not yet available on the market then the consultant will discuss with you the best treatment available for you now.
If you have been taking a new drug and it is available and you felt it was of benefit to you, then you will discuss this with your consultant and if you both think it will benefit you then there is a good possibility you can stay on that drug.
All participation is voluntary and there is no payment for taking part. However you will be reimbursed for any expenses that you have to pay for to get to the hospital. Normally the company sponsoring the trial will pay your petrol money and the cost of the parking. If you have no transport then often a taxi can be arranged.
Author: Karen Norcott (Diabetes Research Nurse)