For some diseases and disorders either no remedy exists at present, or no remedy exists that is effective enough to cure or control the disease or disorder in question. The pharmaceutical industry is therefore occupied with the development of new medicines. Kendle Clinical Pharmacology Unit contributes to this by investigating the effects of new medicines and whether they are sufficiently safe. This is not possible without the help of volunteers. Together with you we work towards the development of new medicines that may help many people including yourself in the future.

What does drug research entail?

Research into new medicines takes place in four phases:

Phase 1 Study of healthy volunteers
In this phase we investigate both the safety of the new drug and how the drug is absorbed, broken down and excreted by the body. Firstly we study
the effects of single doses, starting with a low dose, and then we test several days treatment with the drug. The safety of the substance is carefully assessed with regular checks on blood pressure, heart function and blood and urine tests.

Phase 2 Study of small groups of patients
In this phase we evaluate the effectiveness of the substance in treating patients with the disease for which the medicine is being developed. Again the safety of the substance is carefully assessed with regular checks on blood pressure, heart function and blood and urine tests.

Phases 3 and 4 Treatment of groups
In phase 3 much larger numbers of patients are treated with the new medicine and the drug is compared with the best treatment already on the market.

In phase 4 studies are carried out on drugs that are already on the market in order to discover more about them or to look for new diseases that they may treat.

Can I participate?

You can participate in most of the Phase 1 studies if you:

• are in good physical and mental health
• do not use any medicines, or do use medicines but could stop without any difficulty
• are not (have never been) addicted to alcohol or drugs
• are not allergic to any medicines.

In addition there may be some specific requirements, depending on the research. For example:

• sex
• age
• proportion of height to weight
• smoking habit

You can take part in a Phase 2 study if you have the specific disorder or disease for which the medicine has been developed, or if you belong to the future target group. The use of medication for your disease is usually permitted in Phase 2 patients. For the rest the same requirements as for a Phase 1 study apply.

How do I know if I am suitable?

You can find out whether you are eligible for participation in a study by filling in the questions under Trials at Kendle. Via the registration form you can apply for the research of your choice. We will then contact you by telephone to ascertain whether you satisfy the research requirements. You will subsequently be invited to an information meeting and asked to undergo a medical examination. During this meeting you will receive a detailed explanation of the research and there will be the opportunity to ask questions.
The outcome of the examination is the deciding factor on whether or not you are eligible for participation.

How long does a study take?