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| Why Volunteer | A A A |
New forms of medication are continually being developed for the treatment of disease. However, the process is complex with many stages of development before a new medicine can be used to treat patients.
Every promising new drug must be extensively investigated before it is thought to be safe to be given to humans. It is then tested in healthy volunteers to determine certain properties of the drug; the correct dosage, the safety of the drugs, and how long a drug may remain in the body etc.
Healthy volunteers and patients play an essential part in the development of new drugs, treatments, assessing products and helping to test new and existing medicines to combat disease.
What happens and what is required?
How do Clinical Trials work?
Every promising new drug must be extensively investigated before it is thought to be safe to be given to humans.
Clinical trials play a vital role in the development of new medicines and it is thanks to people volunteering for clinical trials that it is possible for them to be fully investigated and advances in medicine to be made.
Phase I Clinical Trials
In Phase I trials a drug is tested for the first time in a small group of healthy volunteers mainly to determine the early safety profile as well as to gather information on the pattern of drug distribution and absorption, metabolism and other pharmacologic actions of the drug in the body. These studies are carried out at dedicated research facilities, such as the Chiltern Clinical Research Unit.
Phase II Clinical Trials
In Phase II clinical trials the drug is tested for the first time in patients with the actual disease condition of interest. In these types of trials information is collected on the initial efficacy of the drug, its optimal dosage and further details concerning its safety. Phase II clinical trials are carried out at multiple investigator sites and are often international.
Phase III Clinical Trials
Phase III clinical trials are large scale, multi-center studies that are carried out in a large number of patients with the target disease. In these types of studies it is important to gather enough data to statistically demonstrate the efficacy of the drug and further safety information. This information is required by the regulatory authorities, who will examine in it before deciding whether to approve the new medicine in their country.
Phase IV Clinical Trials
Even after a drug has been approved, clinical studies continue to be conducted in order to gather more information on the drug used in the general population. These types of studies are known as Phase IIIb or Phase IV clinical trials. They are structured to obtain long-term safety data on the drug in specific or additional patient populations, data for different formulations or even to gather economic information on the use of the new drug.
Why choose Chiltern?
At Chiltern we have over 20 years experience in clinical research, testing medicines and new products for the worldwide pharmaceutical industry and currently have over 4000 healthy volunteers between the ages of 18 and 75. We pride ourselves on our friendly professional approach and our experienced recruitment team will be delighted to answer all your queries.
We have a purpose built 30 bed clinical research unit, (CCRU), conveniently placed just west of London where the comfort as well as the safety of our volunteers is very important to us. It offers a volunteer lounge where you can watch videos, play pool, or generally relax. Beds are curtained for privacy and have lockable bedside cupboards for safekeeping of valuables. Our housekeeper is on site to assist with meals. Previous Chiltern volunteers will vouch that these are not your average hospital meals!
As trials often require staying in for several days or short visits to the unit an appropriate payment is made at the end of the trial as compensation for the time devoted to the trial. A travel allowance is given to cover travel expenses to the unit.
Chiltern Japanese Panel
Chiltern has a panel of both male and female Japanese volunteers. In order to license medications in Japan it is necessary to find out whether in Japanese a drug differs from that of Western Caucasians, Chiltern International is one of the leading organisations using Japanese subjects for such clinical trials in the United Kingdom and has over 6 years experience conducting clinical trial using Japanese volunteers.
JSTV is available for our Japanese volunteers and Internet access is provided.
Chiltern also provides an onsite Japanese national interpreter to help with any language difficulties and welfare. Japanese volunteers will have all study details and written information translated into Japanese and procedures of the clinical trial will be explained thoroughly before participation.
What happens and what is required?
During any drug trial volunteers safety and good clinical practice are our primary concern.
Volunteers are seen by one of our medical doctors to check their suitability and health before entering a trial. This might include a blood and urine sample, height, weight, an ECG to monitor heart and blood pressure. Volunteers will be tested for recreational drugs. This is an additional safety measure to detect any illegal drug substance, which may react with the medicines on trial.
A full explanation of the study will be given by one of our doctors and volunteers will be asked to sign a consent form indicating that they understand the nature of the trial and are willing to take part.
All volunteers are free to withdraw from the trial at any time without detriment to their medical care.
Is it safe to volunteer?
Trials are conducted under strict medical supervision in our Clinical Research Unit (CCRU) near Slough, West of London. An Independent Ethical Research Committee reviews each trial to ensure that the highest possible safety standards are maintained to protect the rights, safety and well being of the subjects. Our qualified staff include: full-time medical doctors, experienced registered nurses and technicians.
Who can take part?
Both Male and Female Volunteers may apply, depending on the criteria for the trial. The age range is normally between 20 and 45, however we do run trials using volunteers of all ages. As a form of identification volunteers are ask to bring in their passport and UK nationals are also required to bring details of their national insurance number.
FAQs
Can I smoke / can I drink alcohol?
Restrictions depend on the trial; smoking may be permitted, or restricted to generally no more than 10 cigarettes a day. If smoking is allowed there are designated areas in the unit. Restrictions on alcohol depend on the trial. No alcohol is permitted in the unit.
Can I do exercise?
This may be restricted during your trial, you will be advised what to do.
Can I drink coffee?
This may be restricted during your trial, you may also be asked not to eat or drink anything containing caffeine, which would include CHOCOLATE, and cola type drinks.
Are there contraceptives requirements?
Usually you will be asked to use a double barrier method of contraceptive. This means if you are a male you will be asked to use a condom and your partner will also have to use a method of contraceptive as well.
Will I be tested for HIV?
It is standard practice on most clinical trials to be tested for HIV, Hepatitis B and C. The results of these tests are all confidential.
Will I be tested for recreational drugs?
YES, you will be tested at screening and often at every admission period for recreational drugs, which includes cannabis, "Es", and other hard drugs. Be warned cannabis stays in your system for at least 3 weeks.
What do I receive for my participation?
You could receive as little as £25 or over £1000 depending on the type of study you apply for. There will be a payment of £15 towards travel expenses.
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