FAQ
- How safe is it?
- Will I be paid for taking part?
- Can women take part?
- How long do the trials last?
- How often I can take part?
- What happens first?
- What sort of medicines do you test?
How safe is it?
Before any participant can take part in a clinical trial, we take great care to ensure that you are suitable to do so. Participants are required to undergo a thorough medical examination which includes taking blood samples for a variety of tests (including Hepatitis and HIV) as well as performing a tracing of your heart (ECG) and blood pressure. Clinical trials are carried out under the strict supervision of qualified doctors, nurses and other health professionals. All our trial protocols are reviewed and approved by the Independent Review Board.
Will I be paid for taking part?
By participating in a Phase I (healthy participants) study, it is not anticipated that you will receive any therapeutic benefit and it is therefore, considered ethical and apt that you should be paid for your time and inconvenience. All payments we make for trial participation will have been approved by an Independent Review Board. The method and frequency of payment will be described in detail in the Informed Consent Form.
Can women take part?
Women can take part in certain clinical trials where either the drugs are available on prescription presently or where we have more detailed knowledge of the drug and possible effects on pregnancy. Whilst a lot of our trials tend to include only men, we do run trials which involve women - for up to date information visit our Trial Listing page.
How long do the trials last?
Each trial varies in length you may for instance, be required to be resident in the unit for anything from 3 nights to 3 weeks. However, for the majority of trials we carry out it will be necessary for you to visit the unit on several occasions over a period of weeks, each stay lasting between 48 and 60 hours.
How often I can take part?
For your health and safety it is important that you do not take part in trials too often and especially not simultaneously i.e. enroll to take part in studies with us and at other centers. If you have taken part in a clinical trial and you are unsure about when you can next safely participate in another one, we are always more than happy to discuss this with you.
What happens first?
If you want to be considered for a particular trial you would make an appointment to come to the Unit. You will be given the information about PAREXEL and the upcoming clinical trial as soon as you arrive.
Having read the information about the trial, one of the doctors will take you through the background and purpose of the study giving you a chance to ask any questions you like. We sometimes do this in small groups and find this approach allows you to get the best understanding of what the trial is all about.
Before anything else happens you must consent in writing to taking part in the study. Once you have done this we will make some measurements (typically height, weight, blood pressure, ECG - a totally painless recording of your heart's electrical activity - and anything else that is required by the specific trial protocol). You will be examined by the doctor and have a chance to discuss the trial with him or her in private. Blood samples (equivalent to a few teaspoons of blood) will be taken through a needle in the arm and we will ask you to provide a urine sample that we will test for recreational and other drugs. Usually that's about it for what we refer to as the 'screening' phase of the study. This usually takes place up to three weeks before the trial itself starts.
It will take a few days before the results of your tests come back. If everything is OK you may be offered a place on the trial. Occasionally we may need to repeat some of the tests and you will be asked to come into the Unit so that we can do this.
The staff will confirm the dates of the trial with you and give you details of what you will need to bring with you for your stay. Remember - at any time you may exert your right to withdraw your consent to take part.
What sort of medicines do you test?
Pharmaceutical and biotechnology companies use the Unit to conduct trials in a wide range of areas. Some of the medicines are newly discovered and may eventually lead to breakthroughs in disease management and patient care. Other trials involve medicines that have been marketed for many years, but the manufacturer may want to develop an improved formulation or a try out a new delivery system. We have conducted trials with a wide range of medicines including those for:-
- cardiovascular disease (problems with the heart or circulation)
- respiratory disease (diseases of the lungs - such as asthma)
- disorders of the central nervous system (such as epilepsy, depression) & treatments for pain
- gastrointestinal disease (disorders of the stomach, gut or bowels)
- metabolic disorders (including conditions such as diabetes)
- infectious diseases (e.g. antibiotics for organisms resistant to current treatments)
3001 South Hanover Street - 7th floor, Baltimore, MD 21225
Free Phone 24 hour: 877-61-STUDY | Email: study.baltimore@parexel.com
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