Frequently asked questions about clinical trials

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If you’ve ever considered participating in a clinical trial, no doubt you have a lot of questions. Here are some answers to those frequently asked questions:

Are the trials safe?

Trials need approval from independent bodies before they can take place. One such organisation is the Research Ethics Committee. This means that you can be confident that studies are safe and designed with volunteer safety at the forefront. The REC examines matters such as health, ethics and safety before sanctioning the start of a Paid Medical Trial.

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Healthy volunteers are used for trials only when doctors have decided the study is safe for them to participate in. However, there are some instances with new drugs where not all potential side effects can be known. It is for this reason that volunteers are provided with an information and consent form before the start of the trial. This provides all the information you need to know, enabling you to make an informed decision about whether you want to proceed and possible side effects. You are given lots of time to read this information and make a decision. Doctors and staff are available in the trial location 24/7 to look after the volunteers. For more details on Paid Medical Trials, visit Trials 4 Us.

What about side effects?

Some people will experience side effects whether they participate in a trial or simply use over the counter medicines. Some cold and flu medicines make people feel drowsy for example. Side effects are usually minor and go quickly with no harm done. To suffer serious side effects is highly rare and medicines used in trials are administered to volunteers in much lower doses than have been deemed safe in animals.

Will any medicine stay in the body?

Different drugs dissipate at different rates, but the majority of drugs are eliminated from the body within 3 months of the last dose being administered.

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How many people take part?

This depends greatly on the trial but is normally around 8-24 volunteers per trial.

What does a ‘definite place’ mean?

If you’ve received an offer of a definite place on a trial, this means that you have passed the pre-trial screening and admission tests and have a guaranteed place on the trial.

If I drink alcohol will I be excluded?

Most trials can still be participated in if you drink less than 21 units weekly for a man and 14 units for a woman. Drinking more than this may mean not passing the blood tests at screening.

What about smokers?

This depends a lot on the nature of the trial. Most trials are just for non-smokers, but some include both non-smokers and smokers. There are usually restrictions for smokers on trials, such as less than 10 a day and there is no smoking allowed at units.

How many blood tests are there?

Many people are not big fans of blood tests, so this is an important question. The reason why blood samples are needed is to monitor how much of the study medicine is in your system. How many tests will depend on the nature of the trial but sometimes a cannula is applied so blood doesn’t have to be taken by needle each time.

 

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