The first thing people ask you when you tell them about drug trials is “What – are you taking drugs?” or “Oh, so they cut off your toe and sew it back on again?”

Nevertheless, whatever the myths or opinions abound, drug trials remain one of the most popular and easy ways for many South Africans to earn a good (and quick) buck.

What It's All About

Generally medical trials are sponsored by big pharmaceutical companies who want to do research on their products – testing how the human body tolerates the drugs. Ways of improving drug performance, evaluating cost efficiency and the actual effectiveness of the drug in the human body are investigated. They do this through research units, which recruit volunteers for particular studies. Each study is different, but it's about research, as outlined above, and not about cutting off parts of your body or stopping your heart for a few seconds. All studies conducted at a unit have to be approved by an independent ethics committee, and only healthy and suitable volunteers will be allowed to take part in a study. (In England medicine is still called “drugs” – this must not be confused with commercial drugs!)

Who May Take Part?

This can differ from study to study, but generally these are the requirements:

•You have to be older than 18 years;

•You may not be a vegetarian;

•You must be a non-smoker (though there may be exceptions);

•If you are a woman, you may not be pregnant or become pregnant during the study;

•You must be healthy, although certain studies look for people with e.g. asthma to do research on the condition and to find a cure for it.

Before you are allowed to take part in a study, you will have to pass a screening test in order to determine your state of health.

Screening Test

The screening is a thorough medical examination, which determines the state of your health and suitability for a particular study. It usually takes place within 14 days prior to the study and takes 1-3 hours. The following is involved:

•A urine sample – test for drug abuse, medicines, etc.;

•A blood sample – test for HIV and hepatitis;

•Blood pressure, body temperature and pulse;

•An electrocardiogram (ECG) and/or brainwave recording (EEG);

•Breath test for alcohol and carbon dioxide levels (to determine whether you smoke);

•Measurement of height and weight ratio;

•Pregnancy test for female volunteers;

•You must provide your GP's telephone and fax number, as well as postal address;

•You must fill in a health questionnaire about medical history and health interview by doctor;

•A doctor will do a general examination and will also explain the intended study to you and give you the opportunity to ask questions;

•You will be given a written explanation of all aspects of the study;

•You are required to sign a consent form for an HIV test.

During the screening the study will be discussed with you, and it will especially be pointed out to you that you may withdraw from the study at any time, and how this will affect payment due to you. You will also be briefed on the history and other aspects of the unit, as well as the drug that is being researched. Everything, including possible side effects, times of testing and payment, will be discussed. Some units will only tell you when you have been accepted for the trial how much the payment will be.

It is important to abstain from the following before screening:

•Alcohol – 48 hrs prior, as it might be detected in urine, blood or breath;

•Heavy exercise – six days prior, as this might influence pulse and liver enzyme levels;

•Medicines – although medicine used a week or more ago is not easily detected, the rule is no medicines should be taken 4 weeks prior to the study;

•Drugs – if it is known that you have been using drugs in the past, the chances are very slim that you will get on to a study, but if you are willing to take a chance, abstain from all substances for at least a month before the study.

•Over the counter medicine – the rule is no such medications should be used 14 days prior to the study;

•Food – certain studies may require that you fast for about 12 hours prior to screening.

They will also claim that vigorous physical activity as well as sexual activity increases the liver enzyme level in your blood, which may rule you out. So keep it down, if you want that trial.

You will have to phone for your results on a given date, but note that the general exclusion criteria are:

•Detection of drug abuse, e.g. cannabis, heroin;

•If you drink more than 21 units of alcohol per week (1 unit = 250ml);

•If you are found to have taken prescription medicine (four weeks prior) and/or over the counter medication;

•If you are found to have taken any medication 14 days prior to the screening;

•If you are found to have participated in a medical study during three weeks prior to the study;

Found to be a smoker (depends on study).

Your results will be confirmed, and if you are accepted you will be informed of the exact times and other essential details. You might get accepted as a stand-by (reserve), in which case you will be offered a place in the study if somebody withdraws or becomes unfit for the particular study. You will have to report to the unit with the other volunteers, and you will be paid an amount even if you don't get to participate in the entire study.

The Study Itself

Studies may range from a one-time visit lasting less than an hour, to a continuous stay in a clinical facility lasting several months. Generally, though, a "typical" study involving some type of medication will consist of multiple "phases" (periods during which the study takes place). The number of phases is usually between one and four, and they usually last between one and seven days (including overnights) during which you stay in the clinic facility. Each phase is followed by a "wash-out" period of three to ten days before the next phase begins. During the "wash-out" period you are usually (but not always) released from the facility. Some studies may consist entirely of out-patient visits (brief visits to the clinic during the day) and some will have out-patient visits during the wash-out periods.

When the study starts the rules will be explained to you and you might get a fine or suspension from the study if you disobey any of these rules. Studies run on a very strict timetable and you are expected to keep track of your appointments. Depending on the nature of the study, you will get three meals per day and a light snack at around 22h00. When they are not taking blood or requiring you to lie down, you are free to watch television, read or play games. Most of the units are equipped with Sky TV and a video machine. There will be a limited number of videos to watch, some books, games and in some units even pool tables to keep you occupied. What you are allowed to do, or not to do on a study, will be explained to you at the screening. Food and accommodation are on the house and cost you nothing.

Dosing

Depending on the study, you could be dosed in any of the following ways:

•A tablet/capsule;

•A cream;

•An intravenous drip;

•An injection;

•An inhaler.

Some volunteers will receive a placebo (dummy drug). Its purpose is to compare the effects of the drug and to see if reported side effects occurred only in those receiving the drug or in those receiving the placebo as well, or by both. Nobody - not even the nurses or doctors - knows who is receiving the placebo.

Blood Sample

Depending on the nature and duration of the study, a sample of between 200ml and 500ml blood will be taken in total, which amounts to less than an ordinary blood donation. A cannula (plastic needle with a ‘tap’) will be inserted into your arm. This is done to help with the collection of blood samples, and so that a needle doesn't have to be inserted into you every time a new blood sample is needed.

Other Samples

Throughout the study you may be required to give urine samples, and in some studies you may even be required to urinate in a time-marked container, which has to be kept in a freezer. Some studies will require you to take these containers home in a cooler-bag, and to return them to the unit at a given time. Every time you urinate, you have to do it in the specific container. You might also be asked to produce a faeces sample (at least they will not require you to carry it around in a cooler bag!).

When You Leave

When you have completed the study, you will be examined by a doctor, who on inspection of blood and urine samples will declare that you are well and that the drug is out of your system. You will be given an emergency card with a contact number, in case you don't feel well after leaving the unit. You will also be given a date and time to return to the unit for a follow-up examination. During the follow-up, where you will once again have to provide samples of blood and urine, it will finally be determined that you are well and that you aren't suffering from any after-effects of the drug. The follow-up is usually 3-5 days after completion of the study. During the follow-up you will be given a date and time to collect your payment.

Payment

If the unit is satisfied with your results, you will get paid by cheque about 3 days after the follow up. If they are not satisfied, you may have to return to the unit for further tests – and they will then deal with it in an appropriate manner. (Don't take stupid chances before the follow-up, like smoking cannabis or drinking excessively).

Payment differs from unit to unit, and from study to study, but is generally £70-£150 per 24 hours spent in the facility, but it could be a more than £100 per day for very specialised trials. It will be emphasised that you are not being paid for a job done, but for expenses and discomfort. Whatever the reason, take the money and be grateful.

A Final Word

As mentioned earlier, drug trials are a popular way amongst South Africans of earning money and they can give you a good kick-start if funds start getting low, or if you need money for touring. Many a person will testify that, while it may feel like prostitution, it is at least fairly safe.

There are a great number of people who go from one trial to another, although you are not supposed to do more than one every 3 months. There is no way in which one unit will know that you have come off a study at another unit within the previous 3 months, but it is a risk that you alone take, and is not advised.

Just remember, don't try and be kamakazi when you walk off a trial. Blood has been drawn from you and your blood pressure could be low. Take it easy.

•Guys Drug Research Unit is recommended. See contacts to the right.

Useful Website for information and contacts:

www.gpgp.net

www.drugtrials.co.uk/clinicaltrials.html

Biotrax Volunteer Advisory 0161 736 7312 www.biotrax.co.uk

Hammersmith Medical Research, Harlesden 0208 963 4502 recruit@hmrlondon.com

Guys, London Bridge 0207 910 7777 clinicaltrials@quintiles.com

Richmond Pharmacology, Wimbledon 0800 085 6464 www.trials4us.co.uk

Chiltern House, Slough 0800 783 0976

Parexel 0800 389 8930 www.drugtrial.co.uk

Cambridge Research Unit 0800 328 4195 uk_cru-cambridge@gsk.com

Clinical Pharmacology Unit, Harlow

0800 373662

uk_cpu-harlow@gsk.com

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