In some stage of your life you will have used prescription medicine or medicine that you have bought over the counter.

When we use medicine prescribed by our doctors we presume that the medicine is safe and that it will have the desired effect. When we buy our medicine over the counter we rely on the pharmacist to tell us about the safety and benefits of the medicine, what is written on the pharmaceutical insert in the package or what is available on internet.

Pharmaceutical manufacturers need to prove that their medicines are safe and that they have the intended therapeutic value before these medicines can be registered and sold.

To achieve this they need volunteers participating in clinical trials, to help them test the medicines. People volunteer for various reasons – often because they themselves have the ailment for which a product is being tested, or just because they would like to participate in helping others in achieving improved health.

Clinical trials are important to develop new ways of treatment and improve existing treatment. These trials are specifically designed to test the therapeutic value and safety of new and existing medication, to test new diagnostic methods and patents and to compare existing treatments.

Initially the molecules of the active ingredients (the ingredients that do the work) are tested on animals in laboratories. Even if they are found to be safe and effective on animals this is no guarantee that the same will apply to humans. The medication is often tested in young healthy volunteers, this is followed by tests or trials on patients with the disease or problem. These tests or clinical trials are conducted according to specific approved protocols. Protocols include rules as to the methods used during the trials, definitions of the exact nature of what is to be tested and methods to be used in measuring the results.

The protocols are strictly evaluated and approved by the relevant government organisation and registered ethics committee. This guarantees the safety of the volunteers participating in the trials, as far as humanly possible.

Should you choose to volunteer for clinical trials you would be making an important contribution to new knowledge in the treatment of diseases. Having taken the decision to be of assistance in the medical arena, it is important that you feel comfortable with what you are doing. For this reason, it is essential that you read the informed consent document, which will be provided during the selection process, carefully before signing it. In this way researchers can be assured that you are fully aware of, and comfortable with all the aspects of the clinical trials for which you have volunteered.

Interested? Then read the rest of our web page. We have tried to answer the frequently asked questions with regard to clinical trials.

Research teams are made up of professionally registered persons, bound by ethical code of conduct, which means that it is unlikely that they would take unfair advantage of someone who is considered to be vulnerable. However for your own peace of mind it is important to know that the decisions you take during the trial are your own and that you are not somebody who can be influenced against your will.

Vulnerable volunteers refer to people or groups of people who can easily be exploited and unduly influenced by expectation, justified or not, in research.

If you are –
◾under 21 years of age
◾mentally disabled (to be noted by carers of the mentally disabled)
◾a sufferer of a substance related disorder
◾in a dependent relationship or a similar situation
◾a prisoner
◾someone who is highly dependent on medical care

you would be considered vulnerable.

This does not mean that you should not register as a potential voluntary participant if you would like to join a trial.

As a participant, your safety is the most important part of the clinical trial.

To ensure your safety a set of guidelines for the trial has to be approved by the Medicines Control Council (MCC) in cooperation with a registered ethics committee. The Medicines control council is the government institution in South Africa that ensures that all medication registered in the country has been tested in an ethical way, and is effective and safe.

These guidelines (also known as protocols) are evaluated by the ethics committee to ensure that the study is planned and performed in a scientifically sound manner, that it is done by properly qualified health practitioners and that it is ethical.

The clinical trial is monitored from the beginning to the end. The researchers are required to report back to the MCC and the ethics committee every six months. In the reports any serious adverse events must be summarized. If there has been any deviation from the guidelines, this must be explained.

Specific adverse events are reported to the MCC and to the ethics committee within five days of them becoming known. Both institutions receive updates continuously after the initial report.

Clinical trials can be discontinued if –
◾the medicine is found to be unsafe as the trial progresses
◾the therapeutic effect is not great enough to justify the potential risk
◾the efficacy and safety of the product becomes overwhelmingly obvious during the trial.

These decisions would be made by a data and safety-monitoring board compiled of physicians, statisticians, advocates and patients who have no connection to the clinical trial in question. This board meets several times during the course of the clinical trial.

You as a participant will be informed of any developments during the course of the trial as part of an ongoing informed consent process. You will always be considered a valued member of the team.

Some people volunteer for a trial before they really understand the implications. If you decide – for whatever reason – to leave the trial after it has begun, you are free to do so, with no problem to the continuation of your healthcare.

If you do decide to leave a trial after it has begun, the research team would need to be informed of your decision for their future planning. The researchers need to do an exit interview with anyone leaving a trial. The reason for this is to obtain valuable feedback on why you have chosen to leave and also for safety reasons. Sometimes researchers request permission to stay in contact with you for follow-up and further safety monitoring, even if you choose to stop taking trial medication.

All dealings with participants are intended to be professional and supportive and there should never be any reason for you to feel uncomfortable about your decisions relating to the trial.

Without a good safety record researchers would not be able to achieve what they do achieve in the advancement of human health. You can be assured therefore that your safety as a volunteer in a clinical trial would be of paramount importance.

The protection of voluntary participants in clinical trials is described on an international level in several documents. In South Africa the voluntary participants are protected by the relevant government institutions as well as accredited Ethics Committees. The nature and aims of these organizations are as follows –

The government has strict guidelines and safeguards to protect volunteers who participate in a clinical trial. Every clinical trial in South Africa must be approved and monitored by the Medicines Control Council (MCC). The MCC must make sure the risks are as low as possible and are outweighed by the potential benefit.

An accredited Ethics committee (accredited by the National Health Research Ethics Council) must approve all clinical trials. The objective of the Ethics committee is to ensure voluntary participants and communities are protected; the planning and execution of a trial is ethical and scientifically sound and done by qualified health practitioners.

In South Africa the Ethics committee is comprised of at least seven members, who must be representative of all the communities. The demographic profile of the country’s population e.g. gender and race must reflected.

The committee must have an official chairperson and the members must be representative of the following –
◾a lay person with no affiliations with the institution, not currently involved in medical, scientific or legal work and who is preferably from the community;
◾a person with knowledge of, and current experience in areas of the research that is regularly considered by the ethics committee;
◾a person with knowledge of and current experience in the professional care, counseling or treatment of people (e.g. medical practitioner, psychologist, social worker, nurse);
◾a person who is legally trained.

With these assurances in place you should feel quite comfortable about your safety during the clinical trial. However, should you need further assurance you can consult one of the web sites quoted below or discuss your concerns with the researchers during the informed consent interview.

It is very important that you continue your relationship with your usual healthcare providers when you are participating in a clinical trial. Your primary healthcare provider, family doctor, clinic, or specialist medical practitioner plays the most important role in your general health.

During the trial you should consider your health from both the short-term and the long-term perspective. In the short-term it is important your primary healthcare provider communicates with the research team , because –
◾your participation in a clinical trial will affect the choice of any other medicine your healthcare provider may want to prescribe;
◾the research team can report changes in your health that are not related to the trial to your healthcare provider and these can be treated;
◾your healthcare provider can inform the research team of anything unusual in your health that can be ascribed to the trial.

In the long-term your medical practitioner needs to know about your participation in a clinical trial for these reasons –
◾It will ensure continuation in your treatment for the disease or condition you were treated for in the trial, when the trial stops
◾He will need to know what medication you are on during the trial as it may have an impact on any other medication he wishes to prescribe
◾He should remain involved with your general and long-term health care, this include your other medical conditions, while you are on the trial as the focus of the researchers will be for a specific medical condition over a short period.

As a volunteer on a clinic trial you play a critical role in the research team. Your feedback is therefore extremely important. To ensure the maximum benefit from your visits it is best to prepare for them as follows –
◾Make sure that you know the date and time of your visit
◾Make a list of the questions that you wish to ask
◾Gather all your medications and supplements to take with you
◾Keep a diary of any visit to your health practitioner, changes in medical treatment e.g. changes in medication dosages or any new medication even if it is non-prescription
◾Record the times and dates when you started and stopped medication
◾Make notes on any changes in your health including times and dates of these changes
◾If you are on any other treatment ask your medical practitioner for a note stating the diagnosis and the details of the prescription

Use this as a checklist.

Now you are ready for the visit. To ensure its success do the following –
◾Take the medication and supplements that you are on with you
◾Take all the study medication and containers to the visit
◾Record the discussion or take notes so that you can listen to it or read it at home.
◾Take someone who knows you well with you
◾Discuss all your trial related problems with the researchers as it is part of their task to help you
◾Print this list and use it as a checklist to take with you.

The medical research members will always assist you; don’t hesitate to discuss your trial related problems with them.

Taking part in a clinical trial gives you the opportunity to –
◾play an active role in your own healthcare
◾gain free access to new treatments that are not available to the public
◾receive free relevant expert medical care at leading healthcare facilities during the trial
◾help others by contributing to medical research
◾be remunerated for phase 0 and phase 1 studies.

Participants in clinical trials are compensated for travel accommodation, meals, and other expenses, subject to approval.

Side effects / adverse events are any unwanted, undesirable or unexpected changes in your health status related or not related to the investigational product. These changes could be related to other standard treatment, other medical conditions and various other factors.

Medication under investigation or registered medication or treatment must be evaluated continuously for short- term and long-term side effects.

With benefit there is usually some kind of risk. This can also be said of clinical trials, although the risks related to the product being tested and any potentially harmful procedures are minimized with careful professional monitoring. All known risks related to the investigational drug, (where applicable) standard treatment, and trial related procedures must be discussed in the informed consent document.

If during the trial, the researchers identify any new risk related to the investigational product, treatment, standard treatment or procedures they must inform you verbally and in writing.

You should continuously weigh the risk against the benefit of participating in the trial. You may withdraw from a trial without compromising yourself in any way.

Not all of the risks to be considered are related to the medicine or the procedure. The risks include
◾side effects/adverse events related to the investigational product
◾the fact that the treatment may not be effective for you (depending on the type of trial, in some trials you may receive placebo)
◾time considerations – including time taken up by possible lengthy or numerous trips to the site, duration of treatment, hospital stays
◾effort considerations – including complex dosage requirements or inconvenient dosage regimes

How you perceive some of the more practical risks would depend very much on your life style and the general pressures of your daily life.

Your participation in a clinical trial starts when you, as a voluntary participant, sign the informed consent document and ends with your last contact with the health research team as prescribed in the protocol.

Everything, including the visits, procedures, and what a participant can expect during the trial is described in the informed consent document.

You will be working with a qualified professional health research team to monitor the safety and efficacy of the investigational product or treatment.

You can expect the research team members to check your health status, to give you the instructions for participation, to monitor you during the participation in the trial and to stay in touch with you.

As a voluntary participant it is important that you have a good working relationship with the health research team and that you follow the protocol diligently. This is the basis for your safety and will help to ensure that accurate, reliable information on the investigational product or treatment is gleaned from the study.

A blind study is a study in which the person who is “blinded” will not know whether the treatment being administered to him or her is active, inactive or a standard medicine.

There are two types of blinded studies. The one is single blinded. This means that either the volunteer does not know or the health team does not know whether the volunteer is receiving an active treatment an inactive treatment or a standard medicine.

The other type of blind study is a double blind study. In this case neither the volunteer nor the research team knows whether the volunteer is receiving an inactive, an active or a standard medication.

The purpose of blinded studies is to take any bias out of the equation. In other words it makes the study more objective. It also gives more weight to the information gathered on the clinical trial to support the conclusion made at the end of the trial.

A clinical trial is a research study which aims to answer specific questions on new therapies and new ways of using known treatment. The treatment can refer to devices or medication (drugs). The trials are designed to show whether or not a treatment is safe and effective.

Before a clinical trial can begin a protocol must be drawn up for it. A protocol describes who may participate in the trial, the schedule of the visits and study procedures, what it is that researchers wish to study, what they aim to evaluate and how they are going to evaluate it. Clinical trials are done in various phases.

Phase 0
Phase 0 refers to first – in human trials.

An investigational product is developed in a laboratory and then tested on animals. If the researchers achieve a favourable outcome, the product is given to a small group of volunteers, (10-15). A single sub therapeutic dosage of the investigational product is administered to determine what the drug does to a human body and what the body does to the drug. This first testing in a human being is called phase 0 in clinical trials. From the data obtained, in these trials the researchers decide whether or not they are going to continue testing the investigational product.

Phase I
During phase I of a clinical trial, researchers test the investigational product or treatment in a small group of volunteers (20-80) to evaluate how safe the investigational product or treatment is, to determine a safe dosage range and to identify side effects. During phase I the researchers also study the absorption and excretion of the investigational product.

Usually healthy volunteers, who meet specific criteria, are involved, except in cases like cancer treatment. For cancer related studies research volunteers suffering from the specific cancer and who meet a set of spesific criteria are invited to participate. If the researchers, government and ethics committees are satisfied with the results of the trial they continue to investigate the product in phase II.

Phase II
In phase II a larger group of volunteers (100- 300) receives the investigational product or treatment. In phase II the purpose of the study is to determine whether or not the investigational product or treatment is effective and safe for volunteers with the disease (medical diagnosis) for which the investigational product is intended. During this phase, volunteers who meet the criteria set in a protocol are invited to assist with the testing of the investigational product or treatment. If the researchers, government and ethic committees are satisfied with the results gathered during phase II the researchers continue to phase III

Phase III
During phase III a large group of volunteers with a specific medical diagnosis (1000 -30000 and sometimes more) who meet a specific set of criteria receive the investigational product or treatment. The purposes of this phase are to confirm the effectiveness of the product, when compared to a placebo, to monitor the side effects, to compare it with other standard treatment and to collect information that will allow the drug or treatment to be used safely. If the researchers, relevant government institution and ethics committees are satisfied with the results gathered during phase III the relevant government institution will register the investigational product or treatment.

Phase IV
Research on a registered medication or treatment continues after it is marketed. During phase IV the researchers continue to collect information on the effectiveness and safety of the registered medication or treatment associated with long- term use in various populations. .

If a treatment or registered medication does not meet the safety and efficacy criteria, the government will withdraw their approval of the medication or treatment.

Feedback from patients on prescription and over the counter medication is important for the continued safety and effective use of registered medication.

The feedback of voluntary participants in trials and co-operation with the clinical research team to meet the criteria set in a protocol during participation in a trial is important and highly appreciated.

A control group in clinical trials is one of the groups of people who meet the criteria for participation in a specific trial. The number of treatment groups in a clinical trial is stipulated in the protocol e.g. an investigational product (the new product) treatment group and a placebo group; or, an investigational product treatment group, a placebo group and a registered medication treatment group.

Volunteers are randomised to different treatment groups. This means that every person has an equal chance to be in any of the treatment groups. Each group receives a different treatment. One of the groups receives the standard registered medication for the illness, another group receives a placebo and yet another group receives the investigational product (the new product) for the indicated illness. The results obtained from the different groups are then compared from the point of view of safety and efficacy.

The use of control groups is a sound and accepted scientific method of evaluation in establishing for certain that a new product meets the criteria for safety and efficacy.

As someone who is interested in clinical trials you may have heard of a “placebo”.

A placebo is an inactive, tablet, capsule, injection, fluid that has no treatment value. It is sometimes referred to as a “dummy pill”.

In clinical trials, the investigational product can be compared with a product that is active or with one that is inactive.

The inactive product, or placebo, is given to a participant to assess the effectiveness of the investigational product. One of the groups in a trial will receive a placebo and the other one will receive the investigational product.

When a placebo is being used in the trial this will be indicated on the informed consent document where the trial will be referred to as “a placebo controlled study”. This does not necessarily mean that the medicine that is being administered to you will be the placebo.

In some cases an active product, a registered standard treatment for a specific medical condition, can be administered to one of the groups and the results compared with results of the product under investigation. The purpose of this comparison is to find out whether or not the investigational product is superior.

The group which is not receiving the active, product under investigation is known as the control group.

A protocol is a plan giving guidelines based on a set of rules formulated for a given clinical trial.

The protocol describes the medical profile of people who may participate in the trial, the schedule of visits, tests, procedures, medication or product under investigation, dosages to be administered, the length of the study as well as the outcome to be measured and how it will be measured.

An investigational product is any medication being tested in a clinical trial.The medication may be an active ingredient, or placebo (a non-active substance). The Investigational product can be in any form e.g. tablet, capsule, injection, fluid.

An investigational product can be a new product not registered by the Medicines Control Council, or a product with marketing authorization (registered at the Medicines Control Council) where the formulation or packaging differs from the approved form, or where it is being used for an unproven (off-label) indication, or where it is necessary to gain further information about the approved use.

The concept of “informed consent” is extremely important for you as a participant in a clinical trial.

The informed consent process is a briefing process and starts before a volunteer agrees to participate in a clinical trial and continues right through until the end of the trial.

Informed consent is put in place so that you can make yourself fully aware of the relevant facts about the clinical trial before you agree to participate in the trial or decide to stop participating.

Every clinical trial has its own informed consent documents.

The following information must be included in the document –
◾why the research is being done
◾a note that the research is experimental
◾details of the drug /placebo/comparison product involved
◾the nature of the research e.g. randomization blinded or not
◾what the research aims to accomplish
◾ number of participants involved in the trial
◾duration of the trial
◾risks involved in the trial
◾ benefits to be expected from the trial
◾ other treatments available for the targeted disease
◾ a note confirming that participation is voluntary
◾ volunteer’s responsibilities
◾ note that volunteers can leave the trial at any time
◾ trial approval details of approval committee
◾ name of researcher in charge of the clinical trial at the site
◾ the site address
◾ contact details of the medical doctor in charge of the trial
◾compensations /or treatment for trial related injury
◾ anticipated relevant expenses (if any) to the voluntary participant
◾confidentiality according to South African laws
◾permission for access to original medical records within the South African law
If you would like to participate you should – ◾review the informed consent document for the specific trial
◾ask for a informed consent document in the language you read and understand best
◾ask questions to clarify any queries you have
◾discuss the document with relatives, friends and or primary health care provider
◾make sure you received a signed copy of the informed consent document
◾know that informed consent is an ongoing process through the duration of the trial till it stops to inform you of new information that become available
◾continue to ask questions all the way through the trial.

Possible participants in clinical trials need to be evaluated, screened, to ensure that they are suitable candidates for the trial for which they wish to volunteer.

If you would like to be involved in a clinical trial, your first step is to find out what clinical trials are recruiting volunteers. Keep your eyes open for advertisements at strategic places in your town, in the newspapers and in radio and TV advertisements. Your medical practitioner may know about trials relevant to you or know of other people taking part in clinical trials. Alternatively, you can put your name on the data base of research units, register on this web site.

Make sure the advertisement is approved by an ethics committee and that the clinical trial is approved by the Medicines Control Council.

The second step is to make yourself available.

Before the final screening as a volunteer, you would need to undergo a pre-screening process, which is conducted in two stages. As a possible volunteer, you would approach the recruitment centre. The recruiter will ask you a series of questions to ensure that you meet the general criteria to be included in the trial. If you meet the general criteria, your details will be posted onto a data base and sent to the investigator’s site. The recruitment officer will need your permission to do this.

Investigators explore the relevant data bases to recruit possible volunteers. Once an investigator has selected you from the data base, you have completed the first part of the pre-screening phase.

In the second part of the pre-screening phase you will visit the investigator’s site. There you will be required to describe your medical history – perhaps with special reference to the condition which is relevant to the trial. You may also be requested to undergo non-invasive physical examinations, for example, an ECG (and electro-cardiograph used to monitor your heart condition), monitoring of blood pressure and weighing. Sometimes it is necessary for the investigator to gain access to your medical records to confirm the finer details of your medical history and to be certain that he knows which medicines you have been taking. At this point you would have completed the second stage of the pre-screening process. Note that nothing is done without your permission or cooperation and that you receive a free medical evaluation.

If – after the second stage of the pre-screening – you have met all the general criteria you will receive detailed information about the specifics of the trial. This information will also be given to you in writing so that you can consider all the implications carefully. If you have decided to volunteer for the specific study you will need to sign an “informed consent document”. An informed consent document is a document which confirms that the possible volunteer is fully aware of all the details of the trial for which he or she has been selected. Having signed this document you are now ready for your official screening.

During the official screening final evaluations follow to ensure that you meet the finer criteria for inclusion in the trial. These trial specific evaluations are stated in the protocol and the informed consent document.

Once again these evaluations are free and even if you were to be excluded at this stage you would have had the advantage of a thorough medical examination.

As a participant in a clinical trial you are an active and important member of the team. To ensure that the trial is a mutually positive experience you would need to make sure that you –
◾are motivated and willing to take part in the trial
◾are available for scheduled site visits and telephone calls
◾inform the site research team in advance if you cannot be available for the scheduled appointments
◾take or administer the investigational product as requested by the site research team
◾follow the protocol instructions as requested by the research team
◾inform the site research team if you could not follow the instructions or if you missed a dosage
◾make a note of the time and date of any deviations from the programme so that the team can clarify variations in the data
◾inform the site research team of any changes in your health status or any change in the medication or supplements
◾make a note of the time and date of any changes in your health status or change in medication of supplements
◾inform the research site if you have withdrawn from the study so that they can arrange a safety follow up
◾receive any further treatment required after your participation in a trial and that this is followed up with your primary health care practitioner
◾receive a signed copy of the informed consent document at the beginning of the trial and with any other changes
◾receive the compensation as approved by the ethic committee to cover your travel, meal and where applicable your lodging expenses.

Taking part in a clinical trial makes you stand still and listen to your body. It also reminds you to take care of your body, something we sometimes forget we have.

A number of the questions that you may be asking yourself before joining a clinical trial will be addressed in the informed consent document. Some of these questions are also addressed here on our web page. However all the practical problems may not have been covered. Use this document as a checklist for all the questions that you may like answers to before participating in the study.

Questions regarding the study itself
◾Why is the research being done?
◾What is the specific purpose of the clinical trial?
◾Who is sponsoring the clinical trial?
◾Who has reviewed and approved the protocol?
◾Why does the research team think the treatment/ investigational drug will work?
◾What kind of therapies, procedures, and test will I have during the trial?
◾Will the test and procedures cause discomfort or pain and how long will it take?
◾How does the tests in the study compare to the test I should have outside the trial?
◾How long will the trial last?
◾How often do I have to go to the research site?
◾Who will provide my medical care after the study stops?
◾Will I be able to take my regular medication during the trial?
◾What medication, procedures, or treatment must I avoid while in the clinical trial?
◾What are my responsibilities during clinical trial participation?
◾Will I need to be admitted to hospital during the trial?
◾Will the research team work with my doctor while I am in the trial?
◾Can anyone find out that I am participating in a trial?
◾Can I talk to other participants in the trial?
◾Will I be able to find out the results of the trial?

Questions about the risks and benefits of the trial
◾How do the risks and benefits of the trial compare to those in the existing standard treatment?
◾What are the possible immediate and long-term side effects of the investigational product or treatment?

Other questions
◾Where is the site?
◾What other treatment options do I have?
◾Will I have to pay anything to participate in the study?
◾Is my insurance likely to cover expenses?
◾What are the professional qualifications of the members of the research team?

You must know as much as possible about the clinical trial. This will ensure that you are certain about your decision to participate. Most of this information will be given to you in an informed consent document which should preferably be in your mother tongue or in a language that you understand very well. You can also ask for translation assistance.

The informed consent document seeks to give you all the known information about the trial including the following –
◾details about the product being investigated, for example what it is made of and what it is supposed to do
◾details about the nature of the treatment, for example how it will be administered and over what period
◾the number of visits
◾procedures
◾the risks and possible benefits.

You must be given enough time to study the informed consent document. It is important to note that different medications have different implications. This means that you should always read the informed consent document carefully even if you have applied to participate in a trial before.

If you have any questions, you must feel free to ask them. The answers to you questions should also be in a language that you understand. It is important for all the parties that you feel that all your concerns have been addressed.

You may take the informed consent document home so that you can discuss the trial with your health care provider, family and friends. If at any stage you feel you would like to withdraw from the trial once you have signed the informed consent document you will be free to do so. The informed consent document is not a contract.

There are various types of clinical trials that people can participate in. You will be included in or excluded from the study based on your medical profile. For some studies volunteers with specific diseases will be required and for other studies the need will be for healthy volunteers.

Protocols pertaining to each specific study are put in place in which the criteria for voluntary participation in a clinical trial are described. The guidelines contained in the protocol include – age, gender, type of disease (if the trial requires participants with a specific disease), stage of disease, medical history, current medical conditions and medical treatment. Before you can take part in a clinical trial, you will sign an informed consent document to confirm that you –
◾have received all relevant information on the trial
◾understand the information and agree to follow the protocol guidelines
◾understand that you can withdraw from the study and that it will not compromise your standard health care
◾give permission to access to your health history
◾understand your personal information will be kept confidential.

After you have given written consent, you will go through a screening process.

If it is found that you meet the criteria set in the protocol you will be included in the clinical trial for which you have applied.

The criteria for inclusion have been put in place only to ensure your safety and to protect the integrity of the study. If you were to be excluded from a clinical trial this would be done merely as a precaution to protect your wellbeing and should not be seen as a rejection.

These criteria also enable the researchers to answer specific questions that will enable them to plan future clinical trials.

Clinical trials are sponsored by pharmaceutical companies, government agencies, universities and individual physicians.
Clinical trials are designed to test the medicines and treatments that your doctor prescribes for you or that you purchase over the counter. The medical fraternity and the relevant government institutions need to be sure that these medications and treatments are going to improve your quality of life and that they are therefore effective and safe for humans to use. To do this they have to test these products on humans and they have to rely on potential volunteers like yourself to help them.

You may have altruistic reasons for wanting to join a clinical trial. However there are also certain benefits in trial participation. You –
◾play an active role in your own healthcare
◾gain free access to new treatments that are not available to the public
◾receive free relevant expert medical care at leading healthcare facilities during the trial
◾help others by contributing to medical research
◾may be compensated for participation in phase 0 and phase 1 studies.

Participants in clinical trials are compensated for travel, accommodation and meals.

A well-constructed, ethically approved clinical trial is not only the only way to monitor the safety and efficacy of any treatment or medication, it is also the only route in developing safe and effective new treatments and the only way in which we can safely and effectively develop the less expensive form of a medication, known as the generic.

Volunteers taking part in trials make a huge contribution to this body of essential knowledge.

People join clinical trials for various reasons depending on the type of trial. Sometimes it is because they themselves suffer from a disease for which no satisfactory cure has been found and they want to expose themselves to new possibilities. In other cases, for example, where a medicine is being tested for its preventative qualities, volunteers may join for altruistic reasons – medical advancement perhaps. Money can be a factor even if it is not the chief motivator.

You can be paid for phase 0 and phase I but not for phases II and III. Receiving payment may impair a participant’s objectivity, which is particularly important for phases II and III, and may lead to bias.

You would usually be reimbursed for expenses associated with the trial.

Expenses would include –
◾transport
◾childcare
◾ meals
◾accommodation
◾other applicable expenses.

All reimbursement has to be approved by the ethics committee. This is an ethical decision that has been taken internationally and nationally by the research community to avoid the exploitation of people in need.