Frequently Asked Questions (FAQ's):
What is a clinical trial?
A clinical trial is a research study in human volunteers to answer specific health questions.
Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health.
Clinical studies are studies conducted to evaluate the safety and effectiveness of new medications. Before a medication can be approved, for use by the public, it must be tested thoroughly according to strict guidelines established by the Medicine Control Council and the protocol must be approved by an Ethics Committee to assure that the study be conducted under strict ethical guidelines.
Clinical studies can be conducted either in healthy volunteers or in a particular patient population.
Why participate in a clinical trial?
Participants in clinical trials can play a more active role in their own health care, and if in a particular patient group, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
What are bioequivalence studies?
All manufacturers of generic medicines must prove that their products achieve and maintain the same blood levels as the original medicine, before they are registered and allowed on the market. To do this, a research unit will perform a strictly controlled scientific study according to a formal protocol, to determine and compare the blood level profiles of the medicines in question. If these prove to be more or less the same, the medicines will be declared “bioequivalent”.
What is a generic medicine?
A generic medicine is the therapeutic equivalent of an originator pharmaceutical product whose patent has expired. It contains the same active substance as the originator product. There is no therapeutic difference between a generic medicine and an originator product.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Inclusion and exclusion criteria are an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some studies seek participants with specific illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors (Principal investigators, sub-investigators), nurses and other health care professionals. You attend an information session and a comprehensive informed consent document is explained to you, which you have to sign before any study procedures can be conducted. The team checks the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
A typical bioequivalence study involving healthy volunteers (students), involves 2 or more separate dosing days, each of which requires a 24 hour stay in the research unit. Throughout the day you are observed by medical staff. Volunteers usually spend time during the day reading, studying, watching television, playing cards or sleeping.
What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation in their home language is made available. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. You may withdraw your informed consent from the trial at any time.
What are the benefits of participating in a clinical trial?
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
- Play an active role in their own health care.
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care at leading health care facilities during the trial.
- Help others by contributing to medical research.
In South Africa healthy volunteers participating in studies are paid for time spent in the research unit. Patient volunteers are reimbursed only for travelling to the research site.
How is the safety of the participant protected in a clinical trial?
The ethical and legal codes that govern medical practice also apply to clinical trials. Before any study can start in South Africa it has to be approved by the Medicine Control Council as well as independent ethics committee. The Ethics committee is an independent committee of physicians, pharmacists, community members, advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected.
Both authorities thoroughly investigate these studies to ensure that the volunteer’s safety and ethical requirements are complied with. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. Individual participants' names are confidential.
How safe are bioequivalence studies and what are the risk involved?
During the information session, the Principal Investigator (medical doctor) will explain all possible risks and side effects involved with taking the particular study medication. Please note that the horror stories you have heard about growing extra toes or stopping your heart is only a myth. The health and safety of our volunteers is our first priority, so we monitor your well being constantly. After completion of the study, you will receive another medical evaluation to ensure that your health status did not change.
What should people consider before participating in a trial?
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the payment involved for participating in the trial.
Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.
How do you become part of a clinical trial?
If you are interested, you can become of part of a volunteer database by:
- Phoning one of our recruiters
- Fill in the online questionnaire
- Send us a SMS
- E-mail us
We will contact you once you have made contact and shown us interest.
Frequently Asked Questions (FAQ's):
What is a clinical trial?
A clinical trial is a research study in human volunteers to answer specific health questions.
Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people and ways to improve health.
Clinical studies are studies conducted to evaluate the safety and effectiveness of new medications. Before a medication can be approved, for use by the public, it must be tested thoroughly according to strict guidelines established by the Medicine Control Council and the protocol must be approved by an Ethics Committee to assure that the study be conducted under strict ethical guidelines.
Clinical studies can be conducted either in healthy volunteers or in a particular patient population.
Why participate in a clinical trial?
Participants in clinical trials can play a more active role in their own health care, and if in a particular patient group, gain access to new research treatments before they are widely available, and help others by contributing to medical research.
What are bioequivalence studies?
All manufacturers of generic medicines must prove that their products achieve and maintain the same blood levels as the original medicine, before they are registered and allowed on the market. To do this, a research unit will perform a strictly controlled scientific study according to a formal protocol, to determine and compare the blood level profiles of the medicines in question. If these prove to be more or less the same, the medicines will be declared “bioequivalent”.
What is a generic medicine?
A generic medicine is the therapeutic equivalent of an originator pharmaceutical product whose patent has expired. It contains the same active substance as the originator product. There is no therapeutic difference between a generic medicine and an originator product.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Inclusion and exclusion criteria are an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some studies seek participants with specific illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
What happens during a clinical trial?
The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors (Principal investigators, sub-investigators), nurses and other health care professionals. You attend an information session and a comprehensive informed consent document is explained to you, which you have to sign before any study procedures can be conducted. The team checks the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.
A typical bioequivalence study involving healthy volunteers (students), involves 2 or more separate dosing days, each of which requires a 24 hour stay in the research unit. Throughout the day you are observed by medical staff. Volunteers usually spend time during the day reading, studying, watching television, playing cards or sleeping.
What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation in their home language is made available. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. You may withdraw your informed consent from the trial at any time.
What are the benefits of participating in a clinical trial?
Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
- Play an active role in their own health care.
- Gain access to new research treatments before they are widely available.
- Obtain expert medical care at leading health care facilities during the trial.
- Help others by contributing to medical research.
In South Africa healthy volunteers participating in studies are paid for time spent in the research unit. Patient volunteers are reimbursed only for travelling to the research site.
How is the safety of the participant protected in a clinical trial?
The ethical and legal codes that govern medical practice also apply to clinical trials. Before any study can start in South Africa it has to be approved by the Medicine Control Council as well as independent ethics committee. The Ethics committee is an independent committee of physicians, pharmacists, community members, advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected.
Both authorities thoroughly investigate these studies to ensure that the volunteer’s safety and ethical requirements are complied with. The trial follows a carefully controlled protocol, a study plan which details what researchers will do in the study. Individual participants' names are confidential.
How safe are bioequivalence studies and what are the risk involved?
During the information session, the Principal Investigator (medical doctor) will explain all possible risks and side effects involved with taking the particular study medication. Please note that the horror stories you have heard about growing extra toes or stopping your heart is only a myth. The health and safety of our volunteers is our first priority, so we monitor your well being constantly. After completion of the study, you will receive another medical evaluation to ensure that your health status did not change.
What should people consider before participating in a trial?
People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the payment involved for participating in the trial.
Can a participant leave a clinical trial after it has begun?
Yes. A participant can leave a clinical trial, at any time. When withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.
How do you become part of a clinical trial?
If you are interested, you can become of part of a volunteer database by:
- Phoning one of our recruiters
- Fill in the online questionnaire
- Send us a SMS
- E-mail us
We will contact you once you have made contact and shown us interest.