Choosing to participate in a clinical trial is an important personal decision. To assist you we have provided a list of frequently asked question. If you would like more information, please visit the US National Institute of Health site. For further information on Bioequivalence Studies, contact us at firstname.lastname@example.org.
For further information on Clinical Trials, contact us at email@example.com
What is a clinical study?
A clinical study (also called clinical trial and medical research) is a scientific study of how a new medicine, treatment, device or procedure works in people. It is also used to test whether existing treatments can be used in new ways.
Why do we need clinical studies?
These studies are done to see if the new drugs or treatments are safe and effective for people to use.
What is a bioequivalence (BE) study?
A BE study is a type of clinical study conducted to compare two products containing the same medicine but produced by different companies. This study checks if the two products produce similar concentrations in the human body at specific intervals after taking the products.
Who takes part in a BE study?
Every year, several million subjects in the world participate in BE and clinical studies. A BE study requires volunteers who are healthy and pass certain inclusion and exclusion criteria, i.e. factors that allow you to and disallow you from taking part in the BE study.
What happens in a BE study?
Volunteers will undergo a medical check-up before the study. For the study proper, they stay for one or more days in study wards reserved for clinical studies. They take one dose of a medical product (Either Brand A or Brand B) and allow the BE study team to collect their blood samples (about a teaspoonful each time) at fixed interval times for one or more days. They then return home. On the next study period, they will check in to the study ward to repeat the procedure but with the medical product which they did not take during the first study period. Finally, they are required to come for a brief follow-up session one week after study period 2.
Should I take part in a BE study?
Choosing to participate in a BE study is a personal decision. Listed below are factors you may want to consider before volunteering:
- To learn more about health topics
- To monitor your health through free thorough physical and medical examinations, laboratory tests and E.C.G.
- To know that you are helping the advance of medical science and improvement of future healthcare
- To obtain satisfaction from helping others who are ill and need medical treatment
- To meet other volunteers
Are BE studies safe? I don’t want to be a guinea pig!
The Malaysian government has strict guidelines and safeguards (Malaysian Guidelines for Good Clinical Practice [GCP]) to protect people who choose to take part in clinical studies. Every clinical study in Malaysia must also be approved, monitored and reviewed by the Independent Ethics Committee (IEC). The IEC consists of people from the medical field as well as lay people to make sure that a clinical study is ethical and that the risks are as low as possible and worth potential benefits.
Are there any risks?
The side effects are no more than taking a dose of medication. Possible side effects include headache, stomach upset and allergy. You will be given the details of the medication in the subject information sheet before you sign the informed consent. You may experience some discomfort from the blood collecting procedures. You will be covered with insurance for any adverse events you may encounter.
What is informed consent?
Informed consent is your agreement to participate in a study after learning the important facts about the study. These facts include:
- Why the research is being done
- What the researchers want to accomplish
- what will be done during the trial and for how long
- What risks are involved in the trial
- What benefits can be expected from the trial
- What other treatments are available
- The fact that you have the right to leave the trial at any time
Can I leave a study after it has begun?
Yes. Your participation in a study is voluntary. You can choose to leave the study at any time, for any reason without penalty or denial of benefits.
What other benefits do I get from taking part in a BE study?
You will be compensated for your time and inconvenience, and reimbursed for expenses incurred. Also, a medical report will be given to you free of charge upon completion of a BE study.
If you are interested in participating in our Clinical Studies (Clinical Trials / Bioequivalence Studies), send us an email firstname.lastname@example.org