1. What are clinical trials?
Clinical trials are research studies to determine whether drugs or treatments are both safe and effective for humans. ALL new medications and devices must undergo several clinical trials, usually involving thousands of people, before they can be released to the public.
2. Why participate in a clinical trial?
By participating in a clinical trial, you are playing a more active role in your own health. You will have access to the newest research treatments before they are available to the general public, as well as to expert medical care at leading health care facilities.
Study-related checks, analyses, treatments, and hospital stays are typically free of charge. You could also be compensated for your time and inconvenience (phase I studies), or reimbursed for your travel expenses.
Participants in clinical trials help others by contributing to medical research.
3. Can I quit a study after I agreed to join?
Yes, you can quit a clinical trial at any time and you do not have to give a reason.
There is no charge or penalty for quitting. If you quit, you may be asked to visit the clinic for a final medical exam for your safety.
4. What do the different phases mean?
Clinical trials take place in 4 phases:
Phase I tests a new drug or treatment in humans for the first time, so they are usually carried out on small (20-40) groups of healthy volunteers.
Phase II expands the study to a larger group of people (20-300), this time to patients who suffer from the condition that is being studied.
Phase III expands the study to an even larger group of patients (300-3000). New treatments can be made available to the general public when they pass a Phase III study.
Phase IV takes place after the drug or treatment has been licensed and marketed, usually involving several thousands of participants.
5. Is it safe to participate in a clinical trial?
Clinical trials are strictly reviewed, approved, and monitored by health authorities and independent ethic committees to ensure that the research is safe and the rights of the participants are protected. Still, any research study may involve risks, discomforts and inconveniences. Side effects to experimental treatments may be unpleasant, serious or even life-threatening.
6. Will I get paid to participate?
Healthy volunteers for phase I studies are usually compensated for their time and inconvenience.
Patients (phases II, III and IV) are usually reimbursed for reasonable travel expenses, and occasionally may receive a small compensation for their time as well.
7. What is an Informed Consent Form (ICF)?
An Informed Consent Form (ICF) is a document that explains in layman's terms everything a participant needs to know about a particular clinical trial before they decide to take part in it. Informed Consent Forms are reviewed by an independent ethics committee to ensure the information is clear, accurate, and detailed.
You are required to sign an ICF before you can take part in a clinical trial, so must read it carefully and ask any questions you may have. Signing the ICF means that you agree to take part in a clinical trial - but remember that you can withdraw at any time without giving any reasons.
8. What is a placebo?
A placebo is a pill, liquid, or powder that has no treatment value - in other words, it's a simulated medical treatment. In clinical trials, it is common to give medication to some participants and placebo to others, without either group knowing what they are taking. This is done to assess how safe and effective a treatment really is.
9. What is a study sponsor?
The sponsor of a clinical trial is the individual, company, organisation or group that funds a research study.
10. What is an Independent Ethics Committee or an IRB?
An Ethics Committee (EC) or Institutional Review Board (IRB) is an organisation charged with protecting the rights and welfare of the people who participate in a medical research study. These organisations review all the documentation and procedures, including the protocol, the ICF, and any marketing material that relates to a clinical trial before the study can take place.
Rules about EC and IRB may vary but it is common that they are composed by a minimum number of members, some being men and some women, some with and some without scientific background, etc.
Bookmark this page
Share this study
Talk to us
Get alerted about other trials
Share this study
Tweet this study
More information about this clinical trial
