What is a clinical trial?
- A clinical trial is the study of a drug or device. The purpose of a clinical trial is to determine the effectiveness and safety of the drug or device. Based upon the findings of the clinical trial, the drug or device may be marketed for the general public.
What is a protocol?
- A protocol is a document that explains what is being investigated and the science behind why it is being investigated. The protocol also outlines the "rules" of the study such as frequency of visits and what procedures are to be done during the visits.
Who are the participants in the clinical trial?
- Subject - is someone who volunteers to participate in the trial
- Coordinator - clinical staff (usually a nurse) that carries out the clinical trial, along with the Principal Investigator, according to the protocol. The coordinator is the first point of contact for the study patient.
- Principal Investigator (P.I.) - physician responsible for the study at a particular site. The Principal Investigator, along with the coordinator, ensures that the patient is followed according to the protocol, and that the patient's safety is monitored throughout.
- Sponsor - is a company (such as a pharmaceutical company) or agency that initiates the clinical trial and oversees the clinical trial.
- Monitor - someone hired by the sponsor to "audit" the data collected by the coordinator/PI to ensure that protocol is being carried out correctly and that patient safety is maintained.
Why should I take part in a clinical trial?
- There are many reasons why you may choose to participate in a clinical trial. Here are just a few:
- Current medications/therapies on the market are not helping
- To get access to drugs/device not currently on the market
- Helping others in the future and possible important medical discoveries. As a participant you will help determine if a drug/device is effective and whether is can be marketed to others.
- Being followed by a medical professional and receiving regular tests will give you assurance that your tests are normal, or, if not normal you can receive early treatment .
How can I ensure that my rights and safety is protected during a clinical trial?
- All clinical trials done at the GILDR Group have to be approved by the Heath Research Ethics Board (HREB) at the University of Alberta. The HREB ensures that the protocol is safe to carry out on humans and that it is in adherence to Health Canada guidelines. Also, any changes made to the protocol during the study, by the Sponsor, have to receive both HREB and Health Canada approval.
- Your confidentiality is protected during the study. Only the Principal Investigator and study coordinator will know your personal information. Once you are on the study you will be assigned a patient number. This patient number will be the only identifier that the sponsor will ever see.
- If at any time during the study the Principal Investigator feels that your safety is comprised you will be withdrawn from the clinical trial immediately.
- All clinical trials are voluntary and you may withdraw from the study at any time at your request.
What is an informed consent form?
- An informed consent form is a document that study subjects have to read, understand, and sign before starting a clinical trial. The consent form is easy to understand and will be reviewed with the study subject with the coordinator and Principal Investigator. This form is also approved by the Heath Research Ethics Board (HREB). The purpose of this form is to ensure that the potential study subject fully understands all aspects of the trial and can make an informed decision before agreeing to participate.
- The consent form includes:
- Purpose of the study
- Study procedures and visit frequency
- Subjects responsibilities
- Possible risks
- Possible benefits
- Alternative therapy
- Compensation for injury
- Right to withdraw from study
- Reimbursement of expenses
- Contact information
What you should consider before participating in a clinical trial?
- The Patient Information Sheet, attached to the consent form, will answer many of your questions but you should ask as many questions as possible before entering a clinical trial so that you feel comfortable in the decision to participate. The coordinator and principal investigator are available to answer any question you may have.
What is a Phase I Clinical Trial?
- A phase I clinical trial is the first phase of the trial conducted on humans, usually conducted on a very small group of people (50-100). Those who participate are usually healthy volunteers. This is generally the first time that drug has been used in humans.
What is a Phase II Clinical Trial?
A phase II clinical trial is the second phase of the trial conducted on patients with the disease that is expected to be helped by the new drug. It is conducted on a larger group of individuals than from previous phase (100-300). This phase will actually look at dose and response.
What is a Phase III Clinical Trial?
- A phase III clinical trial is the third phase of the trial and is conducted on a much larger group than the previous phases (1,000-5,000). This phase will determine if the drug/device is producing the desired result and whether it is effective enough for the drug to be marketed.
- During all phases of a clinical trial potential side effects of the compound is monitored.
What is a double-blind clinical trial?
- A double-blinded clinical trial is a trial in which neither the study subject nor the Principal Investigator/Coordinator know what treatment is being given to the study subject (drug or placebo (an inactive substance)). The reason for this type of trial is to prevent personal bias from influencing the results of the trial. The sponsor will randomly assign drug or placebo. At the end of the study the Sponsor will "unblind" the Principal Investigator and you will be sent a letter (copy to your family doctor) as to whether you were on placebo or on drug.
What is an open-label clinical trial?
- An open label trial is a trial where the subject is actually receiving drug and the subject and Principal Investigator/Coordinator are aware of this. Usually the trial starts double-blinded then if subject meets the criteria they can sometimes go into an open-label trial.
What is a single-blind clinical trial?
- A single blind clinical trial is a trial in which the Principal Investigator/Coordinator know what the study subject is receiving (drug or placebo), but the study subject does not know.