Frequently Asked Questions

All prescription medications (including things like aspirin and Tylenol for example) available today have gone through clinical research studies. Because of this research, we now have new, more effective treatments for hundreds of diseases.

By participating you may have a chance to receive a new therapy that is not available to the general public. It gives you the opportunity to participate in breakthrough research that may aid the future understanding and care for others with your disorder and the knowledge that you are helping to advance medical science.

You may be monitored more closely than normal follow up visits with your own doctor.

To determine if a new drug or therapy is safe and effective, some participants may be administered the study medication in different doses, while others sometimes will take a placebo (a sugar pill that contains no active medication) as a comparator.

Those who decide to volunteer for a particular clinical study will be advised of the potential risks and benefits of participating when they review the informed consent with their physician or study coordinator and will be informed of exactly how the study medication will be tested in the group.

Clinical studies are carefully monitored by a team of doctors and nurses, in addition to government health authorities and medical ethics groups. All information is kept confidential. Participation is completely voluntary throughout and you can stop at any time without affecting your care.

Participants will be given contact information to reach us at any time. Participants are asked to report all medical concerns or changes they notice that occur during the research study no matter how insignificant they seem.

Your doctor will be kept up on your status in the study and will be sent any results that are collected during your participation.

After discussing the study with the study doctor and nurse and after reading the informed consent, make sure you completely understand the following and that all your questions have been answered as each study is different:

• the purpose of the study
• the type of medication being investigated and its general mechanism of action
• known potential risks and side effects of the study medication
• length of the study
• number of visits involved and what will occur at each
• results of previous investigations using the experimental approach
• description whether a placebo will be used
• type(s) of evaluation to be done
• limitations on access to medical records if any
• confidentiality requirements for investigators
• other treatment options available
• the right to discontinue at any time

Please make sure you ask questions!

Prior to participating in a clinical trial, a potential participant is required to undergo a thorough screening process to ensure suitability for the study in question. During this process, the investigator and or nurse will conduct an examination of your medical history, a physical examination and usually a blood is drawn for laboratory testing. This is done to make sure you match the criteria of the group being studied and that it will be safe for you to participate.

• You may experience possible side effects from the medication being studied including some we may not know about. Make sure you understand these from the informed consent and that you are comfortable with them.
• In some studies you may receive a placebo (sugar pill) that contains no active medication. There are no guarantees the treatment will actually work but this still contributes greatly to our understanding.
• You may find out new information about your health status that you may not otherwise have known. For some people this could be viewed as good news and therefore a benefit and for others as bad news and therefore a risk.