Below are some common questions and answers about this study and clinical research studies in general.Will I receive the investigational drug? How long will this study last? What if I cannot make an appointment? How am I protected in this study? Can I leave a clinical research study? What happens after a clinical research study?
Some people in this study will receive the investigational drug, and others will receive placebo (dummy drug), which looks like the investigational drug but contains no active medication. Placebo is possible in the TANGO studies with approximately 42 week or 52 week durations.
You will be assigned to your treatment group at random. Neither you nor your study doctor will know if you are receiving the investigational drug or placebo. The study staff can answer any questions you have about the chances of receiving the investigational drug.Back to top
Your total participation in the study will approximately be 44 weeks, 52 weeks, or 84 weeks, depending on which TANGO study you joined.Back to top
It is important that you attend all your appointments so that doctors can monitor your health. If there is a reason you cannot make an appointment, contact your study staff as soon as possible to set up a new appointment time.Back to top
Clinical research studies are regulated, following rules set by health authorities. The research study will follow a protocol, which is a detailed study plan explaining what researchers will do in the study.
Each research study must also be approved by an institutional review board (IRB) or ethics committee (EC). IRBs and ECs are groups of people who help protect the rights and welfare of people participating in research studies. IRBs or ECs are usually made up of doctors, scientists, religious representatives, and other medical and nonmedical people.
YYour privacy will also be protected. The research team cannot tell anyone that you are participating in a research study without your permission. All of the information collected during the study will be kept confidential, and your name will not be listed in any reports based on the study.Back to top
Yes, you have the right to leave a research study at any time. When you want to leave, tell the doctor or research team and explain your reasons for leaving, but you don't have to give reasons if you don't want to.Back to top
After a clinical research study is finished, all of the information is collected and analyzed to help determine the medication's safety, effectiveness, and side effects.
Please talk to your doctor or healthcare provider about your treatment options after you complete this study.Back to top