Randomized is used to describe a research study that hopes to compare two or more different treatments or procedures. Randomized means that you will be assigned to a study group by chance, like flipping a coin.
The length of each trial can vary anywhere from a few days or weeks, to months or years. Each trial is different. There is an informed consent process that occurs before you can officially enroll in a trial. At this time, you will be told the study details and exactly how long the trial is scheduled to last.
Yes. Participating in a clinical trial is completely voluntary and you can leave the trial at any time.
Yes. You may see your regular doctor at any time while participating in a trial.
At the end of a study, the researchers analyze the data that were collected from all participants throughout the study. Findings and data collected about you will be compared to other participants. In clinical trials, doctors and specialists in biostatistics would conduct the analysis and report the findings to scientific meetings and medical journals. Data will also be shared with experts and various government agencies responsible for the approval of new drugs, biologics and devices. Not all experimental treatments receive final FDA/Health Authority approval in the end.
You will be informed honestly and without bias what the known and potential risks are for participating in the trial. This information will be submitted to you in a language you will be able to understand. There is an Institutional Review Board (IRB) requirement that every participant in a clinical trial be informed about the possible risks, benefits and available alternatives. All of the information necessary to assist you in determining whether or not to participate in a clinical trial is provided in a document called the "informed consent document." This document informs you of how to let the investigator know if you think you are experiencing a problem with the research and what resources are available to help you. You should ask any questions you may have about a clinical trial before signing the informed consent document. Even after you have signed the informed consent document to participate in a clinical trial, you should always speak to the investigator if you have questions or problems.
It may be necessary for a researcher to create new health information about you or to review information in your medical records as part of your participation. Before being able to do this, the researcher must obtain your authorization to access your health information. As part of the informed consent process, you will receive a description of the type of health information to be viewed or created as part of the research, understand who will view the information, for what purposes, and for how long. After reviewing this information, you will be asked to grant permission for the use of your information by providing "authorization."