What are the stages of trial participation?
Clinical trials have many different stages. Depending on the type of trial, you may take part in all or only some of the following stages:
You are randomly assigned (like the flip of a coin) to a study treatment group.
You may have to wait before starting the study treatment. During this time, investigators observe your health before treatment begins.
Before starting the study treatment, you may be asked to stop taking a medication and wait for a period of time. This allows the body to get rid of all traces of the medication and avoid harmful treatment interactions.
The length of time that investigators plan to have you on a treatment before they evaluate its effect. This is usually 12, 24 or 48 weeks.
Before and during the treatment period, you will be asked to come to the clinic for regular visits. The frequency of these visits is usually higher than for routine care. The follow-up may be once a month for the first six months. Sometimes, you will be asked to come after the end of the study treatment period.
The study usually ends when all participants have completed the study treatment or follow-up period. This means that if you are one of the first participants in the study, you will be in the study for a longer period than if you are one of the last participants to enroll in the study. A study may be ended early if the risk affecting one of the treatment groups is determined to be too great.
What are my responsibilities?
Your main responsibility is to be sure that you understand the rules of the trial and are realistic about your ability to follow them. If you feel that you will not be able to keep appointments or follow the schedule, talk to trial staff. There may be ways to work around your schedule. Given the strict guidelines of trials, participants who do not follow the trial rules will be withdrawn.
Remember: You can also leave a trial at any time, for any reason.
What is the role of my family doctor?
As a clinical trial participant, your health will be monitored at the trial site. However, you should also continue to see your own doctors – those responsible for your overall health — for regular check-ups and lab tests. It is not ethical for the trial doctors to take over general medical care of participants. To avoid having the same tests repeated, family doctors and site investigators usually work out a way to share test results.
When family doctors are also trial investigators, they ask another doctor to review the trial protocol and informed consent with their patients. In addition, they often recommend that their patients who are participating in the trial see another doctor for regular care during the trial. This is one way to ensure that the doctor’s interest in enrolling volunteers for the trial does not conflict with his/her obligation to provide the best possible patient care.
What happens after the trial?
When your time in a trial ends, you will be asked to participate in an exit interview. During this interview, you may be told what treatment you were receiving (if you don’t already know). Since the code in double-blind trials is not broken until everyone has completed the trial, participants in those trials may not find out what treatment they were getting until some time after they finish the study.
You should expect to receive the results of the trial when it is finished. Ask the study nurse or doctor for information about how results will be given to you if this is not explained in the informed consent form. Also, keep in mind that not all volunteers are enrolled at the same time, so a two-year trial may take several years to reach its conclusion — the last person enrolled must have been in the study for a full two years.
It is important for you to stay in touch with investigators after a trial ends, so that you can report any recurring symptoms or side effects. Investigators can also pass on any new information about the treatment to you and other participants.
As noted earlier, if any new information about the trial treatment becomes available during the trial, the sponsors and the investigators must tell all trial participants.