Being a Backup
Friday, September 12th, 2008What is a backup subject? A backup subject is just that, a backup to the primary subjects.
Why are there backup subjects? Most studies require screening labs to be done at check-in to verify that you still meet study requirements as the gap between screening and check-in can be several days to several weeks. To this end, not all subjects will qualify at check-in and thus there needs to be more than the amount of subjects needed for the study, thus backups. Additionally, some people will decide not to show up to check in. So it is important to have extras on hand in order to fill a complete panel. It is costly to run additional groups so the clinic will try to bring in enough people to cover any disqualifications.
Why am I a backup? Technically, all subjects are backups. You are not actually in the study until you take the first dose of the study drug. Again, just because you check-in as a primary subject doesn’t mean that you are guaranteed to dose. And just because you check-in as a backup subject doesn’t mean you’re not going to get into the study. Each clinic has their own procedures for placing subjects in order for the study. Most clinics have priority subjects, subjects whom have been a backup in a previous study and were not used, and they will be guaranteed a space provided they meet all study requirements. After that, most clinics place subjects in the order that they complete all screening requirements including repeats if necessary. So someone who screens in the first screening session will most likely have a better chance of getting in than someone in the last screening. Some clinics put subjects in order based on their screening results.
What do backups do? There are two types of backups. The first type is a check-in backup. The clinic brings in one or two extra people incase some people do not make it to check-in. There may be more depending on the size of the study. If everyone scheduled to check-in makes it in, then the check-in backups will be sent home. There is usually a minimal stipend and usually a priority card or status for your next study. The second type of backup will usually stay the night or up to the first dose. Backup subjects are always first in order as they need have all of their procedures done before the first primary subject in order to take their place if needed. From check-in to the first dosing, backups may be swapped with primary subjects and vise-versa. This may be due to labs, vitals, BMI or other factors. On the morning or evening before the first dose, all the backups will wait in the dosing area and if needed, they will be used in the order determined by the study staff. If you are dosed, then you are in the study. Any backup subjects who are not used and are qualified for the study will be sent home and will receive a small stipend and usually a priority card or priority status for their next study. Stipend information for backups is outlined in the informed consent.
Is there anything I can do to prevent being a backup? While there is no sure fire way to prevent being a backup as all subjects are backups until the first dose, there are ways to increase your chances of being near the front. Always take the earliest screening date and time. Make sure you complete all screening requirements as early as possible. Show up to screenings and check-in on time or early. If you are late, you can be moved to the back of the order. High paying studies with few subjects will be hard to get into without a priority card so you should avoid these if possible.
Some final notes: If you are a backup, don’t panic! I see this happen all the time. There are many instances where backups get angry and leave the study but little did they realize that they would have been dosed if they had stayed. I know it sucks to travel from out of state only to find out that you’re a backup but again, everyone is a backup when they check-in. I have been in studies where no backups have been used and I’ve been in studies where all backups were used. You never know what will happen between check-in and the first dose, so don’t draw any conclusions until the end of the first dose. Don’t take it out on the clinic staff, the coordinator or recruiter. They are following clinic and study protocol and it is ultimately the sponsor who determines who is in the study and who is not. The only great thing about being a backup is that you usually get a priority card or status to the next study you screen for so you might get into a better study after all. After doing studies for four years, I’m usually a backup at least 2 or 3 times a year and only once in the four years I did not get used.
