Thoughts from a Lab Rat

Backup. The very utterance of this term brings shivers to longtime labrats. Nobody wants to be a backup but it’s one of those necessary evils. Truth be told, EVERYONE is a backup until the first dose. Certainly, some check-ins are easier than others. For the most part, clinics will bring in several backups in addition to the number of subjects needed for the study. The reason for having extras is in the event that not everyone shows up and not everyone qualifies after checking in. Most study protocols call for rechecking of labs at check-in as your laboratory results can change between the screening and the check-in. If your check-in labs are out of range or of great variance from your screening labs, you may be disqualified from the study.

Many subjects ask why they weren’t notified over the phone that they were a backup. Simply put, EVERYONE is a backup before the first dose. Yes, when you check-in, everyone is separated in to a dosing spot and a backup, but that is based on each clinic’s placement policies. The majority of the clinics I know place people based on the order they completed screening. In all fairness, the people who screened earliest typically have priority of those who screened last. Some clinics also give preference to backups of previous studies who were not used. Either way, the final decision comes from the study doctor and the sponsor. Long story short, if people were told that they were a backup before they came, most would not show up.

It is important for the study that everyone shows up. It is possible that a study can be cancelled or postponed if not enough people show up. I have seen studies where no backups were used and I have seen studies where all of the backups were used. You just don’t know. Most times, clinics will try to place backups who were not used into future studies and may give preference (priority/vip cards). No one is guaranteed a dosing spot in a study. It sucks. Believe me I know. It sucks to set aside the time, spend the time and money to screen only to not get in. But these are voluntary positions so nothing is set in stone. The best thing to do is just try again and perhaps you’ll get into a better study. Regardless, medical science cannot advance without the timely completion of clinical research studies. Consider it taking one for the team when you’re a backup.

I know many people do it. What am I talking about? Plan B. It’s tough to get into a study sometimes and with the possibility of cancellations, postponements and just not getting into a study, it only seems right to have a backup plan. While it may seem like good intentions, it can backfire.
Let’s say that you signed up to screen for Study A on the 1st and it checks in on the 14th. You then sign up for Study B which screens on the 3rd and checks in on the 18th. So, if for whatever reason you don’t get into Study A, then you could still get into Study B. Sounds simple, right? Wrong! So let’s assume that you pass the screening for both studies so you check into Study A. You make it in. So when Study B calls to confirm check in, you of course have to decline. While yes, you can withdraw your consent at anytime, a clinic may penalize you on future studies. Some clinics will temporarily ban you from doing studies while others will do nothing. It’s not so bad when you cancel a study before the screening as the clinic hasn’t spent but a few dollars but if you cancel once you have screened, the clinic has spent on average $450 to screen you. This is of course part of running a study but if the clinic has too many qualified people canceling at the last minute, then it eats into the bottom line and of course clinics are businesses (there to make money) so they will make adjustments to their policies to curve the problems. Furthermore, if too many people cancel out of a study and the clinic can’t screen enough people to replace those in time; the study can be postponed or cancelled. So the problems you’re trying to avoid can lead to the same problems for your fellow volunteers.
Okay, so is it bad to have a backup? Yes and no. If you cancel a study for a legitimate reason such as a death in the family, family emergency, then no, that’s life. But if you have a pattern of constantly signing up and canceling studies, then clinics are going to notice and may crack down.

What 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.

Nobody wants to be a backup but somebody has to be one. Every study is going to bring in a few extra subjects as backups in case one or more of the primary subjects fails to show up or pass the check-in procedures. Sometimes no backups are used and sometimes all of the backups are used. You never know. Some sponsors will not run their study unless they have a full panel, so having enough backups is a must. Even if you are a backup and don’t get used, you will usually get some money for your troubles and priority preference for your next study. Who knows, it could be a blessing in disguise and you get into a much higher paying study.