Thoughts from a Lab Rat

First and foremost, research subjects are volunteering to participate in a clinical research study. Nobody is forcing anyone to do a study. Certainly the clinics make it enticing with the prospects of earning a small or large stipend for completing a study, but it is still your decision to screen and check-in to a study.

The primary concern of the clinic is to get valid and accurate study results from the volunteers. Every procedure is timed for a reason. The drug company and the FDA must know that every subject was given the study medication, all blood collections and study procedures were collected at the same time intervals. If some subjects are late, then the results are useless because the time intervals are different. It is your responsibility to keep an eye on your upcoming procedures and to be early. Times listed on your clipboard or itinerary is the time the procedure must be done, not when you should show up. You should always show up 3 to 5 minutes before the scheduled procedure. Many studies have additional restrictions and rules. These are usually put in place due to the class of drug you are taking and because of known potential side-effects. The clinic is also concerned about your safety and will enforce these restrictions. Bottom line, the clinic is paid by the sponsor to carry out the study in a predetermined way and the clinic staff will follow the protocol to the T. If you don’t wish to continue the study, you are free to leave at any time.

Every clinic has rules of conduct that are to be followed by all research subjects. Why do clinics have rules? Because without rules and protocols, the study would be chaos. Sometimes even with rules, the studies can be chaotic because some volunteers choose not to follow some or all of the rules. It’s pretty simple. And more clinics are taking a more serious stance on infractions. If you break the law while driving your car, you get fined. If you commit a serious enough offense, you get arrested. It is the same in a research study. Most clinics will fine you if you are late to a procedure. They may fine you more if you are constantly late. They may fine you more for more serious infractions like vandalism. If you commit a major infraction like fighting, theft or serious vandalism then you may be removed from the study with the loss of part or most of your earned study stipend and not allowed to do future studies which in the real world would amount to life in prison without parole.

Some volunteers believe that if they don’t get caught, their not causing any harm. Well, I’ve got news for you! When you participate in a research study, you are confined to a relatively small space with many other volunteers from various backgrounds, ethnicities, religious beliefs, ages and so on. What seems appropriate to you and your background may be offensive to someone else. Simple manners here. It seems silly to even have to write an article about this but if I didn’t see this happen all day long in the studies I do, then I wouldn’t be writing this! Treat others as you would like to be treated. Respect others people belongings including the clinic’s property. Don’t borrow stuff unless you ask the rightful owner. Throw away your trash into a trash receptacle. Flush the toilet. Throw your towels in the laundry hamper. Turn your lights out at bed time. These are all simple manners you should have learned in preschool but many of the volunteers must’ve missed that day.

Long story short, every clinic has an informed consent form and a rules agreement. When you sign those forms, you are agreeing to follow the rules and outlines of the study, Failure to do so is a breach of contract so don’t be surprised if you get fined or thrown out of a study for not following the rules. There are many people out there who would love the chance to volunteer for a study and get paid, so if you don’t like doing studies, don’t complain all day and make it miserable for others around you. Go do something else. Go back to work at Taco Casa. If you choose to participate in a study, take it seriously because the lives of millions are at stake. People need medications to treat their aliments and the longer a potential drug is tied up in clinical trials, the more people suffer. Look beyond the money and see what clinical research is all about.

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.

I have heard this happen to a lot of people and it has even happened to me! *Gasp!

What am I talking about? Mistakes. They happen.

Case in point. Last year I was screening for a study and I was told by the tech that I was excluded because my pulse rate was 100 and the cutoff was 90. I didn’t feel like my pulse was high. So as I was walking out to leave, something told me to go back and look at the machine. A closer inspection showed that my pulse was actually 70 and the tech was looking at a number that had nothing to do with the systolic, diastolic or pulse rate. I called the tech on this and another tech verified my claim and my pulse rate was corrected and I made it into the study. I have heard other stories with not so good results.

Unfortunately, most things are set in stone as soon as it is written on your records. If you say the wrong thing during a phone screening, they must take your first answer. It is important that you pay attention to everything that goes on during your screening, check in and other procedures throughout the study. Always check to make sure that techs are signing their initials and putting down the correct time. You don’t want to have your coordinator come to you a week later trying to find out who did your procedure last week. When giving a UA sample, make sure you’re using the right cup if subject information is printed on them. When doing vitals, check the results on the machine to the results written down. After doing many studies, you should be aware of your weight and height both in centimeters and inches and kilograms and pounds. Though these numbers can change, definitely be aware of these numbers as BMI is very important.

While you may say that it is up to the techs and staff to make sure that everything is being done correctly, mistakes still happen and many of these mistakes are easily caught if you’re paying the least bit attention. Nobody wants to get excluded from a study, especially for some silly mistake. After the fact, even mistakes mean nothing. Even if the staff made a mistake, you will still not get into the study. It’s unfortunate, but that’s the way clinics operate. So, pay attention to questions on the phone, during your screenings and throughout the study and hopefully everything will go smoothly. But of course, even the best laid plans run into wrinkles.