What to Expect: Clinical Trials Participant's Guide
A Guide to Covance Clinical Trials
Taking part in a clinical study is a big decision. The following information will help answer your questions.
The first step to participating in a clinical research study is to contact our call center at 1-866-429-3700. Our call center is open Monday – Friday from 8:30 a.m. to 6 p.m. EST (7:30 a.m. to 5 p.m. CST). The phone screen agents need to make sure you will pre-qualify for a study and will ask you a lot of questions about your medical history including any medicines you take. Please be honest and thorough in your answers. This is for your own safety.
Once you pass the phone screen you will be scheduled for a screening appointment at the clinic. It is important to follow any fasting requirements before this appointment. Bring a current, valid, government ID with you and be on time. Not showing up for an appointment could hurt your chances of getting in a study later on. Please allow 2–4 hours for this appointment.
Before any procedures are done in screening, you will be given an Informed Consent document to read. This is a very detailed overview of the entire study. This document will explain what the study drug is being tested for; how much of the drug you will receive, if any; all procedures that will be done on the study, including how many times we will take your blood and how much blood we will take; and any known side effects reported so far with this drug. It is very important that you read this entire document so you understand your role in the study and any potential risks. A trained staff member will be available to explain the study and answer any questions you may have. We ask you to sign this document so we know that you have read and understood it. This does not obligate you to do the study.
Once you have signed the Informed Consent document, we may take your height and weight measurements. We will collect a urine sample for a drug screen, check your blood pressure, draw a small sample of blood, and check the performance of your heart via an electrocardiogram (ECG). We will also review your medical history with you to make sure everything we have on file is correct. Some of these procedures may not be performed or they may occur in a different order depending on the study. Other procedures may be done as well during this visit including a physical examination, an eye test or other study-specific procedures. A staff member will get back with you as soon as we have all the results from your tests.
The clinic doctor will review the results from your screening procedures to make sure you are a good fit for the study. Your safety and well-being are always the priority. We will call you with these results and let you know if you have been selected for the study. If selected, we will give you check-in information, including if you need to fast before your admit visit, what foods or supplements you need to avoid and where you should park at the clinic when you arrive.
When you check in at the clinic, a staff member will review all the criteria for the study to make sure you are still eligible. More procedures may be done to make sure it is still safe for you to participate. These can include a blood pressure check, a blood draw, a urine sample and an ECG. If you are participating in an overnight study, we will check your belongings to make sure you didn’t bring anything with you that would disqualify you from the study.
Most of the time participants check into the clinic the day before the study begins. This is to help you get settled and comfortable. We will assign you to a room, give you a wrist band, and go over the rules of the clinic and anything particular to your study. The clinics are very much like a hospital floor. You will share a room with at least four other people of the same sex. You will have a secure place to store your belongings. We want you to be comfortable and at ease while you are at the clinic. When you are not having procedures done, you can read, watch TV, play games, join in activities like pool and Bingo, or use your laptop or phone if you’ve brought one. Each clinic has laundry facilities as well if you will be staying with us for a while.
Some of our studies are short, only one or two overnight stays, and some are longer. When you are in the clinic you are not allowed to leave or receive visitors. This is to keep you safe and to control the study data. When you admit into the clinic the staff will go over all procedures and dosing times so you will know what to expect. Each study is different but you should expect multiple and daily blood draws, urine collections, blood pressure checks and ECGs. Additional procedures like continuous heart monitoring might be required for different studies.
The first day of the study can be busy with procedures. You may be receiving the first dose of study drug or placebo (an inactive pill or liquid that will look, taste and feel just like the study drug but contains no medicine), or the staff could be gathering baseline data from each participant. It is very important that you are ready and on time for all procedures. All procedures, even meals, are timed to the exact minute. If you are scheduled for a blood draw at 8:04 then that is exactly when it needs to happen…not a minute earlier or later. Covance is hired by pharmaceutical and biotech companies to collect data. It is essential that this data is accurate. These companies analyze this data to determine if the study drug justifies further testing.
There might be a lot of people around on dosing day, including the study sponsor. Again, everyone wants to make sure that you are safe. The clinic staff will ask you often how you are feeling. Your answers are very important to our doctors, as well as to the study sponsor. After dosing you may feel perfectly fine or you may have a few symptoms such as a headache or an upset stomach. You could develop diarrhea or a rash. Our staff will be on hand to make you as comfortable as possible and to monitor and help manage your symptoms.
Three meals a day plus snack(s) will be provided, unless you are required to fast for a certain length of time. Some of the studies require that you eat a certain amount of your meals; some studies require a high fat diet while other studies are not as restrictive. The clinic staff will need to record what time you eat and how much. You will be in the clinic with other people doing different studies so you may see some people eating a different meal from you. Remember, each study has different requirements and procedures.
We want your stay with us to be as positive as possible. When you are not having procedures done, you are free to relax and enjoy having nothing to do! You can participate in group activities, catch up on sleep, study (each clinic has free Wi-Fi), watch movies or play video games (you may bring your own gaming system). However, it’s lights out as early as 11 p.m. We want you to be well-rested. Sometimes procedures start very early in the morning.
At the end of your study we will give you a voluntary survey to complete. It is a quick form to gather your feedback on what we did well, where we need to improve, and if the study met your expectations. We value your comments and are committed to continually improving what we can. More than 60% of our participants have done more than one study. It is our goal to welcome you back for your next study as soon as possible.
It’s almost time to go home and we will go over any requirements or restrictions, as well as return any items that were removed from your luggage at check in.
Some studies require follow-up visits or phone calls. It is important that you keep all these appointments. We will also want to know how you are doing after the study.
You will be paid for your time and participation in the study. Compensation is based on the length of the study, the number of overnight stays in our clinic, and the number of outpatient visits you attend. Payment details will be discussed with your study team at your first visit.