During your first visit to the study center (screening visit), you will come across a lot of important forms and information that you will have to sort through as you come one step closer towards making your decision about joining the study. I recommend you bring a family member or a loved one with you to help guide you in your decision making process. If you got to the point where you are even showing up to your first study visit, you have already come a long way.
Chances are, you’ve been pre-screened over the phone or in-person by someone at the research center. Some research centers are hybrids of study centers and a physician private practice. My company, SCCT, falls under this category. In these cases, your physician conducts studies within his practice and chances are he might mention a clinical trial to you whenever he deems it appropriate. If he happens to be conducting a trial that he feels may be beneficial to you, he will tell you about it. Often, this is the best way to get introduced to the world of clinical trials. You and your doctor have an existing relationship, and many people first hear about clinical trials through their physicians. In my opinion, these types of research centers are ideal for both the study participant and the drug companies to deal with but of course, I’m a little biased.
Regardless of the type of study center, screening visits are virtually the same. The first (and most important) procedure is going over the Informed Consent. You will sit in a private room with the doctor or a member of his study team. The member of the study team will go over the purpose of the study, the risks, benefits, known side effects, as well as all procedures that will be required during the trial. These forms usually range anywhere from 9 pages to over 26 in some cases, and basically spell out every last detail of the study. These are legal forms that require signatures and dates and initials and resemble any typical legal document that you can think of. You should be encouraged to ask any questions regarding the study, and can take as long as you want in terms of making a decision on whether to join the study or not. You should even be encouraged to take the form home and discuss it with your family or other support system. As a side note, you can withdraw from the study at anytime, even immediately after signing the consent form, and for any reason.
Once the consent form has been explained, discussed and signed by all applicable parties (some studies require a caregiver or other such individual to be present during this process) you will begin the procedures of the actual study. This is where studies differ amongst themselves depending on the therapeutic indication or phase of the study. Virtually all studies will require blood draws, urine samples (for drugs and pregnancy), ECG’s (monitor’s your heart activity), vital signs, and some type of study participant survey such as quality of life assessments or something along those lines. The purpose of all of this is to capture your data before you start the study drug.
You most likely will NOT be given the study drug at your first visit. They want to make sure that you are healthy enough to join the trial and that you don’t have any pre-existing medical conditions that might make it seem as if the study drug caused them. Once it’s determined that you are healthy enough to take the study drug, you will be scheduled a 2nd study visit.
With all the hoopla that comes with a screening visit, you don’t even take the study drug until a later study visit, and you very well may not even qualify for those next visits due to a number of different reasons that may or may not even be clinically significant. You also may have changed your mind between the screening visit and your next visit, and chose to quit the trial. You have every right to do so.