So, you signed up to participate in a clinical trial! Maybe you wanted to help advance future treatment options, or you wanted access to new breakthrough treatments before the general public, or maybe you just needed the free medication and compensation. No matter what made you get involved, what you can expect from your clinical trial experience follows the same process. Let’s take a look at what that experience should be!
Informed Consent – I need to sign what?
The first thing you will do after your initial phone call with the site to determine potential eligibility, is come in for your Screening Visit. This visit is meant to be an introductory visit for you to get to know all about the study. This is also where you will first meet the Primary Investigator and his/her team. Remember at this point you are not “enrolled” in the study yet. The first thing the study team will discuss with you is the informed consent.
During this time, they will explain every aspect of the study to help you understand if you want to participate. You will be informed of all the risks, potential benefits, and alternatives to participating in research. Only once you fully understand the study will you sign the informed consent document but remember this is not a contract. This is only stating that you understand the study and are willing to participate, you may withdraw your consent at any time during the study.[1]
Screening Period – And the tests begin…
Once you fully understand the study and have signed consent, you will then enter the “screening period”. This is where the study team will do all of your initial testing to see if you are eligible to actually be enrolled into the study. This time varies between studies. It can be as short as a few minutes to as long as a few weeks. The kind of tests needed vary as well between studies. Most studies require vitals, blood work and some kind of questionnaire for the patient to fill out. Some studies require more extensive testing, but that will be explained during the informed consent process.[2] Finally, when all your test results are in you will either be enrolled in the study or you will “screen fail” (which basically means you did not meet the necessary criteria to enroll in the study).
Randomization – Finally!
Once you are enrolled into the study you will be randomly assigned into a study group. At this point you may either receive the investigational medication, placebo, or an active comparator depending on how your study is designed. Again, the study design will all be explained during the informed consent process.
Continued Visits – Wow you really do care!
After you are randomized into the study you will continue to return to the research site for regular visits. At these visits the study team will conduct additional tests to determine how the drug is affecting you. You may also be asked to keep a diary of your dosage or symptoms. The study team will also be checking these at this time to monitor your symptoms and your compliance. The main goal of the study team is to ensure that you are receiving the best possible care.[3] If you are having any negative side effects or you fear your condition is worsening this would be the time to tell the study team so they can report it. Remember, you can withdraw your consent at any time!
Now that you know a little more about what you can expect from your clinical trial experience, we look forward to seeing you at your screening visit! We can’t wait to get started!
If you have not signed up for a clinical trial yet, but are interested please visit http://neresearch.org/clinical-trials/#!/ to see all of our currently enrolling studies! Remember all study related care is provided to you at no cost and compensation may be available for qualified participants.
[3] https://www.clinicaltrialsandme.com/informed-consent-clinical-trials.html
[2] http://www.clinicaltrials.com/study-participants/what-to-expect/
[1] https://clinicaltrials.gov/ct2/about-studies/learn
