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THE CLINICAL TRIAL EXPERIENCE
While each clinical trial experience is different, here are a few of the things that you could experience along your clinical trial journey.
WHAT TO EXPECT
In most cases, you can learn about clinical trials from your doctor, or ask them if they can help you search for one. You can also find a trial yourself.
Below you will find an outline that describes the clinical trials process from start to finish:
CONSIDERATION
INFORMED CONSENT
POST-SCREENING AND POST-TESTING
IDENTIFY TRIAL
PRE-SCREENING AND PRE-TESTING
TREATMENT
FOLLOW-UP AND RELEASE
INSTITUTIONAL REVIEW BOARD
Every clinical trial is overseen by an independent committee called the Institutional Review Board (IRB), that approves, monitors and reviews the study is organized and run. The IRB was created to protect the rights, welfare, privacy and health of people that are recruited to participate in clinical research trials. ​ Read more
THE TRIAL TEAM
A large team of people work collaboratively to ensure your safety and standard of care during the clinical trial. You will meet a few during your enrollment in one of trial but many of them work behind the scenes to provide your care.
PRINCIPAL
INVESTIGATOR (PI)
PRINCIPAL INVESTIGATOR (PI)
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This is the person responsible for all aspects of the research study. They are responsible for developing the study concept; writing a detailed description of how the study will be conducted; and submitting the proposal for approval to the Institutional Review Board (IRB).
CLINICAL
NURSE
CLINICAL NURSE
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This person is responsible for obtaining accurate and complete medical history; obtaining blood and urine samples; and collecting, documenting and maintaining accurate patient records. This person is also responsible for reviewing the risks and benefits of the study with the participants.
PSYCHOLOGIST/
PSYCHIATRIST
PSYCHOLOGIST/PSYCHIATRIST
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These are board certified therapists/doctors who work with the PI to monitor and care for those who participate in the study. They treat participants according to the clinical trial design, evaluate and record participant responses, and document any side effects.
SCHEDULER
SCHEDULER
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The person is responsible for scheduling diagnostic and therapeutic procedures for clinical research participants, and all required follow up appointments.
RESEARCH NURSE
(also known as the Research Coordinator)
Research Nurse:
(also known as the Research Coordinator)
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This person is responsible for explaining the study details to patients and health providers in the community who could refer their patients. The person also helps with giving the study medicines and assists the PI in monitoring for side effects.
STUDY COORDINATOR
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The study coordinator handles many of the activities for a research study. Study coordinators ensure participants understand the requirements of the study and agree to participate. They work with the PI, the research institution, monitors, and others involved to make sure that the study follows research regulations.
STUDY
COORDINATOR
PHLEBOTOMIST
PHLEBOTOMIST
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The phlebotomist collects and processes blood samples from participants as well as assisting the nursing staff in obtaining vital signs, height/weight, body mass index (BMI) and ECG/EKG data, and other data to report for the clinical trial.
RESEARCH
ASSISTANT/RECRUITER
RESEARCH ASSISTANT/RECRUITER
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This research assistant/recruiter is responsible for identifying, pre-screening, and scheduling appointments for potential participants to enroll in clinical research trials.
AND LAST, BUT CERTAINLY NOT LEAST...
YOU
Clinical trials would not exist without people like you who are willing to take a leap in the name of hope and science that these clinical trials may benefit you or future generations of people with the same condition(s) as you.
INFORMED CONSENT
ASK QUESTIONS. STAY INFORMED.
Participation in a clinical research trial is completely voluntary. It is important for you to know what to expect before you agree to sign up. In order to help you understand, our psychologists, nurses, trial coordinators or another member of our trial team will explain the "informed consent" document that will provide you with information about the research being conducted, what is required from you and the treatment/interventions being performed.
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Signing this document demonstrates that you understand what to expect.
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TAKE THE NEXT STEP: FIND A TRIAL
There are several ways to search and find a trial. You can call one of numbers to speak with a Sarkis Clinical Trials representative or fill out a form and someone will be in contact with you.