About Clinical Trials
WHAT IS A CLINICAL RESEARCH STUDY?
Clinical research studies, also called clinical trials, are research studies in which
participants are asked to take an investigational drug under the supervision of a physician
and other research professionals. An investigational drug is one that is not approved by a
health authority such as the US Food and Drug Administration (FDA), Food Branch, Health
Canada of Canada (Canada HPFB) or the European Medicines Agency (EMA).
Clinical research studies must be reviewed by an institutional review board (IRB) or ethics
committee (EC). An IRB or EC is a group that is responsible for helping to protect the safety,
rights and welfare of study participants. In addition, every study participant is monitored with
study-related medical tests and exams before, during, and sometimes even after the study.
WHO CONDUCTS CLINICAL RESEARCH STUDIES?
Governments and sponsor companies (such as pharmaceutical or biotechnology) typically run clinical
research studies. They are responsible for creating a strict study protocol (a written description of
a research study) that is acceptably safe and ensuring that all people involved follow it throughout
the course of the study.
WHAT SHOULD I EXPECT?
Before you participate in a clinical research study, a detailed description of the study – as well
as possible risks and benefits – will be provided in writing in an "informed consent form." This form
will be shared and discussed with you. You will have an opportunity to ask any questions. You will be
asked to review and sign the informed consent form prior to participating to confirm that you understand
the study and its possible risks and benefits.
If you qualify, you will be eligible to enroll in the clinical research study. Once enrolled, feel free
to discuss your research care with the study doctor or study team members at any time during the course
of your study participation.
It is important for you to:
- Attend all scheduled visits
- Adhere to the treatment and follow-up schedules
- Complete the e-diaries as required by protocol
- Describe your physical state, feelings, and well-being accurately and honestly to the study doctor
- Discuss any questions regarding the study with the study doctor
As a study participant, you will have the right to contact the study’s IRB or EC representative regarding your rights as a research participant. You will also have the right to leave the study at any time for any reason.
CAN I LEAVE THE STUDY IF I CHANGE MY MIND?
Participation in any clinical research study is always completely voluntary, and participants may withdraw
from a clinical research study at any time for any reason without penalty or loss of medical care or benefits
to which you are entitled. If you would like to leave the study, you should discuss this with your study doctor,
who will give you information about how to do this safely and arrange for further medical care and follow-up.