What you should know about clinical research studies.  

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) 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 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) 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” and will be 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 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.

CAN I TAKE PART?

In order to qualify for the CeD-LA-3001 study, certain criteria must be met. Some of the basic criteria are listed below.

  • Are 18 years old or older
  • Were diagnosed with Celiac Disease more than 6 months ago
  • Are actively experiencing symptoms related to Celiac Disease
  • Have been on a gluten-free diet for at least 6 months

Other criteria must be met to participate. A study doctor will need to perform various health tests and examinations to confirm if you are able to participate in the CeD-LA-3001 study.
There is no cost to you to participate in this study. Health insurance is not required to participate.