ENTRUST Study | SHTG Clinical Trial

Here are some common questions and answers about study participation.

What are clinical research studies (trials)?

Clinical research studies help scientists and doctors explore whether a medication is safe and whether it works. Before a doctor can prescribe a new medication, it must go through several phases of clinical research:

Phase 1: First study of the medication in people (often healthy volunteers) to test safety
Phase 2: Study of the medication in people with the condition the medication is for to further test safety and efficacy
Phase 3: Study confirming how well the medication works and provide evidence for approval to be prescribed
Phase 4: Further research after the medication is approved

The ENTRUST study is a Phase 3 study.

Clinical research studies rely on volunteers. Remember that taking part in the study is your choice. Sometimes the research may not immediately or directly benefit you, but it may provide evidence of benefit to others in the future with the same condition. Know that the rules and ethics that doctors must follow to practice medicine also apply to clinical research studies.

What is informed consent?

Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.

What does study participation involve?

Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.

Participation in clinical research studies is your choice, and you may stop at any time

How are clinical trials being conducted during the COVID-19 pandemic?

The COVID-19 pandemic continues to impact clinical trials in different ways. For more information, visit the COVID-19 and Clinical Trials page.

If you have additional questions about participating in a clinical research study, contact a study clinic near you.

Overview of Clinical Trials

What are clinical research studies (trials)?

What is informed consent?

What does study participation involve?

How are clinical trials being conducted during the COVID-19 pandemic?