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understanding
clinical trials

A CRITICAL STEP IN DEVELOPING NEW MEDICINES FOR PATIENTS

A type of scientific research study, a clinical trial is designed to evaluate whether an investigational new drug is safe and effective for use in humans.

understanding
clinical trials

A CRITICAL STEP IN DEVELOPING NEW MEDICINES FOR PATIENTS

A type of scientific research study, a clinical trial is designed to evaluate whether an investigational new drug is safe and effective for use in humans.

The participation process

Joining the clinical research process can be exciting, but also should be carefully considered.

While a trial may offer the opportunity to access an investigational medicine before it is approved by the U.S. Food and Drug Administration (FDA), the drug may not be effective, may have side effects or may involve a more complicated treatment process than your usual care.

The most important first step is to discuss participation with your doctor, to determine if a specific trial is right for you. Once you’ve determined that you’d like to participate, here are some of the steps that may be required:

KEY PLAYERS

Research Sponsor

The organization responsible for the trial, often a biopharmaceutical company, academic research institute or government agency.

U.S. Food and Drug Administration

The U.S. government agency responsible for protecting and promoting human health. They oversee the drug development process, including the approval of new medicines.

Institutional Review Board (IRB)

Also called an independent ethics committee, an ethical review board or a research ethics board, this is a group of doctors, researchers and community members. Their job is to review and monitor clinical research protocols to protect the rights and welfare of research participants.

Data Safety Monitoring Board (DSMB)

Also known as a Data Monitoring Committee (DMC), this is an independent group of experts whose job is to protect research participants during a clinical trial by reviewing specified data as it is collected and making recommendations to the sponsor about how to move forward.

Clinical Investigators

Doctors who deliver the investigational medicines to patients and care for them during the course of the clinical trial.

  • Research Sponsor

    Research Sponsor

    The organization responsible for the trial, often a biopharmaceutical company, academic research institute or government agency.

  • U.S. Food and Drug Administration

    U.S. Food and Drug Administration

    The U.S. government agency responsible for protecting and promoting human health. They oversee the drug development process, including the approval of new medicines.

  • Institutional Review Board (IRB)

    Institutional Review Board (IRB)

    Also called an independent ethics committee, an ethical review board or a research ethics board, this is a group of doctors, researchers and community members. Their job is to review and monitor clinical research protocols to protect the rights and welfare of research participants.

  • Data Safety Monitoring Board (DSMB)

    Data Safety Monitoring Board (DSMB)

    Also known as a Data Monitoring Committee (DMC), this is an independent group of experts whose job is to protect research participants during a clinical trial by reviewing specified data as it is collected and making recommendations to the sponsor about how to move forward.

  • Clinical Investigators

    Clinical Investigators

    Doctors who deliver the investigational medicines to patients and care for them during the course of the clinical trial.

Clinical trial phases

Typically, clinical trials follow 4 phases.

The first 3 phases are part of the drug approval process. The last phase usually takes place after the drug is approved.

For diseases that are rare or very serious, the FDA has tools it may use to support the expedited development of a new medicine.