About Clinical Trials

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What is a Clinical Trial

Clinical trials are studies that test new ways to prevent, detect, diagnose, or treat health conditions. The goal of clinical trials is to find out if a new test or treatment works and is as safe as possible. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses. People who take part in clinical trials help contribute to medical knowledge and to potentially improving cancer care.

Types of Clinical Trials

A clinical trial is the first step before a drug, device, or procedure can be approved for wider use by patients. These studies will test to see if they work and are safe. There are 2 types of clinical trials:

Interventional

This is the study that comes to mind when you think of a clinical trial. Patients get an intervention based on a study plan. It is called an intervention because action is taken to improve a situation, like someone’s cancer. Patients who get the study drug may be compared to patients who get no drug or a drug they would’ve gotten if they weren’t in a clinical trial. This is called standard of care. Sometimes all patients get the same drug but in different doses. The information in this web site will refer to interventional studies.

Observational

In this type of study, a patient’s health is tracked over time in their daily life. Patients in these studies aren’t assigned to a study drug or treatment group. The treatments they get are part of their regular medical care. This kind of study can help to better understand a disease or things that may be linked to a disease. This kind of study may be used to learn about lifestyle choices that may be linked to heart problems or risk factors for diabetes.

This is the study that comes to mind when you think of a clinical trial. Patients get an intervention based on a study plan. It is called an intervention because action is taken to improve a situation, like someone’s cancer. Patients who get the study drug may be compared to patients who get no drug or a drug they would’ve gotten if they weren’t in a clinical trial. This is called standard of care. Sometimes all patients get the same drug but in different doses. The information in this web site will refer to interventional studies.

Clinical Trial Phases

New treatments are studied in several different phases. Each trial phase is designed to help scientists and doctors answer specific questions about a treatment.1

Phase
01
Phase 1 trials  are usually small and include just 15 to 30 people. The goals are to:
  • Find a safe dose
  • Understand how a new treatment should be given
  • See how a new treatment affects the human body
Phase 1 trials usually last several months.
Phase
02
Phase
03
Phase
04
  • Phase
    01
  • Phase
    02
  • Phase
    03
  • Phase
    04
Phase 1 trials  are usually small and include just 15 to 30 people. The goals are to:
  • Find a safe dose
  • Understand how a new treatment should be given
  • See how a new treatment affects the human body
Phase 1 trials usually last several months.

Outcomes & Possible Benefits of Clinical Trials

There are possible benefits to taking part in clinical trials. The benefits of participating in a clinical trial may include:

  • Regular and careful medical attention from a research team that includes doctors, nurses, and other health professionals 4
  • Opportunity to help other people who need to be treated for the same or similar disease in the future 1
  • Chance to contribute to scientific understanding of a disease 1

Possible Risks of Clinical Trials

You may have concerns about whether clinical trials are safe. Many people wonder about that. But you should know that there are laws and rules to keep patients safe in clinical trials. Each trial is designed with these rules in mind. The goal of clinical trials is to make sure patients are safe and the study is completed. And if you do decide to sign up, it’s always voluntary and you can drop out at any time if you change your mind.

All clinical trials have risks. Your study team can talk to you in more detail about the risks of being in the trial. The potential risks of participating in any clinical trial may include:

  • The new treatment being studied may not be better than or as good as standard therapy 1
  • The new treatment being studied may have harmful side effects that doctors do not expect or that are worse than those associated with standard therapy 1
  • Health insurance may not cover all routine care costs in a trial 1
  • You may have extra visits to the study doctor and more tests done.
  • Even if the new treatment works, it may not work for all patients.

All clinical trials are reviewed by a country's regulatory department like the FDA. In addition, each hospital or clinic that conducts a clinical trial must have the study reviewed and approved by an Institutional Review Board (IRB). The IRB reviews all aspects of a clinical trial to make sure that the rights, safety, and well-being of people in the trial will be protected. 1

Clinical trials may also use a group of advisors called the Data and Safety Monitoring Board (DSMB) to monitor the research. DSMB members are experts in clinical research and clinical trials. They ensure that trial data are complete, and they can stop a trial early if safety concerns arise or if an answer to the main research question is found earlier than expected. 1

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