Clinical Trial Participants

Clinical trials are research studies in which participants help find answers to specific health questions. When carefully conducted, they are the safest and fastest way to find new treatments and ways to improve health.

Clinical trials are conducted according to a plan, called a protocol, which describes:

• the types of patients who may enter the study
• the schedules of tests and procedures
• the drugs involved
• the dosages, or amount of the drug
• the length of the study
• what the researchers hope to learn from the study.

Participants in the study must agree to the rules and terms outlined in the protocol. Similarly, researchers, doctors, and other health professionals who manage clinical trials must follow strict rules set by the regulator. These rules make sure that those who agree to participate are treated as safely as possible.

Learn more about the basics of clinical trial participation, read first-hand experiences from actual clinical trial volunteers, and see explanations from researchers at the NIH Clinical Research Trials and You website (https://www.nih.gov/health-information/nih-clinical-research-trials-you).

Clinical trials are conducted for many reasons:

• to determine whether a new drug or device is safe and effective for people to use.
• to study different ways to use standard treatments or current, approved treatments so that they will be more effective, easier to use, or decrease certain side effects.
• to learn how to safely use a treatment in a population for which the treatment was not previously tested, such as children.

Some people participate in clinical trials because none of the standard (approved) treatment options have worked, or they are unable to tolerate certain side effects. Clinical trials provide another option when standard therapy has failed. Others, including healthy people, participate in trials because they want to contribute to the advancement of medical knowledge.

All clinical trials have guidelines, called eligibility criteria, about who can participate. The criteria are based on such factors as age, sex, type and stage of disease, previous treatment history, and other medical conditions. This helps to reduce the variation within the study and to ensure that the researchers will be able to answer the questions they plan to study. Therefore, not everyone who applies for a clinical trial will be accepted.

It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people, because different people may respond differently to treatments.

Government regulators work to protect participants in clinical trials and to ensure that people have reliable information before deciding whether to join a clinical trial. The Federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks. Although efforts are made to control the risks to participants, some may be unavoidable because we are still learning more about the medical treatments in the study.

The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Before joining a particular study, you will be given an informed consent document that describes your rights as a participant, as well as details about the study, including potential risks. Signing it indicates that you understand that the trial is voluntary and that you may leave at any time. The informed consent is part of the process that makes sure you understand the known risks associated with the study.

There are a number of benefits to participating in a clinical trial:

• Participants get early access to treatments that are being developed, whether they are vaccines (eg. Flu or RSV) or specific treatments (eg. Weight loss or cholesterol treatments), often years ahead of those treatments being available to the market.
• As part of a clinical trial, participants undergo additional testing and monitoring, which can have positive outcomes on your long-term health.
• By participating in clinical trials, you are helping with the next generation of healthcare treatments for the community.

An individual cannot participate in a clinical trial without having given their consent. The consent process is an acknowledgement that you understand the research process, the purpose of the trial and what you will need to do or be asked to do on the clinical trial. It is important that these are all clearly explained to you and that you understand them. If at any point you require further clarity, please notify one of our staff and we will ensure that you are provided with any information required. An individual can withdraw consent at any point in time.

Before joining a clinical trial, it is important to learn as much as possible. Discuss your questions and concerns with members of the health care team conducting the trial. Also, discuss the trial with your health care provider to determine whether or not the trial is a good option based on your current treatment. Be sure you understand:

• what happens during the trial
• the type of health care you will receive
• any related costs once you are enrolled in the trial
• the benefits and risks associated with participating

The regulators make sure medical treatments are safe and effective for people to use. They do not develop new therapies or conduct clinical trials. Rather, they oversee the people who do. The regulators meet with researchers and perform inspections of clinical trial study sites to protect the rights of patients and to verify the quality and integrity of the data

A placebo is a pill, liquid, or powder that has no treatment value. It is often called a sugar pill. In clinical trials, experimental drugs are often compared with placebos to evaluate the treatment’s effectiveness.

In clinical trials that include placebos, quite often neither patients nor their doctors know who is receiving the placebo and who is being treated with the experimental drug. Ask the trial coordinator whether there is a chance you may get a placebo rather than the experimental drug. Then, talk with your doctor about what is best for you.

Clinical trials go through phases. These phases indicate what stage they are at in the research process. Generally speaking, the earlier phases of trials have smaller groups of participants and are shorter in length.

• Phase 1: Testing the safety, dosage, and side effects of a drug or treatment.
• Phase 2: Testing the effectiveness (efficacy) and safety of a drug or treatment in a larger group of people who have a specific disease or condition.
• Phase 3: Testing the effectiveness, safety, and side effects of a drug or treatment in a large group of people who have a specific disease or condition, compared to a standard or existing treatment.
• Phase 4: Testing the long-term safety and effectiveness of a drug or treatment after it has been approved and marketed.

Clinical trials can be described in the following categories.

• Medical Devices, which are used to diagnose, prevent, treat and monitor medical conditions (for example, ventilators or pacemakers)
• Drug treatments
  • Treatments with a large addressable population (for example, a flu or RSV vaccination), which will often look to recruit healthy participants who reflect the mix of people in the community.
  • Treatments with specific addressable populations, such as treatments in the area of:
    • Dermatology (for example, for eczema, psoriasis or acne)
    • Metabolic (for example, for diabetes or obesity)
    • Cardiac (for example coronary artery disease or hypertension)
    • Mental Health (for example, depression, anxiety or PTSD)
    • Women’s Health (for example, reproductive health, menopause or endometriosis)
    • Respiratory (for example, asthma or chronic bronchitis)
    • Rheumatology (for example, rheumatoid arthritis or lupus)
    • …and many more

• US Food & Drug Administration (fda.gov)
• US National Institute of Health (nih.gov/health-information/nih-clinical-research-trials-you)
• Australian Therapeutic Goods Administration (tga.gov.au)
• Australian Clinical Trials (australianclinicaltrials.gov.au)

Joining our database is a great way to be kept up-to-date on the clinical trials for which we are recruiting. There is no obligation to participate in any trials if you are on our mailing list.