Network members

The National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health (NIH) in Bethesda, Maryland funds the PETAL Network. The NIH has created an online resource for people interested in learning more about participating in research. The following questions and answers are summaries of the NIH page from early 2018; we highly encourage you to go to "The Basics" for more in depth information.

What are clinical trials and why do people participate?

Clinical research is medical research that involves people like you. When you volunteer to take part in clinical research, you help doctors and researchers learn more about disease and improve health care for people in the future.

What are clinical trials and why would I want to take part?

Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease. People take part in clinical trials for many reasons -- some take part to help others and to contribute to moving science forward, and some may take part to possibly receive the newest treatment.

How does the research process work?

The idea for a clinical trial often starts in the lab. After researchers test new treatments or procedures in the lab and in animals, the most promising treatments are moved into clinical trials.

What are clinical trial protocols?

Clinical trials follow a plan known as a protocol. The protocol is carefully designed to balance the potential benefits and risks to participants, and answer specific research questions.

What is an Institutional Review Board?

Most clinical trials in the United States are approved and monitored by an Institutional Review Board (IRB) to ensure that the risks are reduced and are outweighed by potential benefits. IRBs are committees that are responsible for reviewing research in order to protect the rights and safety of people who take part in research, both before the research starts and as it proceeds.

What is a clinical trial sponsor?

Clinical trial sponsors may be people, institutions, companies, government agencies, or other organizations that are responsible for initiating, managing or financing the clinical trial, but do not conduct the research.

What is informed consent?

Informed consent is the process of providing you with key information about a research study before you decide whether to accept the offer to take part. The research team provides an informed consent document that includes details about the study, such as its purpose, how long it’s expected to last, tests or procedures that will be done as part of the research, and who to contact for further information. The informed consent document also explains risks and potential benefits. You can then decide whether to sign the document. Taking part in a clinical trial is voluntary and you can leave the study at any time.

What are the types of clinical trials?

There are several different types of clinical trials, such as "prevention trials", "screening trials", "diagnostic trials", etc. Please visit the NIH page for information about the different types of clinical trials.

What are the phases of clinical trials?

Clinical trials are conducted in a series of steps called “phases.” Each phase has a different purpose and helps researchers answer different questions. Please visit the NIH page for more information about the different phases of clinical trials.

What do the terms placebo, randomization, and blinded mean in clinical trials?

• A placebo is an inactive product that resembles the test product, but without its treatment value.
• Randomization is the process by which treatments are assigned to participants by chance rather than by choice. This is done to avoid any bias in assigning volunteers to get one treatment or another.
• Blinded studies are designed to prevent members of the research team and study participants from influencing the results.

For more information, please visit the NIH page.

Who takes part in clinical trials?

Many different types of people take part in clinical trials. Some are healthy, while others may have illnesses. Researchers follow clinical trials guidelines when deciding who can participate in a study. These criteria are based on factors such as age, gender, the type and stage of a disease, treatment history, and other medical conditions. Before joining a clinical trial, you must provide information that allows the research team to determine whether or not you can take part in the study safely.

For more information on healthy volunteers and patient volunteers in clinical trials, please see the NIH page.

What do I need to know if I am thinking about taking part in a clinical trial?

Clinical trials may involve risk (as can routine medical care and the activities of daily living). When thinking about participating in a clinical trial, you should think about both the risks and the benefits you may receive. The NIH page goes through some of these risks and potential benefits.

What questions should I ask if offered a clinical trial?

The NIH page has a very good list of some of the questions you should consider asking if you are approached for a clinical trial. These include questions about the purpose of the trial, who has reviewed and approved it, the various risks and benefits (both long and short term) of the trial, what alternatives to the trial exist, what procedures and tests are a part of the trial, if there are any cost issues involved, and many more.

How is my safety protected?

There are many protections in place to try and ensure that you are not unnecessarily put at risk. In additional the ethical guidelines of clinical research, the IRB review and the informed consent process are important parts of this protection. For more information, and links to some further reading, please visit the NIH page.

What happens after a clinical trial is completed?

After a clinical trial is completed, the researchers carefully examine information collected during the study before making decisions about the meaning of the findings and about the need for further testing. When a phase III trial is completed, the researchers examine the information and decide whether the results have medical importance. Results from clinical trials are often published in peer-reviewed scientific journals. Ask the research team members if the study results have been or will be published.

How does clinical research make a difference to me and my family?

Only through clinical research can we gain insights and answers about the safety and effectiveness of treatments and procedures. Groundbreaking scientific advances in the present and the past were possible only because of participation of volunteers, both healthy and those with an illness, in clinical research. Clinical research requires complex and rigorous testing in collaboration with communities that are affected by the disease. As research opens new doors to finding ways to diagnose, prevent, treat, or cure disease and disability, clinical trial participation is essential to help us find the answers.