Each year, billions of dollars are spent on medical research in order to learn more about various diseases and improve healthcare. As a young woman, there are many health topics being studied that may affect you directly or affect someone you know. Learning about medical research will help you understand how developments in medical care come about and how you can be a part of that process.

What is Clinical Research?

There are two different types of medical research: laboratory and clinical. Laboratory research involves studying diseases at a microscopic level. Laboratory researchers usually have little to no contact with patients. Clinical researchers, on the other hand, work almost exclusively with patients in a clinic setting such as: a hospital, outpatient clinic, or doctor’s office. Research is a way for doctors, nurses, and scientists to learn more about diseases, behaviors, or medical procedures that affect a person’s health. Other names for clinical research include: “clinical trial”, “medical study”, or “clinical investigation.” Some research studies may have direct benefits to those who participate and improve a participant’s health while other studies may not help the participants themselves, but may help people in the future. Through research, doctors are hoping to find better ways to take care of people as well as make important advances in the medical field.

Main Types of Clinical Research

Drug Trial: A “drug trial” is a study that tries to figure out if a medication is safe and will help treat patients with an illness. Sometimes a study compares two medications to learn which one works best. Other studies may test how well one medication works. One example would be a study that tests whether or not a new medicine will help relieve the pain of headaches.

Observational Study: An “observational study” looks at the health of individuals who have certain medical conditions and are already receiving treatments, such as drugs, medical devices, or procedures before the study starts. In this type of study, patients who receive a specific treatment are observed, and there is no attempt to affect the outcome. In other words, treatment itself is not prescribed by the study. Unlike drug trials, this type of study looks at the health outcomes of participants rather than testing specific drugs, devices, or procedures. For example, a study might observe a group of older adults to learn how different lifestyles affect bone health.

Device Study: A “device study” tests a piece of medical equipment used to help patients. For example, a device study could test whether or not a new piece of equipment helps patients with asthma breathe easier.

Procedural Study: A “procedural study” investigates whether a method of providing care is safe and effective. For example, if a new surgical technique is created, it must be tested in a research study and approved before it is approved for the general public. A procedural study may test a new type of surgery to remove someone’s tonsils or appendix.

Behavioral Study: A “behavioral study” investigates why people act a certain way. For example, doctors sometimes want to know if specific feelings influence peoples’ actions. A study that investigates if certain feelings make people more likely to eat dessert is a behavioral study.

Genetic Study: A “genetic study” is a study that looks to identify and understand the relationship between our genes and some illnesses. This research explores the ways in which certain genes may make someone more or less likely to develop a specific condition or illness. Information gathered from genetic studies may allow doctors to improve their ability to predict disorders in their patients.

Exploratory or Formative Study: An “exploratory study” or “formative study” is typically conducted to learn more about a problem or condition that is relatively unknown in order to help design future studies in that area. Focus groups, interviews, and surveys are common methods used to collect data for this kind of study. For example, a focus group of cigarette smokers might be asked for their thoughts about what kind of help they would need in order to quit smoking. Then, this information gathered from smokers may be used to develop and test an approach to help people cut down on their cigarette use.

Who is involved in a research study?

The Principal Investigator (PI) is the person in charge of the study. Often, he/she is a doctor that specializes in the research topic. Other doctors may also work on the study as co-investigators. The Research Coordinator or Assistant is the person that helps run the daily operations of the study, such as recruiting patients. Participants often meet with the Research Assistant when they have clinic study visits. Participants are the people who have decided to take part in the research study by signing a consent form.

Who can participate in a research study?

Anyone can participate in research; however, every research study has a list of requirements for who can and cannot participate. Age, gender, and health conditions are things that may influence whether you can participate in a certain study. These requirements are not meant to exclude anyone from research, but are meant to help the researchers target certain groups of people and ensure the safety of all volunteers.

Do I need my parent’s permission to participate?

If you are under 18 years of age, you will most likely need to have your parent’s/guardian’s permission to participate. There are some exceptions to this rule. It’s important to talk with your parents/guardian about participating in research studies and the potential benefits and risks.

What is the “consent form”?

A consent form is a document that describes all the details of the study. It tells you why the study is being done, how the study works, how long the study takes, the risks and benefits of participation, if you will receive anything for participating, alternatives to participating, and how your information will be kept confidential. The consent form will help you decide whether or not you want to participate in the study. Before you enter a study, the Principal Investigator or Research Coordinator must read through the consent form with you and answer any questions you or your parent may have. If you decide to participate, you will be asked to sign the consent form. If you’re under 18 years old, your parents have to sign the consent form too. The person who explains the consent form to you, often the Principal Investigator or Research Assistant, will also sign the form. By signing the form, you and the researcher are recognizing that you and your parents/guardian have been told all the information about the study and that you want to participate. This is called the “informed consent process.” The consent form is not a legal agreement, meaning that you can stop the study at any time if you decide you do not want to participate anymore. Once signed, you’ll be given a copy of the consent form, which includes the names of the research staff and their contact information. You can contact the research staff if you have questions about the study at any point during your participation.

What is an experimental group?

The experimental group is the set of participants who test the new type of health care. They could be trying a new drug, medical device, type of therapy, medical or surgical procedure, educational program, etc. For some studies, all participants are in the experimental group.

What is a control group?

A control group is a set of participants to which the experimental group is compared. There are many different types of control groups. Sometimes the control group is made up of participants who do not receive the treatment being studied. For example, two patients, A and B, have a medical condition that requires drug treatment. Patient A (experimental group) is given the new drug being tested and Patient B (control group) is given the old drug or a placebo (see below). The researchers want to see if there is a difference between the information gathered from Patient A and Patient B. A control group can also be made up of participants that differ in one characteristic from the experimental group. For example, a study investigating people with asthma may want a control group made up of patients without asthma. Control groups are often used in studies to compare the different methods of treatment or to compare the effects of having a certain illness to not having that illness.

What is a placebo?

A placebo is an inactive pill or liquid that has no medical value. For example, a study evaluating whether a drug helps patients with asthma may give the experimental group the new drug and the control group a placebo pill. The participants do not know whether they are taking the drug being tested or the placebo. At the end of the study, the researchers will compare the results from both groups to see if there is a difference. If the asthma of patients taking the drug improved more than the patients taking the placebo, then researchers would know that the drug helped. If the results were the same for both groups, then researchers would know the drug had no effect.

How do I know which group I will be placed in?

For drug trials, you may be assigned to the placebo, the control, or the experimental group. Studies are often randomized, meaning each participant is placed in either the control or experimental group completely by chance. Usually, neither the participants nor the researchers know which group the participant is in. This is called a double-blind study. Double-blind studies help make sure that the results are not influenced by what the researchers and participants may expect should happen if the participant takes the medication, receives therapy, etc.

How do researchers try to make the study as safe as possible?

Before studies can begin recruiting patients they must be approved by a group of doctors, scientists, and other health care professionals called the Institutional Review Board (IRB). The IRB’s job is to protect the rights and wellbeing of patients. They make sure that the study will not harm the participants. Research is done in carefully designed studies called protocols, which are guidelines for the study to follow to make it as safe as possible. For many studies, a group of people also review the study while it’s in progress to make sure the risk to participants have not changed.

What are the risks and benefits of participating in a study?

Each study has different side effects, risks, and benefits. During the informed consent process, the risks and benefits of that particular study will be explained to you. For example, if you’re participating in a drug study, the pill you take may make you tired, or a behavioral study may involve asking questions that make you feel uncomfortable. These side effects may be considered “risks”. However, a drug study may help improve your symptoms, or a behavioral study may help you change your lifestyle, and those may be considered “benefits”. A study may also have unanticipated side effects, risks, or benefits, while other studies have little to none. It’s important to ask the researchers before you begin the study about the side effects, risks, and benefits. Although studies are designed to minimize the risk to participants as much as possible, each participant should weigh the risks and benefits of participating in research for themselves.

What if I decide I do not want to continue with the study?

Participation in a research study is completely voluntary. It’s your right to drop out of the study at any time. However, before you decide to join a study, it’s important to really think about whether or not you want to participate for the whole time period and whether or not you can follow through with the procedures. If you’re unsure whether you’ll be able to complete the study activities, you should discuss your concerns with the Principal Investigator or Research Assistant.

If I do not participate in a study will it affect the health care I receive?

No. Deciding not to participate will in no way affect the health care you receive. No one, including your doctor, will be upset if you decide not to participate. Research is completely voluntary, and you should never feel pressured to participate or stay in a study if you don’t feel comfortable.

What questions should I ask when I am considering whether or not to participate in a research study?

• Why are you doing the study?
• What is the study about?
• What do I need to do while I’m in the study?
• Will taking part in the study affect my daily life?
• How long will I be in the study?
• Are there any risks? Are there any potential side effects?
• Will I benefit from participating in the study?
• Are there any costs to participate? Will I receive any compensation or reimbursement for expenses?

How do I get involved?

At your next medical appointment, you can ask your health care provider if he/she knows of any research studies that you would be eligible to participate in. You can also ask to speak to a Research Coordinator or Research Assistant, who can tell you about current studies looking for volunteers.