What is medical research?

Medical research studies help us to obtain information on health or disease, to learn how our bodies work, why we become ill, and what we can do to become and stay healthy.

What are the different types of medical research?

There are several types of medical research. Some studies aim to learn what causes a disease or condition, how to prevent or avoid getting sick and how to diagnose and screen for various conditions, while others aim to improve or develop new treatments. Specific types of studies include:

Experimental studies

Is where a therapeutic, preventive or diagnostic intervention is tested in one group of people and is compared to another group of people who did not receive the intervention.

Observational and Epidemiological studies

Compare or look for patterns of health conditions in groups of people. The process often involves following the same people over a period of time to observe what happens to their health. For example, rates of lung cancer development in people who smoke could be compared with people that don't smoke.

Observational and epidemiological studies cannot prove causes of illness or support specific treatments. However, they can make suggestions about possible behaviors, exposures and health experiences that might be responsible for causing the condition or disease and potential treatments that then need further intervention studies.

Clinical trials or intervention studies

Are experimental studies that are carried out to learn the best ways to treat or sometimes even to prevent illness. This kind of prevention study may test a lifestyle change such as regular physical activity and improving diet quality. The length of clinical trials will vary from trial to trial as will the time commitment. The best clinical trials are those that involve randomisation, which is the process where participants are assigned to one or another treatment (possibly a placebo or dummy treatment) by chance and are then compared (randomised control trials).

Clinical trials involving a new drug, vaccine or device

Clinical trials are often completed in stages, which are called 'phases'. If you are thinking about volunteering for a clinical trial involving a new drug, vaccine or device, you should know which stage of testing the drug or device is in. The different phases include:

Phase I

Aims to determine the best dosage to be used in further testing, and to measure how quickly the drug is broken down in the body.

Phase II

 Aims to find out if the treatment has the desired effect in people, to confirm the best dosage to be used in further testing, and to confirm testing for safety.

Phase III

Aims to measure how well the treatment works and to determine how much of a drug is needed to achieve the best result.

Phase IV

Begins after the results of Phase I–III trials have been given to the government for approval. These trials are done for many reasons; to test different dosages, to determine if the treatment works for other diseases or conditions, or to test different ways of taking the treatment (e.g. tablets, syrups).

Why are women needed for medical research studies?

For many years, researchers didn't include women in medical research studies. They just assumed that if a treatment worked for men, it would work the same way for women.

Now we know that women and men can respond differently to the same treatment, and that some treatments that work for men may not work as well for women and vice versa. In addition, there are many diseases and conditions that only affect women, such as cancer of the uterus or ovaries, pregnancy and menopause.

Who can participate in medical research?

Nearly every woman can qualify to be part of a medical research study at some time in her life. However, each study has a specific set of criteria that participants must meet in order to be involved. Even perfectly healthy people may participate in observational studies and Phase I clinical trials. If you are currently healthy but are at risk for a disease, you may qualify for a prevention study. And if you get sick, you may want to consider entering a clinical trial to test a treatment.

Ethics approval

All studies involving animals or humans must be approved by an intensive ethics approval process, where the study is reviewed by a panel of scientists, doctors, lawyers, community representatives and religious leaders. Once a study is approved by an ethics committee it is deemed to be an important study where harm to participants is minimised and the potential benefits to human health are valuable.

What will I be told about the study?

All participants in medical research volunteer to participate by choice. Researchers use a process called informed consent to make sure that volunteers understand what will happen during and after the research study, prior to agreeing to participate in the study.

During the informed consent process you should learn the following:

• the purpose of the research and what you will be expected to do and when what the treatment or intervention is (if any)
• if a clinical trial, is there a chance that you will receive a placebo (inactive treatment)
• what are the chances of being harmed (risks) and chances of being helped (benefits)
• what alternative treatments are available (if any)
• any costs to you or your health insurance company for taking part in the study
• who will have access to your medical and personal information (confidentiality protocol)
• who is responsible for paying for treatment if you are injured as a result of being in the study
• who is paying for the study
• if you will be paid or compensated for taking part in the study
• length of the study and whom to contact if you have any questions

Note: if you change your mind about being involved in a study you are not obligated to participate and can withdraw at any time.

What are the risks of participating in medical research?

The answer to this question depends on the type of study. Some studies involve little or no risk, while others may be risky. Most studies are somewhere in between. Participants should always be informed about any foreseeable risks, side effects or discomfort, prior to participating in medical research studies. There are two risks that are particularly important for women:

Pregnancy

When a woman is pregnant, any drugs that she takes may have an effect on her foetus. Because the risks of new drugs and other treatments to the foetus are not always known, women who are pregnant or who may become pregnant must take these risks into consideration.

Birth control pills and hormone replacement therapy (HRT)

Can affect how your body handles drugs. It is important to discuss any hormones or other medications you are taking, including 'bioidentical' hormones, herbs and dietary supplements.

How will the research study benefit me?

Benefits of participating in research are mostly indirect; you are helping researchers learn more about health and disease, which may improve the health of others, now or in the future. It is important to understand that participation in medical research is not the same as getting medical care. If you have an illness or condition that requires medical care, you should seek that care from a physician or other accredited healthcare provider.

Where can I find more information?

http://www.nhmrc.gov.au/publications/ethics/2007_humans/section5.1.htm - National Statement of Ethical Conduct in Research Involving Humans (2007), NMHRC

Content Updated March 2011