Sometimes the information from trials and research can help you to make decisions about your own health. You may use the finding from research or you may be asked to take part in trial and research. There are several types of medical research. Some studies focus on:
- what causes a disease or condition
- how to prevent or avoid getting sick
- how to diagnose and screen for various diseases
- how to improve or develop new treatments
|Types of medical research|
These are usually studies of a treatment or preventive intervention.
The treatment or intervention is applied to one group of people and their responses are then compared to another ‘control’ group who did not receive the treatment/intervention.
|Observational and epidemiological studies||
These studies look at the patterns of disease in groups of people. They might follow the same people over a period of time to observe what happens to their health. For example, a study might compare the rates of lung cancer in people who smoke with the rates in people who do not smoke.
Observational and epidemiological studies do not prove the causes of an illness or support specific treatments.
Their usefulness lies in insights about possible behaviour, exposure (e.g. to cigarette smoke) or health experiences that might be responsible for a disease or condition and potential treatments. These insights then need other studies.
These studies aim to learn the best ways in which to treat or prevent disease.
A prevention study may test the effect of a lifestyle change, such as regular exercise and improving diet quality, on general health or a condition.
These trials aim to learn the best ways in which to treat or prevent disease. Clinical trials involve a new drug, vaccine or device.
The best clinical trials are randomised controlled trials (RCT). The participants are assigned to a treatment or to a placebo (dummy) treatment; whether a particular participant is allocated to a treatment or a placebo is determined by chance.
If you are thinking about volunteering to participate in a clinical trial involving a new drug, vaccine or device, you should know which stage/phase of testing the drug or device is in:
|Phases||Aims of the phase|
begins after the results of phases I-III have been given to the government for approval
Who can participate in medical research?
Nearly every woman can qualify to be part of a medical research study at some time. However, each study will have a specific set of criteria for participants.
Observational studies and phase I clinical trials generally include a wide range of participants. If you are currently healthy but at some risk of developing a disease (perhaps because of your family history), you may qualify for a prevention study. If you have a health condition, you could consider entering a clinical trial to test a treatment.
Need for women in clinical trials and medical research studies
Women are needed as participants in clinical trials and other medical research studies because of a lack of research data about women’s health.
For many years, researchers did not include women in studies. They often assumed if a treatment worked for men, it would work the same way for women. Now we know women and men can respond differently to the same treatment, and 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 which require research data.
All studies involving animals or humans must be approved by an intensive ethics approval process. A study must be approved by an ethics committee which is 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.
Researchers use a process called informed consent to make sure participants who are volunteering to take part in a study understand and agree to what will happen during and after the research study. Researchers must obtain this informed consent from all participants before starting the study. Before taking part, a participant should receive the following information about the study:
Requirements for ‘informed consent’:
- The purpose of the research
- What the participant will be expected to do – and when
- What the treatment or intervention is – if any
- If it’s a clinical trial, whether there is a chance that you will receive a placebo (‘dummy‘ treatment)
- The chances of being harmed as a result of taking part
- The chances of being helped as a result of taking part
- 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
- 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
- Whether you will be paid or compensated for taking part in the study
- The length of the study
- Who to contact if you have any questions
- A statement that if the participant changes her mind about being involved in the study, she can withdraw at any time
Risks of participating in medical research
This 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 projects.
Important areas of risk for women to assess before taking part in a study include:
- when a woman is pregnant, any drugs she takes may have an effect on her foetus
- any treatment already being taken with the potential to affect hormones including the oral contraceptive pill (the pill), hormone replacement therapy (HRT), 'bioidentical' hormones, herbs and dietary supplements can affect how a woman responds to other drugs
Further information is available in the National Health and Medical Research Council statement on ethical conduct in human research.
This web page is designed to be informative and educational. It is not intended to provide specific medical advice or replace advice from your health practitioner. The information above is based on current medical knowledge, evidence and practice as at February 2014.