Should i do a clinical trial

Treatment trials test experimental treatments, new combinations of medicines or new types of surgery or radiation therapy. Prevention trials test new ways to prevent certain diseases or prevent a disease from returning. Quality of life trials look at new ways to improve quality of life for people with chronic illness. Clinical trials are done in phases, designated as I through IV. Each phase has a different purpose, the NIH says:.

Phase I trials use a small group of people, usually 20 to 80, to check the safety, dosage, and side effects of a treatment. Phase II trials expand to people to people and look at how well a treatment works and how safe it is.

Phase III trials include 1, people to 3, people and try to confirm the results of the earlier trials and compare the new treatment with other commonly used treatments. More data are collected to help determine safe usage.

Phase IV trials are done after the treatment is approved for the general public. These trials collect additional information on risks and benefits of the new treatment. The good news is that most clinical trials test treatments that already have shown some promise of working better than existing therapies. All U. The IRB helps make sure of low risks and correct trial procedures. All clinical trials have guidelines that describe the criteria for participants.

To ensure that a trial's results are reliable, people are included or excluded from the trial according to these criteria. In most trials, one group of patients is given a standard treatment.

Another group receives the therapy being tested. This is because rare side effects that were not obvious in clinical trials may show up for the first time. The results of clinical trials are usually published in specialist medical journals and online libraries of evidence.

You can use a search engine such as Google to look for articles and read summaries abstracts. But you cannot usually see the full articles without a subscription to the journal. Also, research papers are not written in plain English and often use many medical, scientific and statistical terms.

They can be very difficult to understand. Page last reviewed: 08 May Next review due: 08 May Clinical trials. How do I take part in a clinical trial? Be Part of Research website The Be Part of Research website has information about clinical trials and other research from several different UK registers. Charities For some health conditions, you can find out about clinical trials from the websites of charities. Will I get paid? Some trials do not offer payment and just cover your travel expenses.

Bear in mind: it can be time consuming — you may be expected to attend a number of screening and follow-up sessions, and some trials require you to stay overnight there may be restrictions on what you can and cannot do — for example, you may be asked to not eat, or not drink alcohol, for a period of time you may experience unknown side effects from the treatment What happens in a clinical trial?

Testing a new medicine All clinical trials of new medicines go through a series of phases to test whether they're safe and whether they work. Phase 1 trials: A small number of people, who may be healthy volunteers, are given the medicine. The drug is being trialled in human volunteers for the first time.

Researchers test for side effects and calculate what the right dose might be to use in treatment. Researchers start with small doses and only increase the dose if the volunteers do not experience any side effects, or if they only experience minor side effects.

Phase 2 trials: The new medicine is tested on a larger group of people who are ill. This is to get a better idea of its effects in the short term. Phase 3 trials: Carried out on medicines that have passed phases 1 and 2.

The medicine is tested in larger groups of people who are ill, and compared against an existing treatment or a placebo to see if it's better in practice and if it has important side effects. Trials often last a year or more and involve several thousand patients. Phase 4 trials: The safety, side effects and effectiveness of the medicine continue to be studied while it's being used in practice.

Not required for every medicine. Only carried out on medicines that have passed all the previous stages and have been given marketing licences — a licence means the medicine is available on prescription. Control groups, randomisation and blinding If you take part in a clinical trial, you'll usually be randomly assigned to either the: treatment group — where you'll be given the treatment being assessed, or control group — where you'll be given an existing standard treatment, or a placebo if no proven standard treatment exists While the treatments are different in the 2 groups, researchers try to keep as many of the other conditions the same as possible.

What should I know before I sign up? You'll also be given some printed information to take away. You may come back with some questions you feel have not been answered. General questions What's the aim of the trial and how will it help people?

Who's funding the trial? What treatment will I get if I do not take part in the trial? Phases of clinical trials Drugs and treatments must pass through phases of testing. The phases include: Pre-clinical studies — the safety and effectiveness of drugs and treatments is tested in animals. Phase I — the safety and side effects of a drug are tested in a small number of healthy volunteers or participants. Phase II — the safety and effectiveness of a drug are tested in to volunteers who usually have the condition that the drug is designed to treat.

Phase III — the effectiveness of the treatment is tested and compared with standard treatments or an inactive placebo in a larger number of people who have the condition that the drug is designed to treat. Phase IV — the drug or treatment is tested for long-term effects after it is released for doctors to use. Consent to participate in a clinical trial People who are deciding whether to enter a clinical trial must understand all the essential facts, benefits and risks.

You will need to know all the details, including: the purpose of the trial how long the trial will take the procedures involved the risks and benefits of the trial the effects on you and your family or carers the costs involved in the trial your key contact people during the trial.

There are special considerations for specific groups of people including: pregnant women and the unborn fetus children and young people people in dependent or unequal relationships people highly dependent on medical care who may be unable to consent for themselves people with an intellectual or mental impairment people involved in illegal activities Aboriginal and Torres Strait Islander people people in other countries.

Participants in clinical trials Clinical trials are voluntary and you should not feel pressured into participating. Benefits for clinical trial participants There are risks and benefits associated with clinical trials. The benefits include: having access to cutting-edge research treatments that are not yet available to the general public having access to leading experts and facilities playing an active role in your own health and treatment having access to new research treatments if you have a rare condition that is difficult to treat knowing that you are contributing to potential future treatments for people around the world.

Risks for clinical trial participants It is important that you understand the risks of a trial before agreeing to participate. Potential risks include: The experimental treatment might have side effects that are different or more serious and unpleasant than the side effects experienced with the current standard treatment. The trial might involve inconvenience such as keeping a diary or collecting urine samples for 24 hours or additional tests, hospital visits or complicated medications.

The experimental treatment might not help your condition if you have one or you might be put into the group that receives the standard treatment or a placebo inactive treatment. Conduct of clinical trials The conduct of clinical trials is tightly regulated in Australia. The guidelines covering clinical trials are: National Statement on Ethical Conduct in Human Research Australian Code for the Responsible Conduct of Research The Therapeutic Goods Administration also has a number of guidance notes and documents, including notes for good clinical practice.

Where to get help Your doctor Things to remember Clinical trials study new ways of preventing, diagnosing or treating conditions and diseases. All research involving humans must be assessed and approved by a Human Ethics Research Committee. If you are thinking about entering a clinical trial, it is important that you understand all the essential facts, benefits and risks.

Write down a list of questions about all aspects of the trial to ask your doctor and do some research about clinical trials on the internet. The Australian clinical trial handbook, , Therapeutic Goods Administration. More information here. Clinical trials, Therapeutic Goods Administration.

Notes for guidance on good clinical practice, , Therapeutic Goods Administration. Give feedback about this page. Was this page helpful?