What is a Clinical Trial?
A clinical trial helps to show if a new approach to prevention, screening, diagnosis or treatment (including supportive care or new combinations of treatments) works better than the currently accepted best available standard of care. Clinical trials are designed to answer a scientific question and are an important part of our health system and improving outcomes for lung cancer and mesothelioma patients.
Clinical trials are usually described as Phase I, Phase II, Phase III or Phase IV trials. Each subsequent Phase expands the number of and variation in participants.
- Phase I clinical trials test safety and find out the right dose of a new drug that has not been previously used in the particular medical condition under study.
- Phase II clinical trials further test safety and the benefit of the drug for the medical condition under study.
- Phase III clinical trials compare to best available standard of care, and gather information on safety, effectiveness, quality of life and cost-effectiveness.
- Phase IV clinical trials are conducted to gather more information on wider use of a drug after the drug has received an approval to market to the general public.
Trials are conducted over a number of years, and it can take some time for the results to be published in medical journals and other scientific literature.
People take part in clinical trials for many reasons including:
- They may be able to access a new treatment before it is routinely available as standard treatment for all lung cancer or mesothelioma patients;
- The treatments offered on a clinical trial include the best current standard treatment, compared with a new treatment which earlier research suggests may be better;
- Playing a more active role in their own healthcare
- Participating in a clinical trial advances medical knowledge;
- Many clinical trial participants are motivated to take part because the results of current clinical trials may help improve treatments and outcomes for others diagnosed with lung cancer or mesothelioma in the future or who are at risk of lung cancer or mesothelioma
There are guidelines, unique to each clinical trial, about who can join, called eligibility criteria. The inclusion criteria outline characteristics that ensure people taking part share certain commonalities, such as gender, age or diagnosis. The exclusion criteria consider factors that could make participation risky for an individual, and generally include current health, medications that could interfere with the clinical trial and pre-existing health conditions.
You may need to undergo tests or procedures to determine if you fulfil the clinical trial eligibility criteria. This may mean that even after you have consented to be part of the clinical trial, you may not be able to join if you don’t fulfil the eligibility criteria. If this is the case you will be offered the best available standard of care treatment.
The guiding document for the conduct of a clinical trial is called a protocol. Clinical trial protocols are written by experienced clinicians and a team of experts in lung cancer or mesothelioma treatment, translational research and trials coordination. Clinical trials must abide by national and international guidelines that prioritise patient safety. The protocol must be approved by an independent panel of scientists, medical professionals and consumers, called an ethics committee, before any patients can be asked to participate in the trial.
All clinical trials have risks, but any medical test, treatment, or procedure has risks. The risks and unknowns may be higher in a clinical trial as the treatment has been studied in fewer people.
Another question to ask is if the possible benefits, such as being helped by the trial treatment, outweigh the risks. It may help to prepare a list of benefits and risks when you are making a decision whether to join a clinical trial.
Before signing onto a clinical trial, you will be given a lot of new information to consider including the aims of the trial, potential side effects, tests and procedures, how the data will be collected and stored and what kind of trial it is.
You may like to consider the frequency and location of treatments and appointments for tests, and what happens if you become unwell from the treatment. While on the trial you need to report any side effects or medical events you experience and, under the guidance of your treating specialist, you may need to stop taking some medications that you are already taking (including herbal or ‘natural’ remedies). It’s important to keep your treating specialist informed.
The information about the clinical trial, the location and frequency of appointments and any side effects of the treatment is in a document called the Patient Information Sheet and Consent Form, which will be given to you when someone explains the clinical trial to you. It’s important that you ask any questions to ensure you understand the clinical trial.
When you sign the Patient Consent Form you agree to follow all the trial processes. You usually don’t have to say ‘yes’ or sign the Consent Form straight away. You can take the information home and discuss it with someone that you trust. Participation is voluntary, and you can withdraw from a study at any time. If you pull out, you will still be able to receive the type of treatment that is currently the best option for you.
Some examples of questions you may like to ask your specialist before joining a clinical trial are outlined here.
- The doctor and/or healthcare team provide information on the clinical trial, explaining the treatment and procedures.
- Once your questions have been answered and you have agreed to participate, you will need to sign a consent form.
- You will be ‘screened’, which may involve blood tests, other health examinations and procedures, to make sure you are eligible for the clinical trial.
- Once you are accepted into the clinical trial, you will be scheduled to attend a ‘baseline’ (Day 0) visit. This baseline visit may involve some more procedures, tests or questionnaires.
- You will be given a schedule for treatment, visits to the doctor, assessments for safety and treatment effect, tests and questionnaires.
- If you are participating in a randomised trial, your treatment will be randomly allocated, a procedure that is similar to flipping a coin.