Deaths due to lung cancer are more than the sum of the three most common cancers (Breast cancer, prostate cancer and colorectal cancer), the 60-70% refer to patients that were diagnosed with metastatic or locally advanced stage, unfortunately only the 5% of these patients are participants in clinical trials who investigate new treatments/drugs.
Clinical trials are an essential part of medical research. They are a way of finding out whether new lung cancer treatments are better than current best practice and can help identify novel treatments for lung cancer.
Clinical trials for lung cancer aim to find out if a new treatment:
Provides better and superior effectiveness than the current used treatment
Proves to be safe
Preserves quality of life
Clinical trials have several different phases
Phase 1
It is the initial investigation of a new treatment in a small group of people, which predominantly looks at posology and side effects of the new drug. At this point safety is usually specified, defying the dose that should be administered in the lutter phase II studies.
Phase 2
Practically the phase 2 is an extension of the phase 1 which investigate the side effects and clinical benefits of a larger amount of participants. The main purpose is to control the drug safety and efficacy so to proceed with the next phase. Some phase 2 trials are randomized.
Phase 3
Clinical trials of phase ΙΙΙ, compare new treatments versus the current “gold standard” treatment to see if it works better in a larger group of patients in a usually manner of 1:1 or randomized arms/combinations. This means that patients are put into a treatment group called trial arms, by chance. A very well designed computer program is used to filter and randomly assign people to the trial arms. Randomization is needed to make sure that the participants in all trial arms are similar. This let scientists to know that the results of the trial are due to the treatment and not differences between the groups. Neither you nor your doctor can choose your group. Every patient in phase III is watched closely.
The study will be stopped if the side effects of the new drug are too severe or if one group has much better results. Phase III clinical trials are often needed before that FDA or EMA will approve the use of a new drug for the general population.
Phase 4
following the approval of the new drug the drug sustainability is tested in several hundreds of thousands of patients. This allows for better research on short-lived and long-lasting side effects and safety. For instance, some rare side effects may only be found in a sub-group of people. Doctors can also learn more about how well the drug works and if it’s helpful when used with other treatments.
Are clinical trials safe?
Hundreds of thousands of people in the world take part in clinical trials annually. Every trial aims to keep the risk of harm to participants to a minimum, but there can be risks to joining a clinical trial as often there is limited understanding of the treatment being tested.
Participants on clinical trials without any personal financial cost, are likely to be monitored more regularly than with standard care. This may include more blood tests, CT scans or other cancer tests. You may also spend more time with your doctor or nurse.
This ensures that any changes in your health, whether related to the treatment you are having or not, are frequently picked up and acted upon earlier than if you were not in a trial.
Does the clinical trial work?
It is important to keep in mind that the drug trial or research study on a new treatment is only carried out to find out if the new option is better than that currently offered. It may be the same, or it may be worse.
Drugs tested in trials may also not be available after the trial ends, though people already getting the drug may continue to receive it for as long as it is effective.
The meaning of the research, what is going wrong?
The vast majority of the patients is not informed that can participate in a clinical study. There is difficulty in understanding the concept of randomization and the possibility of being on a placebo treatment or in a non-treatment arm. The possibility of having adverse events might cause a negative impact in the quality of life. It is also very common to hear the phrase of “animal testing” which is wrong.
Why clinical trials are mandatory for Greece?
Benefits patients
- Approximately 5.000 patients per year are having access to innovative medicines, especially to severe or/and chronic conditions
- Timely access to new therapies
- Improvement of the therapeutic options
- Increase of therapeutic options
- Regular and comprehensive monitoring of the disease
- Increase of life expectancy
- Improvement of quality of life
- The opportunity of up to date information for clinical trials in the country (Self-management of the disease)
Benefit for research sites
- Specialized clinics and researchers have the opportunity of novel therapies
- Publications and research funds.
- Possibility of participating in pharmaceutical research and potential development of new medicines
- The ability to choose better therapeutic options
- Scientific questions that needs answers
- Opportunity to deepen their knowledge
- Increase o the experience and good practice
- Legal and transparent way of the investigators fees
Does the health system affect? Does this involves state resources?
- Timely access to new therapies
- Improvement of the therapeutic options
- Increase of therapeutic options
- Regular and comprehensively monitor of the disease
- Increase of life expectancy
- Improvement of quality of life
- The opportunity of up to date information for clinical trials in the country (Self-management of the disease)
- Significant revenue for the medical system
- New working positions.
- Multidisciplinary skills of medical doctors and other scientists.
- Ensuring of a high level skills in young doctors and reducing the cost of medical system.
Copyright Fairlife L.C.C. © 2024