What is a clinical trial?
The translational Medicine team was formed to bring promising new treatments to patients faster. For patients, this means more treatment options at IPC than they might find elsewhere.
Not all patients are cured with standard therapy, and some standard treatments may have more side effects than desired. So patients may seek help through clinical trials, to have the first chance to benefit from treatments that have shown promise in earlier research. They also make an important contribution to medical science by helping doctors learn more about the disease.
Clinical trials Progress in four phases
Before a new cancer drug or treatment is tested in humans, scientists must have good reason to believe - from work in the laboratory and from pre-clinical trials in animals - that it will be at least as effective as the standard treatment.
Even then, testing with human subjects progresses slowly through Phase I, Phase II, and Phase III trials. A Phase I trial will have a small number of patients, perhaps as few as 10, while a Phase III trial may enroll hundreds or even thousands of people.
The risk to patients is higher in a Phase I trial--which is the first test of the drug or treatment in people--and to qualify you usually must have advanced cancer for which there is no effective treatment.
If you are considering a clinical trial, you will want to understand what is being tested in each type of trial.
- In Phase I trials, investigators try to determine the most effective and safe dosage.
- In Phase II trials, which involve a larger group of patients, researchers hope to build on what they learned in the first phase by trying to establish response rates and response durations, and by trying to determine what side effects will occur.
- In Phase III trials, researchers compare the experimental treatment with the standard treatment.
- In Phase IV trials, researchers monitor the effects of long-term usage.
What to Expect in a Clinical Trial?
Your experience in a clinical study will depend on the type of study you enroll in and the type of cancer you have.
Some studies test new ways of preventing cancer, or of keeping it from coming back. Other studies compare different types of imaging (mammogram vs. other types of scans, for example), to see which is the more accurate. Some compare two or more types of treatment, to see which is more effective or has fewer side effects. And some trials look at the quality of life or coping skills of people living with cancer.
Sometimes, participating in a cancer clinical study is as simple as agreeing to let researchers have a copy of the results of a test you would have had anyway, such as an MRI.
Other studies are more involved and may require more tests and visits to the clinic than a standard treatment regimen would.
You will receive the same high level of care at IPC whether you are enrolled in a clinical study or not. Similarly, the quality of care will not vary if you choose one clinical trial over another.
Patient safety is important to us at IPC. We do everything we can to protect all our patients against unnecessary risks while in cancer treatment, whether in a clinical study or not.
Should I Participate in a Clinical Study?
The decision to take part in cancer research belongs to you, the cancer patient. The decision you make will probably result from a combination of diverse reasons--some large, some small, some based on scientific evidence, some based on personal attitudes and feelings about health and disease.
Start by doing some research on clinical trials, and discuss the issue with your family and your doctor. Here are some pros and cons to consider:
- You will receive care from doctors who are leading cancer specialists.
- You may gain access to new drugs that are not otherwise available.
- You may get closer monitoring.
- You want to help others.
- You want to help advance scientific knowledge of cancer.
Clinical trials are not for everybody. Here are some reasons you might decide not to participate:
- Fear of the unknown. In a Phase III clinical trial, you probably will not know which drug or treatment you are receiving.
- The risk of side effects.
- Loss of choice, if you are assigned randomly to receive one treatment or the other.
- You don't have the time. Clinical trials may require more time than standard treatment.
Even if you decide not to participate in a clinical study, the fact that IPC provides treatment for patients enrolled in clinical studies and is doing research on new therapies is an excellent indication that IPC is committed to developing advances in cancer treatment and that you will receive a high standard of care.
Are all patients eligible?
In order to participate in a clinical trial, a patient must meet a specific number of conditions, known as “inclusion criteria”.
The inclusion criteria are specific to the particular clinical trial. Because each trial has a specific objective, some patients and not others, will be invited to participate in a particular trial based on their characteristics, such as the size or type of their tumor.
Is participating in a clinical trial useful in advancing research?
Yes, patient participation in clinical trials is a vital contribution to the discovery of new treatments and new strategies which could benefit a large number of people affected by cancer.
Advances in medical science, particularly in cancer treatment, are the fruits of clinical research, thanks to trials conducted in a rigorous, methodical manner which guarantee a certain level of scientific proof. However, there remain numerous situations which demonstrate the uncertainty and inadequacy of current treatments. So there are also numerous advances still to be made, both in researching new treatments and in developing new therapeutic strategies.
It should also be noted that thanks to the act passed on 4 March 2002 on patients' rights and healthcare system quality (called the Kouchner Act), people who have participated in research that was part of a clinical trial can ask to be informed of the overall results at the end of the study.
Am I free to participate in a clinical trial that has been recommended to me?
And can I change my mind later once I’ve accepted?
Your participation is free and voluntary.
Even after agreeing to participate in a trial, you will be free to quit at any time, in which case your doctor will recommend a different treatment tailored to your disease.
This decision will not affect the medical team’s commitment to treating your disease in any way.
Does participating in a clinical trial offer me more opportunities for better treatment?
Participation in a trial does not in any way jeopardise a patient’s chances for treatment administered outside of a clinical trial. But this participation does in certain cases offer the possibility of gaining access to more innovative treatments.
Nevertheless, if you decline to participate in a clinical trial that is offered to you, this decision will not have any consequences on the treatment of your disease, your relationship with your doctor and the healthcare team and on the quality of the care you will receive.
Will I run any personal risks by participating in a clinical trial?
As with any treatment, treatments used in clinical trials can produce side-effects. In most cases these are well known and documented. However, despite conducting extensive laboratory studies prior to conducting these trials on humans, it may occur that certain particularly rare symptoms have not been identified. Moreover, additional testing and examinations to study the unexpected adverse effects may be necessary and would involve some additional constraints on the patient.
All methods of patient treatment and monitoring involved in a clinical trial are precisely defined and subject to numerous regulations (both national and international) and to stringent supervisory bodies.
Throughout the trial, the medical team will be available to provide you with any explanations you find useful regarding the nature and course of the treatment.
However, side-effects vary from patient to patient. In Phase III comparative trials, they are typically comparable with those observed in standard treatments and for the most part are temporary and will go away once the treatment has ended.
Patient safety is guaranteed by law
In France, all clinical trial participants are protected by the act on the protection of people participating in biomedical research, known as the 1988 Huriet-Serusclat Act, amended by the Public Health Act of 9 August 2004.
What benefits will I receive by participating in a clinical trial?
Participating in a clinical trial offers the possibility of gaining access to an innovative treatment.
It also involves special supervision of treatment and customized, rigorous monitoring, both during and after the end of treatment.
The doctors conducting a clinical trial follow a treatment plan (therapy plan) scrupulously. This plan defines all of the trial’s methodologies (inclusion criteria, duration, treatment schedule, additional examinations, etc.). The therapy plan also provides for patient monitoring throughout the course of the trial in order to verify the effectiveness of and tolerance to the treatment. As a result, all doctors and nurses working on a clinical trial monitor the patient constantly in order to verify that the treatment is producing the expected benefits and to intervene immediately should the slightest side-effect appear.
Therefore, with respect to new treatment, patients taking part in clinical trials enjoy extremely rigorous monitoring throughout the course of the clinical trial as well as after the end of treatment.
Will I be properly informed in order to make my decision freely?
Yes, before participating in a clinical trial, the doctor is obliged to provide the patient with information, first orally, then in writing, covering the list of expected benefits and potential risks. This information may sometimes appear complicated and difficult to understand. Please do not hesitate to contact your doctor for clarification. This way, you can be aware of all the information needed to understand the trial and examine any reasons you may have for participating, while also taking the necessary time to make a well thought-out decision. You will also be informed of possible alternatives if you decide not to join the trial.
Only those patients who give their consent after receiving all the information needed to understand the clinical trial can participate in it. Therefore, it is impossible to be included in a trial without knowing.
Your free, informed consent will be confirmed in writing using a consent form provided by your doctor. This form will confirm your agreement and attest that you have received the information on the study. It will be signed by you and your doctor.
To participate or not to participate: the choice is yours
Please do not hesitate to ask for further information on any points that seem unclear to you. And if after giving the matter some consideration you decide that you are not interested in participating in the trial, you will have every right to decline. This will not have any impact whatsoever on the devotion of your doctor and medical staff to your care.
Freedom to quit the trial whenever you want
If the treatment administered during a clinical trial does not help the patient, the doctor can decide to withdraw the patient from the study and recommend a different treatment. The patient is also free to ask to quit the clinical trial at any time. This decision would not have any consequences on the treatment of the disease, the patient’s relationships with the doctor and healthcare team and the quality of care.
Two obligatory documents for patient information and consent:
- The information notice
- The informed consent form
Where do the clinical trials ?
It depends :
- day hospital
- in ETOH unit.