In oncology, a clinical study is a scientific study conducted with patients, the objective of which is to find better ways to manage cancer.
Essays are generally distinguished by:
Clinical trials are subject to strict regulations, both medically and ethically and legally. Patients can only participate in a clinical trial after giving their consent. To do so, they receive comprehensive and detailed information, both oral and written, before signing an informed consent form. At any time, patients have the right to change their mind and withdraw from the study.
This is a subtype of interventional clinical trial whose objective is to test a new treatment (medication, radiotherapy, surgery...). The aim of a therapeutic trial is generally to study whether the new treatment provides an advantage over the treatments usually used: better effectiveness, reduction of side effects, improvement of the quality of life, etc.
A cohort in a clinical trial refers to a Specific group of participants in a clinical research study who share certain characteristics or specific inclusion criteria or receive the intervention according to a specific modality. Clinical trials may have one or more cohorts, depending on the purpose of the study and the complexity of the disease.
In so-called comparative trials (e.g. phase 3 trial), the results of the clinical trial are generally analyzed by comparing the results of the cohort receiving the experimental treatment (called interventional group) with those of a control group that receives either the reference treatment or the placebo (in the absence of a validated standard treatment).
Inclusion and exclusion criteria are criteria defined in advance to select participants in a clinical trial. They are used to ensure that participants are suitable for the study and to ensure the safety and reliability of the results.
Inclusion criteria are the characteristics that participants must have in order to be included in the clinical trial. Exclusion criteria, on the other hand, are characteristics that prevent participants from being included in the clinical trial. To enter a clinical trial a patient must meet all of the inclusion criteria and have no exclusion criteria.
It is essential to answer as many questions as possible during the Klineo search in order to match the patient's profile and pathology with the inclusion and exclusion criteria, and to find the most relevant clinical trials.
A placebo is a product that has the same appearance as the drug being evaluated, but which does not contain an active substance.
Placebos are used in clinical trials to allow the effects of an active drug or treatment to be compared with those of a placebo. The placebo is given to the participants in the control group of the clinical trial, while the active drug or treatment is given to the participants in the experimental group. Participants often don't know if they're getting the medication or the placebo, which makes it possible to measure the true effectiveness of the active treatment by comparing the results between the two groups.
However, placebos are not used in all clinical trials and are not appropriate for all medical conditions.
For therapeutic trials testing a drug, phase 1 clinical trials most often correspond to the first administration of a drug to humans. Phase 1/2 trials are a variant of phase 1 trials, they allow a preliminary evaluation of the effectiveness at the selected dose or to test drug combinations.
They generally include a small number of patients (10 to 40). The main purpose of these trials is to study drug tolerance and to define the dose and frequency of administration that will be recommended for the following studies. A phase 1 trial usually lasts between one and two years. Only certain cancer services are authorized to set them up.
Thus, the maximum tolerated dose, the toxicity profile and the pharmacological activity of the drug alone or sometimes in combination with another drug, are determined at the end of the test. Generally, the trial takes place in two stages: first, a dose escalation phase with the participation of a limited number of patients per dose level (typically 3 to 6 patients), then an extension phase during which several dozen or even a hundred patients (phase 2 part of the trial) are included (phase 2 part of the trial) to confirm preliminary anti-tumor activity and tolerance.
The advantage of these phase 1/2 trials is to facilitate rapid access to innovative molecules, in particular so-called “biological” drugs.
For therapeutic trials testing a drug, phase 2 clinical trials aim to confirm the preliminary clinical and/or pharmacological activity of the drug at the recommended dose at the end of phase 1.
A phase 2 clinical trial is a study that evaluates the effectiveness and safety of an investigational treatment on a larger number of patients with the target disease (40 to 80 on average).
A limited number of patients are included in these trials (40 to 80 on average). Some phase 2 trials compare two treatments. The duration of a phase 2 is generally two to three years, depending on the pathology selected and the number of patients.
For therapeutic trials testing a drug, phase 3 clinical trials, also called comparative trials, aim to assess the effectiveness of a new medication compared to standard treatment. These trials include a large number of patients, ranging from several hundred to several thousand, and generally last between four and five years, depending on the disease and the expected effect.
Depending on the results of the phase 3 trials, the sponsor may apply for marketing authorization (MA) which will later allow the marketing of the new product.
For therapeutic trials that test a drug, a phase 4 clinical trial is a study that is conducted after the treatment has been approved and marketed. Medications continue to be monitored strictly over the long term, so-called post-AMM, in order to gather information on the long-term effectiveness and safety of treatment, in particular by examining rare side effects that may not have been detected in previous phases (Pharmacovigilance).
Phase 4 trials may also be intended to evaluate this new approved drug under different administration conditions, for example the frequency of administration, the number of courses, the duration of the infusion...
A clinical trial is usually conducted in several centres simultaneously. It is said to be a multicenter trial. Although the expert centers such as University Hospital Centers (CHU) or Cancer Control Centers (CLCC) are generally the main places where clinical trials are carried out, they are increasingly opening up in peripheral or private medical centers.
With Klineo, patients can easily find the nearest center where the clinical trial is open by simply entering their address or that of their hospital/center.
Currently, according to the latest report published by the INCa (National Cancer Institute) on clinical trials in oncology in 2019, 30,000 patients participate in oncology clinical trials in France, but this represents less than 5% patients.
Increasing the number of inclusions in clinical trials in France is one of the objectives of the new ten-year strategy that follows on from the previous Cancer Plans.
Participating in a clinical trial can have several benefits in improving cancer management. Here are a few examples:
These potential benefits may vary depending on the treatment being studied, the patient's health condition, and other factors. It is important to talk to your doctor about the potential benefits of participating in a clinical trial.
More generally, participation in a clinical trial can contribute to the advancement of medical research and help improve treatments for new patients. Past and current scientific advances have only been possible thanks to the participation of healthy and ill volunteers in clinical research. Any treatment prescribed by a doctor has previously been the subject of a clinical trial.
As with any treatment, treatments received during clinical trials are likely to have side effects.
Side effects may vary depending on the treatment received and the medical condition studied. Before deciding to participate in a clinical trial, participants receive detailed information on the objectives of the study, procedures and potential risks, and must give their informed consent if they want to participate. At any time, they can reconsider their decision and leave the study.
Generally, in oncology, a clinical trial is indicated:
It is important to discuss with your doctor the possibility of participating in a clinical trial to determine if it is appropriate for you based on the evolution of your condition and medical history.
In general, it is not appropriate to enter a therapeutic trial if the current treatment is still working and well tolerated. However, with Klineo, it is possible to create a patient file to be informed of relevant trials even before the transition to a new treatment line.
Some clinical trials are not open to patients with brain metastases. Other tests, for their part, are open to cancer patients with brain metastases. It is important to discuss with your doctor the possibility of participating in a clinical trial to determine if it is appropriate for you based on the evolution of your condition and medical history.
Participation in a clinical trial for a patient is gratis but unlike a healthy volunteer, it does not give rise to financial remuneration or compensation. However, all medical expenses such as examinations and necessary care are fully covered by the sponsor. In addition, in industrially promoted trials, the costs incurred, such as transport costs during the clinical trial, are generally covered in full.
If the treatment proves to be ineffective or poorly tolerated, the research team may decide to change treatment or end patient participation prematurely in the clinical trial in accordance with the study protocol.
Participants in a clinical trial have a close and regular access to the medical team in charge of the study, who closely monitors their health and addresses any concerns or questions related to the treatment given. If the treatment proves to be ineffective, the medical team will work with the study participant to develop an alternative care plan. At any time, patients also have the right to withdraw from the study.
On Klineo, you have the option of sharing clinical trials that seem relevant to you with your oncologist.
To share them, simply associate your profile with that of your oncologist, by entering their information on your patient home page. Your oncologist will then receive a notification in order to connect to the platform. Klineo to validate this association. You can then share your trials directly with him and he can also do a new search to find other clinical trials adapted to your pathology.
If one or more tests seem suitable for you, he can then contact directly via Klineo the investigative doctors in charge of the clinical trial.
The results of clinical trials are subject to a rigorous examination before being published in scientific journals. This peer review process involves the review and evaluation of the report by experts to ensure the reliability of analysis and conclusions.
When a new approach has been proven safe and effective in a clinical trial, it can become a new standard of medical practice. This may result in a change in treatment for patients with the same condition.
How is my safety guaranteed during my participation in a clinical trial?
Clinical trial protocols are strict, regulated and overseen by regulatory bodies, guarantee the safety of participants in a trial. A therapeutic trial is subject to the approval and control of scientific councils, the CPP (Committee for the Protection of Persons) and the health authorities (National Agency for Drug Safety).
Before participating in the study, the physician should inform patients about the goals, treatments used, possible side effects, and required surveillance exams. Patients must give their consent in writing and receive an information leaflet. By participating in a therapeutic trial, patients are closely monitored by the healthcare team who continuously monitors their safety by immediately reporting any unwanted side effects or medical complications. Patients have the freedom to withdraw their consent and leave the study at any time.