What is a clinical trial?

In oncology, a clinical trial (or clinical study) is a scientific study, conducted in collaboration with patients, which aims to find better ways to manage cancer.

On the one hand, a distinction is made between interventional clinical trials and observational clinical trials.

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What does an interventional clinical trial correspond to?

Among the interventional trials, there are different types of clinical trials. ‍

- Therapeutic trials

Les therapeutic trials allow the evaluation of a new treatment (medication, radiotherapy, surgery, etc.). Their aim is to provide an improvement over existing treatments such as better efficiency, a reduction in side effects or a gain in quality of life.

- Diagnostic tests

Les diagnostic tests will evaluate new cancer detection techniques such as imaging or genetic sequencing.

- Supportive care trials

The so-called essays “supportive care” correspond to care or support administered, in parallel with treatment, to a patient (or a caregiver) to improve their physical, psychological or social quality of life. For example, psychological support or nutritional care are supportive care.

- Other tests

There are other types of trials depending on the scientific question asked: prevention trials, screening tests, etc...

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What are the different phases of a therapeutic clinical trial in oncology?

In oncology, therapeutic clinical trials are divided into four phases.

- Stage I

La Phase I allows you to evaluate the security of the treatment. It is ensured that the tolerance of the medication is acceptable for patients. Following this phase, carried out on a few dozen people, the dose and the optimal administration protocol are determined.

- Stage II

La Phase II allows you to highlight a signal ofefficiency of the new product on a few dozen, even hundreds, of patients and, thus, confirms the dose defined in phase I by continuing to monitor tolerance.

- Stage III

As for the Phase III, between a few hundred and a few thousand patients will integrate it in order to compare the new treatment or the new strategy in order to ensure that it is more effective than the standard treatment already on the market (or placebo in the absence of recommended treatment).

- Stage IV

In some cases, a Stage IV can be conducted, once the product is on the market, to obtain information on the long-term tolerance and effectiveness of the treatment in real life.

NB: A patient wishing to join a clinical trial does not participate in all the steps described above but only in a phase according to the start date of the trial and the criteria for inclusion and exclusion of the trial.

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What happens after the clinical trial phases?

Once the first three phases have been validated, a request forMarketing authorization (AMM) is made by organizations such as the EMA (European Medicines Agency).

In the event of a favorable opinion, the Haute Autorité de Santé (HAS) will then assess the level of SMR (Medical Service Rendered) and ASMR (Improvement of Medical Service Provided) of the new treatment to determine its reimbursement rate before it is put on the market.

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Sources: ARC Foundation, Unicancer, Corasso, National Cancer Institute