Institut Claudius Regaud

One of the Institute's doctors can suggest that a patient takes part in a "clinical trial." Clinical trials form part of clinical research aimed at increasing knowledge related to cancer treatment and recovery. They involve new types of surgery, radiotherapy techniques or even new drug combinations. The Institute carries out 95 trials per year. Patient's are free to decide whether they want to participate in a trial or not. They can also decide to stop their participation in a trial at any time. In this case, another type of treatment will be offered.

Trial: What to expect

Trial protocol is created by a specialised tem in the pathological area being researched. These trials are regulated by the health law from August 9th 2004. There are four stages to clinical trials. Each stage is designed to provide new information:

• Stage 1: determines tolerance of the drug based on dosage
• Stage 2: determines the effectiveness of and tolerance for the treatment
• Stage 3: compares the treatment under study against the best treatment in the field to ensure it offers a similar or better performance
• Stage 4: is carried out after the drugs have been commercialised to increase awareness of the product and to highlight effects that are less well known.

Trial are carried out on groups of patients and not just one single patient. Patient data must be similar in terms of age, type of tumour and treatment already administered. Trials are carried out based on "randomisation." During certain trials, treatment is allocated at random: this method is validated as part of the scientific plan. It ensures that only objective criteria are taken into consideration and that no prejudices are being made. Even if you agree to take part in a trial you might not be involved. If the results from the first scans, blood tests or other examinations are not compatible with specifications for the trial, the doctor will recommend another form of treatment. The entire medical team are trained in carrying out these kind of trials and provide all the information required before, during and after the clinical trial.

Being included in the trial

After receiving all the information required, the patient participating in the trail must provide their written agreement by way of a 'consent' form. Throughout treatment, extra monitoring will be carried out: consultations, blood tests etc. Data gathered will provide information about tolerance levels, side effects and the effectiveness of treatment. This information will be recorded in a confidential file - the patient's name will never appear on the file. All measures possible are implemented to ensure the safety of the patient "participating in the trial." Clinical trials are carried out according to various laws and guidelines. All stages of treatment are detailled in the protocol.