Clinical trials

Innovative diagnosis and therapy strategies are based on clinical research in order to progress. Physicians implement clinical trials in all disciplines. The IUCT Oncopole has an INCa-designated early-phase clinical trial center (CLIPP) and a clinical trials administrative center that is ISO 9001:2008 certified for the design and management of clinical trials in oncology.

Clinical trials are clinical studies that enable the assessment of :
- a new drug (or new combination therapy),
- a new method of administration (for example, tablets instead of injections),
- innovative treatments (radiation therapy or surgery) or diagnostic techniques (e.g. bioassays).


The objective is to determine whether new treatments are effective, well tolerated and whether they may eventually be offered to all patients affected. They are proposed only when an existing therapeutic strategy is not entirely satisfactory.  

Clinical trials are subject to specific regulations and are conducted according to strict scientific protocols. Participation in a trial is free and voluntary (Hurriet Law).  If you decide no longer to participate in a trial, you may leave of your own accord and will be given another appropriate treatment for your disease. This decision will not call into  question the commitment of the medical team to treating you.

 

Early-phase trials (Phase I and   II)
Phase I trials are designed to evaluate a new drug (or drug combination) to determine the recommended dose administration; they are proposed only when no existing treatment is entirely satisfactory. Phase II trials   essentially measure the efficacy of a new treatment method (a drug or a new combination of drugs). The IUCT Oncopole has an INCa-designated early-phase clinical trial center (CLIPP). Its administrative unit obtained ISO 9001:2008 certification. This activity requires the use of specialized teams and accredited regulatory structures with stringent requirements for both the collection and monitoring of data.
The trials are conducted in close collaboration with the pharmacokinetics unit, whose objective is to study what happens to a drug after it is administered into the body.

Phase III trials evaluate in detail promising new treatments identified during phase II trials. The new treatment is compared to the best available standard treatment.