Clinical research at Institut Curie
Innovation is not enough. We need medical progress that benefits as many patients as possible. To provide access for all to progress in research, Institut Curie has made clinical research a priority, including radiotherapy, oncogenetics, surgery, chemotherapy, targeted therapy, immunotherapy, imaging and supportive care; all aspects of treatment are subject to clinical research.
Clinical research has always played a central role at Institut Curie. The institute is recognized for its ability to innovate and apply scientific progress at the patient’s bedside, and has a number of certifications to support this:
- Direction de la recherche clinique et de l’innovation (DRCI) certification, issued by the French ministry for health, awarded for its clinical-trial promotion activities.
- Centre de Recherche clinique (CRC) certification, issued by the ministry for its investigative activities.
- Centre d’essais cliniques de phase précoce (CLIP²) certification from INCa, for early-phase trials in adults and children.
- SiRIC certification as an integrated cancer research site, also under the auspices of the INCa.
At Paris and Saint-Cloud, the institute has a Clinical Investigation Unit (UIC) devoted to early drug trials. Evaluating new treatments in early phases, such as new targeted therapies or immunotherapy strategies, requires close monitoring and complementary tests. This often requires collaboration among the various oncological therapeutic disciplines (medical or pediatric oncology, radiotherapy, surgery), the medical disciplines (anesthesia-intensive care, supportive care, psycho-oncology), nursing care, anatomopathology labs, genetics, immunology, imaging (radiology, nuclear medicine), pharmacology, and pharmacy.
Note, however, that clinical trials are only available to patients covered by the French national health insurance scheme.
Clinical research: a collaborative approach
All the physicians at Institut Curie adhere to this approach, and clinical research nurses support them, to provide optimum care to patients. The paramedical professions (such as nurses and medical physicists) are not only vital links in the improvement of the quality of care, of the comfort and well-being of patients, and ensuring patients’ safety throughout the clinical trials; they also develop their own research projects. Caregivers and researchers are not the only ones involved in clinical research. They are supported by bio-statisticians, who design the methodology of clinical trials and analyze the considerable flow of data collected in databases by the data managers; the project managers help develop studies and track the budget, while clinical research associates help collect data and monitor research protocols.
The research protocols are designed by a group of experts and validated by independent bodies. Representatives from all disciplines evaluate the scientific aspects – such as involvement of the disciplines concerned and the methodology, as well as logistical issues, such as budget and assessment of needs in terms of clinical research assistants – of the research projects conducted by Institut Curie alone or in partnership with other French or international centers.
Several large-scale trials conducted at Institut Curie...
There are clinical trials for industrial purposes and those for academic purposes: regardless of the type of trial, the caregivers at Institut Curie can either participate by including patients that meet the inclusion criteria or coordinate the trial. When a physician from Institut Curie is the promoter of a trial, he/she is responsible for developing the study, establishing the budget, raising the funds needed to complete it, and conducting the study at Institut Curie and in the partner centers in accordance with best clinical practices, as well as analyzing, communicating and publishing data.
Several clinical trials are currently being coordinated by physicians at Institut Curie. They cover fields from immunotherapy to development of new targeted therapies (SHIVA02) and radiotherapy, to innovations such as nanoparticles activated by radiotherapy.
To give these patients access to the most innovative care, Institut Curie wants to step up its involvement in early trials. Indeed, new knowledge on molecular and immunological anomalies of cancer has produced a real paradigm shift in the therapeutic approach. Treatment no longer depends solely on the tumor location and its extension, but also, and above all, on its molecular profile, identified on complex biological platforms that benefit greatly from the proximity of researchers. This new aspect needs to be investigated in early clinical trials in order to provide the benefits of this fundamental progress to patients as quickly as possible.
Clinical research in pediatrics
There are a number of pediatric cancer trials at Institut Curie. These are rare diseases. The aim of clinical trials is twofold: to improve recovery rates, particularly for diseases that are currently the least under control, as well as to limit side effects and after-effects of the disease and its treatments in adults treated for cancer during childhood.