Increase in accrual capacity and the quality standards
On 11 February 2019, Gustave Roussy and Institut Bergonié announced that they have signed an agreement intended to widen the range of therapeutic innovation for cancer patients and to increase even more their accrual capacity and their quality standards in the conduction of early phase trials.
The two institutions thus formalise cooperation and partnership axes allowing the development of knowledge in oncology in the context of early phase clinical research, onco-immunology as well as in strategic therapeutic areas such as thoracic cancers and rare tumours.
Among the strategic objectives of the partnership agreement:
- The development of clinical research – in particular early phase trials, in order to offer patients the widest possible portfolio of innovative therapeutics while guaranteeing industrial promoters a simplified procedure for signing agreements, a broad potential for inclusion and the best data quality standards.
- The development of precision medicine through common molecular tumour boards by developing the portfolio of clinical trials guided by the genomic and immunological profiling of tumours.
- Translational research: essential bridge between basic research and clinical research to accelerate innovation for the benefit of patients, particularly in the field of onco-immunology (mechanisms of sensitivity and resistance) but also rare tumours with the use of tools focusing on artificial intelligence.
Professor François-Xavier Mahon, general director of Institut Bergonié said in accompanied press release: “On behalf of the Institut Bergonié, I am particularly proud of the formalization of this long-standing collaboration between Institut Bergonié and GustaveRoussy. This partnership will lead to the constitution of a major strategic axis that will make the Institut Bergonié-Gustave Roussy pole, a European model of innovation in oncology and early phase trials.”
Professor Alexander Eggermont, General Director of Gustave Roussy said in press release: “This collaboration between our two institutes is patient-focused and aims, thanks to a synergy between our clinical research teams to facilitate access of our patients to innovative therapies. It is a concrete and structural response to the need to bring together our scientific and medical forces to address the problems that pose cancer.”
Professor Antoine Italiano, Head of Early Phase Trials Unit, Institut Bergonié said in press release: “I am glad to announce our latest partnership with Gustave Roussy. This agreement will increase the capacity of our both institutions to implement early phase clinical trials through a fast track process allowing contract signatures within an unprecedented short time and with an ultimate goal of making sure the accrual target and the data collected meets the highest quality, integrity and reliability standards to industrial sponsors.”
Dr Christophe MASSARD, Head of DITEP said in press release: “The agreement between Institut Bergonié and Gustave Roussy allows us to create an unique network of expertise in France the field of oncology early-phase clinical studies, precision medicine and immunotherapy. This allows us to increase access to early phase trials for cancer patients.”
Institut Bergonié is labelled by the French National Cancer Institute as a reference centre for early-phase clinical trials (CLIP2) in oncology and a national referral centre for the diagnosis and management of patients with sarcomas. Between 2015 and 2018, the early phase clinical trial unit led by Professor Antoine Italiano enabled more than 3,000 patients with advanced cancer to benefit from an early phase clinical trial, making the Institut Bergonié a European leader in the field of therapeutic innovation.
The Early Phase Clinical Trials Unit supports industry-sponsored research in patients with all types of solid tumours and haematological cancers. The clinical space comprising of 10 beds is highly rated by patients as delivering quality care in a comfortable environment.
There is a dedicated interventional radiology unit co-located on the ward which enables high quality sequential tumour biopsies with record keeping, to demonstrate custodianship of the samples (conformity > 92%).
A team of experienced investigators, research nurses and clinical fellows work across the broad portfolio of studies, providing expertise in patient management and protocol compliance. By taking a systematic approach to data capture, data entry is highly compliant and the team is trialling real time data entry.
As a department dedicated to phase I clinical trials at Gustave Roussy, DITEP’s mission is to offer patients in therapeutic failure access to innovative molecules and to accelerate the development of new treatments in oncology. DITEP is one of the largest early testing centres in the world. Created in September 2013, it is labelled by the French National Cancer Institute as an Early Phase Center (CLIP2). The activity of DITEP is led by a multidisciplinary expert committee in medical oncology, immunotherapy, radiotherapy, haematology, imaging, biology and pathology. In 2017, more than 1250 patients were participating in an early phase trial or molecular medicine programme in DITEP, including 460 patients in a phase I trial. Gustave Roussy, the first centre for the fight against cancer in Europe, is a worldwide recognised comprehensive cancer centre dedicated to patient care and clinical research. It brings together 3,100 professionals whose missions are care, research and teaching.