The Research Center monitors and controls clinical studies in accordance with the rules of Good Clinical Practice and the regulations in force (in France and in Europe).

It is divided into:

DEPARTMENT OF CLINICAL RESEARCH AND INNOVATION

The Center is the guarantor of quality, confidentiality and statistical analysis of biomedical research data in order to obtain reliable and reproducible results. It also provides information and training to physicians / health professionals conducting research projects in-house or associated with trials as investigators in clinical research.
The priority of the Clinical Research and Innovation Department is to increase patients’ access to experimental and innovative treatments (inclusion rate) while increasing the visibility of clinical trials within the Center.
The other missions of the Clinical Research and Innovation Department revolve around its two main areas of activity: promotion and investigation.

Promotion

The Clinical Research and Innovation Department teams and the Epidemiology and Biostatistics Unit provide investigators of Lacassagne a support in respect of methodology, writing, logistics and administration throughout the life of the protocol (from its conception to publication of results), and help them develop their ideas.

The Epidemiology and Biostatistics Unit collaborates with the investigators to establish the methodology of the trial (number of subjects needed, experimental plan, …). It also has a data management unit which is responsible for preparing the study electronic observation journal, always in cooperation with the investigators.

The Clinical Research and Innovation Department ensures the logistics of the study, assists investigators in the drafting of the protocol and fully supports the submission of the protocol to the authorities and all administrative procedures (insurance contract, agreement with investigative centers …).

The management and statistical processing of the data is carried out by the biostatistics unit in order to publish the results.

THE INVESTIGATION

As a research center, the Clinical Research and Innovation Department handles a large number of biomedical (interventional and observational) research for industrial, institutional or academic promotion in addition to studies for internal promotion. The Clinical Research Associates team helps the Center’s physicians to manage and include patients in clinical trials for which they are investigators. The administrative procedures around the logistics of these trials (establishment of biomedical research conventions, overhead grids …) are provided by the investigation unit.

ROLE OF THE DEPARTMENT OF CLINICAL RESEARCH AND INNOVATION

The DCRI is headed by Mrs Christine LOVERA.

The role of the DCRI can be summed up as dealing with all technical, regulatory and administrative aspects of the clinical trials at the Center, whether they are for internal or external promotion (industrial, academic, institutional):

  • Assistance in the design of projects in accordance with regulations and according to technical and logistical constraints (feasibility study)
  • Definition of projected budgets for research projects
  • Training and informing research actors (investigators, interns, research associates, nurses …) on Good Clinical Practices and the obligations towards the sponsor
  • Dealing with regulatory aspects (submission to authorities, biomedical research agreement, management of allocated budgets)
  • Help drafting responses to calls for tender (European, PHRC, ministerial and private)
  • Storing of research data
  • Ensuring confidentiality of included patient data and research
  • data quality monitoring (monitoring of single and multi-center trials),
  • surveillance and urgent safety measures (pharmacovigilance),
  • quality assurance system,
  • management of research in associated centers.
  • Achievement of specific missions for investigators:
  • patient recruitment (information and obtaining consent from patients),
  • compliance with protocol procedures, data collection,
  • declaration of all adverse events,
  • set up the resources necessary for the trial,
  • management of experimental products
  • Writing end of study documents with the principal investigators
  • Help writing and submitting articles related to clinical trials

UNIT OF EPIDEMIOLOGY AND BIOSTATISTICS (UEB)

The Epidemiology and Biostatistics Unit is headed by Dr. Emmanuel CHAMOREY.

It is divided into two complementary teams:

  • The data management team, which guarantees quality, reliability, security and conservation of study data for which Lacassagne is sponsor.
  • The team of methodologists and biostatisticians who ensure the choice of the study design, statistical analysis and publication support.

The UEB is responsible for biostatistics and data management activities:

  • Development of methodology of clinical and epidemiological research projects
  • Writing a statistical analysis plan that meets the objectives of the study
  • Writing observation notebooks with investigating physicians
  • Database design
  • Elaboration of electronic observation notebooks (e-CRF)
  • Randomization (by list, by minimization, with or without stratification)
  • Secure access control to the e-CRF
  • Verification of data (parameterization of consistency tests, issuance of correction requests)
  • Coding of adverse events and antecedents with the MedDRA dictionary
  • Import of external data
  • Export data according to CDISC standards
  • Participation in coordinating committees and piloting of case reviews
  • Freezing and archiving studies

Statistical analysis of the data and writing of end-of-study statistical report

  • Participation in the development of research projects
  • Advice and methodological expertise to doctors and researchers

It participates in the improvement of data in order to obtain high quality results and also ensures the informing and training of physicians / health professionals carrying out research projects internally or associated with trials as investigators in clinical research.

The central aim of the Research Center is to increase patients’ access to experimental and innovative treatments (inclusion rate) while increasing visibility of clinical trials within the center.


CLINICAL RESEARCH CENTER

Lacassagne was made an accredited Clinical Research Center by the DGOS in 2011, in partnership with the University Hospital of Nice.
As a result, each institution has its own platform, but are managed in synergy.
The Clinical Research Center is governed by a coordinating physician, supported by two bodies:
– a Strategic Committee
– a Technical Committee

The objectives of the Clinical Research Center and its two platforms are:
– the improvement of quality of clinical trials carried out in health establishments
– the acceleration of patient recruitment in trials
– improving safety of patients included in clinical trials
– optimization of resources dedicated to clinical research

At Lacassagne, the Clinical Research Center is located within the Day Hospital and has 6 day hospital beds, and its own nursing team, screening technicians, ARC and doctor.


PHARMACOVIGILANCE CELL

Since the start of MEDICYC in 1991,there have been three themes of research at the Mediterranean Proton Therapy Institute: clinical research, research in physics and research in radiobiology. The launch of Proteus®One and its associated beam channels will broaden the spectrum of these themes.
The primary focus is the use of Medicyc’s low energy pathway (65 mev) for research purposes
In Clinical Research


Since the start of MEDICYC in 1991,there have been three themes of research at the Mediterranean Proton Therapy Institute: clinical research, research in physics and research in radiobiology. The launch of Proteus®One and its associated beam channels will broaden the spectrum of these themes.
The primary focus is the use of Medicyc’s low energy pathway (65 mev) for research purposes

In Clinical Research

A prospective database that records the dosimetric and clinical data of patients treated with ocular proton therapy has been maintained since June 1991. It serves as a support for writing articles. A phase IV trial is currently recording all efficacy and toxicity data of patients treated with proton therapy. Some proton therapy treatments are performed solely because of the demonstrated computer advantage of the best dose distribution without the need for phase I, II or III testing; Phase IV trials will confirm computer-simulated data. All patients treated at the Mediterranean Proton Therapy Institute should be included in a Phase IV trial.

  • Irradiations of electronic chips of automobile meters have been made in order to quickly trigger their blocking so that the manufacturer has elements to solve the conceptual defect.
  • Many children treated for cancer around the world are included in trials to identify the best treatment strategies; several trials will be opened at the Mediterranean Institute of Proton Therapy, in particular in the management of ependymomas (International Society of Paediatric Oncology (SIOP) EP II) and medulloblastomas (SIOP PNET 5).
  • In future, new proton therapy irradiation regimens will be tested for unconventional proton therapy indications in phase I / II or III trials.
  • The hosting of proton / photon comparative studies using all dose delivery techniques (SFUD, IMPT / CK, Tomotherapy, VMAT) on the ProtonShare database will facilitate the exchange and sharing of dosimetric data between CAL and FranceHadron’s clinical partners (CHUG, CLB, CFB, ICPO …). Clinical follow-up of patients could be considered from this same database.