Clinical studies in private medical practices and in hospitals

Objectives :

  • Application for an Article 13.5 or 14 claim from the appropriate authorities 
  • Application to the HAS(1)  for an ADFMS reimbursement (dietary food taken for specific medical reasons)
  • Writing of articles in scientific journals in order to inform health professionals.

These clinical studies are carried out :

  • In private medical practices belonging to a CEN Nutriment network involving about 1000 investigating physicians specializing in nutrition
  • In hospitals (for studies requiring specific investigations)
  • In retirement homes (for studies jointly undertaken with the Interregional Gerontology Network in Burgundy/Franche Comté

Contrary to the healthy volunteers recruited from panels or press announcements, the medical histories of patients recruited in private or hospital practice are recorded and monitored by the investigating physician, who is also the volunteer’s personal general practitioner, hence providing the following advantages :

  • Limitation of any bias incurred by including volunteers who could deliberately withhold important information due to their wish to receive remuneration for participating in the study.
  • Acceleration of the selection process of patients since their medical records are available to the investigating physician.
  • Recruitment of patients on the national scale for very specific projects.

 

Study phases managed by CEN Nutriment :

► Analysis of the literature and EFSA guidelines :
Selection of evaluation criteria validated and recognized by EFSA (after consultation with appropriate experts)

► Calculation of number of required subjects :
The integrated medical and statistical approach used by CEN Nutriment identifies the minimum number of subjects required for demonstrating a beneficial effect

► Writing of the protocol
CEN Nutriment is responsible for writing the protocol in French and in English

► Creation of Case Report Form :
Creation and lay-out of the Case Report Form in triplicate, thus ensuring optimum traceability of data

► Compliance with compulsory regulations :
- AFSSAPS(2)  application : Completion of technical documents for submission to AFSSAPS
- CPP(3)  application : Protocol presented to the CPP committee
When necessary : CNOM(4)  and CNIL/CCTIRS(5)  applications are made

► Setting up the study
The trial assigned to CEN Nutriment clinical researchers is set up with the investigating physicians who are selected by standard operating procedure, in compliance with GCP principles (Good Clinical Practice).  GCP compliance is essential if these studies are to be acceptable to EFSA.

► Monitoring
Monitoring visit made to investigating physicians upon inclusion in the trial of the first subjects, in order to detect soonest any potential errors and thus correct them.
Throughout the study process : progress reports sent weekly.
Final visit made to investigating physicians for checking and retrieval of Case Report Forms, and for collection of unused product samples.

► Data Management
Data captured and managed using CAPTURE SYSTEM V6.0 according to standard written procedures :
- Independent double entry
- Computerized quality control
- Edit request
-Data checking and database freeze
This software provides total traceability of all the tasks undertaken, which is absolutely essential for compliance with GCP.

► Statistical analysis :
Descriptive and explanatory analyses undertaken using SAS V9.2
- Definition of statistical analysis plan
- Programming of analysis plan and clinical validation
- Report of preliminary analysis
- Presentation of data
- Complementary analyses
- Statistical report using ICH format.

► Writing of clinical report :
In French/English using ICH format

► Study publication :
- Abstract written in French/English
- National/international study report written

 

(1) HAS : Haute Autorité de Santé (French National Authority for Health)
(2) French Agency for Health Safety of Health Products
(3) French Ethical Review Board
(4) French National Committee of Practitioners
(5) French National Commission for Data Processing and Civil Liberties/Consultation Committee for Data Processing in Health Research