Prsentation PowerPoint

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THE BIOMETRICS ROLE IN THE CLINICAL TRIAL
PROCESS
Dominique MOCCATTI Director of Methodology in
Therapeutic Research and Development EFIM
Clinical Research Course 2006 4 6 May, 2006
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To assume The validation and the exploitation
of the data coming from a clinical trial, two
jobs
DATA MANAGEMENT
BIOSTATISTICS
within Biometrics unit
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CLINICAL TRIAL PROCESS
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DATA ACQUISITION STEP To participate in
development and approval of Case Report Form
(CRF) According to MDB Minimal Data Base, the
library of standard forms
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DATA BASE DESIGN Step To set up the standard
data architecture
DATA BASE VALIDATION Step To set up the load
specification manual
CONTACTS WITH CROs Central laboratories Centralis
ed rereading centre
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DATA PROCESSING To assure that data is reliable,
complete and accurate
Data clarification Form (DCF)
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MedDRA Medical Dictionary for Regulatory
Activities WHO-DRL World Health Organisation
Drug Reference List
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Finally, participation of the Data Management in
the Medical review process

• To consider the patient  behind  the CRF,

• To check clinical consistency of each patient
  case,

• To provide a better quality of clinical data
  regarding both efficacy and safety in addition to
  the logical checks of Data Management.

Need of a local and central medical review in
multicentric clinical trials.
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DATA MANAGEMENT REGULATORY REQUIREMENTS

• ICH guidelines
• E6 Good clinical practice consolidated
  guideline
• E8 General considerations for clinical trials
• E2B Clinical safety Data Management Data
  elements
• for transmission of individual case safety
  reports.
• M2 Recommendation on electronic submission of
  individual case safety reports message
  specification.

• FDA  Guidance for industry, computerized systems
  used in clinical trials 
• - Major impact on CDM
• - Requirements much more demanding and specific
  than ICHs.

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FRENCH PROFESSIONNAL ASSOCIATION FOR DATA
MANAGEMENT DATA MANAGEMENT BIOMEDICAL DMB
(since 1995) www.dmb-asso.com (300 members)
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PARTICIPATION IN THE TECHNICAL PROTOCOL On the
methodological side (Study design,
characteristic of the populations, randomisation
plan of the treatments).
On the statistical side (strategy of the
statistical analysis, estimation of the minimum
sample size).
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• To write the Statistical Analysis Plan (SAP)
• To write computer programs for statistical
  analysis
• (More often with the SAS Software)
• To perform interim statistical analysis

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• To participate in the Blind-Review process
• Agreement with the Blind-Review report
• To perform planned statistical analysis and
• tabulated the results

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• To elaborate the statistical documentation
• To carry out unplanned statistical analysis

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BIOSTATISTICAL REGULATORY REQUIREMENTS

• ICH guidelines
• E9 Statistical principles for clinical trials
• E10 Choice of control group in clinical trials
• E3 Structure and content of clinical study
  reports
• E4 Dose-response information to support
• drug registration
• Statistical Points to consider from EMEA

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FRENCH PROFESSIONNAL ASSOCIATION FOR
BIOSTATISTICS (250 members) BIOPHARMACY AND
HEALTH GROUP OF SFdS (since 1987) (SFdS Société
Française de Statistique) www.sfds.asso.fr (1000
members) Member of the European Federation of
Statisticians in The Pharmaceutical Industry
(EFSPI)
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THE MEDICAL WRITING KEY WORDS - Factual -
Exhaustiveness - Objectivity -
Transparency
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THE  MEDICAL WRITING  TASKS
To participate in the clinical trial process as
early as possible.
DURING the trial To set up a draft model of the
study report
AFTER the trial To write the clinical study
report