Transcript PMS担当者研修テキスト

MedDRAの基礎知識
出典：MSSO-DI-6225-7.1.0 2004 Northrop Grumman Corporation.
PMS担当者研修テキスト
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スライドは英語のままですが、ノート部に訳がついています。
保存後確認ください。
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Data Quality, Coding and
MedDRA®
MedDRA® is a registered trademark of the International Federation of
Pharmaceutical Manufacturers Associations (IFPMA)
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Course Overview
To provide an understanding of:
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Importance of good quality data
How clinical data are coded
MedDRA background
Coding examples
Benefits of good quality data
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Data Quality and Clinical Trials
• Highly regulated environment with increasing
emphasis on safety surveillance and data quality
• EU Clinical Trials Directive effective May 1, 2004
– Key provisions include conduct of clinical trials &
pharmacovigilance
– Notification of suspected unexpected serious adverse
reactions (SUSARs)
• Similar FDA regulations governing pre- &
postmarketing safety reporting
• Objective is global harmonization
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What is meant by
good quality data?
• Complete
• Accurate
• Diagnosis supported by appropriate
investigations
• Causality assessment for adverse events
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Quality of Input = Quality of Output
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Coding of Clinical Trial Data
• Most data entered on Case Report Forms are “coded”
in some form
• Facilitates storage, retrieval, analysis and
presentation of data
• Some coding is performed by investigators at point of
data entry
– e.g. numeric codes for severity of adverse event: 1= mild,
2= moderate etc.
• Other coding of text data is performed by the
sponsor company after data collection
• Accuracy of initial coding determines accuracy of
analysis
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MedDRA Background
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What is MedDRA?
Med = Medical
D = Dictionary for
R = Regulatory
A = Activities
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MedDRA Definition
MedDRA is a clinically-validated
international medical terminology used
by regulatory authorities and the
regulated biopharmaceutical industry.
The terminology is used through the
entire regulatory process, from premarketing to post-marketing, and for
data entry, retrieval, evaluation, and
presentation.
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Key Features of MedDRA
• Standardized terminology
• International scope - translated into
several languages, including Spanish,
French and Japanese
• Managed by Maintenance and Support
Services Organization (MSSO) and
updated bi-annually with input from
User Groups (company subscribers)
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Key Features of MedDRA (cont)
• Structure facilitates data analysis and
reporting and electronic communication
• Large terminology with > 60,000 terms at
lowest level - allows greater specificity
• Approx. 16,000 Preferred Terms, each
representing a unique medical concept
• Typically used for coding adverse events,
signs and symptoms, procedures,
investigations, indications and medical and
social histories
• MedDRA is not a drug dictionary
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Regulatory Status of Mandate
• US FDA
– MedDRA used in FDA’s internal adverse event database
– Proposed Rule for Safety Reporting Requirements (2003): FDA
proposes to use MedDRA for postmarketing safety reports
• European Union
– All reports (electronic) – January 2003
– EudraCT (European Clinical Trials Database) requires MedDRA
– SUSARs (Suspected Unexpected Serious Adverse Reactions)
require MedDRA
• Japanese Ministry of Health, Labour and Welfare
– Electronic reports mandatory from October 2003
– MedDRA to be used in Periodic Infection & Safety Reports from
April 2004
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Regulatory Status of Mandate (cont)
• Common Technical Document
– A standard format for new drug and biologic product
applications to regulatory authorities
– Includes summary documents and reports from
individual clinical trials
– MedDRA is the recommended terminology for
describing adverse events, both serious and nonserious
– CTD format is mandatory in EU and Japan and is
highly recommended in the US from July 2003
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Scope of MedDRA
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Drug product terms
Population-level qualifiers
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Diseases
Diagnoses
Signs
Patient demographic
Numerical values for
Symptoms
terms
results
Therapeutic indications
Investigation names & qualitative
results
Medical & surgical procedures
Medical, social, family history
Terms from:
Severity descriptors
Device failure terms
COSTART ©
WHO-ART©
HARTS ©
Equipment, device,
diagnostic product terms
Clinical trial study design terms
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Making the Most of MedDRA
• To take advantage of MedDRA’s richness and
specificity, the source data should be
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clear
concise
complete
accurate
• General principles apply to all clinical data
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Problems with coding data
• Appropriate coding requires clear initial data
• A meaning that is clear to the investigator at
the point of data entry may be unclear to the
sponsor at the point of data coding
• Example: Ambiguous information
– Congestion (nasal, liver, sinus, pulmonary?)
– Cramp (muscle, menstrual, abdominal?)
– Pain (pain where?)
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Problems with coding data (cont)
• Example: Ambiguous abbreviations
– MI (myocardial infarction or mitral incompetence?)
– GU pain (gastric ulcer pain or genito-urinary pain?)
– Decreased BS (breath sounds, bowel sounds or
blood sugar?)
– COLD (feeling cold, common cold or chronic
obstructive lung disease?)
Exercise caution with abbreviations that could be
misinterpreted
ECG, URI, HIV are examples of standard abbreviations
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Problems with coding data (cont)
• Example: Vague information
– Patient felt “fuzzy”, “weird”, “experienced every
adverse event”
Try to use accepted medical terminology
• Example: Non-specific information
– “Left wrist edema” (coded as Peripheral edema)
– More specific - “Injection site edema left wrist”
(coded as Injection site edema)
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Problems with coding data (cont)
• Death is an outcome and is not usually
considered to be an adverse event
• Provide details of cause of death if known
• Example:
– “Death due to myocardial infarction”
– Myocardial infarction is coded and death is
captured as the outcome
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Problems with coding data (cont)
• Example: Ambiguous laboratory data
– “Glucose of 40”
– (Source of specimen - blood, urine, CSF? What units?)
– Would have to code as “glucose abnormal” if additional
clarification is not obtained
• Example: Conflicting laboratory data
– “Hyperkalemia with serum potassium of 1.6 mEq/L”
– Would have to code as “serum potassium abnormal”
If using numeric values, provide units and reference
range. Be specific about specimen source and
diagnostic result/clinical diagnosis
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Problems with coding data (cont)
• Example: Combination terms
– Diarrhea, nausea and vomiting
Try to avoid combination terms - these will have to be
split into 3 individual terms
Diarrhea
Nausea
Vomiting
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Reporting a specific diagnosis
• Where possible, report the most important
medical event or specific diagnosis rather than
individual signs and symptoms
• Can provide provisional diagnosis e.g.
“possible”, “presumed”, “rule out”
• Accuracy is important in preventing dilution of
safety signals or generating false signals
SIGNS & SYMPTOMS
Chest pain, dyspnea,
diaphoresis, ECG changes
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DIAGNOSIS
Myocardial infarction
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Safety signals
• Accuracy in diagnosis is important for detection
and evaluation of safety signals
• Events of importance in drug safety
surveillance include:
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QTc prolongation
Hepatotoxicity
Stevens Johnson syndrome
Convulsions
Rhabdomyolysis
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Generating Quality Data
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Clear
Concise
Complete
Accurate
Be specific if necessary - MedDRA can handle
multiple specific medical concepts:
– Headache - more than 50 types, including cluster,
sinus, migraine, lumbar puncture headache
– Organisms - down to species level e.g.
Staphylococcus aureus
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Miscellaneous Verbatims:
Coding Challenges
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Recurrent fatal stroke
LK RTCTL UNSP XTRNDL ORG
Hears New Age music when furnace turns on
Funk exacerbated
Normally normal after drinking coffee
Went to hell
Patient is intermittently tiresome
Infection in first finger of the right foot
Fireballs in uterus
Blast (menopause)
Flintstone feet
Barely visible posterior
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Company-specific conventions
• Insert slides as required to cover company’s
specific data collection and recording
conventions
• Could include instructions on how to complete
data fields for adverse events, medical history
etc. on paper or electronic CRFs
• Could include general principles of how to
record text-based information as well as
specific instructions for particular therapeutic
areas
Benefits of Quality Data
• Fewer queries for investigator and sponsor
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Benefits of Quality Data (cont)
• Accurate and timely information on issues that
affect conduct of clinical trial and affect patient
safety
• Improved communication among sponsors,
investigators and regulatory agencies about
medicinal products
– Aids in safety signal detection and evaluation
– Ensures accuracy of information about the product
including investigators’ brochures and prescribing
information
– Benefits medical professionals
– Benefits patients
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Quality Data
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OUT
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Course Evaluation
• Thank you for taking this course
• Please take the time to fill out the
evaluation form
• Thank you for your feedback
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MSSO Contacts
• Mail
MSSO
VAR1/MSSO
12011 Sunset Hills Road
Reston, VA 20190-3285
USA
• Telephone
– Toll-free Worldwide 877.258.8280 (AT&T)
• Web page
– www.meddramsso.com
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Acknowledgements
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MedDRA® is a registered trademark of the International
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COSTART Thesaurus Fifth Edition Copyright 1995 US
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Hoechst Adverse Reaction Terminology System
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WHO Adverse Reaction Terminology
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Federation of Pharmaceutical Manufacturers Associations (IFPMA)
Food and Drug Administration (FDA)
(HARTS)© 1992 Aventis Pharma
(WHO-ART),
World Health Organization Collaborating Centre for
International Drug Monitoring
Copyright
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