Common Drug Review
Clinical Review Report
Sample Template for a CDR Clinical Review Report (February 2014)
Drug
Indication
Listing request
Manufacturer
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
TABLE OF CONTENTS
ABBREVIATIONS ........................................................................................................................................... iii
EXECUTIVE SUMMARY ................................................................................................................................. iv
1.
2.
3.
INTRODUCTION ..................................................................................................................................... 1
1.1
Disease Prevalence and Incidence............................................................................................... 1
1.2
Standards of Therapy .................................................................................................................. 1
1.3
Drug ............................................................................................................................................. 1
OBJECTIVES AND METHODS.................................................................................................................. 2
2.1
Objectives .................................................................................................................................... 2
2.2
Methods ...................................................................................................................................... 2
RESULTS................................................................................................................................................. 3
3.1
Findings from the Literature ........................................................................................................ 3
Figure 1: QUOROM Flow Diagram for Inclusion and Exclusion of Studies ............................................... 3
4.
5.
3.2
Included Studies .......................................................................................................................... 5
3.3
Patient Disposition ...................................................................................................................... 6
3.4
Exposure to study treatments ..................................................................................................... 6
3.5
Critical Appraisal .......................................................................................................................... 7
3.6
Efficacy......................................................................................................................................... 8
3.7
Harms........................................................................................................................................... 9
DISCUSSION......................................................................................................................................... 11
4.1
Summary of Available Evidence ................................................................................................ 11
4.2
Interpretation of Results ........................................................................................................... 11
4.3
Other Considerations................................................................................................................. 11
CONCLUSIONS ..................................................................................................................................... 11
Appendix 1: PATIENT INPUT SUMMARY ..................................................................................................... 12
Appendix 2: LITERATURE SEARCH STRATEGY ............................................................................................. 13
Appendix 3: EXCLUDED STUDIES................................................................................................................. 14
Appendix 4: DETAILED OUTCOME DATA .................................................................................................... 15
Appendix 5: VALIDITY OF OUTCOME MEASURES ....................................................................................... 16
Appendix 6: SUMMARY OF OTHER STUDIES ............................................................................................... 17
Appendix 7: SUMMARY OF COMPARATORS ............................................................................................... 18
REFERENCES ................................................................................................................................................ 19
i
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
Tables
Table 1: Summary of Results ...........................................................................................................v
Table 2: Key characteristics of Drug X, Drug Y, and Drug Z ............................................................ 1
Table 3: Inclusion criteria for the systematic review ...................................................................... 2
Table 4: Details of Included Studies ................................................................................................ 4
Table 5: Summary of Baseline Characteristics ................................................................................ 5
Table 6: Patient Disposition ............................................................................................................ 6
Table 7: Key Efficacy outcomes....................................................................................................... 8
Table 8: Harms .............................................................................................................................. 10
Figures
Figure 1: QUOROM Flow Diagram for Inclusion and Exclusion of Studies ..................................... 3
ii
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
ABBREVIATIONS
AE
CI
DB
EMEA
FDA
ITT
LOCF
PP
RCT
RR
SAE
SD
WDAE
adverse event
confidence interval
double blind
European Medicines Agency
Food and Drug Administration
intention-to-treat population
last observation carried forward
per-protocol
randomized controlled trial
relative risk
serious adverse event
standard deviation
withdrawal due to adverse event
iii
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
EXECUTIVE SUMMARY
Introduction
Results and Interpretation
Included Studies
Efficacy
Harms
Other Considerations
Pharmacoeconomic Summary
Conclusions
iv
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
TABLE 1: SUMMARY OF RESULTS
Outcome
Study Name
Tx 1
Tx 2
Tx 1
Study Name
Tx 2
Study Name
Tx 1
Tx 2
Key Efficacy Outcome A
n, N (%)
OR (CI) or RR (CI)
NNT
Key Efficacy Outcome B
n, N (%)
OR (CI) or RR (CI)
NNT
Withdrawals
Total, N (%)
SAEs
n, N (%)
OR (CI) or RR (CI)
NNH
WDAEs
n, N (%)
OR (CI) or RR (CI)
NNH
Notable harms(s)
n, N (%)
OR (CI) or RR (CI)
NNH
v
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
1.
INTRODUCTION
1.1
Disease Prevalence and Incidence
1.2
Standards of Therapy
1.3
Drug
Indication under review
Listing criteria requested by sponsor
TABLE 2: KEY CHARACTERISTICS OF DRUG X, DRUG Y, AND DRUG Z
Drug X
Drug Y
Drug Z
Mechanism of Action
Indicationa
Route of
Administration
Recommended Dose
Serious Side Effects /
Safety Issues
Other
a
Health Canada indication
1
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
2.
OBJECTIVES AND METHODS
2.1
Objectives
2.2
Methods
Studies were selected for inclusion in the systematic review based on the selection criteria presented in
Table 3.
TABLE 3: INCLUSION CRITERIA FOR THE SYSTEMATIC REVIEW
Patient Population
Intervention
Comparators
Outcomes
Study Design
2
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
3.
RESULTS
3.1
Findings from the Literature
Figure 1: QUOROM Flow Diagram for Inclusion and Exclusion of Studies
N
Citations identified in literature
search
N
Potentially relevant reports
from other sources
N
Potentially relevant reports
identified and screened
N
Total potentially relevant reports identified and screened
N
Reports excluded
N
Reports included
Presenting data from N unique studies
3
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
TABLE 4: DETAILS OF INCLUDED STUDIES
DESIGNS &
POPULATIONS
Study Name
Study Name
Study Name
Study Design
Locations
Randomized (N)
Inclusion Criteria
Exclusion Criteria
NOTES
OUTCOMES
DURATION
DRUGS
Intervention
Comparator(s)
Phase
Run-in
Double-blind
Follow-up
Primary End Point
Other End Points
Publications
4
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
3.2
Included Studies
3.2.1
Description of studies
3.2.2 Populations
a) Inclusion and exclusion criteria
b)
Baseline characteristics
TABLE 5: SUMMARY OF BASELINE CHARACTERISTICS
Title
Title
Title
Title
Title
Source:
3.2.3
Interventions
3.2.4
Outcomes
5
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
3.2.5
Statistical analysis
3.3
Patient Disposition
TABLE 6: PATIENT DISPOSITION
Study A
Tx 1
Study B
Tx 2
Tx 1
Study C
Tx 2
Tx 1
Tx 2
Screened, N
Randomized, N (%)
Discontinued, N (%)
ITT, N
PP, N
Safety, N
Source:
3.4
Exposure to study treatments
6
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
3.5
Critical Appraisal
3.5.1
Internal validity
3.5.2
External validity
7
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
3.6
Efficacy
3.6.1
Key efficacy outcome 1
3.6.2
Key efficacy outcome 2
3.6.3
Other efficacy outcomes
TABLE 7: KEY EFFICACY OUTCOMES
OUTCOME A
N (%)
OR (CI) or RR (CI)
NNT / NNH
P value
OUTCOME B
N (%)
OR (CI) or RR (CI)
NNT / NNH
P value
OUTCOME C
N (%)
OR (CI) or RR (CI)
NNT / NNH
P value
Study Name
Tx 1
Tx 2
Tx 1
Study Name
Tx 2
Tx 3
Tx 1
Tx 2
Tx 1
Tx 2
Tx 3
Tx 1
Tx 2
Tx 3
Tx 1
Tx 2
Tx 1
Tx 2
Tx 3
Tx 1
Tx 2
Tx 3
Tx 1
Study Name
Tx 2
Tx 3
Source:
8
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
3.7
Harms
3.7.1
Adverse events
3.7.2. Serious adverse events
3.7.3
Withdrawals due to adverse events
3.7.4
Mortality
3.7.5
Notable harms
9
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
TABLE 8: HARMS
AES
Subjects with > 0 AEs, N (%)
Most common AEs
AE X
AE Y
AE Y
SAES
Subjects with > 0 SAEs, N (%)
Most common SAEs
SAE X
SAE Y
SAE Z
WDAES
WDAEs, N (%)
Most common reasons
Reason
Reason
Reason
DEATHS
Number of deaths, N (%)
Most common reasons
Reason
Reason
Reason
NOTABLE HARMS
Number of deaths, N (%)
Most common reasons
Reason
Reason
Reason
Study Name
Tx 1
Tx 2
Tx 1
Study Name
Tx 2
Tx 1
Tx 1
Study Name
Tx 2
Tx 3
Source:
10
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
4.
DISCUSSION
4.1
Summary of Available Evidence
4.2
Interpretation of Results
4.2.1
Efficacy
4.2.2
Harms
4.3
Other Considerations
5.
CONCLUSIONS
11
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
Appendix 1: PATIENT INPUT SUMMARY
12
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
Appendix 2: LITERATURE SEARCH STRATEGY
13
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
Appendix 3: EXCLUDED STUDIES
Reference
Reason for Exclusion
14
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
Appendix 4: DETAILED OUTCOME DATA
15
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
Appendix 5: VALIDITY OF OUTCOME MEASURES
16
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
Appendix 6: SUMMARY OF OTHER STUDIES
17
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
Appendix 7: SUMMARY OF COMPARATORS
18
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)
COMMON DRUG REVIEW CLINICAL REPORT FOR [BRAND NAME]
REFERENCES
19
Common Drug Review
Sample Template for a CDR Clinical Review Report (February 2014)