CADTH Common Drug Review Template — Table of Studies
Instructions for Manufacturers
Carefully review the instructions below before populating the table of studies.
Studies to include in each section of the table:
1. Contact CADTH for guidance if the drug for the indication(s) to be reviewed, or a component active
ingredient, has been available for more than 10 years in Canada or internationally. Please note that this
does not apply to submissions for subsequent entry biologics (SEBs). For all SEB submissions, only include
studies involving the SEB in the completed table of studies (i.e., do not include studies involving only the
reference product).
2. Studies are to be listed in the table irrespective of their publication status (i.e., both published and
unpublished studies must be listed).
3. The table of studies must be divided into the following three sections:

“List of All Completed Studies for the Indication(s) to be Reviewed by CDR” must include:
 All pivotal studies for the indication(s) to be reviewed.
 Any additional interventional phase 2, 3 or phase 4 studies.
 Any institution- or investigator-initiated randomized controlled trials (i.e., clinical trials not
initiated by a commercial sponsor).

“List of All Ongoing Studies for the Indication(s) to be Reviewed by the CDR” must include:
 All ongoing randomized controlled trials for the indication(s) to be reviewed.
 All ongoing extension phase studies for the indication(s) to be reviewed.

“List of Completed Studies for All Indications Other Than the Indication(s) to be Reviewed by CDR”
must include:
 Any completed pivotal studies for all indications other than the indication(s) to be reviewed.
Completing the sections of the table:
1. Study ID(s)
 Provide the combination of numbers and/or letters used to identify the study.
 If the study has multiple identifiers, please list the most commonly used one first.
2. Sponsor:
 Please provide the complete name of the study sponsor.
3. Description:
 Provide the title of the study.
 Using the sub-headings provided in the template, briefly describe the study design (e.g., duration,
randomized, blinded, etc.), number of patients, intervention and comparators, key outcomes, and the
patient population.
4. Phase:
 Indicate if study is in Phase 2, 3, or 4 (do not include Phase 1 studies in the table unless they are
considered pivotal).
5. Abstracts, Publications and Errata
 Using the Citing Medicine format, provide complete citations for all abstracts and publications for each
listed study.
Revised April 2015
6. Location in Submission
 Only complete this column for the first section of the table (i.e., List of All Completed Studies for the
Indication(s) to be Reviewed by CDR).
 Using the checkboxes, indicate where the data for the study is located in the submission (check all
locations that apply or check “not included” if study data is not provided)
 Section 2.7.3 of the Common Technical Document
 Section 2.7.4 of the Common Technical Document
 Clinical studies folder
 Clinical Study Report (if provided in the submission)
 Not included
7. All abbreviations used in the table are to be listed in alphabetical order below the table.
Filing the Completed Table:
 Remove the instructions section of the template
 Save the completed table as an unlocked PDF file or Microsoft Word document and include it in the category
1 requirements submission package.
If you have any questions regarding the completion of this table, please contact requests@cadth.ca with the
complete details of your question(s).
Revised April 2015
Table of Studies for [insert Brand Name of drug]
Study
ID(s)
Sponsor
Description
Phase
Start & End
Date
Abstracts, Publications
and Errata
Location in
Submission
List of All Completed Studies for the Indication[s] to be Reviewed by CDR
Title:
Study Design: double blind, placebocontrolled, multicentre RCT
2, 3, or
4
Start: MM/YYYY
1. Citation #1
End: MM/YYYY
Randomized N: Total sample size
2. Citation #2
Population: Brief description
*all citations must use
the Citing Medicine
format
Intervention(s): Drug under review,
dosage, administration frequency
Comparator(s): Comparator(s) dosage,
administration frequency
☐ CTD section 2.7.3
☐ CTD section 2.7.4
☐ Clinical studies
folder
☐ CSR provided
☐ Not included
Outcomes: Primary and key secondary
endpoints
List of All Ongoing Studies for the Indication[s] to be Reviewed by CDR
Provide a brief description
2, 3 or 4
Start: MM/YYYY
End: MM/YYYY
1. Citation #1
*all citations must use
the Citing Medicine
format
N/A
1. Citation #1
N/A
List of Completed Studies for All Indications Other Than the Indication(s) to be Reviewed by CDR
Title:
Study Design: double blind, placebocontrolled, multicentre RCT
Randomized N: Total sample size
2, 3 or 4
Start: MM/YYYY
End: MM/YYYY
2. Citation #2
Population: Brief description
Intervention(s): Drug under review,
dosage, administration frequency
Comparator(s): Comparator(s) dosage,
administration frequency
*all citations must use
the Citing Medicine
format
Outcomes: Primary and key secondary
endpoints
Abbreviations: (Add to the following alphabetical list of abbreviations used in the table, as appropriate)
CDR=CADTH Common Drug Review; CSR=Clinical Study Report; CTD=Common Technical Document; N=total number of patients; N/A=not applicable;
RCT=randomized controlled trial.
Revised April 2015
Example of a Completed Table of Studies Entry for Drug A
Study
ID(s)
Sponsor
Description
Phase
Start &End
Date
Abstracts, Publications
and Errata
Location in
Submission
1. Jones, F. Drug A:
efficacy results from a
phase 3 clinical trial.
Journal Name. 2008 Jan;
62(1):112-6
☒ CTD section 2.7.3
☒ CTD section 2.7.4
☒ Clinical studies
folder
☒ CSR provided
☐ Not included
List of All Completed Studies for the Indication[s] to be Reviewed by CDR
AB12345
Bones
Manufacturer
Inc.
Title: Efficacy of Drug A in reducing hip
fractures in adults with osteoporosis.
Study Design: A two-year randomized,
double blind, placebo-controlled, multicentre trial
Randomized N: 552
Population: adults with osteoporosis
Intervention(s): Drug A: 50 mg orally BID
Comparator(s): Comparator 1: 50 mg
orally BID
Outcomes: Hip fractures, bone mineral
density
3
Start: 02/2005
End: 06/2017
2. Jones, F. Drug A:
interim results from a
Phase 2/3 clinical trials
[abstract]. Association
for Research in
Osteoporosis Annual
Meeting. 2005 April 2526; New Orleans.
Abstract No. 23.
Abbreviations: (Provide a list of all abbreviations used in the table)
CDR=CADTH Common Drug Review; BID=twice daily; CSR=Clinical Study Report; CTD=Common Technical Document; N=total number of patients; N/A=not
applicable; RCT=randomized controlled trial
Revised April 2015