Download The Clinical Research Source - Alberta Innovates: Health Solutions

The Clinical
Research Source
Vol. 1, Issue 1
v
Do You Have Feedback on the Proposed TCPS2 Revisions?
The ACRC is collating your feedback to be part of a formal response from Alberta
on the proposed revisions to TCPS2.
The Panel for Research Ethics invites
comments on the proposed revisions of
the 2nd edition of the Tri-Council Policy
Statement: Ethical Conduct for Research
Involving Humans (TCPS 2).
Proposed revisions include:
• responses to interpretation questions
submitted by the public,
• strengthen and clarify responsibilities
related to clinical trials, and
• integration of stem cell guidelines
currently only referenced.
Please submit comments by December
31st to [email protected].
New Health Canada Guidance: Clinical Trial Applications
Are you studying a new drug, conducting a comparative bioavailability study or
trial that involves a marketed drug outside of the approved use (i.e. a different
indication, target population, route of administration or dosage regimen)?
If yes, your study may require a Clinical Trial Application (CTA).
The Guidance Document for Clinical Trial
Sponsors: Clinical Trial Applications (May
29, 2013) is the definitive guide for
sponsors (whether industry, academic, or
contract research organization) who seek
to sell or import a drug for a clinical trial in
Canada.
The guidance document walks you
through the process of a clinical trial
application, including guidance on
application requirements for comparative
bioavailability trials, filing requirements for
the importation of clinical trial supplies,
The Health Canada Clinical Trials
Database is a public listing of Phase I, II
and III clinical trials for pharmaceutical
and biological products that have had a
Clinical Trial Application (CTA) approved.
The database lists trials that were
approved by Health Canada starting
from April 1, 2013.
Patients/participants can determine if a
clinical trial has met regulatory
requirements, as well as find clinical trials
relevant to specific medical conditions.
Let us know if this is helpful or if
you have an idea for the next
issue.
In this Issue:
Proposed revisions to TCPS2
HC - Clinical Trial Applications
Guidance Document
HC – Clinical trials database
Health Canada and FDA news
Newly opened trials in Alberta
Alberta in Publication - Diabetes
clarifications to amendment and
notification requirements, study
termination and closure criteria,
application and review processes,
adverse drug reaction reporting criteria,
and format requirements.
Check with your sponsor if a CTA is
required and has been filed prior to
starting the studying. Or if you are unsure
whether a CTA is needed, contact either
the [email protected] or your
local research administrative office.
Health Canada launches new clinical trial database
Want to know about currently approved
clinical trials in Canada?
To support strengthening of
clinical research in Alberta, six
times a year the ACRC will bring
news relevant to you.
The database does not include clinical
trials in healthy volunteers, or clinical trials
involving natural health products or
medical devices.
In accordance with TCPS2 (Article 11.3),
clinical trials are to be registered in a
registry that is compliant with the criteria
set by the World Health Organization
(WHO) or International Committee of
Medical Journal Editors (ICMJE) as of Nov
2010. Researchers are to provide the REB
with the number assigned to the trial.
Check with your sponsor if the trial has
been registered. Other clinical trial
databases include: Clinicaltrials.gov.
The ACRC is a provincial
initiative involving clinical
researchers and administrators
working together to achieve
the vision of ‘high quality,
integrated and efficient clinical
research in Alberta.’
Partner organizations: Alberta
Health Services, Alberta
College of Physicians &
Surgeons, Alberta Innovates Health Solutions, CHRC
(Covenant Health), NACTRC
(AHS/University of Alberta) and
CCCR (University of Calgary).
Email:
[email protected]
www.aihealthsolutions.ca/acrc
Health Canada and FDA News
Keeping you informed of changes in regulations
Plain Language Labeling Initiative Consultation (HC): Health
Canada is making improvements to ensure health product
labels are clear and accurate, and minimize opportunities for
confusion with labels, packages or names. The Plain
Language Labelling initiative closed for input on Sept 6th.
Electronic Data Submission (CDER/FDA) - The Center for Drug
Evaluation and Research (CDER) of the FDA releases a new
data standards strategy and action plan for electronic study
data submission.
Monitoring (FDA) – In the FDA final guidance document on
monitoring. ‘‘Oversight of Clinical Investigations—A Risk-Based
Approach to Monitoring’’, find out how to develop risk-based
monitoring strategies and plans for clinical investigations of
human drugs, biologics, medical devices, and combinations
of the above. With help from the document, sponsors can
develop approaches to meet their responsibilities for
monitoring investigational new drug or investigational
device exemption studies that will enhance human subject
protection and the quality of clinical trial data.
Pediatric Study Plans (FDA) - The FDA announces the draft
guidance " Pediatric Study Plans: Content of and Process for
Submitting Initial Pediatric Study Plans and Amended
Pediatric Study Plans." The document outlines how to submit
initial and amended Pediatric Study Plans as required under
the Food, Drug and Cosmetic (FD&C Act), as amended by
the FDA Safety and Innovation Act (FDASIA). Also included is
who must submit a PSP, when a PSP is to be submitted, and
what should be included in a PSP. A template is included.
Newly opened trials in Alberta
Since June, the following clinical trials opened for recruitment. If you have a clinical trial that will be
opening for recruitment in the upcoming month, let us know and we will include it in the next issue.
•
Minocycline in Acute Spinal Cord Injury (MASC) Calgary (Foothills)
•
A Study of Subcutaneously Administered RoActemra/Actemra (Tocilizumab) in Patients With Systemic Juvenile Idiopathic
Arthritis Calgary
•
Investigations of Mechanisms and Treatment in Post-traumatic Joint Contractures Calgary (Peter Lougheed Centre)
•
Comparison of TAK-875 With Sitagliptin When Used in Combination With Metformin in Patients With Type 2 Diabetes Red
Deer
•
Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1
Diabetes Edmonton
•
Feasibility of a Walking Program for Cancer Survivors Receiving Radiation Therapy Edmonton (CCI)
•
Confirmation of Correct Tracheal Tube Placement in Newborn Infants - a Randomized Control Trial Edmonton (RAH)
•
Randomised Controlled Trial to Investigate the Effect of Parental Presence at Intensive Care Unit to Ward Transfer Bedside
Rounds on Parental Anxiety and Children's Safety Edmonton (Stollery)
Alberta in Publication – Diabetes Research
Each issue will highlight
a research area that
has been recently
published by Alberta
researchers.
Go to the ACRC
website for a full listing
of other articles.
•
Breaking Down Patient and Physician Barriers to Optimize Glycemic Control in Type 2
Diabetes*
•
Changes in Depressive Symptoms and Changes in Lifestyle-Related Indicators: A 1-Year
Follow-Up Study Among Adults With Type 2 Diabetes in Quebec
•
Concordance Between Self-Report and a Survey-Based Algorithm for Classification of Type 1
and Type 2 Diabetes Using the 2011 Population-Based Survey on Living With Chronic
Diseases in Canada (SLCDC)-Diabetes Component
•
Assessment of Serum Creatinine and Kidney Function among Incident Metformin Users
•
Optimizing Diabetes Literacy: Lessons from African Canadians in Calgary about Type 2
Diabetes Diagnosis
•
Glycated Hemoglobin and Risk of Death in Diabetic Patients Treated With Hemodialysis: A
Meta-analysis
*Dr. Stuart Ross is the Chair of the ACRC Strategic Priority 1 working group.
Page 2
ACRC 2013 ● Volume 1, Issue 1 ● www.aihealthsolutions.ca/acrc