An investigator initiated study supported by the GSK CIRF-FRIC program will require the Principal Investigator to assume the following responsibilities:

• Protocol writing
• Contract negotiation(s)
• Institutional and regulatory submissions and approvals
• Registration on a public clinical trials registry (if applicable)
• Packaging/labeling of drug supply (if applicable)
• Study conduct
• Adherence to Good Clinical Practice Guidelines, including serious adverse event reporting to GSK and Health Canada, and to the Investigator’s Institutional Review Board (if applicable)
• Analysis and interpretation of the results
• Manuscript writing and submission of the study results for publication

The GSK CIRF-FRIC program for the 2009-2010 round will have separate streams for clinical and non-clinical studies.

• Clinical studies eligible for the program are studies involving human subjects that are randomized controlled trials, observational studies, health outcomes studies, health economics studies and epidemiology studies in asthma and COPD.



• Non-clinical studies eligible for the program are translational studies involving in vitro experimental systems, animal models, and human tissue experiments. In addition to studies in asthma and COPD, studies in idiopathic pulmonary fibrosis and mechansitic studies of relevance to multiple respiratory diseases are also eligible for this program.

Several scientific areas of interest have been identified for both the clinical and non-clinical streams of the CIRF-FRIC program. These scientific areas of interest will be provided to applicants once they have registered for the program. The extent to which a proposal aligns to one or more of these scientific areas of interest will be one of four evaluation criteria (see Evaluation Criteria for details).

If you have questions regarding for which stream to apply, please contact us.

The following types of research are not eligible for the GSK CIRF-FRIC program:

• Testing of devices
• Skin test studies
• Mortality studies
• Studies involving the use of non-GSK medicines outside of their approved indication(s) in Canada

Key dates for the GSK CIRF-FRIC program are:

The application process for the GSK CIRF-FRIC program is outlined on the introductory section of the website. The GSK CIRF-FRIC program is comprised of two stages of review which are outlined below.

Stage 1: Review of letters of intent

A review committee reviews all letters of intent. The review committee is comprised of a multi-disciplinary team from GSK and a panel of independent Canadian experts. These experts have the option to consult with up to two additional external experts if they feel this is required.

The research proposals will be evaluated and ranked based on the criteria outlined under Evaluation Criteria. GSK and the external experts have equally weighted input into the evaluation of the letters of intent.

Stage 2: Review of full proposals

Only applicants with the highest ranked letters of intent will be invited to submit a full proposal for further evaluation by the review committee. The request for a full proposal will include comments on the letter of intent from the review committee. These comments should be addressed in the applicant’s full proposal.

Funding recommendations will be made by the review committee pending final review and approval by GSK Global Research & Development. This review includes an assessment of proposals for medical, scientific, and ethical merit, overlap with ongoing or planned GSK funded studies and complement to the global development program.

* Important additional information:

• Applicants should review the scientific areas of interest for the CIRF-FRIC program when preparing a letter of intent. These scientific areas of interest will be provided to applicants once they have registered for the program.
• Applications with missing sections or those that do not meet eligibility requirements may not be considered for review by the committee. Please refer to the guidelines for completion of the letter of intent.
• Full proposals will be accepted only from applicants who have been invited to submit one.
• Submission of a letter of intent or full proposal does not imply or guarantee approval for support.
• Only one proposal per principal investigator will be accepted. However, an investigator can be a co-investigator on one or more proposals.

The letter of intent should include the following:

1. Name and contact information of principal investigator
2. Title of proposal
3. Area of research interest
4. Summary of the research project (purpose, objectives, endpoints/aims, and study design)
5. Drug supply requirements
6. Data analysis plan (hypothesis and sample size justification)
7. Projected proposal timelines
8. Budget module (inclusive of Institutional overhead)
9. Abbreviated Curricula Vitae (Principal Investigator and Co-Investigator(s))

Maximum length for the letter of intent is 2-3 pages. Letters of intent are to be submitted electronically by email.

The full proposal application and guidelines will be emailed to the selected applicants. The completion of a full proposal will require the following elements:

1. Project title
2. Background and significance of selected topic
3. Objectives, hypothesis and endpoints/aims
4. Study design
5. Study assessments and procedures
6. Data analysis (sample size justification and analysis plan)
7. Projected timelines
8. Presentation / publication plan
9. References
10. Itemized budget (inclusive of Institutional overhead)

Maximum length for the full proposal is 10 pages. Full proposals are to be submitted electronically by email.

Please refer to Program Timelines for the key dates for the program.

The personal information that you provide to GSK is strictly confidential and will only be used for the purpose of evaluating and selecting research proposals related to the GSK CIRF-FRIC program. By providing personal information requested on this site to GSK, you are consenting to GSK collecting, using, disclosing and retaining such information in accordance with the GSK Privacy Policy.

The committee will evaluate the letters of intent based on the following 4 equally weighted criteria:

• Potential clinical application of the proposal’s findings.
• Scientific merit of proposal (i.e. novelty & importance of research question).
• Applicants’ ability to complete the study based on:
• the quality of the research plan (i.e. is the study design, research methods and analysis plan appropriate to answer the research questions)
• the feasibility to conduct the study (i.e. is the project deliverable based on challenges with the study design, institutional resources, timelines, budget)
• the investigators’ research experience.
• Alignment with the scientific areas of interest for the CIRF-FRIC program.

The committee will evaluate the full proposals based on the following 4 equally weighted criteria:

• Scientific merit and potential clinical application of the full proposal.
• Research quality and feasibility of the studies proposed, as described above.
• Applicant’s ability to deliver the proposed research and the applicant’s research experience.
• Alignment with the scientific areas of interest for the CIRF-FRIC program.

Please note that the scientific areas of interest for CIRF-FRIC program will be provided to applicants once they have registered for the program.

Budgets to support clinical research proposals would be expected to be in the range of $100,000 - $150,000 CDN per year, for a total maximum amount of $400,000 CDN for multi-year proposals (inclusive of institutional overhead).

Budgets to support non-clinical research proposals would be expected to be in the range of $50,000 - $75,000 CDN per year for a total maximum amount of $200,000 CDN for multi-year proposals (inclusive of institutional overhead).

See Scope of Research for the definitions of clinical and non-clinical studies that are eligible for the program.

Please note that budgets for successful applications are based on an assessment of fair market value of the procedures, materials, etc to support the studies proposed.

GlaxoSmithKline is pleased to announce the 2008-2009 recipients of the GSK CIRF-FRIC Program. On behalf of GSK and the external reviewers, congratulations to all recipients!

Dr. Margaret Kelly
Dr. Paul Kubes
Title: The role of IL-17 and Neutrophilic Airway Inflammation in Airway Remodeling in a Mouse Model of Chronic Allergen Exposure

Dr. Robert Newton
Drs. Mark Giembycz, Richard Leigh, Margaret Kelly
Title: Mechanism-based Evidence that Adivair®, but not Corticosteroid Alone, Induces a Novel Anti-asthma Phenotype

Previous CIRF-FRIC Recipients:

Dr. Andrew J Halayko
Drs. Abdel Soussi-Gounni, Jamila Chakir, and Michel Laviolette
Title: Statins and Rho Kinase Inhibitors as Treatment Options in Asthma and COPD

Dr. Mark Inman
Title: The Role of Eosinophils in the Development of Sustained Airway Hyperresponsiveness and Airway Remodeling in a Mouse Model of Asthma

Dr. Luke J Janssen
Title: The Sodium/Calcium Exchanger as a Source of Calcium for Airway Contraction

Dr. Manon Labrecque
Drs. L.P. Boulet, F. Ducharme, L. Blais, M.F. Beauchesne, K. Lavoie, and S. Bacon
Title: Intervention by Community Pharmacists to Increase Adherence to Maintenance Medication for the Treatment of Asthma

Dr. Roma Sehmi
Dr. Mark Inman
Title: Role of Bone Marrow Derived Progenitors in Airway Angiogenesis in a Mouse Model of Asthma

Dr. Louis-Philippe Boulet
Dr. Jamila Chakir, Dr. Michel Laviolette
Université Laval, Québec, Québec
Characteristics of symptomatic asthma remissions

Dr. Jean Bourbeau
Dr. Vasanthi Govindaraju, Dr. Manuel Cosio, Dr. Harvey O. Coxson*, Dr. Céline Bergeron**
McGill University, Montréal, Québec
*University of British Columbia, **Université de Montréal
Characterization of morphological phenotypes of COPD subjects by MDCT scan and their relationship to physiological and inflammatory features.

Dr. Chung-Wai Chow
Dr. Jeremy A. Scott
University of Toronto, Toronto, Ontario
The role of Syk in regulating airway inflammation and obstruction following rhinovirus infection

Dr. James Hogg
Dr. Peter Pare, Dr. Don D. Sin, Dr. Michael Kobor, Dr. Joel Cooper*
University of British Columbia, Vancouver, British Columbia
*University of Pennsylvania
Molecular pathogenesis of COPD

Dr. Catherine Lemière (Université de Montréal)
Dr. Shawn Aaron (University of Ottawa), Dr. Louis-Philippe Boulet (Université Laval), Dr. Mark FitzGerald (University of British Columbia), Dr. James G. Martin (McGill University)
Should non-eosinophilic asthmatic subjects be treated with inhaled corticosteroids?

Drs Julie Milot and Yves Lacasse
Université Laval, Québec, Québec
Effects of fluticasone/salmeterol in outpatients with COPD acute exacerbations

Dr. Robert Newton
Dr. Mark A. Giembycz, Dr. Richard Leigh, Dr. David Proud
University of Calgary, Calgary, Alberta
A mechanism for the enhanced efficacy of the combination therapy salmeterol plus fluticasone in the clinical management of asthma and COPD

Dr. Denis E. O’Donnell
Ms. Katherine A. Webb
Queen’s University, Kingston, Ontario
A 6-week, randomized, double-blind, placebo-controlled, crossover study to assess the effect of fluticasone/salmeterol combination on exertional dyspnea in patients with symptomatic mild COPD

1. What is included in the GSK CIRF-FRIC program information package that will be emailed to me once I’ve registered for the program via the GSK CIRF-FRIC website?

The GSK CIRF-FRIC application package includes the highlights of changes to the 2009-2010 round compared to previous rounds along with the letter of intent template, the guideline for completion of a letter of intent and the scientific areas of research interest for the program.

2. May I submit my application in French?

Presently, applications are only being accepted in English. The templates for the letter of intent and the full proposal are also only available in English.

3. Do I complete the letter of intent online?

No. The letter of intent template will be emailed to you as a part of the GSK CIRF-FRIC application package. The maximum length is 2-3 pages. The letters of intent must be submitted to GSK by the date specified in the Program Timelines section on the GSK CIRF-FRIC website. Letters of intent are to be submitted electronically by email.

4. How do I know that my letter of intent has been received?

Once your letter of intent has been submitted, you will receive an email notification acknowledging the receipt of your letter of intent. For verification purposes, this email will contain the title of your proposal.

5. Who reviews the applications?

A review committee reviews all letters of intent. The review committee is comprised of a GSK multi-disciplinary team and independent Canadian external experts. These experts have the option to consult with up to two additional external experts if they feel this is needed.

If you have any questions about the GSK CIRF-FRIC program, please contact us by email.

Please note: Your own health care professional is the best source of information regarding your health. This form is not intended as a means for reporting an adverse event for any GlaxoSmithKline product. If you need to report an adverse event, please call: 1-800-387-7374 and ask for Medical Information.