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New Frontiers Program (Archived)


Request for Applications

Institute of Circulatory and Respiratory Health

In partnership with

The Lung Association
Heart and Stroke Foundation of Canada



Summary

The New Frontiers Program supports workshops, consensus conferences, opportunities for research collaboration and similar activities for specific research topics and issues. It is expected that this targeted investment will lead to the identification of research priorities and the development of highly successful new research proposals.

Timeline

March 1, 2005 Full applications must be courier stamped by this date.
Mid-March 2005 Anticipated Notification of decision.
Mid-March 2005 Anticipated start date.

Value and Duration

Duration of projects Up to 1 year.
Funds Available For this initiative:
$225,000 over a total of 1 year, at a minimum.
Per grant/award:
Grants will range between $50,000 - $100,000/year.

Table of Contents

Summary
Background
Partners
Objectives and Eligible Research Areas
Funding Information
Eligibility
Evaluation Criteria and Process
General CIHR Guidelines and Conditions of Funding
Communications Requirements
Monitoring, Performance Measurement and Evaluation
How to Apply
Contact Information
Description of Partners
Detailed Information for the Developmental Areas

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Background

The New Frontiers Program was designed:

This year, ICRH and stakeholders have identified three areas that require immediate development by the research community. The areas have been identified as priorities during consultations with researchers and partners over the past year.

It is anticipated that ICRH and its partners will continue to monitor the current research trends and dialogue with the community in moving to select particular future areas. The Program will continue to evolve through the years in order to continue the planning and development necessary to achieve an integrated strategic research agenda.

For this particular request for applications, there will be no open call for Development grants.

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Partners

ICRH is dedicated to identifying and developing collaborations with other CIHR institute(s), branch(es) or office(s), funding organizations and stakeholders to enhance the availability of funding for this strategic initiative, and to create, where appropriate, opportunities for knowledge exchange and translation related to the scope of this particular initiative. Applicants are invited to visit the Description of Partners to find a list of partners and their respective mandates and/or strategic interests. This list will continue to evolve as new partners join in this initiative. The specific research foci and requirements for each partner are outlined in the section "Objectives and Eligible Research Areas."

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Objectives and Eligible Research Areas

NFP Development Grants are designed for the purpose of bringing the research community together around specific areas in need of development. In most cases, Development Grants will be used to coordinate a workshop or small-scale national consensus conference to set a research agenda and priorities. In some cases, the discussion may focus on resolving an issue that will assist the research community toward conducting better research.

The specific objective of the NFP Development Grant is:

Highly detailed descriptions of the 3 eligible areas and their expected outcomes are linked to the areas below:

Eligibility of Randomized Controlled Trials Applications

Randomized Controlled Trials (RCTs) will NOT be considered under this RFA. RCTs are defined as any study involving humans where at least two interventions are compared using random allocation, statistical methodologies and blinding techniques for the purpose of determining whether an innovative intervention leads to improved health.

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Funding Information

Mechanism of Support

This Request for Applications will follow the General Guidelines for All Research Grants.

Allowable Costs

Applicants should review Use of Grant Funds and Eligibility of Expenses, Employment under Grants within the General Guidelines for All Research Grants for a complete listing and description of allowable costs and activities.

The full application must provide a detailed justification of all costs.

Funds Available

Only 1 grant will be funded for each development area. Further details regarding the maximum amount per grant is found in the detailed description of each eligible area of development.

Applications receiving a score of less than 3.5 will not be considered for funding.

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Eligibility

Eligibility Criteria

Eligibility criteria for all CIHR research funding programs apply. The business office of the institution of an eligible Nominated Principal Applicant generally administers CIHR funds. Please refer to the Eligibility Requirements for CIHR Grants and Awards regarding the eligibility requirements for individuals and institutions.

Specific Eligibility Requirements

Eligibility requirements specific to this Request for Applications include the following:

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Evaluation Criteria and Process

Evaluation Criteria

Each proposal must describe how the grant will address one of the important health issues described under "Objectives and Eligible Research Areas." General criteria for assessing applications are listed below. Because different applications will emphasize different approaches to research and to knowledge translation, it is understood that reviewers and committees will weigh questions such as these differently from one application to another.

The research proposed:

  • How clearly the rationale for developing this specified area is articulated? 
  • How important and original are the contributions expected from the initiative proposed? What is the potential for important new knowledge or impact in health research? 
  • How appropriate are the processes for the carrying out the proposed workshop and/or network development?  How well have the applicants anticipated difficulties in their approach and considered alternatives? 
  • How critically is the relevant literature appraised and evaluated or, how is the rationale supported by evidence?

The applicant's productivity, experience and training:

  • How appropriate to the proposed is the training or track record of the applicant(s)? How important and original is the recent productivity of the applicant(s)? How much confidence do you have that the applicant can do the work proposed? (The proposed time commitment to the research may influence this judgment.)

In addition to these general criteria, the peer review committee will consider the criteria below:

  • How the initiative provide added value for health researchers and other stakeholders;
  • Feasibility of the proposed project with special attention to appropriateness, coherence, design, timelines, milestones, and first-year budget;
  • Appropriateness of the proposed governance structure and management of the network or workshop planning group (as applicable to the development area).

Evaluation Process

All personal information collected by CIHR about applicants is used to review applications, to administer and monitor grants and awards, to compile statistics, and to promote and support health research in Canada. Consistent with these purposes, applicants should also expect that information collected by CIHR may be shared as described in Use and Disclosure of Personal Information Provided to CIHR for Peer Review.

Prior to peer review, the appropriate CIHR institute, portfolio and partner representatives may first review proposals for relevance to their strategic interests. The relevance review will be based on the extent to which the proposed research relates to the mandates or strategic priorities of the Institutes, portfolios and partners. As such, representatives will have access to the anonymized project titles and summaries. This review will have no impact on the peer review process. 

On completion of the review, the appropriate CIHR institute, portfolio and partner representatives will receive the ranking list, merit scores (ratings) and recommendations of the peer review committee with regards to funding level, for the submitted applications that fall in the fundable range.

A CIHR peer review committee will evaluate the full applications. The committee will be created specifically for this Request for Applications.  Committee members are selected based on suggestions from many sources including the institute(s) / portfolio(s) and partner(s), following CIHR's policy on Conflict of Interest, Confidentiality and Privacy Issues in Peer Review. For information on CIHR's peer review process, see Peer Review.

Access to Information Act and Privacy Act, and the Personal Information Protection and Electronic Documents Act (PIPEDA)

CIHR as a federal entity is subject to the Access to Information Act and the Privacy Act, therefore the requirements of these two statutes will apply to all information located in CIHR's premises including, without limitation, cost-sharing agreements related to this Request for Applications and all matters pertaining thereto.

The parties, while respecting the application of the Privacy Act to federal entities, will also be bound by the PIPEDA. All personal information (as identified by the PIPEDA) collected, used or disclosed in the course of any commercial activity under cost-sharing agreements related to the Request for Applications will be collected, used and disclosed in compliance with the PIPEDA.

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General CIHR Guidelines and Conditions of Funding

All conditions specified in CIHR General Grants and Awards Policies shall apply to applications funded through this Request for Applications. Conditions cover areas such as Applicant and Institutional Responsibilities, Ethics, Official language policy, Access to Information and Privacy Acts, and Acknowledgement of CIHR Support. Successful applicants will be informed of any special financial conditions prior to the release of funds or when they receive CIHR's Authorization for Funding (AFF) document.

In addition to CIHR standard guidelines and requirements, the following special conditions shall apply:

  • Within six months after the end of the grant's term, the Nominated Principal Applicant is required to submit a final performance report, summarizing the results and describing how the grant funds were used.  A standard form will be provided by CIHR.
  • For the development area, "Cardiovascular Complications of Diabetes", a report of workshop findings is due to ICRH/HSF by June 30, 2005.

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Communications Requirements

Grant recipients are required to acknowledge CIHR, its institutes and partners in any communication or publication related to the project. See CIHR General Grants and Awards Policies, Acknowledgement of CIHR's Support for details on CIHR's communication requirements. The contributing institutes / partners will be identified on the Authorization for Funding and decision letter.

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Monitoring, Performance Measurement and Evaluation

CIHR is committed to demonstrating results to Canadians for the money invested in health research. Therefore, processes for monitoring progress and appropriate use of funds, as well as for performance measurement and program evaluation are in place. As a result, funding recipients must:

  • Adhere to CIHR's reporting requirements and provide required information in a timely fashion;
  • Contribute to the monitoring, review and evaluation of CIHR's programs, policies and processes by participating in evaluation studies, surveys, workshops, audits and providing data or reports as required for the purpose of collecting information to assess progress and results;
  • Encourage their associates, trainees and administration to participate in the monitoring, review and evaluation of CIHR's programs, policies and processes as required.

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How to Apply

Registrations are not required for this Request for Applications.

Review the application instructions provided in How to Apply for a Grant or Award.

Select Operating Grants (Registration and Application) from the Research Funding Programs Application Packages.

Additional instructions must be followed for this RFA:

In a maximum of five (5) pages (not including references, key words or budget), include:

  • Title of the NFP developmental area
  • A statement of the planned objectives and how they address the topic/issue as outlined in the RFA
  • Appropriate scientific citations in framing the objectives, and in relation to the proposed team composition
  • A summary work plan, including the organizational and administrative arrangements and schedule
  • A rationale for the constitution of the coordinating group and a listing of the proposed other participants, including invited international participants and potential partners
  • Plans to disseminate and translate the outcomes
  • A list of key words
  • In the Research Funding Program section of the Research Module (page 7 of the web form printed report), select "Strategic Initiative/RFA" and enter the title of this RFA.
  • Only the full CV of the nominated principal applicant is required.
  • Only a listing of the coordinating group and brief statement of their contributions to the development grant is required.

Send 1 original and 5 copies of the Application by Courier to:

RE: "New Frontiers Program"
Canadian Institutes of Health Research
Room 97, 160 Elgin Street
Address locator: 4809A
Ottawa, Ontario K1A 0W9

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Contact Information

For questions on CIHR funding guidelines, how to apply, and the peer review process contact:

Martine Parent
Program Delivery Coordinator
Canadian Institutes of Health Research
Telephone: (613) 941-4634
E-mail: mparent@cihr-irsc.gc.ca

For questions about this initiative and research objectives contact:

Elissa Hines Reimer
Assistant Director, ICRH-Ottawa
Canadian Institutes of Health Research
Telephone: (613) 954-0544
Fax: (613) 954-1800
E-mail: ehinesreimer@cihr-irsc.gc.ca

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Description of Partners: CIHR Institutes and Partner Organizations

Note: Additional partners, including partners from industry and the private sector are expected to join this funding initiative over the coming year.

Canadian Institutes of Health Research (CIHR)

CIHR is Canada's major federal funding agency for health research. Its objective is to excel, according to internationally accepted standards of scientific excellence, in the creation of new knowledge and its translation into improved health for Canadians, more effective health services and products and a strengthened Canadian health care system.

CIHR - Institute of Circulatory and Respiratory Health
The mission of the ICRH is to support research into the causes, mechanisms, prevention, screening, diagnosis, treatment, support systems, and palliation for a wide range of conditions associated with the heart, lung, brain (stroke), blood, blood vessels, critical and intensive care, and sleep.

Partners:

Heart and Stroke Foundation of Canada
The mission of the Heart and Stroke Foundation of Canada (HSFC) is to improve the health of Canadians by preventing and reducing disability and death from heart disease and stroke through research, health promotion and advocacy. The Foundation is a leading funder of heart disease and stroke research in Canada and is committed to supporting research across the full research spectrum.

The Lung Association
Our mission is to lead national and international lung health initiatives in preventing lung disease; helping people manage lung disease and promoting lung health. A unique partnership of 10 provincial Lung Associations from coast to coast, the Canadian Lung Association acts to strengthen the work of the provincial associations through support of research, advocacy of improved respiratory health, communications and coordination of services.

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Detailed Information For The Developmental Area:
Cardiovascular Complications of Diabetes

Introduction

The CIHR Institute of Circulatory and Respiratory Health (ICRH) and the Heart and Stroke Foundation of Canada (HSFC) have each identified the research arena of cardiovascular complications of diabetes as requiring further attention by the research community. As such, ICRH, HSFC and other health research institutes and partners anticipate launching a Request for Applications (RFA) in mid-Fall of 2005. Before the launch of a large strategic program, ICRH and HSFC would like to solicit input and feedback from leading researchers working and publishing in this arena with respect to the current state of knowledge and knowledge gaps.

The purpose of this New Frontiers Program (NFP) call for a workshop proposal related to cardiovascular complications of diabetes is to bring a diverse and representative group of researchers working in this general arena together to discuss current state of knowledge and gaps, pressing research questions, opportunities and challenges, and possible future directions. The successful workshop applicant (or co-applicants) will receive resources for the planning and organization of the workshop.

The successful workshop applicant (or co-applicant) will be required to submit a synthesis report to ICRH and HSFC within two weeks following the workshop. The synthesis report will assist ICRH and HSFC and all funding partners in crafting the most appropriate RFA. It is anticipated that by bringing researchers together, in a workshop setting, researchers will also submit stronger and more meaningful applications in this arena to other grants competitions of CIHR, HSFC and other health research funding organizations.

Context

In fiscal years 1999/2000, over 1.1 million Canadians age of 20 years and older were living with diagnosed diabetes (either type 1 or type 2) (2). This represents a prevalence of 4.8 percent, however, population-based studies have identified prevalence rates to be 30 to 50 percent higher, suggesting that the true prevalence may be greater than 7 percent (3). The Canadian Diabetes Association estimates that over 2 million Canadians are currently diagnosed with diabetes. In 2000, the mortality rate (per 100,000, males and females combined) for Canadians diagnosed with diabetes was 19.27 as compared to 123.12 for ischemic heart disease, 42.40 for cerebrovascular disease and 50.64 for other circulatory diseases (Major Chronic Diseases Surveillance Online). The proportion of ischemic heart disease deaths that are attributable to cardiovascular complications of diabetes is unknown and probably represents a significant proportion of these deaths (4). For example, a recent Canadian study showed that out of 447 individuals admitted for acute myocardial infarction, 128 were diagnosed with diabetes (5).

Diabetes is a well-known risk factor for cardiovascular disease, although the exact biological mechanisms underlying these complications or the best ways to prevent or manage them are unknown. The interaction between the diabetic state and other risk factors for cardiovascular diseases can not be over-stated in its importance (6). Most patients with a high risk of ischemic cardiovascular disease have multiple, interacting risk factors (7). While the exact nature of these interactions are poorly understood, it is clear that the clustering of risk factors such as obesity and high blood pressure result in metabolic disturbances including insulin-resistance and impaired fasting glucose, and contribute to the development of diabetes and cardiovascular complications.

It is well established that if diabetes is not treated properly (e.g., through drug therapies such as insulin or antihyperglycemic agents and life-style changes), the high levels of sugar in the blood and accompanying biologically active compounds like reactive oxidative species result in damage to the small and large blood vessels and in so doing contribute to such conditions as stroke, ischemic heart disease and other debilitating conditions (8-10). Table 1 summarizes some of the cardiovascular complications of diabetes in the heart, and small and large blood vessels. In the final analysis all life-threatening and disabling consequences of diabetes can be deemed cardiovascular (11).

Table 1. Macro- and micro-cardiovascular and cardiac complications of diabetes.
 Vascular Component Clinical Complication(s) Health Outcome (Canadian Diabetes Association, Framingham Heart Study)
Macrovascular Ischemic heart disease, Stroke
  • Heart disease is two to four times more common in people with diabetes than without.
  • Diabetes eliminates the general atherosclerosis-resistance that non-diabetic women enjoy as compared to men (1).
Peripheral vascular disease
  • Worldwide, half or more of all non-traumatic limb amputations are due to diabetes.
  • Diabetes is a major cause of erectile dysfunction.
Microvascular Retinopathy
  • Diabetes is a leading cause of adult blindness.
Nephropathy
  • In Canada, people with diabetes account for 28 per cent of all new cases of serious kidney disease.
Cardiac Cardiomyopathy
  • Beyond ischemic injury of the myocardium, diabetes is associated with heart muscle dysfunction and failure.

The association between diabetes and ensuing cardiovascular complications is reinforced when one looks at the effects of diabetes in vulnerable populations. For example, 13% of First Nations people diagnosed with diabetes have had a stroke, while only 3% of a comparable non-diabetic cohort have had the same sequela (12). Given the rising incidence of diabetes in the younger Canadian population, the potentially devastating consequences of diabetes in relation to cardiovascular health are going to grow. The same can be said for women where the prevalence of diabetes in Canadian women has increased from 4.1% to 4.6% to 4.9% in fiscal years 1997/1998 to 1998/1999 to 1999/2000, respectively (2).

An aging population, increased immigration of high-risk populations to Canada, and growth in the Aboriginal population are demographic trends speculated to contribute to an increased prevalence of diabetes in Canada. The increasing prevalence of obesity and insulin resistance in both adult and child populations will also contribute to an increased burden of diabetes. All of these factors will affect health service requirements in the acute, chronic and home care sectors (3).

Type 2 diabetes may be largely preventable and research is needed to identify, implement and evaluate effective strategies for the prevention of diabetes and resulting cardiovascular complications. In addition to effective preventive initiatives, improvements to cost and efficiency of healthcare delivery are needed. Diabetes and vascular complications are costly to both to the affected individual and to society. The economic impact of diabetes in 1998 was estimated to be between $7.07 and $7.65 billion dollars (CDN) (13). An increased prevalence of diabetes will inevitably lead to increased healthcare costs.

The Opportunity

The goal of providing a New Frontiers Program Development Grant is to support one nationally-scoped workshop application in the arena of cardiovascular complications of diabetes. Workshop applicants are encouraged to engage as many Canadian researchers from different disciplines and themes as possible to ensure depth and breadth of discussions and analysis at the NFP workshop. International representation, especially from the United States, on the workshop planning committee and at the workshop itself is encouraged. The workshop leader and their planning group will work closely with ICRH and HSFC staff during the planning of the workshop in order to ensure that workshop objectives and information needs of ICRH and HSFC are met.

Partners

The ICRH and HSFC will co-fund the successful workshop application to a maximum of $75,000. Over the coming months, ICRH and HSFC will identify other partners who would like to participate in the RFA call scheduled to be launched in the fall of 2005.

Specific Objectives and Expected Outcomes

The objectives of the NFP workshop are:

  • To review the current state of knowledge related to cardiovascular complications of diabetes.
  • To identify and prioritize the pressing research questions and knowledge gaps in this arena emphasizing opportunities for novel advancement.
  • To identify, for the purpose of deliberations, priority areas for Canada that pertain to cardiovascular complications of diabetes. Some information gathering exercises include the following:
    a. past and current RFA offerings (national and international) that are focused on some aspect of cardiovascular complications of diabetes
    b. the existence of large-scale research programs in Canada that are focused on some aspect of cardiovascular complications of diabetes
    c. current level of research funding (nationally and internationally) in this arena (e.g., National Institutes of Health, health charities, federal funding programs and agencies like Canada Researcher Chairs/Canada Foundation for Innovation, etc.)
  • To develop a prioritized list of research foci that could become the focus of a Request for Applications (RFA) programs and corresponding rationale for these recommendations.

The workshop leader's summary report will be expected to include information collected before the workshop and a concise summary of the workshop discussions, feedback and recommendations for submission to ICRH and HSFC within two weeks of the meeting. For these reasons, it is highly recommended that a professional process consultant/facilitator be retained for this workshop.

Deliverables and Timeframe

The workshop leader(s) is expected to complete the following tasks by the specified date:

Workshop: The workshop should be held by no later than June 15, 2005. Approximately 35-50 leading researchers and clinicians could be invited to attend and participate in the workshop.
Synthesis Report: The synthesis report should be submitted to ICRH and HSFC in electronic format no later than June 30, 2005. It is important that the synthesis report be submitted by this date to allow partners organizations to make decisions on priority areas for future funding through Request for Applications (RFA) programs . The synthesis report should cover as many of the topics mentioned under the workshop objectives section as possible (see above). It would be helpful if the synthesis report included organized tables and lists as opposed to lengthy narratives.

Workshop Leader and Team

The workshop leader (or co-leaders) can be any established, successful investigator(s) working in Canada whose primary area of investigation is cardiovascular complications of diabetes. We recommend a maximum of two workshop leaders. The workshop leader (or co-leaders) are strongly encouraged to engage as many researchers as possible from different disciplines and themes on the planning committee and at the workshop itself. The planning committee should be national in scope and comprise 4-5 leading researchers working and publishing in this arena, and spanning disciplines and themes. Additional members from across the country can be included in an advisory capacity. Given that funds are limited, we anticipate that approximately 30-50 leading researchers, clinicians/health professionals be invited to attend and participate in the workshop.

Statement of Work and Time

Planning for this meeting is likely to take approximately 50 hours in the planning and organization of the workshop and 12 hours in the preparation of the synthesis report. Therefore, it is highly recommended that the workshop leader (or co-leaders) retain an individual to assist with process/meeting design, preparation of meeting materials, meeting facilitation and production of the final report.

References

  1. Di Carli MF, Afonso L, Campisi R, et al. Coronary vascular dysfunction in premenopausal women with diabetes mellitus. Am Heart J 2002; 144:711-718.
  2. Health Canada. Responding to the Challenge of Diabetes in Canada: First Report of the National Diabetes Surveillance System (NDSS), 2003.
  3. Canadian Diabetes Association Clinical Practice Guidelines Expert Committee. 2003 Clinical Practice Guidelines.
  4. Mitka M. Diabetes group warns vascular complication is underdiagnosed and undertreated. Jama 2004; 291:809-810.
  5. Imran SA, Cox JL, Ur E. Diabetes control among patients presenting with acute myocardial infarction in a Canadian tertiary health care setting. Can J Cardiol 2003; 19:1407-1410.
  6. Deedwania PC. Diabetes and vascular disease: common links in the emerging epidemic of coronary artery disease. Am J Cardiol 2003; 91:68-71.
  7. Watkins LO. Epidemiology and burden of cardiovascular disease. Clin Cardiol 2004; 27:III2-6.
  8. Wautier JL, Schmidt AM. Protein glycation: a firm link to endothelial cell dysfunction. Circ Res 2004; 95:233-238.
  9. Basta G, Schmidt AM, De Caterina R. Advanced glycation end products and vascular inflammation: implications for accelerated atherosclerosis in diabetes. Cardiovasc Res 2004; 63:582-592.
  10. Guzik TJ, Mussa S, Gastaldi D, et al. Mechanisms of increased vascular superoxide production in human diabetes mellitus: role of NAD(P)H oxidase and endothelial nitric oxide synthase. Circulation 2002; 105:1656-1662.
  11. Hu FB, Stampfer MJ. Is type 2 diabetes mellitus a vascular condition? Arterioscler Thromb Vasc Biol 2003; 23:1715-1716.
  12. Centre for Chronic Disease Prevention and Control, Population and Public Health Branch, Health Canada. Diabetes in Canada - Second Edition, 2002.
  13. Dawson KG, Gomes D, Gerstein H, et al. The economic cost of diabetes in Canada, 1998. Diabetes Care 2002;25:1303-1307.

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Detailed Information For The Developmental Area:
Canadian Respiratory Clinical Trials Network

Introduction

In October 2003, the Institute of Circulatory and Respiratory Health and The Lung Association (CLA) co-hosted a New Frontiers Workshop entitled, "Enhancing & Advancing the Respiratory and Critical Care Agendas in Canada." One of the recommendations stemming from this meeting was the development of a Canadian Respiratory Clinical Trials Network, modeled after the Canadian Critical Care Trials Group and other successful Canadian clinical trials groups.

Context

Over 3 million Canadians suffer from a respiratory disorder (1). Among the common respiratory diseases, asthma and chronic obstructive pulmonary disorder (COPD) are increasingly prevalent in Canada. In some diseases such as lung cancer and COPD, prevalence of the disease is occurring more for women than men. It is anticipated that by 2010, chronic respiratory diseases will be a major factor in health care utilization in Canada.

In Canada and globally, infectious respiratory diseases continue to be a major concern. Tuberculosis continues to effect Aboriginal Peoples and inner city marginalized populations disproportionately to other populations in Canada.

An additional factor is the increased prevalence of these disorders in persons older than sixty five. The prevalence of this age group will increase significantly in coming years and will not only see more of them suffering from chronic lung disease but also, in many cases, bringing significant co-morbidities. An indication of the impact of this disease category is that already, respiratory diseases, including lung cancer, were the third most common cause for admission to hospital in 1998. The proportion of direct health care costs associated with lung disease was 8.6% in 1993 (the last year when data was available) compared to cardio vascular disease (16.7%) and mental disorders (11.5%) (1).

The recent emergence of SARS and ongoing concerns regarding the occurrence of a new influenza pandemic all point to the need to have an infrastructure in place to carry out important clinical intervention studies to address key management issues related to these diseases. The need for large outcomes studies, with indicators such as mortality also highlights the need for a national clinical trials infrastructure.The Canadian respiratory community is well-positioned to take a leadership role in identifying guideline recommendations which are not supported by Level 1 randomized controlled trial data and developing protocols to address these deficiencies.

The Opportunity

The goal of providing a New Frontiers Program Development Grant is to set up national respiratory clinical trials network infrastructure that:

  • Identifies, develops, implements and evaluates clinical trials protocols in respiratory health
  • Is inclusive of all stakeholders in respiratory clinical trials (e.g. researchers, clinicians - physicians, nurses, therapists and other health professionals, clinical trials implementers, patients, etc.)
  • Complements and works in collaboration with other national, provincial and regional clinical trials networks
  • Promotes knowledge transfer and translation into health benefits for patients
  • Is inclusive of researchers from across disciplines and health themes (biomedical, clinical, health services, and population health).
  • Has a strong emphasis on knowledge translation and its evaluation
  • Is sustainable over the long-term.

Partners

ICRH, with the in-kind support of the CLA, will provide up to $100,000 for the planning, development and early implementation steps of a nationally-scoped, Canadian Respiratory Clinical Trials Network.

Specific Objectives and Expected Outcomes

The application must address the following points:

  • The need for, and benefits of a Canadian Clinical Trials Network
  • Rationale for the number and location of the initial nodes of the clinical trials network
  • Brief descriptions of the individual universities/hospitals/centres that will be part of the network and their added value to the network. What will centres specifically bring to the network and what will centres be able to do as members of the network that they cannot do on their own?
  • Added value for the Canadian respiratory research community. How will the network constitute a unique and valuable research resource? What will this resource allow Canadian researchers to do more than what they are doing now?
  • Functional design of the network
  • Governance and organizational structures and their appropriateness, as well as the responsibilities and accountability of the various elements of the structure.
  • Core activities of the network
  • The scope and appropriateness of standard operating procedures to be developed for the network.
  • The description and appropriateness of the proposed administrative, database architecture, and informatics requirements needed to support the activities of the network.
  • A proposed strategy to deal with Intellectual Property (IP) issues.
  • Initial plans for long-term sustainability of the network, including proposed partnerships and interactions with the public, voluntary and private sector.
  • Well-supported rationale for projected costs

The proposal should outline a plan to meet the following proposed actions and/or propose a modified schedule with appropriate rationale.

Action Timeframe (Months)
Establish a National Steering Committee inclusive of:
  • Researchers, Clinicians (physicians, nurses, therapists and other health professionals)
  • 1-2 Clinical Trials Network experts from fields outside respiratory health
  • 1-2 International experts
1 - 2
Organize and hold a face-to face meeting of the steering committee, international and clinical trials experts (e.g., Critical Care Trials Group) for lessons learned in setting up a network and establishment of themes, standard operating procedures, terms of reference, etc. 2-5
On-going conference calls of the Steering Committee to:
  • assemble potential protocols
  • plan a meeting of network investigators
  • inventory of people, resources, expertise
  • develop functional and governance structure
  • plan for sustainability of the network
  • evaluate work done to date
3-12
Hold a network meeting to:
  • formalize the organization, governance and intellectual properties concerns of the network
  • agree on network themes
  • determine initial protocols and organize teams for grant submission and implementation through the network
8-9
Pursue partnerships/collaborations, applications for funding and other avenues for sustained funding 3-12
Prepare final report to ICRH/CLA 12

Eligible Expenses

Due to the development nature of this initiative, funds may be utilized as follows:

  • Salary and benefits of staff hired to support the network development
  • Services of a consultant(s), as required
  • Database and/or website design and implementation
  • Dedicated communication equipment, computer hardware and software, as required
  • Travel and subsistence for face-to-face meeting(s) of the steering committee and guest experts and for the first network meeting
  • Regular costs associated with meetings (e.g. teleconference calls, meeting materials, etc.)

Leader and Team

The network development leader can be any established, successful investigator(s) working in Canada whose primary area of investigation is respiratory research, with an established track record for clinical research and team building. A maximum of two co-leaders is recommended. The workshop leader (or co-leaders) are strongly encouraged to engage as many researchers and clinicians/health professionals as possible from different disciplines and themes on the planning committee and at the workshop itself. The planning committee should be national in scope and comprise 4-5 leading researchers working and publishing in this arena, and spanning disciplines and themes. Additional members from across the country can be included in an advisory capacity.

Statement of Work and Time

Planning for this network is likely to take considerable administrative time and efforts Therefore, it is highly recommended that the workshop leader (or co-leaders) retain an individual(s) to assist with process/meeting design, preparation of draft materials, organization of meeting logistics, meeting facilitation, business plan development, production of the final report and other tasks.

References

  1. Editorial Board. Respiratory Disease in Canada. Health Canada. Ottawa, Canada, 2001.

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Detailed Information For The Developmental Area:
Canadian Critical Care Trials Group

Introduction

The Canadian Critical Care Trials Group (CCCTG) was created in 1989 to improve the care of critically ill patients through investigator-initiated research, and to provide a national forum for continuing education about research methods. Since that time, the CCCTG has grown to be a highly successful organization in Canada with approximately 110 members, and 41 peer-review journal article publications, and 51 abstracts published to date. CCCTG has developed essential organizational processes including terms of reference for group process, protocol presentations, executive renewal, and group authorship. This multi-disciplinary group has a proven track record of success with respect to: identifying research gaps in knowledge concerning critical care; developing new research projects in response to those gaps; and, implementing the clinical trials with the goals of changing clinical practice.

Context

Critical care studies cover a diverse range of topics and disciplines, including such areas as: sepsis, acute respiratory distress syndrome (ARDS), systemic inflammatory response syndrome (SIRS), resuscitation and emergency medicine, transfusion medicine, palliative and end of life care. These studies are vital to the research enterprise since patient care for critically ill patients, both in the emergency room and in the intensive care units is extremely costly (1). Treatment of conditions such as severe sepsis in cancer patients has proven to be extremely expensive, both in terms of hospitalization costs and mortality (2). Hospitalization costs include the time spent by health professionals, life saving and sustaining technology, and treatment interventions.

In addition to critical care studies which impact on the cardiovascular, pulmonary, vascular and hematopoietic systems, ICRH recognizes the need for new research that examines ethical and quality of life issues, and research that supports translation of knowledge into practice.

The Opportunity

The goal of providing a New Frontiers Program Development Grant is to enable critical care researchers to develop and implement strategies that will achieve their stated strategic goals:

  • To improve data management platforms
  • To enhance research ethics
  • To increase international collaboration
  • To engage in additional translational research

Specific Objectives and Expected Outcomes

The application must address the following points:

  • The rationale for the four chosen strategic areas (data management platforms, research ethics, international collaboration, translational research) and detailed objectives and timelines for each area
  • Added value for the Canadian respiratory research community. How will the network priority areas constitute a unique and valuable research resource? What will this resource allow Canadian researchers to do more than what they are doing now?
  • Governance and organizational structures and their appropriateness, as well as the responsibilities and accountability of the various elements of the structure.
  • Core activities of the network
  • The scope and appropriateness of standard operating procedures to be developed for the network.
  • The description and appropriateness of the proposed administrative, database architecture, and informatics requirements needed to support the activities of the network.
  • Initial plans for expansion and long-term sustainability of the network, including proposed partnerships and interactions with the public, voluntary and private sector.
  • Well-supported rationale for projected costs
  • Expected outcomes after 12 months

Leader and Team

The leader should be a member in good standing of the CCCGC and an established, successful investigator(s) working in Canada whose primary area of investigation is critical care research. We recommend a maximum of two workshop co-leaders. The workshop leader (or co-leaders) are strongly encouraged to engage as many researchers and clinicians/health professionals as possible from different disciplines and themes on the planning committee and at the workshop itself. The planning committee should be national in scope and comprise 4-5 leading researchers working and publishing in this arena, and spanning disciplines and themes. Additional members from across the country can be included in an advisory capacity.

Statement of Work and Time

Planning for the network expansion and further development of new strategic directions is likely to take considerable administrative time and efforts Therefore, it is highly recommended that the workshop leader (or co-leaders) retain an individual(s) to assist with process/meeting design, preparation of draft materials, organization of meeting logistics, meeting facilitation, business plan development, production of the final report and other tasks.

References

  1. Huang, David T. Clinical review: Impact of emergency department care on intensive care unit costs. Critical Care. 2004;8:498-502.
  2. Williams, Mark D et al. Hospitalized cancer patients with severe sepsis: analysis of incidence, mortality, and associated costs of care. Critical Care. 2004; 8:r291-r298.

Created: 2005-02-08
Modified: 2005-02-09
Reviewed: 2005-02-08
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