Important Dates

Notices

Table of Contents

• Description
• Objectives
• Eligibility
• Guidelines
• Performance Measurement
• Review Process and Evaluation
• How to Apply
• Contact Information
• Partner/Collaborator Description

Description

In Canada and worldwide, there are gaps in information on the safety and effectiveness of drugs used in real-world settings. More information is needed on the safety and effectiveness of pharmaceuticals when used by diverse patient populations outside the controlled experimental environment of clinical trials. This funding opportunity is intended to provide one year of support for research projects that address gaps in knowledge concerning real-world drug safety and effectiveness in which research evidence is generally understood to be lacking.

Background

It has been long recognized that there are significant gaps in the research to make evidence-based decisions with respect to the safety and effectiveness of drug products across the Canadian healthcare system. It is also understood that investigator driven research does not always align with the information needs of decision makers. Decision makers often need new information within relatively short periods of time and efforts are needed to improve the utility of research to support evidence-based decision making. In order to increase the evidence currently available to decision makers, CIHR is launching this Catalyst Grant to fund research on the post market safety and effectiveness of drugs used in the "real world".

By way of background, the Government of Canada is supporting the establishment of the Drug Safety and Effectiveness Network (DSEN), hosted at the Canadian Institutes for Health Research (CIHR), as part of the Food and Consumer Safety Action Plan (FCSAP). The DSEN will become fully operational over the course of the next few years at which time it will begin funding research projects specific to the objectives of DSEN. More detailed information on the DSEN is available on CIHR's website.

For this specific funding opportunity alone the relevant research areas and topics were established through the identification of information gaps by various stakeholders including Health Canada, the Canadian Agency for Drugs and Technologies in Health (CADTH) and the research community. Work is underway to establish a formal process for setting research priorities. Once established, the research priorities of the Network and accompanying funding opportunities will be set through a process involving the input of representatives of federal and provincial governments and relevant stakeholders.

Before the DSEN is fully operational, CIHR is taking the opportunity to stimulate research through a Catalyst Grant, a program that provides seed money, on a short-term basis, to support health research activities which represent a first step towards the pursuit of more comprehensive funding opportunities (e.g. operating grants, team grants), such as:

• the planning and execution of pilot projects or feasibility studies aiming to generate preliminary data, observations, or knowledge that can be shared within the research community;
• the planning and execution of novel projects which clearly demonstrate the potential for significant impact, but which are considered high risk in nature in that they may be unsupported by proof of concept / preliminary data;
• development and / or validation of new inventions, tools, methodologies, protocols, theoretical models or frameworks;
• planning and / or development activities of expert teams (multi-disciplinary, trans-disciplinary, etc…) coming together to address health research priorities.

Funds Available

CIHR's contribution to the amount available for this initiative is subject to availability of funds voted annually to CIHR by parliamentary appropriations, and the conditions that may be attached to them.

• The total amount available for this funding opportunity is $1 million. This amount may increase if additional funding partners decide to participate.
• The maximum amount awarded for a single grant is $ 100,000 per annum for a maximum of one year. The equipment amount, where applicable, is awarded in year one.
• Separate funding pools have been established to ensure that at least one meritorious application is funded in each of the eight relevant research areas. Applications will be funded within each pool in rank order according to the specifications in the relevant research areas section.
• Each of the relevant research areas contains one or more topics for investigation and applications must focus on a single topic. Applicants are invited to submit more than one application to this funding opportunity provided that each application addresses a different topic.
• If after peer review there are an insufficient number of applications deemed fundable within a pool, unspent funds will be re-allocated to a general pool. The general pool will consist of the remaining topics from the relevant research areas; topics already funded will not be included in the general pool. Funds will be allocated in rank order within the general pool for no more than one application responding to any of the remaining topics until exhausted.

Partner/Collaborator Participation

CIHR is dedicated to identifying and developing collaborations with other funding organizations and stakeholders to enhance the availability of funding for this funding opportunity, 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 Partner/Collaborator Description section to find a list of partners/collaborators and their respective mandates and/or strategic interests. This list will continue to evolve as new partners/collaborators join in this funding opportunity. The specific research foci and requirements for each partner/collaborator are outlined in the "Objectives" section.

Objectives

The primary objectives of the Catalyst Grant program are to:

• Generate observations, data or knowledge,as a first step towards the pursuit of more comprehensive funding opportunities (e.g., operating grants, team grants) by researchers or teams of researchers
• Support original, high quality projects which have the potential to generate high impact results and/or innovative research proposals, research tools, techniques, devices, inventions, or methodologies.

The Catalyst Grant program is further expected to contribute to:

• Providing new or established investigators with funding to pursue new areas of investigation
• Providing investigators the opportunity to pursue high risk health research questions with the potential for high impact
• Providing the opportunity for a unique combination (e.g. multi-disciplinary, trans-disciplinary, international) of individual researchers to develop as a team
• Development of a culture of invention and innovation in Canada
• Mobilization of research communities to develop research agendas and/or action plans to advance research in specific priority areas.

Specific Objectives

Within the framework of the overall objectives of the CIHR Catalyst Grant Program, the specific objectives of this funding opportunity are:

• To stimulate collaboration among researchers by promoting the sharing and/or combining of data sources and methodologies;
• To provide timely research evidence on gaps in knowledge of real-world (post-market) drug safety and effectiveness as defined below:
  • conducting research, for which the results provide an answer within one year
  • developing critical steps in the research needed to deliver research results, which require more than one year to reach

For this Catalyst Grant, new knowledge is considered to have the greatest impact on evidence-based decision making, where the research results lead to an answer being reached within the study period. The next highest impact research is considered to flow from the sharing of interim results/critical steps of research; where results are made available to other researchers or teams of researchers for further investigation. The lowest impact would be attributed to projects that develop critical steps to be undertaken solely by the applicant in future years.

Relevant Research Areas:

The following research areas are relevant within this funding opportunity. Within each relevant research area, one or more research topics are specified. Applications must clearly address one of the topics described below. Applicants are invited to submit more than one application to this funding opportunity provided that each application addresses a different topic.

Separate funding pools have been created for eight relevant research areas. Detailed information concerning research topics and the total funding in each research area is provided below:

1. Atypical Antipsychotic Agents
2. Drugs for Attention Deficit and Hyperactivity Disorder (ADHD)
3. Bisphosphonates
4. Long-Acting Beta-2-Agonists (LABAs)
5. Proton Pump Inhibitors (PPIs)
6. Intravenous Immune Globulins (IVIG)
7. Non-steroidal anti-inflammatory drugs (NSAIDs)
8. Drugs used by Pregnant or Lactating Women and in Paediatrics

1. Atypical Antipsychotic Agents: research projects must focus on a comparison of outcomes that are clearly representative of the risk of breast cancer, blood dyscrasias including agranulocytosis or therapeutic effectiveness among users of different atypical antipsychotic agents.

   A total of $100,000 has been allocated to projects that address one of the following topics:

   1. Given the variable increases in prolactin levels observed during treatment with atypical antipsychotic drugs, is there a corresponding increase in risk of breast cancer?
   2. What is the risk of blood dyscrasias, including agranulocytosis, among users of atypical antipsychotics?
   3. Are atypical antipsychotic drugs more effective than older agents in reducing the occurrence of hospitalization?


2. Drugs for Attention Deficit and Hyperactivity Disorder (ADHD): research projects must focus on cardiovascular events among stratified age groups receiving drugs used to treat ADHD.

   A total of $100,000 has been allocated to projects that address the following topic:

   • Comparatively, what are the associations between rates of serious cardiovascular adverse events and drugs used to treat ADHD in Canada among stratified age groups including children between 6 and 18 years of age?


3. Bisphosphonates: research projects must focus on the safety and/or effectiveness of bisphosphonates.

   A total of $100,000 has been allocated to projects that address the following topic:

   • What is the evidence concerning the safety of bisphosphonates as they relate to atrial fibrillation and/or their effectiveness in achieving therapeutic outcomes?


4. Long-Acting Beta-2-Agonists (LABAs): research projects must focus on the association between serious respiratory adverse events and the use of LABAs (single ingredient vs. combination products) among stratified age groups including children.

   A total of $100,000 has been allocated to projects that address the following topic:

   • What is the association between serious respiratory events and the use of long-acting single ingredient beta-agonists versus combination products for the treatment of asthma across stratified age groups including children?


5. Proton Pump Inhibitors (PPIs): research projects must focus on the risk of myocardial infarction among users of PPIs.

   A total of $100,000 has been allocated to projects that address the following topic:

   • What is the risk of myocardial infarction among users of PPIs and are these risks similar amongst various user populations?


6. Intravenous Immune Globulins (IVIG): research projects must focus on the differences in risk of haemolytic anemia with different brands of IVIG.

   A total of $100,000 has been allocated to projects that address the following topic:

   • Are there any differences in risk of haemolytic anaemia with the different brands of intravenous immune globulin (IVIG)?


7. Non-steroidal anti-inflammatory drugs (NSAIDs): research projects must focus on gaps in evidence concerning gastrointestinal or cutaneous adverse events associated with different NSAIDs.

   A total of $100,000 has been allocated to projects that address one of the following topics:

   1. What are the safety and effectiveness profiles of products within the NSAID class with respect to gastrointestinal adverse events?
   2. What are the safety and effectiveness profiles of products within the NSAID class with respect to cutaneous adverse events?


8. Drugs used by Pregnant or Lactating Women and in Paediatrics: research projects must focus on the safety and effectiveness of drugs used by pregnant and/or lactating women or in paediatric populations.

   A total of $300,000 has been allocated to projects that address the following:

   • There is a general need for information regarding safety and effectiveness of drugs used by pregnant and/or lactating women, and children. Applications will be accepted for general and investigator driven research proposals that address frequently used therapies in pregnant and nursing women and in paediatric populations for the treatment of conditions outlined in Table 1. The conditions are listed by population and each condition/population combination is considered a unique research topic.
   • Applications that focus on the treatment of ADHD will NOT be accepted to this funding pool.

Table 1: Relevant Conditions in which Drugs are used by Pregnant/Lactating Women and Paediatric Populations

Note: Within this research area, the intention is to distribute the funding to research proposals that focus on different topics (a to s). Applications will be funded in rank order according to the topic considered in the research proposal. Only the top ranked application for each topic within this pool will be funded. (For example: if the two top ranked applications both have a research focus on the treatment of arthritis in pregnant women, only the top ranked application for this topic would be funded.)

In order to provide further detail on the objectives and funding pool structure of this funding opportunity a teleconference may be scheduled for interested applicants. Please contact CIHR prior to Sept 9, 2009 for more information. The teleconference would be held prior to the CIHR Registration deadline.

Eligibility

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.

Randomized Controlled Trials (RCTs) will not be considered under this funding opportunity.

Specific Eligibility Requirements

Eligibility requirements specific to this funding opportunity include the following:

• Applicants must be eligible to receive funding (according to eligibility requirements for CIHR Grants and Awards described above) by the funding start date.

Guidelines

General CIHR Guidelines

This funding opportunity will follow the General Guidelines for Grant Programs. Applicants are encouraged to demonstrate the use of Gender and Sex-Based Analysis in applications.

Allowable Costs

Applicants should review the Use of Grant Funds section of the Tri-Agency (CIHR, NSERC and SSHRC) Financial Administration Guide for a complete listing and description of allowable costs and activities.

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

Conditions of Funding

All conditions specified in CIHR General Grants and Awards Policies shall apply to applications funded through this funding opportunity. Conditions cover areas such as Applicant and Institutional Responsibilities, Ethics, Official languages policy, Access to Information and Privacy Acts, and Acknowledgement of CIHR's Support. Successful applicants will be informed of any special financial requirements 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 requirements 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.
• As a condition of funding, the Nominated Principal Applicant and/or designated Principal/co-applicant may be required to participate in an evaluation exercise or end-of-grant knowledge translation forum planned in relation to this Catalyst Grant and hosted by the CIHR coordinating office of the Drug Safety and Effectiveness Network initiative.

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

All personal information collected by CIHR about applicants is used to review applications, to recruit reviewers, 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.

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 Funding opportunity and all matters pertaining thereto.

While respecting the application of the Privacy Act to federal entities, all signing parties involved in a collaborative agreement will also be bound by the Personal Information Protection and Electronic Documents Act (PIPEDA). All personal information (as identified by the PIPEDA) collected, used or disclosed in the course of any commercial activity under collaborative agreements related to the Funding opportunity will be collected, used and disclosed in compliance with the PIPEDA.

CIHR Guidelines for Health Research Involving Aboriginal People

The CIHR Guidelines for Health Research Involving Aboriginal People came into effect as policy for CIHR-funded research on July 1, 2008. Applicants whose proposed research will involve Aboriginal People are strongly encouraged to familiarise themselves with these guidelines and in particular with the section "Application of the Guidelines," which outlines the situations in which these guidelines apply.

Policy on Access to Research Outputs

CIHR believes that greater access to research publications and data will promote the ability of researchers and knowledge users in Canada and abroad to use and build on the knowledge needed to address significant health challenges. Open access will promote accessibility to CIHR-funded research and will serve to increase the international visibility of Canadian research. As of January 1, 2008, CIHR grant recipients are reminded to adhere with the responsibilities outlined in the Policy on Access to Research Outputs. Under this policy, grant recipients must make every effort to ensure that research papers and bio-molecular data generated from CIHR funding are freely accessible online.

Communication 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, Public Communication and 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.

Performance Measurement

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:

• 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.

Review Process and Evaluation

Relevance Review

The CIHR coordinating office of the Drug Safety and Effectiveness Network (DSEN) initiative will provide funding for applications that are relevant to (in alignment with) the objectives and topics outlined within each of the relevant research areas described in the Objectives section.

Prior to peer review, the coordinating office of the DSEN initiative and any partners will have access to anonymized project titles and summaries to conduct relevance review. Applications that are not deemed relevant will not be evaluated by peer review and the proposed project will no longer be considered in this competition.

The following criteria will be used in conducting the relevance review:

• Alignment of the proposed research with the objectives and topics outlined within each of the relevant research areas of this funding opportunity

Upon completion of peer review, the CIHR coordinating office of the DSEN initiative will receive the ranking list, merit scores (ratings) and recommendations on funding level and award term for the applications that fall in the fundable range and have been determined to be relevant to the specific research areas and objectives of the initiative. The list will be used for funding decision-making purposes and will remain anonymous.

Peer Review

A CIHR peer review committee will evaluate the full applications. The committee may be drawn from one of CIHR's pre-existing committees or may be created specifically for this funding opportunity. 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 and Confidentiality in the context of Merit, Relevance and Peer Review (CCIP). For information on CIHR's peer review process in general, see the Understand Peer Review section of CIHR's website.

Evaluation Criteria

Peer review will be conducted in accordance with the CIHR Peer Review Process – Policies and Responsibilities of Grants Committee Members. Reviewers will use the following set of criteria for the evaluation of all CIHR grant applications:

1. Research Approach
2. Originality of the Proposal
3. Applicant(s)
4. Environment for the Research
5. Impact of the Research

A detailed elaboration of these criteria can be found in the Information for Peer Reviewers section of CIHR website.

To support the strategic objectives of this funding opportunity, the following factors will be considered in addition to the standard set of evaluation criteria:

1. Research Approach

• How clearly do the hypotheses, questions, or issues to be addressed align with the relevant research areas and topics of this funding opportunity and how clearly are they formulated?
• How clearly described are the identified limitations of the proposed research project?
• How well will the proposed approach address the hypotheses or questions? How well have the applicant(s) anticipated difficulties in their approach and considered alternatives? How relevant is the review of the literature relative to the question to be addressed?

3. Applicant(s)

• How appropriate to the proposed research activities is the training or track record of the applicant(s)? Are the reviewers confident that the applicant(s) can accomplish the work proposed?
• To what extent does the proposed research demonstrate collaboration amongst researchers?

5. Impact of the Research

• How applicable are the outcomes expected from the proposed research activities?
• How great is the impact of the result of the research activity to be undertaken by the proposal? What is the potential for important new knowledge or impact in health research, or for the expected outcomes to build a foundation for the pursuit of more comprehensive funding opportunities?

Notes:

While all criteria are to be considered in reviewing the applications, to meet the program objectives as detailed herein more emphasis will be placed on the Impact of the Research and the extent of collaboration proposed by the Applicant(s).

Researchers, regardless of career stage, would not be expected to have an extensive publication record in a new field, but rather to possess a set of transferable competencies that will enable them to accomplish the proposed objectives.

CIHR recognizes that applications will emphasize different approaches to research and to knowledge translation, therefore reviewers and committees are expected to weight evaluation criteria such as the above differently from one application to another.

A detailed elaboration of these criteria can be found in the Information for Peer Reviewers section of CIHR website.

How to Apply

Note: This funding opportunity requires the use of ResearchNet to apply for funding.

• The application process for this funding opportunity is comprised of two steps: Registration and Application.
• To complete your Registration and Application, follow the instructions identified in the Catalyst Grants - ResearchNet "Registration" Phase Instructions and the Catalyst Grants - ResearchNet "Application" Phase Instructions.
• An overview of CIHR's application processes can be found under Apply for Funding.
• Reminder to applicants: Please ensure that your application is complete (including all required signatures) and submitted on time to CIHR. Effective September 1, 2008, CIHR will assume no responsibility in following-up with applicants who submit an incomplete application. Incomplete or late applications will not be accepted into the competition.

Additional instructions that must be followed for this funding opportunity:
(Note: These additional instructions supersede all other policies or guidelines published by the Canadian Institutes of Health Research, including, but not limited to, the Grants and Awards Guide, the Memorandum of Understanding, etc.)

• The Research Proposal in the "Enter Project Information and Supporting Documents" task under "Project Information", is limited to 8 pages excluding figures or tables.
• Please ensure that your full application contains the following information:
  • Applicants must clearly indicate at the top of the 'Summary of Research Proposal' the relevant research area and topic, as listed in the relevant research areas in which they would like to be considered. Only one topic can be selected per application.
  • Applicants must provide a description of how the proposed research aligns with the objectives and relevant research area of this funding opportunity.
  • Clearly indicate the level of impact to be obtained by the proposed research, as outlined in the Evaluation Criteria.

Your Application will be submitted using ResearchNet. Only the signed Signature Pages must be sent (courier stamped no later than the application deadline date) to:

RE: "Catalyst Grant: Post Market Drug Safety and Effectiveness"
Canadian Institutes of Health Research
Room 97, 160 Elgin Street
Address locator: 4809A
Ottawa, Ontario K1A 0W9

Contact Information

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

Liliane Chénard
Team Lead, Program Delivery
Canadian Institutes of Health Research
Telephone: 613-957-8842
Fax: 613-954-1800
Email: liliane.chenard@cihr-irsc.gc.ca

For questions about this initiative and research objectives contact:

Krissy Davidge
Program Manager, Drug Safety and Effectiveness
Canadian Institutes of Health Research
Telephone: 613-948-2786
Fax: 613-954-1800
Email: krissy.davidge@cihr-irsc.gc.ca

Partner/Collaborator Description

Canadian Institutes of Health Research (CIHR)
CIHR is the Government of Canada's agency for health research. CIHR's mission is to create new scientific knowledge and to enable its translation into improved health, more effective health services and products, and a strengthened Canadian health-care system. Composed of 13 Institutes, CIHR provides leadership and support to nearly 12,000 health researchers and trainees across Canada.

CIHR – Drug Safety and Effectiveness Network (DSEN)
The Drug Safety and Effectiveness Network (DSEN) is a new initiative hosted at the Canadian Institutes for Health Research (CIHR). The objective of the DSEN is to expand the body of evidence on the safety and effectiveness of drugs in a real world context, through a comprehensive, trusted national program that will provide timely and high quality information upon which policy makers, healthcare providers and patients may make reasoned decisions. The DSEN is dedicated to increasing capacity, within Canada, to undertake quality research into the real world safety and effectiveness of drugs.