(in the picture: Brynn and Addison - pediatric heart transplant recipients)

 

National Child Health Transplant Team Grant Competition - 2016

 

 

COMPETITION CLOSED

VIEW THE RESULTS OF THE 2016 COMPETITION

 

Background

The Canadian National Transplant Research Program (CNTRP), Alberta Transplant Institute (ATI), the Transplant Research Foundation (TRF) of BC, Astellas Canada Inc. and the BC Children’s Hospital Foundation (BCCHF) are partnering to develop a National Child Health Transplant Research partnership aimed to support research to improve outcomes for pediatric transplant patients through cross-Canada, multi-disciplinary collaboration. This partnership will provide a unique opportunity to conduct research with a team of experts from centres across Canada that would not be possible at a single centre.

 

After raising an initial $25,000 in August 2015, the TRF joined forces with the CNTRP and the ATI to launch the National Child Health Transplant Team Grant competition that is dedicated to improving the lives of pediatric transplant patients across Canada. Initially conceived as the Addison Pediatric Project in BC, the vision of this new expanded partnership is to support an innovative pediatric transplantation project that unites researchers across Canada to work together toward substantial improvement in outcomes for pediatric transplant patients. In March 2016, Astellas Canada and the BC Children’s Hospital Foundation (BCCHF) officially joined the partnership to increase the funding available for this pediatric grant competition. With TRF, ATI, Astellas and the BCCHF each committing $25,000, the current total available for the competition is $100,000. We are actively seeking additional partnerships with other regional and national organizations to enhance this funding even further.

 

This peer-reviewed team grant competition will fund one team grant to allow researchers across the country to work together within the structure of the CNTRP (www.cntrp.ca/research) to conduct research not possible at a single centre. This opportunity provides funding for researchers across disciplines to build a multicentred team to undertake research (e.g., new hypotheses, techniques, or ideas) aimed at direct improvement of outcomes for pediatric transplant patients. This national competition, focused exclusively on improving outcomes for pediatric solid organ transplant patients, is a first in Canada.

 

Key Dates

Competition Launch:                        July 13, 2016                                                  

Application Deadline:                       November 1, 2016                                                   

Notification Date:                              January 16, 2017                                       

Funding Start Date:                           February 1, 2017                                              

Study update submitted to NIC:    Within 24 months of receipt of the Grant  

 

 

 Download Application Form and Budget Template 

 

 

Management

The initiative is managed by the CNTRP and co-led with the CNTRP, ATI, TRF and other partners. The scientific aspects of the program, including peer review of the applications and management of the competition, will be overseen by the CNTRP New Initiatives Committee (NIC), based on previous peer-reviewed grant competitions managed by the CNTRP. Under the guidance of the NIC, the TRF, ATI and other partners, a peer review committee will be formed consisting of Canadian and international research experts from relevant fields in pediatric and transplant research that will review all applications submitted to this competition. Together, the CNTRP, TRF and ATI have drafted these public terms of reference for the competition. The CNTRP will accept the electronic application submissions, will coordinate the acceptance offer to the successful applicants and will coordinate the grant agreement and disbursement of funding. The successful project funded in this competition will be integrated into the research structure of the CNTRP and will receive the full support of the national structure and core platforms. Following the competition, the ATI, TRF and other partners will continue to support the funded team by promoting the outcomes of the project and creating links with key knowledge-users and decision-makers necessary to advance the research findings for full impact.

 

Objectives and Scope

The objective of the National Child Health Transplant Team Grant competition is to support one peer-reviewed research project that is patient-focused and aims to have direct impact on improving health outcomes of pediatric solid organ transplant patients. The successful application will support a team of junior and senior researchers working together across disciplines and across Canada within the research structure of the CNTRP. The successful research team will be led by a group of Team Leads (with at least one Team Lead in BC and one Team Lead in Alberta) that will provide the leadership for the project and will be responsible for the conduct of the research. Applicants are encouraged to involve and incorporate patients and family members as team members in the application, to help design, implement, evaluate and disseminate the project as active patient partners.

 

The grant will be awarded to the successful team of applicants via the Team Leads’ institutions. It is anticipated that 1 grant of $100,000 CDN will be provided to the successful applicant team by the National Child Health Transplant Team Grant competition over a 24-month performance period. Of the total $100,000 available to the successful team:

  • $50,000 ($25,000 each from TRF and BCCHF) must be allocated to support team member(s) in British Columbia,

  • $25,000 from ATI must be allocated to support team member(s) in Alberta, and

  • $25,000 from Astellas can be allocated to any team member(s) at any eligible institution(s) across Canada. This amount can be allocated amongst several researchers at several institutions if required. 

 

 

Eligibility

The CNTRP NIC will receive and process applications and will organize a Peer Review Committee to evaluate the submitted proposals. Proposals will be deemed eligible based on the following:

 

Eligible Applicants

The successful applicant tea, must:

  • Be comprised of independent researchers working at Canadian universities or research institutions

  • Conduct the research at Canadian institutions (study subjects may be enrolled from other countries)

  • Agree to integrate their study within the CNTRP structure if funded and become a new project aim under the CNTRP framework

  • Agree that all principle team members will become participating CNTRP members

  • Include at least one current CNTRP member as a team member on the submission

  • Agree to sign a Research Grant Acceptance Letter with the Canadian National Transplant Research Program who, in partnership with the Canadian Liver Foundation (who will manage the Astellas funding), the ATI and the TRF, will provide financial administration for the National Child Health Transplant Team Grant competition

  • Agree to provide a progress report, including publication plan, to the CNTRP, who will share the report with ATI, BCCHF and TRF to assist with dissemination of study results

  • If successful, agree to have their application shared in confidence with ATI, TRF and Astellas for internal documentation and auditing purposes

 

 

Eligible Research Proposals

Eligibility for the competition:

 

  • Examples of eligible projects include, but are not limited to, investigator-initiated clinical trials, clinical research, ethics, patient-centred projects, and/or basic research projects

  • Research projects must have direct impact on solid organ transplantation and may have secondary impact on areas related to donation and hematopoietic transplantation

  • Must be focused exclusively on a pediatric population

  • The funded team must include (at a minimum) one Team Lead in British Columbia and one Team Lead in Alberta, both located at institutions eligible to receive funding. The research team may include additional Team Leads from other centres across the country. Applicants are encouraged to involve patients and family members as active team members on the project.

  • Preference will be given to research that can improve pediatric transplant care on a national scope

  • Projects that involve external collaboration are eligible and encouraged

  • An individual can be a Team Lead on only ONE application per competition, but can be a team member on any number of other applications

  • The funded application must become a new project aim under the CNTRP framework

 

Non-eligible Research Proposals

The following types of proposals will not be eligible:

  • Proposals for projects that have received funding from another source, including government or industry sponsors, will not be eligible to receive a National Child Health Transplant Team Grant unless said funding is shown by the applicant to be directed to a portion of the overall project/research that is separate and distinguishable from the portion to which the proposal relates

  • Proposal budgets in excess of $100,000 CDN will not be considered unless there are available matching funds from the applicant’s institution or other source

  • Proposals for pharmaceutical product development (including studies on non-approved indications for drugs) and/or product comparison, or product promotion will not be considered

  • Research proposals that have already received funding from a CNTRP, ATI, TRF, or BCCHF sponsored research grant will not be considered.

 

Review Criteria

All proposals will be first reviewed by the CNTRP NIC to ensure eligibility and relevance to the terms of the competition. Applications that are deemed either to be not eligible or not relevant to the competition will be removed from the competition and will not be evaluated by the peer review committee. Relevant research proposals will be evaluated based on the following criteria:

 

Significance

  • Scientific merit (validity, integrity, originality)

  • Contribution to advancement of scientific knowledge and patient outcomes in the field of pediatric transplantation

  • Clinical relevance or potential clinical value and applicability

 

Feasibility

  • Feasibility of study design, methodology, analysis

  • Adequate power and sample size

  • Study budget

  • Proposed timelines

 

Collaboration and strength of the research team

  • Strength of the Team Leads and the entire research team

  • Feasibility of the research collaboration

 

Guidelines for Application Submission

The research proposal should be novel, previously unpublished and not exceed 5 pages (excluding references and budget table), with a maximum of 3 additional pages for figures or tables.

Suggested headings for the research proposal include 1) Statement of objective(s), 2) Brief review of literature and background information, 3) Recent relevant research by applicants, 4) Description of the research team 5) Hypothesis(es), 6) Design and methodology, including data analysis 7) Anticipated timeline, 8) Impact, future research plans and knowledge translation, and 9) Budget (separate page; use budget template).

 

 

In additional to the 5-page proposal, the application must:

  • Submit a short summary of the research proposal that highlights how the research proposal addresses the theme of improving outcomes for pediatric transplant patients. This summary will be used to assess relevance of the application to the scope of the competition. (Max 1 page)

  • Attach a separate description of how the proposal will integrate and fit within CNTRP framework (Max ½ page)

  • Include a list of all team members and their expertise, and clearly identify the Team Leads

  • Attach a lay abstract (max. 250 words) that can be used to explain the proposal to the general public and could be posted publically if funded

  • Include a copy of CIHR Academic Common CV for each Team Lead

  • Provide the names and contact information of 3-5 Canadian or international researchers that the team suggests as potential reviewers for the application. These individuals will be considered as either potential external reviewers or members of our peer review committee, however there is no guarantee that these individuals will be selected.

  • Provide the names of up to three individuals that would be in conflict and should NOT review the application (if applicable)

  • (Optional) Include letters of support and/or commitment from the Chair of the Department/Division indicating the level of institutional and/or university support.

 

The entire application must be written using Times New Roman or Arial font, size 11 points or larger. Use at least 0.75-inch margins (top, bottom, left, and right) for all pages. The section name and the name of the Principal Applicant should appear in the header.

 

The CNTRP NIC must receive the completed application no later than 11:59pm PDT on November 1, 2016. The magnitude of the project should match the size of the award; the award is not intended to supplement a major grant.

 

Documentation received after the submission deadline will not be submitted for review. The applicant is responsible for ensuring completeness of the application; incomplete or unsigned applications will not be considered. 

 

 

Conditions of the National Child Health Transplant Team Grant 

 

Research Ethics Board approval

The successful applicant must provide evidence of appropriate ethics committee approval from each participating centre along with consent forms where human subjects are involved in the study before the funding is released.

 

Financial Considerations

The amount of each grant is intended to cover all costs associated with the study, including all direct costs (labour and study costs), study drug costs (if applicable), and indirect costs (publication, and software license fees). Costs associated with ‘labour’ are to support trainee and technician salaries. Salary support for PI, Co-PI and co-applicants is not allowed. Institutions are expected to waive overhead fees that might otherwise apply to industry-funded research.

 

Research Grant Administration

 

Template Grant Agreement

A copy of the Template Grant Agreement, signed by the grant recipient and the grant recipient’s affiliated institution (if applicable) must be returned to the CNTRP prior to disbursement of grant funds. Upon review and approval of the signed Template Grant Agreement and receipt of evidence of ethics committee approval, the CNTRP will authorize the ATI, the TRF and the CLF to issue a Research Grant Acceptance Letter to initiate disbursement of research grant funds to the specified team members for the National Child Health Transplant Team Grant. Studies must be designed to be completed within 24 months after receipt of funding, yielding results that would merit submission as an abstract to a scientific meeting and subsequent publication in a peer-reviewed journal.

The Team Lead(s) from Alberta will receive their funding directly from the ATI and the Team Lead(s) from BC will receive their funding directly from the BCCHF and TRF. The Canadian Liver Foundation will distribute the funding from Astellas to the Team Lead(s) indicated in the application budget.

 

 

Progress Reports

The grant recipient must provide a progress report to the CNTRP, to be shared with each of the competition partners, within the first 12 months of receipt of the grant summarizing work to date, including any publications, as well as an accounting for funds. The grant recipient must provide a second progress report to the CNTRP, to be disbursed to all funders, after 24 months of receipt of the grant summarizing work completed, including any publications, as well as an accounting for any unspent funds.

 

Publications

Grant recipients are expected to present their findings at scientific meetings, including the CNTRP Annual Scientific Meeting, and to submit their work for publication in peer-reviewed journals. The CNTRP requires a copy of all proposed publications upon submission for publication or other public disclosure and will provide said information to all funding partners. All publications that result from a project supported by the National Child Health Transplant Team Grant should carry the following acknowledgement: “This research was supported by the National Child Health Transplant Team Grant funded by the Canadian National Transplant Research Program, Transplant Research Foundation of BC, BC Children’s Hospital Foundation, Alberta Transplant Institute and Astellas Pharma.”

 

Grant Recipient Responsibilities

The following responsibilities must be assumed and carried out by the Team Leads:

 

  • Study contract review and execution

  • Become a CNTRP researcher (if not already one) and comply with all of the current CNTRP investigator responsibilities

  • Research Ethics Board submission and approval (if applicable)

  • Health Canada Clinical Trial Application (CTA) submission and approval (if applicable)

  • Compliance with all applicable laws, regulations or guidelines (e.g. ICH- GCP, etc.)

  • Study-related activities such as data management, statistical analysis, medical writing, monitoring, etc.

  • Registration and posting of study results on http://prsinfo.clinicaltrials.gov

  • Safety reporting to Health Canada, the research ethics board (as per local requirements), and if a drug product is involved, the Product Safety/Pharmacovigilance group for the appropriate company. Please refer to the Serious Adverse Events and Lack of Therapeutic Efficacy Reporting Section.

  • Communication of progress updates to the CNTRP NIC

  • Integration of the study into the CNTRP structure

  • Forwarding a copy of abstract(s)/manuscripts(s) to the CNTRP upon submission to congress/journal

 

 

Notification of Decision for the National Child Health Transplant Team Grant

Grant recipients will be notified of the decision regarding funding around January 16, 2017. Both successful and unsuccessful applicants will receive a summary and a constructive critique from the CNTRP review committee.

 

Address for Submissions

Please send completed electronic submissions, as a single PDF file, no later than 11:59pm PDT on November 1, 2016 to:

 

Stephanie Maier

Program Manager

Canadian National Transplant Research Program
maiers [at] ualberta.ca

 

 Download Application Form 

 

 Download Budget Template 

 

Download the Terms and Reference for this competition

 

 

Serious Adverse Events (SAE) and Lack of Therapeutic Efficacy

  1. As sponsor of the study, the grant recipient is responsible for reporting SAEs and Lack of Therapeutic Efficacy directly to Health Canada (pursuant to the Canadian Food and Drug Regulations) and to the local REB, as required.

  2. If a drug product is involved, the Grant recipient is also required to notify the Product Safety/Pharmacovigilance group for the appropriate company1

 

A Serious Adverse Event is any untoward adverse event/adverse drug reaction that at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, is a congenital anomaly/birth defect, or results in other medically important events.

 

Lack of Therapeutic Efficacy – If a health product fails to produce the expected intended effect, there may be an adverse outcome for the patient, including an exacerbation of the condition for which the health product is being used. Clinical judgment should be exercised by a qualified health care professional to determine if the problem reported is related to the product itself, rather than one of treatment selection or disease progression since health products cannot be expected to be effective in 100% of the patients.

________________________________________

 

1 - If the research involves a drug product marketed by Astellas Pharma Canada, Inc., the Grant recipient is required to notify Astellas Pharma Global Development – Product Safety & Pharmacovigilance (PSP) at fax: 1-847-317-1241 or Email: Safety-us@astellas.com within twenty-four (24) hours of receiving a SAE or Lack of Therapeutic Efficacy report.

 

Also required to be collected by the Independent Investigator

Product Safety Information (“PSI”) including but not necessarily limited to:

  1. Death (always considered serious)

  2. Abuse/Misuse/Overdose

  3. Medication Errors (in prescribing, dispensing, or administration)

  4. Drug Exposure during impregnation, pregnancy, breastfeeding or as a result of one’s occupation

  5. AEs reported in association with suspected or confirmed quality defects or counterfeit reports

  6. Suspected transmission of an infectious agent

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