Investigator Form CLINICAL EVIDENCE COUNCIL (CEC)

Investigator Form CLINICAL EVIDENCE COUNCIL (CEC)

INVESTIGATOR INITIATED RESEARCH (IIR)
GRANT APPLICATION FORM – Renal PD APAC
*only grant applications aligned to specific research objectives outlined below are eligible for funding:
All Asia- Pac
Additional Country Specific Objectives
China
India
Japan
Korea
Australia/New Zealand
Thailand
Singapore
Vietnam
Malaysia /
  • Exploring the impact of optimal (team) standardized care and guideline adherence, or Quality improvement initiatives on PD patient outcomes (hospitalization, clinical, HRQoL and patient-centered) and/or health economic outcomes in peritoneal dialysis therapy. Specific areas of interest include initiatives around:
  • PD catheter insertion
  • prevention of peritonitis and exit site infection
  • improving care and access to care in developing or rural communities
  • Exploring sustainable solutions for PD clinical quality improvement through database/registry linkage
  • Exploring the effect of APD on patient outcomes (hospitalization, clinical, HRQoL and patient-centered)
  • Exploring the effect of low, regular, and high calcium dialysate on mineral metabolism, CVD, and metabolic bone disease.
  • Exploring the impact of PD catheter insertion programs and/or catheter education programs on:
  • success of urgent start PD, and/or
  • early (i.e. first 90 day) technique outcome (catheter function and survival), and/or
  • early (i.e. first 90 day) complications (peritonitis, exit site infection), and/or
  • incident modality selection
  • Economic evaluation (cost-effectiveness, cost utility) of PD versus in-centre HD from a societal or payer (rather than provider) perspective, especially but not necessarily exclusively in developing and rural populations
  • Exploring the effect of enhanced standardized low-clearance / predialysis care on patient outcomes (hospitalization, clinical, HRQoL and patient-centered) and incident modality selection
  • Exploring the effect of PD versus HD for patient-centered PD outcomes (HRQoL, employment status, patient-centered such as the ability to enjoy leisure activities)
  • Exploring the effect of shared decision-making around modality choice on patient-centered PD outcomes (HRQoL, patient satisfaction, adherence to care)
  • Exploring the effect of low glucose PD therapy (using Extraneal and/or Nutrineal) on outcomes in PD patients, including
  • biochemistry / metabolism (e.g. hyperglycemia in diabetic patients without fluid overload, body composition, MIA), and/or
  • cardiovascular disease and events (e.g. extracellular volume in patients with fluid overload), and/or
  • infectious complications and events
  • peritoneal membrane structure and function, and/or
  • hospitalization, and/or
  • HRQoL and patient-centered outcomes, and/or
  • economic outcomes that might accrue
  • Assessing the impact of remote monitoring on clinical and economic outcomes in PD populations. More specifically, clinical parameters of interest include the following: patient adherence, blood pressure control, volume management, dropout/technique failure (particularly for high risk patients), ED visits, hospitalization, and facility-clinic workflow/resource utilization
  • Assessing the impact of availability of APD technology and remote monitoring on incident patient modality selection
  • Assessing the clinical-economic impact of urgent start PD programs
  • Exploring the effect of health service delivery through PD satellite centers on outcomes in PD patients (hospitalization, clinical, HRQoL and patient-centred) and/or incident patient modality selection
  • Exploring unmet need for (untreated) ESRD and/or estimating of the attributable benefit (life years saved) of greater access to dialysis
  • Exploring the effect of enhanced health care delivery models (PD counselling center, enhanced low-clearance clinic care, PD Start Nurse) on outcomes in PD patients and/or incident modality selection
  • Exploring the effect of assisted PD for improving outcomes (hospitalization, clinical, HRQoL and patient-centred) and/or incident modality selection
  • Clinical studies to evaluate the efficacy of Reguneal, with particular view on improved biocompatibility, peritoneal membrane preservation, and acid-base balance
  • Clinical studies to evaluate the efficacy of Tsunagu
  • Exploring the effect of PD versus HD chosen for “medical” indications on outcomes of Japanese patients (hospitalization, clinical, HRQoL and patient-centred). This would involve analyses in well-defined patient subgroup e.g. incident patients with residual renal function, young healthy patients, elderly co-morbid patients
  • Exploring the effect of PD+HD combination therapy on preservation of peritoneal membrane and/or improved fluid volume/solute clearance for Japanese patients
  • Exploring unmet needs and burden of disease around urgent starts on dialysis and assessing the clinical and economic benefits of greater access to urgent start PD
  • Exploring the barriers to “Home First / Preferred” or “PD First / Preferred” policies and practice patterns
  • Exploring the effect of “Home First / Preferred” or “PD First / Preferred” policies and practice patterns on patient outcomes (hospitalization, clinical, HRQoL and patient-centered), and/or incident modality selection
  • Exploring the effect of “Home First / Preferred” or “PD First / Preferred” policies and practice patterns on economic outcomes from a societal (rather than provider or professional) perspective
  • Exploring the effect of the PD First policy on the previous unmet need around untreated ESKD, in terms of population outcomes (life years saved)
  • Impact of health care delivery models (PD counselling centre, enhanced low-clearance clinic care, PD Start Nurse) in Singapore on outcomes of PD patients and/or incident modality selection
  • Exploring the effect of health service delivery through PD satellite centers on outcomes in PD patients (hospitalization, clinical, HRQoL and patient-centred) and/or incident patient modality selection
  • Exploring the effect of enhanced nursing models of care (ratio, experience, nurse education training programs) on outcomes in PD patients (hospitalization, clinical, HRQoL and patient-centered)

CLINICAL EVIDENCE COUNCIL (CEC) FOR RENAL PERITONEAL DIALYSIS (PD)

Instructions & Submission Process:

  • The IIR Grant Application Form must be completed ONLY by the Investigator submitting the Grant Application. No Baxter personnel may assist in the preparation of the form.
  • The IIR Grant Application Form must be completed in English, typed, single-spaced, font size 10
  • Complete all fields providing as much information as necessary to clarify the study. All fields are expandable. For any fields not applicable to the specific study, mark ‘N/A’.
  • E-mail the completed IIR Grant Application Form to:
  • Attach the CV of the principal investigator to the grant application email
  • IIR Grant Application Forms MUST be sent to by the published submission deadline
There are two opportunities for submission of grant round proposal(s).
Round I / Round II
Investigator submits to Baxter Medical Affairs team member or to by: / April 24, 2015 / August 25, 2015

Funding:

  • Up to $50,000 USD per year for up to 3 years
NOTE: Incomplete applications will render your request ineligible to be considered for the current funding
cycle.
Questions: Contact the Grant Program Manager at
Baxter’s acceptance of a proposal and request for funding is not an indication that Baxter will fund research. By submitting materials to Baxter for review, you, the investigator, acknowledge that Baxter will not treat the information as confidential or proprietary and that Baxter has no obligation to keep the information confidential.
Please do not consider any request approved without written documentation of approval of the application from Baxter. Any award is contingent on availability of funds and subject to terms and conditions required by Baxter, and will be included in a grant agreement.
Actual receipt of funding is contingent upon timely execution of a grant agreement by both parties. Approval of a grant alone is not sufficient for disbursement of funds.
Submission of one or more grant application(s) is deemed to be acceptance of these provisions.

 Complete the grant application form for funding of an Investigator Initiated Research (IIR) study

 Complete all fields providing as much information as necessary to clarify the study. All fields are expandable.

 For any fields not applicable to your study, mark ‘N/A’.

 Submit the grant application form with the CV of the principal investigator

In order to be eligible all requests must be received by Baxter Healthcare Corporation in accordance with the submission instructions and published submission deadlines

NOTE: Incomplete applications may render your request ineligible for the current funding cycle.

THIS FORM MUST BE COMPLETED BY THE INVESTIGATOR SUBMITTING THE GRANT APPLICATION

COMPLETE ALL FIELDS PROVIDING AS MUCH INFORMATION AS NECESSARY TO CLARIFY THE STUDY

IF A FIELD IS NOT APPLICABLE TO YOUR STUDY, MARK ‘N/A’; ALL FIELDS ARE EXPANDABLE

Center/ Institution Contact Information

Date:

/

Grant Number: Baxter use only

Principal Investigator

/ Co-Investigator* /

Study Coordinator

Name (First, Last) / / / Title / / / Institution / / / Address/Department City/State/Prov. Postal Code/Country / / / Telephone / / / Fax / / / Email / / / Signature / / /

Sponsor (Head of the department of the institution submitting the grant application, who on behalf of the department, commits to provide the necessary resources to ensure execution of the research and fulfillment of the legal responsibilities as sponsor)

Name:

/

Email:

/

Signature:

Have you previously applied for a Baxter grant?

Yes No If “Yes”, when?

/

Was the study funded? Yes No

Study Title:

*There may be more than one Investigator if appropriate.

research study
Study Conduct Location(s): / Number of Sites:
Facility / Institution Name / Country
Is all research to be performed outside of the United States? Yes No / Signature:
Title:
Date:
Study Title:
Research Question:
Study Background & Rationale: (background information including previous studies as applicable )
Primary Endpoint: (align with the research question stated above; on which the power calculation is based)
Secondary Endpoints:
Study Design
Study Type: (select one)
Clinical Interventional Clinical Non-Interventional Non-clinical (i.e., benchwork, in-vitro, animal model)
Other (explain):
Does the proposed research require an Investigational New Drug (IND)/Investigational Device Exemption (IDE) application (US), a Clinical Trial Application (CTA) (Canada and EU), and/or any other similar regulatory filing?
Yes No Explain the basis for your determination:
Pathology, disease state, or condition to be treated/studied and incidence:
Study Population (ages, gender, relevant disease states):
Key Inclusion Criteria:
Key Exclusion Criteria:
Duration of subject participation:
Total number of subjects to be enrolled:
  • Number of study or comparison groups:

Specific details of Treatment/Intervention: (prescription and/or therapy, devices, equipment, solutions, product to be used in conducting study:
Efficacy Assessments (What data will be collected/utilized?):
Statistical Methods (for analyzing primary & secondary endpoints):
Is the study sufficiently powered (adequate sample size) to answer the research question? Explain:
Is Baxter product support requested (drugs and biologics, or devices)? Yes No Not Applicable
If YES - Provide details
Drugs and Biologics:
Baxter Product(s):
Product Name/Code
Dose Range
Dosing Schedule
Duration of Treatment
Drug Amount Requested
Route of Administration
Reference Product(s)/ Comparator(s):
Dose Range
Dosing Schedule
Duration of Treatment
Drug/Device Amount Requested
Route of Administration
Devices:
Baxter Product(s):
Product Name/Code
Amount Requested
Describe how devices will be used in the study:
Time Estimates/Dates - If not applicable, mark ‘N/A’
Study Start/End Date: / Start: / End:
Study Duration (either FSFV/LSLV, or applicable): / FirstSubjectFirstVisit:
LastSubjectLastVisit: / Other:
Will you seek IRB or Ethics Board Approval? / Yes
No (explain): / Anticipated approval date:
Are other internal reviews required by your institution? / Yes (identify):
No / Anticipated approval date:
Will informed consent be obtained? / Yes (describe process to obtain):
No (explain):
Adverse Event Reporting (for clinical research including interventional and non-interventional studies)
If awarded, Baxter will specifically describe the Adverse Event Reporting requirements set forth below in the Grant Agreement, which will include a requirement that the adverse event reporting and notification principles are clearly reflected and described in the protocol; therefore, the Investigator is expected to have the appropriate systems, resources and training to meet the requirements for Adverse Event Reporting.
  1. Investigator is responsible for reporting AEs to IRB, participating investigators and applicable regulatory authorities as required per regulations with an expedited copy sent simultaneously to Baxter; and
  2. If Baxter product is used in Study, all SAEs/significant safety concerns must be sent to Baxter within 24 hours [include non-serious AEs for non-interventional studies if they are collected per protocol].
Describe the method and plan for meeting the reporting requirements:
Publication Plan (describe the proposed publication plan with dates including abstract(s) to congresses and journal publications for this study):

Center / Institution Budget Information

Provide full justification for all budget items relative to the proposed research. The budget requested must accurately reflect the actual funds required to execute the proposed research. Permitted expenses include a contribution towards the salary of the principal investigator, co-investigators, and support staff, e.g. coordinator or data manager, statistician, plus equipment and supplies specifically required to complete the study’s aim. Travel expenses directly related to the implementation of the study are allowed plus those required disseminating the results at scientific congresses. In addition, the costs associated with the publication of the research are permitted. Costs associated with applying for an IND or its equivalent and with IRB/ethics board review are also allowed. If requested and approved, Baxter will provide product. Institutional Overhead Payments (IOP) may be requested and should be included in the amount requested. IOP will be paid out of the amount funded, not in addition to it.
  • Budget may be for one or multiple years depending upon the requirements of the study
  • Identify all expenses that make up the Total Study Budget, even if only a portion of the funding is being requested from Baxter

Personnel – (i.e., percentage of time)
State roles and explain why you require the level (in terms of qualifications & salary) that you are requesting. / Year 1
(US$) / Year 2
(US$) / Year 3
(US$) / Total
(US$)
Investigator:
Research Assistants:
Other personnel (please specify):
Total personnel expenditure:
Detail & Rationale:
Materials, Supplies & Services - Expendable
Itemize the expendables and services; for example, number and cost of animals, nature and amounts of reagents, number of subjects, etc. / Year 1
(US$) / Year 2
(US$) / Year 3
(US$) / Total
(US$)
Animals:
Laboratory Supplies (expendables):
Services:
Other (please specify):
Total expendable expenditure:
Detail & Rationale:
Leasing of Equipment and/or Maintenance Items – Non-expendable
Indicate – a) anticipated extent of use; b) availability of similar equipment; c) reason for choice in relation to alternatives; d) as applicable, necessity for upgrade of existing equipment or service contract. Any equipment should be leased and returned at end of study. / Year 1
(US$) / Year 2
(US$) / Year 3
(US$) / Total
(US$)
Equipment (non-expendable):
Maintenance (non-expendable):
Total non-expendable expenditure:
Detail & Rationale:
Other Related Expenses – IRB/REB/IACUC Review, Travel, Publications, Database Leasing, etc. (please detail):
Indicate all expenses and fees anticipated for the study. / Year 1
(US$) / Year 2
(US$) / Year 3
(US$) / Total
(US$)
Ethics Review Fees (please specify):
Travel (please specify):
Publication(s), e.g. poster design/printing, manuscript writing/editing (please specify):
Database Leasing (please specify):
Other Expenses (please specify-add rows as needed):
Total other expenditure:
Detail & Rationale:
Additional Budget Detail & Rationale (provide any additional detail)
Budget & Funding Summary
Year 1
(US$) / Year 2
(US$) / Year 3
(US$) / Total
(US$)
Total Study Budget in US Dollars:
Funding
Funding support requested from Baxter (excluding Baxter Product and Institutional Overhead Expense):
Institutional Overhead Expense (IOE) may be requested and should be included in the Budget & Funding Summary. IOE may not to exceed 20% of funding support requested from Baxter. IOE will be paid out of the amount funded, not in addition to it:
Total funding support requested from Baxter (sum of above two lines):
Total other 3rd Party funding support. Describe any concurrent funding including current grants, pending grant applications and any planned grant applications. Include a statement regarding potential overlap of the concurrent funding with the present application. Specify source(s) and dollar amount(s).
Total of all Funding (should equal Total Study Budget + Institutional Overhead Expense):

Submission Checklist: Only complete applications will be reviewed. All fields on the application are required. If not applicable, list N/A.

Completed and signed Investigator Initiated Research (IIR) Grant Application Form

Curriculum Vitae of principal investigator

You may also attach additional supporting documents (optional; please check box if applicable)

Application Submission: Send your complete grant application form and required attachment(s) via email (preferred), courier, or fax by the published submission deadline:

There are two separate grant round opportunities for submission of proposal(s).

Round I / Round II
Investigator submits to Baxter Medical Affairs team member or to by: / April 24, 2015 / August 25, 2015

Mailing address:

Baxter Healthcare Corporation

Attn: Kelly Machak

25212 W. IL Route 120, RLT-10

Round Lake, Illinois 60073

Email:

For additional information contact the GPM at:

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