ASPIRE EMRISTA | FAQ

Frequently Asked Questions


What are the EMRISTA Research Awards?

The Emerging Markets Thrombosis Investigator-Initiated Research Program (EMRISTA) has been established to fund innovative medical research from researchers across Pfizer’s Emerging Markets, including Africa, Asia, Latin America and the Middle East  top

 


Who is eligible to apply for EMRISTA Research awards?

  • The principal investigator holds a MD, PhD, or PharmD.
  • The principal investigator and institution must be based in the one of the eligible countries.
  • All research must be conducted in accordance with regulatory, legal, and ethical guidelines, including posting on a clinical trial registry where appropriate. Pfizer assumes no responsibility for the conduct of the selected studies.
  • The principal investigator is not receiving or will not receive funding from another source for the submitted research proposal
  • The study must start within 6 months of contract execution and the duration of study treatment and follow-up should not exceed 2 years.
  • All funded research should merit submission as abstract to scientific meetings and subsequent publication in a peer-reviewed journal.

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What is the role of Pfizer in the EMRISTA Research awards?

While Pfizer will fully fund successful EMRISTA Research Awards, the proposals will be reviewed and ranked by an independent, external expert panel. Pfizer will provide infrastructure and administrative support to facilitate the application and the review process as well as notify applicants and distribute awards.  top

 


How many EMRISTA Research Awards are available and what is the monetary amount of each award?


For the 2017 cycle, up to 4 awards will be granted. The amount of each award will be up to approximately $100,000, for up to 2 years, inclusive of institutional overhead (capped at 28%).  top

 


What is the deadline for application?

Applications must be received by March 15, 2017.  top

 


When will the EMRISTA Research Awards for 2017 be announced?

The successful awardees will be notified by approximately April 2017.  top

If my application is successful, when will the funding commence?

Awards will commence on or around June 2017, pending receipt of all required documents noted on the application form. Contracts that are unable to be executed by mid-2017 are subject to loss of funding.  top

Will I receive a copy of the Review Committee’s evaluation of my grant proposal?

A summary review of the independent expert review panel’s comments will be provided on request to unsuccessful applicants in order to assist them in further refining their grant proposals for possible future submissions.  top

 


Is the funding a per-annum or per-study amount?

Yearly grant monies will be distributed on a per-annum basis.  top

 


Does the funding include Institutional overhead costs and indirect costs?

Yes, the funding award includes indirect costs, and institutional overhead costs. Final budgets of those studies awarded a grant will be reviewed for fair market value before the contracting process begins.  top

What are indirect costs?

Indirect costs are additional study expenses such as costs for publication, IRB/IEC review fees, supplies, software license fees, and travel.  top

What are institutional overhead costs?

Institutional overhead costs, are costs to the institution for the support of your study. They are not easily identifiable in an economically feasible way as exclusively related to a particular project but are necessary to conduct the grant. Some examples of these costs are human resources department costs, payroll processing and accounting costs, janitorial services, utilities, property taxes, property and liability insurance, and building maintenance.  top

How are the funds dispersed?

Yearly grant monies will be distributed at 50% at the beginning of the award year and 50% upon a subsequent milestone such as submission of the yearly grant progress/final report.  top

How may the EMRISTA Research funding be used?

Funds may be used to cover the awardees’ salary and fringe benefits, as well as other direct expenses incurred during the research project. Direct expenses may include the salary of technical associates; the purchase of relevant laboratory supplies; direct expenses necessary for proper conduct of research (e.g. subject-related costs, study-related personnel costs, diagnostic fees/services, data management expenses). Indirect costs may include and travel expenses to scientific meetings, software licensing fees, publication costs etc.

No other government, non-governmental, or industry-sponsored projects may cover the same work scope as the grant application to the EMRISTA Program. However, an EMRISTA Research Program grant may be related to other funding from foundations or government agencies, as long as there is no direct overlap. It is the responsibility of the applicant to justify the novelty of the proposal and provide evidence that the application does not overlap with any current or pending funding.  top


Can EMRISTA Research Award funding be used to purchase equipment?

No. EMRISTA Research funds may not be used to purchase equipment, although the purchase of relevant laboratory supplies is allowed. top

 


Are the EMRISTA Research awards renewable?

No. Each EMRISTA Research award is a one-time, non-renewable research grant.  top

Are the EMRISTA Research awards open to researchers working outside the United States?

Yes, the EMRISTA Research awards are open to researchers within Pfizer’s Emerging Markets, including Africa, Asia, Latin America and the Middle East. .  top

 


What areas of research meet the criteria for the EMRISTA Research Awards?

Pfizer will consider applications which address the following areas
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  • Advance the understanding of the practical use of non-vitamin K oral anticoagulants (NOACs), in atrial fibrillation (AF), treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).
  • Advance the understanding of use of NOACs in real-world clinical practice settings in the approved indications.
  • Advance the understanding of patient adherence to therapy, the appropriate use of NOACs and their impact on quality of life, and health-related outcomes.
  • Advance the understanding of bleeding management related to the use of NOACs
  • Other potential areas of interest and/or unmet need involving anticoagulation.  top

 


Are there any specific research areas that are excluded from EMRISTA Research Awards?

The following topics fall outside of the scope of the EMRISTA Research Program:
 

  • Patient populations where the risk of NOACs use is greater than the benefit
  • A use that is contraindicated in the apixaban prescribing information or outside of product label
  • Pregnant and lactating women • Any head-to-head clinical trial comparison of apixaban versus another novel oral anticoagulant [NOAC])
  • Repeat/duplication of research, (e.g. ablation, reversal or “acute” cardioversion)
  • Repeat of any Phase 3 trials
  • Any pharmacokinetic/pharmacodynamic properties described in the USPI e.g. crushed tablets, hemodialysis
  • Reducing the recurrence of acute coronary syndrome (ACS), percutaneous coronary intervention (PCI)
  • Post coronary artery bypass graft (CABG), prosthetic (mechanical and bioprosthetic heart valves or devices)
  • Patients with any atherothrombotic or hemorrhagic stroke, or any stroke within 7 days
  • Venous thromboembolism prophylaxis (VTEp) in patients with stroke and hemiparesis
  • Evaluation of the safety of apixaban in patients with end-stage renal disease on hemodialysis
  • Efficacy of apixaban in secondary prevention of TIA/CVA. top

 


Will non-drug research proposals be considered?

Yes. Both drug and non-drug proposals will be considered for funding.  top

 


If the study uses a Pfizer drug, what are Pfizer’s procedures for reporting of Serious Adverse Events?

Reporting of Serious Adverse Events is a key responsibility of the Research Award Principal Investigator.

For All Studies Using a Pfizer Product and/or Device:
Reporting of Serious Adverse Events is a key responsibility of the Research Award Principal Investigator Reporting of Serious Adverse Events. Within 24 hours of first awareness of the event (immediately if the event is fatal or life-threatening), Principal Investigator will report to Pfizer by facsimile any Serious Adverse Event (“SAE,” as defined below) for which reporting is required under this provision (as described below). Such SAEs are to be reported for (1) Study subjects who are assigned or, in the case of a blinded Study, possibly assigned to receive the Pfizer Product or (2) individuals otherwise exposed to the Pfizer Product as described below. Principal Investigator should report SAEs as soon as they are determined to meet the definition, even if complete information is not yet available.
 

  • Reporting Forms. Principal Investigator will report SAEs using one of the following forms: (1) a reporting form approved by the local regulatory authority, (2) a CIOMS form, (3) a Pfizer-provided Investigator-Initiated Research Serious Adverse Event Form, or (4) any other form prospectively approved by Pfizer. The Reportable Event Fax Cover Sheet provided by Pfizer must also be included with each SAE submitted.
  • SAE Definition. An SAE is any adverse event, without regard to causality, that is life-threatening (i.e., causes an immediate risk of death) or that results in any of the following outcomes: death; in-patient hospitalization or prolongation of existing hospitalization; persistent or significant disability or incapacity (i.e., substantial disruption of the ability to conduct normal life functions); or a congenital anomaly or birth defect. Any other medical event that, in the medical judgment of the Principal Investigator, may jeopardize the subject or may require medical or surgical intervention to prevent one of the outcomes listed above is also considered an SAE. A planned medical or surgical procedure is not, in itself, an SAE
  • Exposure During Pregnancy, Exposure During Lactation, Occupational Exposure, and Lack Of Effect. Even though there may not be an associated SAE, exposure to the Pfizer Product during pregnancy, exposure to the Pfizer Product during lactation, and occupational exposure to the Pfizer Product are reportable, and lack of effect of the Pfizer Product may also be reportable. These requirements are further explained in the training material provided by Pfizer (see Pfizer-Provided Training, below). As used in this Agreement, the term SAE will be understood to include exposure during pregnancy, exposure during lactation, occupational exposure, and reportable instances of lack of effect.
  • Hy’s Law Cases. Cases of potential drug-induced liver injury as assessed by laboratory test values (“Hy’s Law Cases”) are also reportable to Pfizer. If a Study subject develops abnormal values in aspartate transaminase (AST) or alanine transaminase or both, concurrent with abnormal elevations in total bilirubin and no other known cause of liver injury, that event would be classified as a Hy’s Law Case. This reporting requirement is further explained in the training material provided by Pfizer (see Pfizer-Provided Training, below). As used in this Agreement, the term SAE will be understood to also include Hy’s Law Cases.
  • Exclusions from SAE Reporting Requirements. Specifically excluded from the reporting requirements for SAEs under this provision is any SAE identified in the Protocol as anticipated to occur in the Study population at some frequency independent of drug exposure, unless the Principal Investigator assesses such an event as related to the Pfizer Product.
  • SAE Reporting Period. The SAEs that are subject to this reporting provision are those that occur from after the first dose of the Pfizer Product through 28 calendar days after the last administration of the Pfizer Product, or longer if so specified in the Protocol. In addition, if Principal Investigator becomes aware of an SAE occurring any time after the administration of the last dose of the Pfizer Product, Principal Investigator should report that SAE to Pfizer if the Principal Investigator suspects a causal relationship between the Pfizer Product and the SAE.
  • Follow-Up Information. Principal Investigator will assist Pfizer in investigating any SAE and will provide any follow-up information reasonably requested by Pfizer.
  • Regulatory Reporting. Reporting an SAE to Pfizer does not relieve Principal Investigator of responsibility for reporting it to appropriate regulatory authorities, if such reporting is required.
  • Pfizer-Provided Training. Pfizer will make available training material that provides information about the SAE reporting requirements for IIR studies. Principal Investigator will review this material and share it with any Study staff engaged in the reporting of SAEs.  top

 


Can an exception be made for certain applicants regarding the eligibility criteria to the EMRISTA Research awards?

The eligibility requirements have been carefully designed to attract appropriate candidates. In keeping with the purpose and intention of the EMRISTA awards, applicants must meet all the criteria in order to be considered for an award. Submissions outside these parameters will not be considered.  top

 


What is the ultimate expectation of projects that receive funding through the EMRISTA Research Awards Program?

Projects are expected to yield results that will advance medical knowledge. It is expected that results will be presented at scientific meetings and published in peer-reviewed journals.  top

 


Is there a time limit for conducting the funded research?

Research should be completed within 2 years of initiation. top

 


How do I apply for an EMRISTA Research Award?

Applications are to be submitted to Pfizer through an online submission website. Visit www.aspireresearch.org, and click on “Awards in NAOC, Emerging Markets”, and click on the “Apply” tile in the blue bar at the top of the page. From there you will be routed to Pfizer’s global investigator-initiated research website. Click on “Submit an IIR Request” and follow the online instructions. When prompted “are you applying for a competitive grant program, select yes and then select appropriate program from the dropdown menu.

Completed application forms must be accompanied by the following documents:

  • Cover letter on institutional letterhead
  • The 3 most relevant articles from the Applicant’s scientific publications (if applicable)
  • An abbreviated curriculum vitae (CV) (limited to 3 pages)
  • Description of available laboratory facilities
  • Listing of other research support available with a description of overlap and, if applicable, a listing of consenting collaborators (including CVs)
  • Bibliography of relevant references
  • Budget for proposed research top

 


Where can I get an application form?

The application form can be found at http://www.aspireresearch.org under the appropriate program. The application form can also be found here  top

 


What if I don’t fully understand the EMRISTA application process?

Please refer to the application guide. If you still have questions, please email the coordinator at IIR@pfizer.com  top

 


What do I do if I have a question that is not covered here?

If you require clarification on an issue not addressed here, please contact the Coordinator,
 email: IIR@pfizer.com  top