ADVANCING THE PHARMACOLOGICAL TREATMENT OF TOBACCO AND NICOTINE DEPENDENCE

An independently-reviewed competitive grants program supported by Pfizer

How to Apply: Quick Guide

All applications must be made using the GRAND Application Form and the GRAND Budget Form and submitted via the Submission Portal.

Please follow the steps below:

  1. Download the GRAND Application Form click here (Please note: You may need to right-click and select "save target as" to download the file).
  2. Download the GRAND Budget Form click here (Please note: You may need to right-click and select "save target as" to download the file). Note that all costs associated with the conduct of the study, including institutional overhead costs and other costs should be identified in full in US $. All grants will be paid in US $.
  3. To read the FAQs click here
  4. When you have completed the GRAND Application Form and the GRAND Budget Form and you are ready to apply click here (Please note: This will open Pfizer's Investigator-Initiated Research [IIR] portal via the following link [https://iirsubmission.pfizer.com/user/login]. We strongly recommend you start your submission at least 1 week before the deadline.

If this is your first time visiting the portal, you must first "Create an Account". Then click on "Create New Proposal" and then click "IIR Program". You will be prompted to select whether you are applying to a Competitive Grant Program. Select "Yes", then select "GRAND 2017" from the drop-down menu. Complete all fields to create your submission.

Key Dates

Application deadline: July 3, 2017 (by 11:59pm Eastern Daylight Time in the United States)
Notifications to GRAND applicants: October 2017
Public announcement of awardees: November 2017
Start of award: An Investigator-Initiated Research Agreement with Pfizer will be set-up starting in January 2018 and the process may take 6-9 months to complete
Study results are expected within 2 years of study start.

In-Scope Topics

Research projects should aim to provide information that could directly advance the use of pharmacotherapy for treating users of any nicotine or tobacco product in clinical practice.

Examples could include:

  • Observational or interventional studies of pharmacotherapy
  • Optimization of the use of currently available medication
  • Effectiveness of pharmacotherapy in real-life settings
  • Development or use of new medications for cessation or harm reduction
  • Specifically designed pharmacotherapy in subtypes of tobacco/nicotine users
  • Use of existing databases to inform the clinical use of pharmacotherapy
  • Policy interventions to increase use of pharmacotherapy.

Out-of-Scope Topics

Non-human studies and educational programs fall outside of the scope of the GRAND Program for 2017 and will not be considered for an Award.

Examples of other topics that fall outside of the scope of the GRAND Program for 2017 and will not be considered for an Award unless directly related to advancing the use of pharmacotherapy include:

  • Genetics
  • Epidemiology of tobacco use
  • Tobacco control policy not focused on pharmacotherapy.

Full Application Guide

It is anticipated that at least 5 Awards, each of between US $50,000 and US $200,000 in value (including direct costs, institutional overhead costs, and other costs) totaling US $1 million will be granted in September 2017. Application for these Awards is open to all researchers from around the world. If requested, Pfizer drug will be provided at no additional cost to Awardees. Drug supply will be provided in bulk bags, to be packaged for the study by your site pharmacy. Please note, that sending a drug supply to some countries is often challenging due to strict regulations and can often lead to delays in the start of any research.

Projects should yield results that merit first submission as abstracts to scientific meetings and, subsequently, publication in peer-reviewed journals.

Eligibility

Applicants must meet the following requirements:

1. Academic Eligibility
The Primary Applicant, (i.e., Principal Investigator) must hold an MD, a PhD, or equivalent. Applications should have one Principal Investigator but can include multiple co-investigators. Applicants should also confirm with, and/or secure appropriate approval from, their institution if there is any conflict of interest by receiving research award funding from Pfizer.

2. Research Requirements
Research projects should aim to provide information that could directly advance the use of pharmacotherapy for treating users of any nicotine or tobacco product in clinical practice.

3. Other Funding
To avoid overlap with a GRAND Award, no other government, non-governmental, or industry-sponsored projects may cover the same work scope as that for which funding is requested in the application to the GRAND Program. However, a GRAND 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. Once awarded, a GRAND Award cannot be amended upwards with additional funding or drug support from Pfizer (via the standard IIR process or separate competitive grant program). If supplemental support is required, it must be secured from sources outside of Pfizer. Similarly, recipients of an ongoing Pfizer supported standard IIR cannot apply for supplemental funding via a Pfizer supported competitive grant program. GRAND Program grants cannot be provided to studies that are already in progress.

Criteria for Selection

Applications will be reviewed by the GRAND Review Committee, which comprises internationally prominent researchers. For details of the GRAND review process click here. In their evaluation, the Committee members will consider the following:

  • Relevance of the proposed research to the scope of the GRAND 2017 program
  • Specifically, does the research proposal aim to provide information that could directly advance the use of pharmacotherapy for treating users of any nicotine or tobacco product in clinical practice?
  • Overall scientific merit of the research proposal, in particular the potential significance and innovation of the proposal
  • Appropriateness of the proposed sample size
  • Realism of the proposed budget
  • Academic qualifications and previous research experience of the applicant
  • Evidence of a suitable research environment.
Submitting your application

Applications must be submitted in English using the GRAND Application Form (click here) and the GRAND Budget Form (click here). All costs associated with the conduct of the study, including institutional overhead costs and other costs, should be identified in full in US $.

Applications must be submitted via the Pfizer Investigator-Initiated Research (IIR) portal via the following link:

https://iirsubmission.pfizer.com/user/login

Click on "Create New Proposal" then select “IIR Program.” You will be prompted to select whether you are applying to a Competitive Grant Program. Select “Yes”, then, select “GRAND 2017” from the drop-down menu. Complete all required fields to create your new submission. If this is your first time visiting the portal, you must first "Create an Account". For the online submission form, you will need to fill in all the relevant sections using the drop-down menus where appropriate. Please remember to have completed your GRAND Application Form (click here) and GRAND Budget Form (click here) before starting your online submission. Please note the following guidance for these specific sections:

STUDY TITLE – Must be no more than 250 characters in length.

PRIMARY PFIZER THERAPEUTIC AREA – Select the most relevant category for your application.

STUDY TYPE – Select ‘Clinical’ (not ‘Pre-clinical’).

In addition to completing each box within every section of the IIR portal, your GRAND Application Form, GRAND Budget Form, and other supporting documents are required to complete your submission and will need to be uploaded in the relevant sections, as detailed below.

Funding Request Section

Upload your GRAND Budget Form – All costs associated with the conduct of the study, including institutional overhead costs and other costs should be identified in full in US $. All grants will be paid in US $. click here to download the GRAND Budget Form, for guidance, the budget should be as detailed as possible and include (as appropriate):

  • Direct Labor Costs – Please indicate the requested budget amount for the Principal Investigator and other staff involved in study conduct
  • Direct Study Costs – Please itemize to include procedural costs, ie, drug packaging, subject visits, X-rays, blood panels, data management and analysis, etc.
  • Institutional Overhead Costs** – Please include applicable overhead percentage for direct study costs. There is no cap to the overhead percentage that can be requested.
  • Other Costs – Please include additional study expenses such as costs for publication, IRB/IEC review fees, supplies, software license fees, and travel.

**Please note that Pfizer does not provide funding for capital equipment.

Study Details Section

Upload your GRAND Application Form – The full proposal should be limited to 5000 words, excluding abstract, references, tables, figures, and details about research facilities. Applications with proposals over this limit will NOT be accepted by the Review Committee. click here to download the GRAND Application Form.

Primary Site Information Section

Upload your Abbreviated Curriculum Vitae (CV) which can be in any format – Maximum 5 pages. The Principal Investigator's CV is required; co-investigator CVs are optional.

Conditions of the Award

Each Award is subject to the following conditions. Before any funds will be disbursed, the Awardee and host institution must indicate their agreement to these conditions by signing a Letter of Agreement with Pfizer.

A. Financial Administration

The GRAND Program grant will be awarded to the host institution on behalf of the Awardee. An Investigator-Initiated Research Agreement will be executed between the award recipients and Pfizer. It is anticipated that at least 5 Awards will be granted in September 2017 each of between US $50,000 and US $200,000 in value, totaling US $1 million. The amount of each Award includes direct costs (labor and study costs), institutional overhead costs, and other costs (additional expenses such as publication, software license fees, and travel costs). Each payment will be made in installments according to milestones, with a maximum of 50% of the funding delivered at the beginning of the project. The last installment of 15% will be made when the final results of the study are available. The final budgets of studies for which a grant has been awarded will be reviewed for fair market value before the contracting process begins.

B. Use of GRAND Funding

Funds from the GRAND Program may be used to support the Applicant's salary and fringe benefits, technical salaries, and supplies.

C. Financial Record Keeping

A separate financial record must be maintained by the Awardee.

D. GRAND Program Awards Progress and Final Reports

The Awardee must submit a final report on study results to the GRAND Program within 6 months after the finalization of the study. Reprints of articles, published or in press or copies of draft manuscripts, should be included with all reports. From time to time, the GRAND Program organizers/members may ask prior Awardees for information on study progress.

E. Required Documents if Proposal Selected for Funding

If your proposal is selected for an Award by the Independent Review Commitee, additional documentation will be required as detailed below (further guidance will be provided after notification of the Award):

  • Two copies of the Signed Research Agreement, which will be provided to the site by Pfizer
  • Final Protocol
  • IRB/Ethics Committee approval documentation, if applicable
  • IND documentation (for US Applicants only) or response from regulatory authorities, as applicable per country regulations
  • W-9 form for your institution (US Applicants only)
  • Due dilligence forms, including Government Official Identification questionnaire.

F. Publications

Awardees are expected to publish their findings in scientific journals. In addition to manuscript publication, Awardees may present their findings at scientific meetings. All publications that result from a project supported by the GRAND Program must carry the following acknowledgment: "This research was supported by a Global Research Awards for Nicotine Dependence Program grant, an independent competitive grants program supported by Pfizer, to (name of Awardee)". Awardees will provide to the GRAND Program organizers/members the opportunity to view manuscripts or abstracts 60 days prior to submission for publication or other public disclosure. Pfizer will review all manuscripts and abstracts for unprotected inventions that relate to the Pfizer product (if applicable) and may provide comments on content. The Principal Investigator will consider any such comments in good faith, but is under no obligation to incorporate any Pfizer suggestions.

G. Patents and Licensing

If the conduct of the research results in any invention or discovery by the Awardee that relates to a Pfizer product, the Awardee will grant to Pfizer a perpetual, royalty-free worldwide, non-exclusive license to each such invention.

H. Stipulations

1. Should the Awardee discontinue the research project or leave the designated host institution, the GRAND Program organizers must be notified without delay.
2. The GRAND Award may be transferred to another institution at the sole discretion of the GRAND Program organizers, acting on the recommendation of the Review Committee. If a transfer is requested, letters from both the Awardee and the new institution must be submitted to the GRAND Program at least 3 months before the date of the proposed transfer.
3. If the host institution or the Awardee wishes to terminate the Award before its completion, an agreement between the host institution and the GRAND Program organizers will be arranged. Termination will be made with the understanding that all unexpended funds will be returned to the GRAND Program organizers and any unpaid balance of the Award will be cancelled.

I. Serious Adverse Events (SAE) Reporting (As Applicable)

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

.
    a. 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.

    b. 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.

    c. 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.

    d. 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.

    e. 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.

    f. 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.

    g. Follow-up information. Principal Investigator will assist Pfizer in investigating any SAE and will provide any follow-up information reasonably requested by Pfizer.

    h. 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.

In addition, for any non-interventional study with sites in the EU, the following requirements also apply:

Reporting of Non-Serious Adverse Events. Certain Non-Serious Adverse Events (“NS-AEs,” as defined below) must also be reported to Pfizer. The NS-AEs that are reportable to Pfizer are those that (1) were specified in the Protocol as being reportable and (2) occur during the NS-AE reporting period (as defined below). Within 24 hours of first awareness of the event, Principal Investigator will report to Pfizer by facsimile any such NS-AE. Principal Investigator should report these NS-AEs as soon as they are determined to meet the definition and reportability criteria, even if complete information is not yet available.

1. Reporting Forms. Principal Investigator will report NS-AEs on 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 Non-Interventional Study Adverse Event Report 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 NS-AE submitted.

2. AE and NS-AE Definitions. An Adverse Event (“AE”) is any untoward medical occurrence in a Study subject receiving the Pfizer Product or an individual otherwise exposed to the Pfizer Product, without regard to whether there is a causal relationship between the Pfizer Product and the medical occurrence. A Non-Serious AE (“NS-AE”) is any AE that does not meet the definition of an SAE (see Section 3.7.b, SAE Definition). For this Study, only NS-AEs identified in the Study Protocol as reportable must be submitted to Pfizer.

3. NS-AE Reporting Period. Unless the Protocol specifies a longer period, the NS-AEs that are subject to this reporting provision are those that occur from after the first dose of the Pfizer Product or the Study subject’s enrollment in the Study (whichever is later) through 28 calendar days after the last administration of the Pfizer Product or the subject’s last Study visit (whichever is earlier).

4. Follow-Up Information. Institution will assist Pfizer in investigating any NS-AE if Pfizer considers it necessary and will provide any follow-up information reasonably requested by Pfizer.

5. Regulatory Reporting. Reporting an NS-AE to Pfizer does not relieve Institution of responsibility for reporting it to appropriate regulatory authorities, if such reporting is required.

6. Pfizer-Provided NS-AE Training. Further information about the NS-AE reporting requirements for non-interventional IIR studies conducted within the European Union is provided in the Pfizer-provided training referenced in Section 3.7, above. Principal Investigator will review this material and share it with any Study staff engaged in the reporting of NS-AEs.

In addition, Pfizer requires reporting of all adverse events for any non-interventional clinical study with at least one study site in the European Economic Area.


If uncertain whether or not your topic is within scope, please contact the GRAND Program Coordinator (Email: enquiries@grandawardsprogram.org. Email messages will receive a reply within 2 business days)