ADVANCING THE PHARMACOLOGICAL TREATMENT OF TOBACCO AND NICOTINE DEPENDENCE

An independently-reviewed competitive grants program supported by Pfizer

FAQs

General Questions 

Study-Related Questions

Study Drug-Related Questions

Proposal-Related Questions

Budget-Related Questions

I have a question that is not covered here

What are the GRAND Awards?
Global Research Awards for Nicotine Dependence (GRAND) Program. The inaugural funding took place in 2008. GRAND is a program of research grants funded by Pfizer to support clinical research into the treatment of tobacco and nicotine dependence with an upper limit of US$200,000 per Award.

How many GRAND Awards are available?
In 2017, the intent of the Program is to fund at least 5 grants of between US$50,000 and US$200,000 in value, totaling US$1 million. These Awards are open to all investigators holding an MD, PhD, or equivalent, from around the world.

How do I apply for a GRAND Award?
For 2017 entries, all applications will need to be submitted via the Pfizer Initiated-Investigator Research (IIR) Portal via the following link [https://iirsubmission.pfizer.com/user/login]. Click on "Create New Proposal", 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 required fields to create your new submission. If this is your first time visiting the Portal, you must first "Create an Account". Please refer to "How to Apply" (click here) or contact enquiries@grandawardsprogram.org.

Are GRAND Awards open to researchers working outside the United States?
Yes, GRAND Awards are open to researchers from any country. All applicants should review applicable local laws, regulations, institutional policies, industrial rules, etc. prior to submission. 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.

Can an exception be made for certain applicants regarding the eligibility criteria for GRAND Awards?
The eligibility requirements — academic, scientific, etc. — are designed and maintained by the Review Committee. These criteria have been carefully designed to attract appropriate candidates at a certain level in their professional development. In keeping with the purpose and intention of the GRAND Awards, applicants must meet all the criteria in order to be considered for an Award. Submissions outside of these parameters will not be considered.

What is the role of Pfizer in the GRAND Awards?
Pfizer fully funds the GRAND Program. Additionally, Pfizer provides the infrastructure and administrative support required to facilitate the application process and the independent review process, as well as notifying applicants and distributing Awards. Otherwise, the Awards are independent of Pfizer. All applications will be formally reviewed by, and only by, an independent Review Committee, comprising internationally prominent researchers in the field. The Review Committee will determine the successful applicants and the final responsibility for selection of Awardees will rest with the co-Chairs of the Review Committee. Please refer to Review Process for more information about the Review Committee.

A preliminary review of submissions will be completed by Pfizer in order to ensure there are no restrictions (i.e., FDA Restricted) on the Principal Investigator, and that there are no concerns with the proposed work from a patient safety or intellectual property perspective.

Please also note that Pfizer is required to collect and document information related to the Foreign Corrupt Practice Act (FCPA). If initially selected for an award, a Pfizer colleague will contact the Principal Investigator to collect relevant information, which must be vetted through appropriate Pfizer Legal channels prior to final approval of the GRAND Award.

Will the Review Committee members be the same as last year?
The two co-Chairs of GRAND 2017 are Karl Fagerström and John Hughes. The Review Committee members will be announced in due course. Please click here to refer to Review Process to see the members of the Review Committee.

Who were the successful applicants last year?
Information relating to previous GRAND Awardees and research topics is available via the following link: Previous GRAND Awards (2008-2016).

When will the GRAND Awards for 2017 be announced?
The successful Awardees will be notified in October 2017 and the GRAND Awards will be announced publicly in November 2017.

If I win do I have to publish the results?
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.

What specific areas of research meet the criteria for GRAND funding?
GRAND 2017 proposals 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.

Are there any specific research areas that are excluded from GRAND funding?
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.

I’m still not sure if my proposed research topic meets the criteria, how can I find out?
Please contact the GRAND Coordinator with a brief description of your proposed research area.
Email: enquiries@grandawardsprogram.org (Email messages will receive a reply within 2 business days)

Is there a time limit for conducting the funded research?
Research is expected to be completed and submitted for presentation/publication within 2 years of study start.

Is the inclusion of pharmacotherapy restricted to Pfizer products?
No, proposals using any type of pharmacotherapy will be considered for a GRAND Award.

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

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

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    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.

When is the application deadline?
Applications must be received by 11.59pm Eastern Daylight Time (US) on July 3, 2017. Unfortunately, we cannot accept applications, or addenda and changes to previously submitted applications after this time. Please Note: No emails can be answered after 1:00PM EDT on July 3, 2017.

Can I resubmit a proposal I have submitted to GRAND in a previous year?
Yes, previously submitted proposals may be resubmitted as long as the research is within scope for GRAND 2017. You are strongly encouraged to address any previous feedback from the reviewers in your GRAND application for this year. 

I'm a previous GRAND Award winner, am I eligible to apply for another GRAND Award?
Previous GRAND grant winners may apply for GRAND Awards in the future. Grants are based upon scientific merit commensurate with the funding that is available every year.

Will Pfizer provide drug supply for my study?
If Pfizer drug is requested and is available, it will be provided at no cost. If the study if open-label, Pfizer may choose to provide the commercially available product. If active and placebo drug is requested, Pfizer will provide to the site in bulk bags, to be repackaged by your site pharmacy as needed per the protocol. Please ensure appropriate costs are accounted for in the budget. 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.

Can I purchase Pfizer drug?
Pfizer will not provide funding to purchase Pfizer drug. Please include requests for Pfizer drug in your submission. 

Do applications have to be submitted in English?
Yes. To ensure that the available funding is directed as much as possible towards the research grants rather than administrative costs, applications in languages other than English unfortunately cannot be accepted.

Can I submit tables and figures with my submission?
Tables and figures that you wish to be considered as part of your proposal should be included within the application form and will not count towards the 5000 word limit. Please make sure that the tables and figures are relevant and kept to a minimum.

When will I hear if my application has been successful?
The Review Committee will make the final decisions in September 2017, and successful applicants will be notified in October 2017.

If my application is successful, when will the funding commence?
Awards will commence in 2018, pending receipt of all required documents as noted on the Application Form. An Investigator-Initiated Research Agreement will be executed between the award recipients and Pfizer. Please note that depending on the institution, the contracting process with Pfizer may take 6–9 months to complete. If your study involves Pfizer drug, a minimum of one additional month after contract execution will be required to ship supply to the research site. Sites outside of the United States may require additional time, based on country specific regulations. Please plan your study start timelines accordingly.

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

How much money can I request?
Budget requests should be between US $50,000 and US $200,000 in value, including direct costs (labor and study costs), institutional overhead costs, and other costs (additional expenses such as publication, software licence fees, and travel costs).

Do budgets have to be submitted in USD?
Yes, all budget requests must be submitted in USD. Budgets submitted in other currencies will be rejected.

Is the funding a per-annum or per-study amount?
Each Award funds the entire research period and is not a sum paid per year.

Does the funding include institutional overhead costs and other costs?
Yes, the total funding for each Award includes institutional overhead costs and other costs.

What are other costs?
Other costs (eg, indirect costs) are additional study expenses such as costs for publication, IRB/IEC review fees, supplies, software licence fees, and travel.

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. Examples of these costs include human resources department costs, payroll processing and accounting costs, janitorial services, utilities, property taxes, property and liability insurance, and building maintenance. Institutional overhead costs should be included within the total requested budget.

How are the funds disbursed?
The Awards will be paid in milestones. Initial payment will be up to 50% of the total grant and there will be payments made based on enrolment (either 50% or 100% patient enrolment) or other milestones depending on study type. Final payment, upon receipt of study results, will be 15%.

How may the GRAND funding be used?
Funds may be used to cover the Awardee’s 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, and direct expenses necessary for proper conduct of research (eg, drug-packaging, subject-related costs, study-related personnel costs, diagnostic fees/services, data management expenses). Other costs may include travel expenses to scientific meetings, software licensing fees, publication costs, etc. If Pfizer drug is requested and is available, it will be provided at no cost. If the study is open label, Pfizer may choose to provide the commercially available product. If active and placebo drug is requested, Pfizer will provide to the site in bulk bags, to be repackaged by your site pharmacy as needed per the protocol. Please ensure appropriate costs are accounted for in the budget. Pfizer will not provide funding to purchase Pfizer drug. Please include requests for Pfizer drug in your submission.

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.

Can GRAND Awards be used to purchase equipment?
GRAND Awards may not be used to purchase equipment, although the purchase of relevant laboratory supplies is permitted.

Are GRAND Awards renewable?
Each GRAND Award is a one-time, non-renewable research grant. Due to the competitive nature of these Awards, Pfizer cannot provide any additional funding and/or drug support beyond that originally requested and approved by the external independent Review Committee.

I have a question that is not covered here
If you require clarification on an issue not addressed here, please contact the GRAND Coordinator:
Email: enquiries@grandawardsprogram.org
(Email messages will receive a reply within 2 business days) 


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)