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GSK call for Independent Medical Education (IME) proposals on Systemic Lupus Erythematosus (SLE)

How we support independent medical education

Our mission is to help people “Do more, Feel better and Live longer”. As part of this mission we support Independent Medical Education (IME), provided by third parties.  We want to enable those closest to the patient and educational experts to collaborate and innovate; to close patient/caregiver understanding and healthcare professional (HCP) performance gaps, achieve evidence-based standards of best practice and ultimately improve patient health.

We support IME at arm’s-length; we have no control, involvement or influence over the content development, logistics, faculty, speaker, or participant selection.

Through this support, we aim to fund initiatives that address an educational need in disease areas aligned to our interests.  Our selection criteria for educational grant funding require providers to demonstrate that their programmes are:

  • credible and independent of the pharmaceutical industry
  • designed to address an educational need
  • improve HCPs practice by advancing better understanding of diagnosis, prevention or treatment of a disease towards an overall goal of improving patient care
  • focused on the key objective of improving patient health and enabling people to “Do more, Feel better and Live longer”

Grant funding for IME is permitted in disease areas where we have an authorised medicine.  If the IME proposal includes providing information on the appropriate use of a GSK product, that product must be approved in locations of the IME target audience, the proposed education consistent with the conditions of approval and approved prescribing information for the product.  If the IME proposal is related to an area in which we have an interest but not an approved product (including areas related to products in development and not yet approved for marketing), the IME proposal must be limited to general, broad-based disease topics.

Systemic lupus erythematosus (SLE) (aka lupus) is a chronic, autoimmune disease characterised by inflammation effecting multiple organs. This complex, heterogeneous and progressive disorder, creates a need for improved understanding of the disease components and optimal management of the patient.             

Please read the following information on our approach to supporting IME to better understand our standards for educational grant proposals as well as details on how to apply.

Disclaimer

The following provides specific guidance and expectations that applicants should use to draft and submit any proposal related to the present call. Only project proposals that match the requirements outlined below will be considered for funding. Please note that any project application not complying with these requirements will not be considered for review and funding. 

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Purpose of the call for proposals

Lupus is a complex, challenging disease to diagnose and manage. We are committed to enhancing understanding the disease and improving patient care through supported medical education of patients/caregivers and HCPs managing lupus worldwide. To enable this we are calling for IME proposals.

Areas of Interest

The supported programme will have the objective of improving the understanding of patient burden, diagnosis, monitoring and treatment of lupus, with a focus on enhancing the patient care and/or benefiting public health.

Key areas of interest include:

  • long-term organ damage (LTOD) in lupus including drivers, risk factors and treatment strategies geared at prevention
    • appropriate use of glucocorticoids
    • immunosuppressant burden
  • disease control & remission related to LTOD outcomes
  • lupus nephritis (LN) disease state education
  • education directed towards different HCP groups (e.g. Rheumatologists, Internists, Nephrologists, Nurse Practitioners etc.)
  • education directed towards lupus patients and caregivers

Requirements

The supported recipient will develop and implement an ex-US IME activity focused on educating non-US patients/caregivers and HCPs who are interested in enhancing their knowledge and practice of managing patients with lupus.

The supported activity should enable users to have ‘on demand’ access to a digital educational programme in multiple languages.

For US-based organisations requesting grant funding to support IME activities for US-based patients/caregivers and HCPs, different guidelines apply and this process is not applicable. Please visit https://www.partnersinknowledge.com/GSKCenterforMedicalEducation/ for details.

Outcome assessment 

An assessment of the programme’s outcome should be conducted and include objective evaluation of the change in HCP knowledge to assess the quality, effectiveness and educational impact of the funded activity and improvement in patients’ health.

Implementation

The planning, execution and monitoring of the IME programme is the responsibility of the grant recipient. We will have no control, involvement or influence over the content development and delivery, logistics, faculty, speaker, or participant selection

Budget and funding

It is the applicant’s responsibility to provide a detailed and itemized budget for the IME programme.

This budget must be reasonable, appropriate and directly related to the development, execution and monitoring of the proposed educational activity.

Funding will be made available over 2020-2021 for the approved activity.

* If required by relevant laws, regulations or applicable industry codes, IME providers must provide us with information on payments and other transfers of value made to HCPs/OHS using GSK’s funding, obtaining consent to do so from the HCP/OHS, to enable GSK to fulfil any transparency policy or disclosure obligation. IME providers provide this information after the activity has been undertaken to ensure that we do not influence HCP/OHS selection.

Timetable

The final deadline for submission of proposals is 14 October 2020. Below are indicated the different stages of the grant application process and the expected corresponding timelines:

  1. submission of proposals to lupusime@gsk.com on or before 14 October 2020
  2. preliminary evaluation and short-listing period until 23 October 2020
  3. information to applicants by 23 October 2020
  4. submission of proposals deemed of interest into the gskgrants.com portal by
    30 October 2020
  5. signature of the grant agreement by 11 December 2020

It is expected that the grant recipient will complete all IME activities no later than within 12 months from grant agreement signature.

The following organisations are eligible to apply for an educational grant:

  • healthcare service provider
  • professional medical society
  • patient group or medical education charity
  • academic institution that trains healthcare professionals
  • medical education company that is an accredited independent provider

Eligible IME providers, or the IME function of the provider, must be independent from industry influence and must not provide non-independent services to GSK. IME providers that provide both product promotional and independent education services will need to demonstrate in their application how their independent education services are free from commercial interest.

Providers need to be able to design and deliver high quality multidisciplinary education initiatives that aim to improve patient health and strive to objectively measure a change in HCP knowledge at a minimum.

We will review all submitted proposals against the following standardised criteria. All educational grant proposals must address these criteria:

Compliance 

All educational grant applications will be reviewed on the completeness and quality of the application as well as the potential impact the proposal could have in enabling patients to “Do more, Feel better and Live longer”.

Providers must comply with the following to qualify for consideration of funding:

  • proposals must be free from commercial influence; educational content must be non-promotional, fair and balanced
  • if the IME proposal includes providing information on the appropriate use of a GSK product, that product must be approved in locations of the IME target audience, the proposed education consistent with the conditions of approval and approved prescribing information for the product
  • if the IME proposal is related to an area in which we have an interest but not an approved product (including areas related to products in development and not yet approved for marketing), the IME proposal must be limited to general, broad-based disease topics
  • the budget must have line items allocated to appropriate categories
  • where possible the educational content should be accredited by a nationally or internationally recognised accreditation body that requires content development and activities to be independent from commercial interest
  • providers must comply with our transparency initiative and EFPIA disclosure requirements. We publicly disclose all approved educational grants provided to healthcare organisations and reserves the right to post summaries of the funded educational initiatives and educational outcomes achieved on our website
  • proposals must include details on how conflicts of interest will be identified and resolved. Anyone who is involved in developing educational content must disclose any relevant financial relationship with commercial interest that creates a conflict of interest. Failure to disclose and resolve known conflicts of interest will disqualify the grant applicant

Identified HCP education need

Proposals for HCP-focused IME programmes must highlight and address evidence-based clinical performance gaps that impact patient health in the selected disease area. This should include a rigorous assessment of the gaps between current practice and evidence-based best practice that identifies HCP learning needs.

Examples of an educational need assessment could be expert interviews, a HCP survey, a review of peer-reviewed scientific literature, an audit of patient records, or a national consensus.

Educational initiative design

Initiatives should clearly define specific, measurable learning objectives that are aligned to the identified HCP educational need and expected knowledge or practice change. Proposed initiatives should incorporate interactive and innovative formats that are designed to improve HCP knowledge, skill, practice and ultimately patient health.

Initiatives should target the intended audience’s learning preferences; they may be multiple curriculum-based initiatives or tailored multidisciplinary learning environments. Whatever format is outlined, a compelling rationale should be provided for the educational design selection.

Educational outcomes

To qualify for funding of HCP-focused IME programmes, providers need to be able to measure a change in HCP knowledge, or a higher level of educational outcome that measures a regional or local change in HCP performance and patient outcomes. Only initiatives that are designed to objectively measure a change in HCP knowledge (minimum Level 3 in Moore’s model below), or a change in HCP practice or patient outcome (higher than a Level 3) will be considered for funding.

Education outcomes

Description

Source of data

Community health (Level 7)

The degree to which the health status of a community of patients changes due to changes in the practice behaviour of participants

Objective: epidemiological data and reports

Subjective: community self-report

Patient health (Level 6)

The degree to which the health status of patients improves due to changes in the practice behaviour of participants

Objective: health status measures recorded patient charts or administrative databases

Subjective: Patient self-report of health status

Performance (Level 5)

The degree to which participants do what the CME activity intended them to be able to do in their practices

Objective: observation of performance in patient care setting, patient charts, administrative databases

Subjective: self-report of performance

Competence (Level 4)

The degree to which participants show in an educational setting how to do what the CME activity intended them to be able to do

Objective: observation in education setting

Subjective: self-report of competence, intention to change

Learning procedural knowledge (Level 3b)

The degree to which participants state how to do what the CME activity intended them to know how to do

Objective: pre-and post-test of knowledge

Subjective: self-report of knowledge gain

Learning declarative knowledge (Level 3a)

The degree to which participants state what the CME activity intended them to know how to do

Objective: pre- and post-tests of knowledge

Subjective: self-report of knowledge gain

Satisfaction (Level 2)

The degree to which the expectations of the participants about the settings and delivery of the CME activity were met

Questionnaires completed by attendees after CME activity

Participation (Level 1)

The number of physicians and others who participated in the CME activity

Attendance records

A strategy to make the educational design or outcomes that have been measured available to a wider HCP audience should also be included.

All applications that would not comply with the requirements outlined in the above sections will be rejected.

The following applicants are ineligible to receive grants and donations:

  • an individual
  • an organisation that is an alter ego of an individual, such as a personal services corporation or a charitable foundation in which that individual or an immediate family member has an instrumental role in the management or leadership
  • an organisation through which healthcare practitioners come together to administer their medical practices (e.g. a medical staff or faculty practice association)
  • departments/ organisations that are involved in the selection, purchase, prescription, recommendation, dispensing, use or reimbursement of our products are ineligible
    • universities or other diversified institutions, where the requesting department is entirely removed from the selection, purchase, prescription, recommendation, dispensing, use or reimbursement of our products, are eligible
  • an affiliate or alter ego of an ineligible recipient
  • an organisation that is reasonably believed to be positioned to act as a “pass through” organisation for provision of resources to an otherwise ineligible recipient
  • political candidates, campaigns, or parties
  • an organisation on which a GSK employee is serving in a board role or other position of influence unless its activities are not of a clinical nature and do not have the potential to impact patient treatment or guidelines (The applicable Grants and Donations Committee may approve an exception to this prohibition in circumstances when, in its judgment, the funding would provide a significant benefit to the medical or scientific community or to patients and would not pose an undue reputational risk to GSK)

We do not provide grants and donations of more than 25% of the total revenue of the recipient during any given calendar year.

Our support disclosure

The IME provider makes clear to programme participants that it is supported by GSK funding. For example, “this educational activity was supported by an educational grant from GlaxoSmithKline.”

The IME provider agrees that we may publicly disclose the funding provided as part of our voluntary or regulatory disclosure requirements.

Application deadline:  14 October 2020

Decisions on funding requests will be made available within 2 weeks following the submission deadline.

Read each section of this document to ensure you are eligible to apply for funding

Complete the following application checklist:

  • Your organisation is an eligible IME provider per GSK requirements stated in this call
    • if your organisation provides both marketing and educational services, evidence must be attached to demonstrate that independent education services are free from commercial interest, for example, organisation ​charts showing separation of business units
  • proposal is aligned with the IME description provided in the call for proposal
  • the following compliance criteria are fulfilled:
    • education development is free from commercial influence and content is non-promotional, fair and balanced
    • conflicts of interest have been sought and disclosed
    • budget is customary, itemised and aligned to appropriate categories
    • provider agrees to GSK’s requirement for transparency
  • proposal includes a comprehensive, evidence-based education need assessment
  • proposal includes rationale and detail on the design of the education initiative
  • proposal seeks to measure educational outcomes that meets GSK criteria for funding
  • proposal outlines a strategy to make the education or outcomes available to a wider HCP audience

Attach any evidence required to demonstrate that criteria have been met

Email: ww.lupusime@gsk.com

Thank you for your interest.

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