Call for IME proposals on Systemic Lupus Erythematosus (SLE)

How GSK supports independent medical education

GlaxoSmithKline’s mission is to help people do more, feel better and live longer. As part of this mission we are embarking on a new initiative in how we support third-party Independent Medical Education (IME). We want to enable those closest to the patient and educational experts to collaborate and innovate; to close healthcare professional performance gaps, achieve evidence-based standards of best practice and ultimately improve patient health.

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

Through this programme, we aim to fund outcomes-driven education initiatives in disease areas in which there are patient needs and mutual scientific interest. We have revised our selection criteria for educational grant funding by requiring credible and independent providers to demonstrate that their programmes are designed to improve healthcare professional practice and patient health using objective data to measure these improvements. While we realise that all programmes are designed to improve clinical knowledge, we are focusing our financial resources on those that we believe have the greatest potential to improve patient health and enable people to do more, feel better and live longer.

Lupus is a chronic, autoimmune condition characterised by inflammation and involvement of multiple organs. The evolving nature of this complex, heterogeneous disorder, relating to both understanding of the disease and optimal management of the patient, highlights a clear medical education need.

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

Disclaimer

The following information 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.

Grant funding for independent medical education is only permitted in disease areas where we have an authorised medicine.

 

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Purpose

Lupus is a complex, challenging condition, in relation to understanding the disease and improving the management of the patient. GSK is committed to supporting the improvement of patient care through enhancing medical education of Physicians managing Lupus across Europe.

GSK is calling for proposals for the IME activity described below.

Content

The supported programme should have the objective of:

  • improving the understanding of patient burden, diagnosis, monitoring and treatment of disease, which may include enhancing the management/care of patients, or benefiting public health.

Framework

The supported programme should develop and implement a European IME activity focused on educating Physicians, based in Europe, who are interested in enhancing their knowledge and practice, of managing patients with Lupus.

The supported activity should enable HCPs to have ‘on demand’ access to a digital educational programme.

For US-based organisations requesting grant funding to support IME activities for US-based healthcare professionals, different guidelines apply and this process is not applicable. Please visit www.partnersinknowledge.com for details.

Output

Some of the expected output of the supported programme would be to:

  • Facilitate dissemination and retention of knowledge and best practices in Lupus management
  • Enhance professional performance in improving patient care

Outcome assessment 

An assessment of the programme’s outcome should be conducted and include objective evaluation of the change in HCP performance and improvement in patients’ health.

Funding scheme

The funding will be made available for a 1 year European pilot, which will be followed by a possible extension for additional 1-2-year funding. This would require re-application and be dependent on annual GSK review of the programme outcomes and funding availability.

Implementation

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

Budget

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.

If required by relevant laws, regulations or applicable industry codes, IME providers must provide GSK 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 GSK does not influence HCP/OHS selection.

Timetable

The final deadline for submission of proposals is March 2nd 2018. Below are indicated the different stages of the grant application process and the expected corresponding timelines:

  1. Submission of applications before March 2nd 2018
  2. Preliminary evaluation and short-listing period until March 30th 2018
  3. Information to applicants by April 12th 2018
  4. Signature of the grant agreement by July 31st 2018

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

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

Providers need to be able to design and deliver high quality multidisciplinary education initiatives. Collaboration amongst providers to capitalise on each others areas of expertise is encouraged. Proposed initiatives must aim to improve patient health and strive to objectively measure a change in healthcare professional performance.

To qualify for funding, providers need to be able to measure a change in healthcare professional knowledge, or a higher level of educational outcome[1] that measures a regional or local change in healthcare professional performance and patient outcomes. Further detail on the possible outcomes that could be measured is outlined in the following section.

[1] Please refer to Moore D. E., Journal of Continuing Education in the Healthcare Professions, 2009, vol. 29, issue 1, pages 1-15 http://www.sacme.org/Resources/Documents/Virtual%20Journal%20Club/Moore_evaluation_article.pdf>

GSK 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, live longer and feel better. 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.
  • Education must be in a disease area or areas in which GSK has an authorised product.
  • The budget must be customary and 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 GSK’s transparency initiative and EFPIA disclosure requirements. GSK publicly discloses 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 healthcare professional education need

Proposals 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 healthcare professional learning needs.

Examples of an educational need assessment could be expert interviews, a healthcare professional 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 healthcare professional educational need and expected knowledge or practice change. Proposed initiatives should incorporate interactive and innovative formats that are designed to improve healthcare professional 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

Initiatives should strive to measure an educational outcome. Only initiatives that are designed to objectively measure a change in healthcare professional knowledge (Level 3 in Moore’s model below)[1] with European reach, or a change in healthcare professional practice or patient outcome (higher than a Level 3) with Europeanreach 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

Table from Moore, D., JCEHP, 29[2]

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

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

[1] Please refer to Moore D. E., Journal of Continuing Education in the Healthcare Professions, 2009, (29), issue 1, pp. 1-15 http://www.sacme.org/Resources/Documents/Virtual%20Journal%20Club/Moore_evaluation_article.pdf

[2]Moore, D. Activitiesin Achieving Desired Results and Improved Outcomes: integrating planning and assessment throughout learning activities:‘TABLE 1. Comparison of an Expanded Outcomes Framework with the Original Framework for Planning and Assessing CME’, Journal of Continuing Education for Healthcare Professions, 2009, (29), issue 1, p. 3. 

The following applicants are ineligible to receive grants and donations:

  • An individual.
  • An organization that is an alter ego of a particular 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 organization 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 GSK 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 GSK products, are eligible.
  • An affiliate or alter ego of an ineligible recipient.
  • An organization that is reasonably believed to be positioned to act as a “pass through” organization for provision of resources to an otherwise ineligible recipient.
  • Political candidates, campaigns, or parties.
  • An organization 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).

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

GSK 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 GSK may publicly disclose the funding provided as part of our voluntary or regulatory disclosure requirements.

 

Application deadline: March 2nd 2018

Decisions on funding requests will be made available within 4 weeks following the submission deadline.

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

Complete the following application check list:

  • Your organization is an eligible IME provider per GSK requirements stated in this call
  • If your organization provides both marketing and educational services, evidence must be attached to demonstrate that independent education services are free from commercial interest, for example, organization 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 healthcare professional audience

Attach any evidence required to demonstrate that criteria have been met.

Email: ww.lupusime@gsk.com

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