FastOA Cohort

Overview

_NOTE: Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date._

The Arthritis Foundation has the goal of supporting research that will improve the lives of arthritis patients by accelerating the development of new treatments. Identifying patient groups with clearly defined clinical features and high risk for developing osteoarthritis over a relatively short time frame can be a resource for successful clinical trials. This Request for Proposals (RFP) invites applications for research proposals to identify and define patient populations with characteristics indicative of risk of “FastOA” of the hip. Members of FastOA Cohorts defined from this RFP may be studied further in the future as candidates for enrollment in interventional clinical trials.

Responsive applications may be focused on retrospective analyses of medical records or surgical outcomes databases for patients with, but not limited to:

* Patients with altered joint morphology or injury that predispose the rapid onset hip OA. For example
* Femoroacetabular impingement
* Acetabular Dysplasia
* Developmental Dysplasia of the Hip
* Perthes disease
* Slipped Capital Femoral Epiphysis
* Patients with joint injury and/or surgery (but not total hip replacement)
* Patients with hip pain at baseline but without radiographic OA

Eligibility

_We've imported the main document for this grant to give you an overview. You can learn more about this opportunity by visiting the funder's [website]().
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Application Details

2025 FastOA Cohort Request for Proposal (RFP)
I. RFP Overview
Participating The Arthritis Foundation (AF)
Organization(s)
Components of Science, FastOA Initiative, Osteoarthritis Clinical Trial Network
Participating Organizations (OACTN)
Funding Opportunity Title 2025 FastOA Cohorts, Hip
Announcement Type Existing
Funding Opportunity 2025-OA-FC-RFP, Rev.1
Announcement Number
Funding Opportunity The goal of this Request for Proposals (RFP) is to identify
Purpose patient groups with risk of accelerated osteoarthritis (OA) of
the hip and to define concepts for future clinical studies
focused on those cohorts.
The funding for this initiative is provided through the AF
FastOA Initiative and OACTN (www.arthritis.org/oactn)
Posted Date Dec 1, 2024
Open Date (Earliest Jan 1, 2025
Submission Date)
Letter of Intent Due Date Jan 24, 2025
Application Due Date Feb 21, 2025
All applications are due by 5:00 PM, Eastern Time Zone.
Applicants are encouraged to apply early to allow
adequate time to make any corrections to errors found in the
application during the submission process by the due date.
Award Announcement Jun 2025
Earliest Project Start Date Jul 2025
Expiration Date This RFP will expire after ‘Application Due Date’ above.
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II. RFP Information
2.1 Purpose and Objectives
The Arthritis Foundation has the goal of supporting research that will improve the lives of
arthritis patients by accelerating the development of new treatments. Identifying patient
groups with clearly defined clinical features and high risk for developing osteoarthritis over a
relatively short time frame can be a resource for successful clinical trials. This Request for
Proposals (RFP) invites applications for research proposals to identify and define patient
populations with characteristics indicative of risk of “FastOA” of the hip (see below). Members
of FastOA Cohorts defined from this RFP may be studied further in the future as candidates for
enrollment in interventional clinical trials.
This RFP invites research proposals for a budget of up to $250,000 over 2 years. If required by
the applicant’s institution, up to 8% indirect (F&A) expenses can be included within the total
$250,000 budget
Studies should comply with clinical and institutional review board (IRB) requirements. Animal
studies are not allowed.
Successful applications should address the following:
 Define and provide a strong rationale for a patient cohort with proposed clinical
features that have potential for high risk of accelerated progression of hip OA.
o Brief clinical trial concepts may be provided to support the rationale of the
cohort.
 Describe a development plan for the cohort that may be sufficient for conduct of
future interventional or observational clinical trials.
Responsive applications may be focused on retrospective analyses of medical records or
surgical outcomes databases for patients with, but not limited to:
 Patients with altered joint morphology or injury that predispose the rapid onset hip
OA. For example,
o Femoroacetabular impingement
o Acetabular Dysplasia,
o Developmental Dysplasia of the Hip,
o Perthes disease, or
o Slipped Capital Femoral Epiphysis
 Patients with joint injury and/or surgery (but not total hip replacement)
 Patients with hip pain at baseline but without radiographic OA
Proposals are encouraged to plan to develop a verified risk calculator to use in eventual
clinical trial screening or for potential use in clinical practice.
Proposals must include a clear, evidence-based method defining the key clinical features,
and onset and/or progression of osteoarthritis that may include, but is not limited to:
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 Symptoms
 Early biomarkers to identify the onset of OA
 Biomarkers (biochemical, genetic, epigenetic among others)
 Anatomic assessments (Radiographic, MRI, ultrasound)
 Risk factors
 Occurrence of a surgical intervention
 Joint function/mechanics/kinematics
 A combination of the above and/or other
Applicants will be expected to
 Participate in a cooperative manner with the OACTN members and AF staff in
all aspects of research;
 Participate in meetings, which are expected to occur monthly. Meetings may
be virtual or in-person; and
 Present progress updates to the OACTN and AF Science staff as well as prepare
detailed annual reports to be submitted to the AF.
2.2 Background
The AF has launched the OACTN, a consortium of leading clinical investigators and research
institutions who are committed to accelerating clinical innovations for the OA patient
community. The AF has awarded and contracted several clinical recruitment sites and
specialized centers to harmonize standardized operating protocols and procedures for
advanced imaging, biomechanics, biospecimen collection, and clinical trial coordination
and biostatistics in support of a Phase II network-based interventional clinical trial.
What is FastOA?
The FastOA Initiative is an effort led by the AF to identify persons with characteristics
at high risk of developing early signs or symptoms of OA within 2-5 years. This effort is
a response to the challenge of OA’s long natural time course, which stagnates the
development of therapeutics.
The rate of OA incidence and progression in non-select populations is low, making it difficult
to demonstrate treatment efficacy in unselected cohorts. Identification of patients at high-risk
for developing or progressing OA could enable better recruitment strategies for clinical trials
of OA prevention and early treatment. Additionally, identification of risk factors for FastOA
could inform the patient and their health care providers when making decisions about lifestyle
changes and rehabilitation regimens for OA prevention outside of clinical trials.
Previous work of the FastOA Cohort Initiative consists of analysis of the Multicenter
Orthopaedic Outcomes Network (MOON) anterior cruciate ligament reconstruction (ACLR)
database. Patient-specific predictive models of clinically important outcomes after ACLR,
including early symptoms and signs of OA, were developed. Risk factors (such as KOOS Pain
score, high body mass index, presence of meniscal injury) were identified and intended to
create a risk calculator that may be used to enrich clinical trials of OA for likely progressors.
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III. Proposal Evaluation Factors
3.1 Overall Impact
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for
the project to exert a sustained, powerful influence on the research field(s) involved, in
consideration of the review criteria below.
3.2 Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of the scientific
merit and strategic importance of each proposal, as they give a separate score for each
factor, as well as an overall score for the proposal. An application does not need to be strong
in all categories to be judged likely to have major scientific impact. The list of evaluation
factors is presented below.
a. Significance
i. Does the proposal address an important problem or a critical barrier to
progress in the field?
ii. Is the prior research that serves as the key support for the proposed project
rigorous?
iii. If the aims of the project are achieved, how will scientific knowledge,
technical capability, and/or clinical practice be improved?
iv. How will successful completion of the aims change the concepts, methods,
technologies, treatments, services, or interventions for OA patients?
b. Investigators(s)
i. Are the Program Directors/Principal Investigators [PD(s)/PI(s)], collaborators,
and other researchers well suited to the project? If Early-Career
Investigators are proposed as PI, do they have appropriate experience
and training, as well as connections/collaborators to make sufficient
progress? If the PI(s) are established, have they demonstrated an ongoing
record of accomplishments that have advanced their field(s)?
ii. If the project is collaborative or multi-PD/PI, do the investigators have
complementary and integrated expertise; Is the governance and
organizational structure appropriate for the project?
iii. Do the key personnel possess appropriate and adequate knowledge and
experience in the field?
c. Innovation
i. Does the proposed research project challenge and seek to shift current
paradigms by utilizing novel theoretical and practical concepts,
approaches, or methodologies?
ii. Is a refinement, improvement, or new application of theoretical concepts,
approaches or methodologies, instrumentation, or interventions proposed?
iii. Does the design/research plan include original elements, as appropriate,
that enhance its potential to advance scientific knowledge or clinical
practice?
iv. Does the design/research plan consider the unique challenges of research
in OA patients?
d. Approach
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i. Are the overall proposed strategy and methodology well-reasoned and
appropriate to accomplish the specific aims of the project?
ii. If appropriate, have the investigators included plans to address lessons
learned from other similar initiatives?
iii. Have the investigators presented strategies to ensure a robust and
unbiased approach, as appropriate for the work proposed?
iv. Is a robust statistical analysis plan included?
v. Are potential problems, alternative strategies, and benchmarks for success
presented?
vi. At the early stages of development, will the strategy establish feasibility
and will particularly risky aspects during formative stage be adequately
managed?
vii. Have the investigators presented an outline of the anticipated challenges
and how they propose to address them?
viii. Are potential ethical issues adequately addressed?
ix. Will outcomes collected allow investigators to assess who will develop OA?
e. Environment
i. Will the scientific environment in which the work will be done contribute to
the probability of success?
ii. Are the institutional support, equipment, and other physical resources
available to the investigators adequate for the project proposed?
iii. Will the project benefit from unique features of the scientific environment,
subject populations, or collaborative arrangements?
iv. Are the administrative, enrollment, and laboratory/testing centers (if
proposed), appropriate for work proposed?
f. Study Timeline
i. Is the projected timeline feasible and well justified?
ii. Does the project incorporate efficiencies and utilize FastOA and other
existing resources (e.g., CTSAs, practice-based research networks,
electronic medical records, administrative database, or patient registries)
to maximize the efficiency of data analysis, as appropriate?
iii. Are potential challenges and corresponding solutions discussed?
3.3 Additional Score Driving Review Considerations
a. Protection for Human Subjects
i. For research that involves human subjects but does not involve one of the
categories of research that are exempt under 45 CFR Part 46, the
committee will evaluate the justification for involvement of human subjects
and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to
the subjects and others, 4) importance of the knowledge to be gained,
and 5) data and safety monitoring for clinical trials.
b. Inclusion of Women, Minorities, and Individuals Across the Lifespan
i. When the proposed project involves human subjects and/or clinical
research, the committee will evaluate the proposed plans for the inclusion
(or exclusion) of individuals based on sex/gender, race, and ethnicity, as
well as the inclusion (or exclusion) of individuals of all ages (including
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children and older adults) to determine if it is justified in terms of the
scientific goals and research strategy proposed.
3.4 Non-Score Driving Review Considerations
As applicable for the project proposed, reviewers will consider each of the following items,
but will not give scores for these items, and should not consider them in providing an overall
impact score.
a. Resource Sharing Plans
i. The research team should demonstrate the ability to successfully comply
with the AF Data and Resource Sharing Policies.
b. Budget and Period of Support
i. Reviewers will consider whether the budget, staffing plan and the
requested period of support are fully justified and reasonable in relation to
the proposed statement of work. Indirect costs (F&A) must be 8% or less as
per AF policy.
IV. Award Information & Eligibility Criteria
4.1 Award Details
Funding Instrument OACTN Research Agreement
Application Types Allowed New
Funds Available and 2 Awards are anticipated for up to $250K up to a
Anticipated Number of 2-year period.
Awards
Indirect costs (F&A) must be 8% or less as per AF
policy.
Award Budget Application budgets must reflect actual needs of
the proposed project.
Award Project Period Up to 2 years
AF funds are primarily obtained from donations. The amount available for scientific awards
each year is determined by the success of the fundraising efforts. Funds for awards are also
derived from partnerships established by the AF, with other groups that share common
interests. Funds for subsequent years of a project, after the first, even if initially approved, are
contingent upon adequate scientific progress and available funds, and are therefore subject
to change. Studies should comply with clinical and institutional review board (IRB)
requirements. Proposals using animal studies are not eligible for this funding mechanism.
4.2 Eligible Organizations Include:
• Higher Education Institutions, including:
• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education
• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Non-domestic (non-U.S.) Entities (Foreign Institutions) and Non-domestic (non-U.S.)
components of U.S. Organizations are not eligible to apply.
4.3 Eligible individuals, Principal Investigator (PI) and co-PI:
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The AF recognizes that a diverse and inclusive workforce is critical for ensuring that the most
creative minds have the opportunity to contribute to realizing our research goals and to
ensuring more equitable health outcomes for all. The AF encourages applications from a
diverse pool of investigators with respect to race, gender identity, sexual orientation, ethnicity,
national origin, and disability.
V. General Application and Submission Information
5.1 Submission
All applications should be submitted using the AF online portal (ProposalCentral) for this
program, available at https://proposalcentral.com/GrantOpportunities.asp. All applications
should be submitted by 5:00 PM Eastern time on the deadline date. Please expect that any
application submitted after deadline, incomplete, or failing to otherwise adhere to instructions
will be administratively declined.
The ProposalCentral platform does not check for page length or other formatting
requirements. If any instructions are not followed, proposals will not be peer reviewed.
Accuracy and completeness of the content including following maximum space limits,
formatting and other instructions are the responsibility of the applicant. The signature page
must be electronically signed, and applicants must click the ‘submit’ button on
ProposalCentral prior to the deadline as no late submissions will be accepted. Once the
application is submitted, applicants will receive an automatically generated confirmation
email that the application was submitted. Please, plan to submit your application in advance
of the deadline to allow time for any submission process troubleshooting required of the
applicant.
5.2 Letter of Intent (LOI)
Submit an LOI (two-page limit) that describes your idea and the fit to the overarching goals of
this program. LOIs will be evaluated to confirm each applicant’s eligibility for subsequent
application submission. The information provided will primarily be used to estimate the
potential review workload and plan the review.
Prospective applicants are also asked to provide in the LOI:
• Descriptive title of proposed activity
• Name(s), address(es), emails, and role(s) of the PD(s)/PI(s) and other key personnel
• Participating institution(s) – subcontracts of lead institution to other institutions are
allowed, but must be indicated in the letter
• General project aims and expected impact
• Estimated budget request for the proposed work
The LOI must be submitted through the ProposalCentral portal.
5.3 Formatting and Page Limits
For both the LOI and the proposal submission, please follow the format requirements. Margins
should be greater than or equal to 1/2" on all sides. Font should be Arial of size no less than 11
points. Applications must be written in English and formatted such that, if printed, would print
to 8.5” x 11” paper. PDF file formats are preferred. Editing permissions must not be restricted
and files must not be password protected.
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Proposals must adhere to a strict limit of 6 pages, single-spaced, including the technical
proposal, personnel, and any additional information. The page limits do not include the
additional biosketches, references, and letters of support.
5.4 Research Proposal Layout
Applicants are encouraged to use the suggested layout below:
Technical Proposal
 Project Summary: A paragraph that emphasizes the key attributes of the
proposed program at the start of the proposal.
 Scientific Background and Research Plan: This section summarizes the overall
importance of the proposed work, including the problem statement, hypothesis
and when available, the preliminary results, plus a list of the Specific Aims,
Proposed Approach and Specific Methodology, a detailed study timeline,
Alternative Hypotheses & Pitfalls, and Rationale and Fit with RFP Purpose &
Objectives
Description of Key Personnel
 Proposed PI, and proposed Team Governance Structure
Additional Information
 any additional information relevant to the Review Criteria listed above
An Appendix, which is not a part of the page count restrictions should include:
 NIH-formatted Biosketches for all Principal Investigator(s), Co-Principal
Investigator(s), and all Co-Investigator(s) (limit 5 pages per biosketch; please
combine all biosketches into one PDF with the PI(s) biosketch listed first.)
 Letters of Support – recommended from collaborators, mentors and institution
 Current and Pending support for all Principal Investigator(s), Co-Principal
Investigator(s), and all Co-Investigator(s)
 References
5.5 Budget
In the Budget Section of the proposal document, please include a budget, which includes
investigator effort and is supported by a letter from your division chief confirming that the
proposed effort is available and confirming investigator salary. The total indirect cost cap is
set at 8%.
Use of the NIH Salary Cap (https://grants.nih.gov/grants/policy/salcap_summary.htm) is
recommended.
The page limit for the Budget Section of the proposal document, including the budget
justification, is 5 pages.
VI. Selection Process and Award Management
6.1 Review and Selection Process
Applications will be evaluated for scientific merit by a Scientific Review Committee,
convened by the AF, and using the above stated review criteria. As part of the scientific peer
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review, highly-ranked applications will receive a written critique in ProposalCentral. Only those
applications deemed to have the highest scientific and technical merit will be discussed and
assigned an overall impact score. A final discussion of the review committee may be required
to recommend a list of the final applicants to be considered for award. The following factors
will be considered in making final AF funding decisions:
 Scientific and technical merit of the proposed project as determined by scientific
peer review;
 Relevance of the proposed project to program priorities (FastOA and OACTN);
 Strategic importance for the AF;
 Availability of funds.
A formal email notification will be provided to the applicant for successful applications. An
award notification is not an authorization to begin performance. Any costs incurred before
receipt of notice of award are at the recipient's risk.
6.2 Award Management and Reporting
After the award has been made, awardees will be required to submit Annual Progress Reports
and Annual Accounting Reports via the ProposalCentral platform in addition to a final report
once the project is complete. Annual reports on work progress will be expected in
presentation form to be given to fellow colleagues of the OACTN during meetings via
teleconference. Individual awards are based on the application submitted to, and as
approved by, the AF and are subject to the specific terms and conditions identified in the
notice of award. Additional regulations that need to be observed include the registration of
clinical trials within 21 days of protocol approval on ClinicalTrials.gov.
All awardees must acknowledge the support from this funding mechanism in all presentations
and publications related to this project by including the following language: “The authors wish
to acknowledge the Arthritis Foundation’s financial support for this work.” Any publications
supported in full or in part by this funding must also cite the grant Digital Object Identifier (DOI)
that will be assigned at the time of award activation.
VII. Contacts
Inquiries concerning this funding opportunity from potential applicants are welcome.
For general grants information and with questions regarding application instructions,
application, and processes, please email: AFscience@arthritis.org (preferred method of
contact)
Scientific/Research Contacts
Michelle McLeod, PhD Jason Kim, PhD
mmcleod@arthritis.org jkim@arthritis.org
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