Improving the Reach and Quality of Cancer Care in Rural Populations (R01 Clinical Trial Required)

Improving the Reach and Quality of Cancer Care in Rural Populations (R01 Clinical Trial Required) is sponsored by National Cancer Institute (NCI). This funding opportunity aims to reduce the burden of cancer and improve care quality in rural, low-income, and underserved rural populations.

Expired RFA-CA-18-026: Improving the Reach and Quality of Cancer Care in Rural Populations (R01 Clinical Trial Required) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Cancer Institute ( NCI ) Funding Opportunity Title Reach and Quality of Cancer Care in Rural Populations (R01 Clinical Trial R01 Research Project Grant September 12, 2019 - This RFA has been reissued as RFA-CA-19-064 .

Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) Funding Opportunity Purpose The purpose of this Funding Opportunity Announcement (FOA) is to reduce the burden of cancer and improve the quality of cancer care in rural areas among low-income and/or underserved populations.

The FOA encourages two types of applications: 1) observational research that includes pilot testing of intervention to understand and address predictors of cancer care/treatment and outcomes in rural low-income and/or underserved populations; or 2) intervention research to address known predictors of cancer care/treatment and outcomes in rural low-income and/or underserved populations.

Specifically, the focus for observational studies (with pilot testing) is understanding and addressing the predictive and/or mediating role of social determinants of health, barriers to care, and treatment; and the focus for interventional research is on addressing quality of care related to cancer diagnosis, treatment and/or survivorship.

Most existing cancer control interventions are not ready for direct implementation and dissemination in low-income rural areas, so proposals should seek to develop, adapt, and/or implement, and test Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date September 19, 2018, by 5:00 PM local time of applicant organization.

All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates. 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.

AIDS Application Due Date(s) It is critical that applicants follow the Research (R) Instructions (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of the Announcement I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Full Text of Announcement Section I.

Funding Opportunity Description The purpose of this Funding Opportunity Announcement (FOA) is: 1) to encourage observational research that includes pilot testing of interventions to understand and address predictors of cancer care/treatment and outcomes in rural low-income and/or underserved populations; or 2) to encourage intervention research to address known predictors of cancer care/treatment and outcomes in rural low-income and/or underserved populations.

Specifically, the focus for observational studies, that includes pilot testing, is understanding and addressing the predictive and/or mediating role of social determinants of health, barriers to care, and treatment. The focus for interventional research is on addressing quality of care related to cancer diagnosis, treatment and/or survivorship by targeting these predictive or mediating factors.

Applicants must include at least one aim that is pilot testing or testing an intervention. Most existing cancer control interventions are not ready for direct implementation and dissemination in low-income rural areas, so proposals should seek to develop, adapt, and/or implement, and test interventions Estimates of the total population living in non-metropolitan (rural) counties in the United States vary from 46.

2 million to 59 million people, compared to more than 250 million people living in urban areas. This represents 14-19% of the US population. Rural communities face notable issues compared to urban areas, including higher poverty rates, lower educational attainment, a higher proportion of elderly individuals, lack of access to health services, and limited resources to support the public health infrastructure.

Because of these and other factors (transportation; medical mistrust; discrimination), rural communities face elevated rates of morbidity and mortality, and greater percentages of potentially excess deaths from the five leading causes of death, including cancer.

Individuals in rural counties have an 8% higher overall cancer mortality rate than those in urban areas, with rural-urban disparities in mortality observed for lung, colorectal, prostate, and cervical cancers. In some cases, adjusting for socioeconomic status attenuates or completely explains the relationship between rurality and higher cancer mortality.

However, further research is needed to disentangle the myriad of social determinants of rural cancer outcomes. Recent studies using different cancer registries and definitions of "rural" report strikingly similar elevated cancer incidence rates in rural areas for many preventable cancers such as lung, cervical, oropharyngeal, and melanoma.

Additional rural-urban disparities across the cancer control continuum have been documented, although the existing literature is nascent and methodologically inconsistent compared with research identifying race-, economic-, and age-based disparities in cancer diagnosis, treatment, and survival.

Unpublished data from the National Center for Health Statistics, CDC, indicates that the HP2020 target of reducing cancer mortality was met by urban areas in 2013 but rural areas are projected to meet that target only in 2022. At least two studies have demonstrated that cervical cancer incidence is higher in rural areas.

Rural women may be less likely to receive follow-up testing after receiving abnormal screening results, and although findings are not consistent regarding rural-urban differences in stage at diagnosis, some research suggests that women from rural areas are more likely to be diagnosed with more advanced breast cancer compared to their urban counterparts. Evidence also suggests that there are rural-urban differences in cancer treatment.

For example, rural women are more likely to receive mastectomies than breast conserving surgery, and rural patients with either endometrial cancer or prostate cancer are less likely to receive radiation therapy than non-rural patients.

Although most research does not indicate that residing in a rural area is independently associated with substantially worse survival, there is evidence suggesting that individuals treated at lower-volume hospitals experience worse survival than those treated in higher volume facilities, and that rural cancer patients are more likely to receive treatment in lower-volume hospitals.

There is also evidence to suggest that rural cancer survivors experience worse quality of life and mental health outcomes than survivors from urban areas, and they may be less likely to use hospice care at the end of life. Specific Research Objectives The main goal of this FOA is to reduce the burden of cancer and improve the quality of cancer care in rural areas among low-income and/or underserved populations .

To reach this goal, we seek to fund studies that delineate the challenges to and strategies for delivering cancer care and treatment in rural areas , and develop and implement interventions in community and/or clinical settings. Proposals may assess and address quality of care indicators, health care delivery, and barriers that contribute to cancer burden in rural low-income and/or underserved populations.

The focus of the FOA is on rural low income/underserved populations. Thus, studies in rural areas may involve studies with small populations that cannot be that cannot be generalized to other contexts/populations.

However, these studies should adopt appropriate study designs to address the primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the does not focus on issues related to recruitment and retention of participants to clinical trials or other research studies; therefore, these would be considered non-responsive to the goals of this FOA and will not be reviewed.

This FOA requires that applicants define the rural population for the proposed study based on the non-metropolitan 2013 Rural-Urban Continuum Codes (RUCC) as defined at this link: https://www. ers. usda.

gov/data-products/rural-urban-continuum-codes. aspx . If questions are related to access and distance to care, applicants can also use the 2010 Rural-Urban Commuting Area (RUCA) codes ( https://www.

ers. usda. gov/data-products/rural-urban-commuting-area-codes/ ) to define the rural population and/or analyze the data.

Applicants are required to justify how their grant addresses a rural population that is also primarily low income and/or underserved.

The greater availability of granular data and better understanding of issues related to place (geospatial and community factors) will allow for local customization and adaptation of interventions, Applications may cover a range of activities that contribute to cancer care delivery and treatment challenges in rural populations, including (but not limited to) the following: Barriers to accessing health services (e.g., financial hardships, such as being underinsured or uninsured; shortage of physicians; oncology specialists; distance from treatment facilities; no personal vehicle and/or lack of access to public transportation to reach services; place/built environment; prejudice/discrimination) Evaluation of natural experiments, programs, and policies to improve care and access to treatment services in rural areas that may interact with the implementation of the intervention and potentially influence effectiveness The role of social determinants of health, including socioeconomic factors, cultural differences that influence trust in and attitudes toward institutions, medical providers, and government-sponsored Limitations in information technology that may limit access to patient portals, telehealth, or other proposed strategies to improve patient-provider communication and care in rural communities IT-enabled, team-based care delivery models that could improve the delivery of guideline-concordant, high-quality cancer care among rural populations (e.g., studies of innovative care delivery interventions using telemedicine and other technologies or novel strategies designed to deliver comprehensive, coordinated, high-quality cancer-related care to rural low-income and/or underserved populations) Interventions designed to improve primary/specialty collaborative care to enhance the dissemination of state of the art cancer care and follow-up.

A wealth of rural health expertise exists outside of the traditional cancer research enterprise, affording many opportunities to better utilize this experience in cancer control studies.

The FOA promotes collaboration among researchers from the cancer control research community and research communities that are less likely to be involved in such research, including demographers, geographers, transportation researchers, economists, and sociologists who have demonstrated experience working on urban-rural differences in diverse factors potentially relevant to cancer care and It is equally important that these projects be developed and designed with relevant community stakeholders and rural health care delivery partners to strengthen or enhance existing, sustainable programs that can be expanded to have a downstream effect on population health.

Applicants are strongly encouraged to collaborate with organizations and programs with experience or infrastructure (e.g., telemedicine, social, clinical and behavioral health services) designed to address other health or social problems in rural populations that could afford substantial opportunities to improve cancer care quality, delivery and outcomes.

For example, partnerships with community-affiliated clinics or hospitals, state or county offices of rural health, departments of health, education, or human services, or other community organizations, and engagement of community advisors are strongly encouraged.

Annual PDs/PIs Meetings and Collaborative Activities Awardees are expected to attend semi-annual and annual meetings and participating in working groups/collaborative committees. The locations of semi-annual meetings will vary depending on sites funded through the initiative.

These meetings will provide a venue for presenting scientific findings from each of the funded studies and are intended to facilitate synergistic interactions among the projects within the evolving community of In order to advance transdisciplinary science in rural communities, awardees may also form collaborative committees that would meet periodically by conference calls as needed.

PDs/PIs will be expected to participate in these conference calls for planning purposes at monthly or other VIII. Other Information for award authorities and regulations. Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on Required: Only accepting applications that propose clinical help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards NCI intends to fund an estimate of 8-10 awards, corresponding to a total of $7 million, for fiscal year 2019. Future year amounts will depend on annual appropriations.

Budgets for applications that propose an observational study that includes pilot testing are limited to $400K direct costs per year. Budgets for applications that propose intervention projects are limited to $500K per year in direct costs. The scope of the proposed project should determine the project period.

The maximum project period is 5 years. Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions o Asian American Native American Pacific Islander Serving Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible Foreign components, as defined in the NIH Grants Policy Statement , are not allowed.

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted.

Registration can take 6 weeks or more, so applicants should begin the registration process as soon as Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number.

After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application. System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually .

The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to must have an active DUNS number and SAM registration in order to complete the Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account.

PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time.

This means that the NIH will A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101 ). Section IV. Application and Submission Information Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA.

See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2. Content and Form of Application Submission It is critical that applicants follow the Research (R) Instructions (R&R) Application Guide , except where instructed in this funding opportunity announcement to do otherwise.

Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: National Cancer Institute (NCI) All page limitations described in the SF424 Application Page Limits must be followed.

Instructions for Application Submission The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an All instructions in the SF424 (R&R) Application Guide SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide Travel: Applicants must plan appropriate travel funds for the PD(s)/PI(s) and selected members of the research team to participate in an annual meeting to enhance the research agenda in rural areas in cancer control.

Budgets should account for the traveling of Key Personnel and other necessary costs. PD(s)/PI(s) are required to attend, while the attendance of other personnel is optional.

All instructions in the SF424 (R&R) Application Guide PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Strategy: The Research Strategy should clearly describe the following within the appropriate section (i.e., Significance, Innovation, The quality of cancer care challenges in rural areas among low-income and/or underserved populations to be investigated, its significance, and the relevance of the approach to the cancer control research question being How the proposed approach could ultimately bring insight to developing and implementing strategies for delivering cancer care and treatment How the approach will lead to reducing the burden of cancer and improve the quality of cancer care in rural areas among low-income and/or Innovation: Rural Populations Cancer Care Delivery Novel or hitherto not used concepts, approaches, interventions, tools, or technologies for the proposed studies.

Approach: Research Design The research design, conceptual procedures, and analyses to be used to accomplish the Specific Aims of the project and the rationale for selecting these approaches. It is appropriate for intervention studies to adopt quasi-experimental designs where appropriate. The potential difficulties and limitations of the proposed procedures and alternative approaches to achieve the aims.

How will the observational studies lead to pilot studies that can address the gaps in research and implementation of cancer control research? How will the interventions lead to reducing the burden of cancer these rural low income/underserved populations?

Although the studies supported by this initiative will not use a common study protocol, whenever possible, investigators are expected to meet after the awards are made and should, to the extent possible, collaborate and report in a standardized manner when they are measuring key common variables, such as social and environmental determinants of health, access to care, etc. Investigators may also use different methods of measuring similar outcome variables when justified.

Investigators may also collaborate in the development of formative assessment measures, such as survey instruments and focus group Describe appropriate milestones to be achieved during the proposed project period toward accomplishing the stated aims of the Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Only limited Appendix materials are allowed.

Follow all instructions for the Appendix as described in the SF424 (R&R) Application PHS Human Subjects and Clinical Trials Information When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions: If you answered "Yes" to the question "Are Human Subjects Involved?"

on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Record: PHS Human Subjects and Clinical Trials Information All instructions in the SF424 (R&R) Application Guide All instructions in the SF424 (R&R) Application Guide PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide 3.

Unique Entity Identifier and System for Award Management (SAM) See Part 1. Section III. 1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Part I.

Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday , the application deadline is automatically extended to the next Organizations must submit applications to Grants.

gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons , NIH's electronic system for grants administration. NIH and Grants.

gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants. gov on or before the application due date and time.

If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide. 5. Intergovernmental Review This initiative is not subject to intergovernmental All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement .

Pre-award costs are allowable only as described in the NIH Grants Policy Statement . Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission Electronically . If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must for Applicants Experiencing System Issues . For assistance with application submission, contact the Application Submission Contacts in Section VII .

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package . Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization's profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide. See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations , NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy . Any instructions provided here are in addition to the instructions in the Section V. Application Review Information Only the review criteria described below will be considered in the review process.

As part of the NIH mission , all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs.

Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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 following review criteria and additional review criteria (as applicable for the Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each.

An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field. Does the project address an important problem or a critical barrier to progress in the field?

Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms?

For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?

For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training?

If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics?

For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center? Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions?

Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice? Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project?

Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success