ACCrual, Enrollment, and Screening Sites (ACCESS) Hub FAQs

I am an investigator interested in finding funding for a specific cancer screening clinical trial. Is the ACCESS Hub RFA a good fit for my study?

It's probably not a good fit. Although the CSRN will support investigator developed studies in the future, the initial funding cycle will be devoted to the Vanguard Study. Applicants can propose screening clinical trials through Division of Cancer Prevention funding opportunities including: PAR-21-035 Cancer Prevention and Control Clinical Trials Grant Program and PAR-22-174 Cancer Prevention and Control Clinical Trials Planning Grant Program.

Application Considerations

Can ACCESS Hubs have subsites?

Yes. An ACCESS Hub can be composed of multiple different institutions (subsites). ACCESS Hubs are intended, but not required, to have multiple affiliates or components. The ACCESS Hub applicants should describe how they have participated in clinical research with affiliated institutions or subsites, and how they will leverage the strengths and diversity of their catchment areas.

Do ACCESS Hub applicants need to include a current NCI grantee, such as an NCI-Designated Cancer Center?

No. ACCESS Hubs are not restricted to current NCI grantees or academic centers. NCI understands there will be interest from current NCI grantees including NCI Community Oncology Research Program (NCORP), National Clinical Trials Network (NCTN), or NCI Cancer Centers. NCI also expects that the CSRN would benefit from settings and organizations that may not have previously been involved in cancer clinical trials and welcomes all interested organizations to apply.

Are there targets for the number of academic centers (versus healthcare systems or other types of applicants) awarded as CSRN ACCESS Hubs?

No. NCI is interested in having a diverse group of healthcare organizations and systems serve as ACCESS Hubs. The selection of the ACCESS Hubs will be dependent upon scientific peer review and geographic distribution so that ACCESS Hubs are balanced across the United States.

How important will it be to have an established track record of cancer or other disease screening trial accrual at a community affiliate organization, as opposed to demonstrating the capacity and potential to accrue participants to screening trials with a new Affiliate Organization in the future?

It is important for ACCESS Hub applicants to have demonstrated experience in cancer or other disease screening trials. The NCI welcomes applicants from new organizations to the CSRN. If an institution experienced in clinical trial believes that a less experienced organization has the potential for participant accrual and the experienced institution can mentor and provide infrastructure for the new site, it would be acceptable for the inexperienced site to partner as an affiliate organization.

Will there be an opportunity for the ACCESS Hubs to propose studies, or screening technologies, for the Network to assess?

Yes. Investigators may identify concepts for potential screening studies in the future. An independent process will evaluate the criteria for any screening technology to be used in CSRN studies. Investigators will have input in the final selection. Of note, it is anticipated that the first study run by the Network will be the Vanguard Study and this will require the bulk of the effort for the Network during the initial four-year award.

What types of trials can be listed in attachments 1 (and 2 for the ACCESS Hubs)?

All completed screening and or prevention trials (no sponsor specifications) over the past 5 years should be listed. Current trials may also be listed. The objective for the attachment(s) is to provide the peer reviewers with the examples of trials in which the institutions within ACCESS Hubs have participated.

What is the definition of a screening trial for attachments 1 and 2? 

The term "screening trial" may be defined broadly. Any trial that addresses cancer screening (for attachment 1) and screening for non-cancer diseases (for attachment 2) may be included. Prevention trials also may be included. This list is not required to be exhaustive, rather, it is intended to provide peer reviewers with examples of trials the institution has performed that are relevant to participation in the CSRN. 

What is required for attachment 3?

The intent for attachment 3 is for applicants to demonstrate, in detail, how a diagnostic workup would be performed if an MCD test returned a positive result. Because there is variability in how a positive result would be reported, applicants should define reporting assumptions, and then demonstrate how the workup would be performed. For example, applicants may state that the MCD returned a positive test with a likely tissue of origin as “intestinal” and then describe the workup that would follow. Please be as detailed as possible in describing how the participant would receive this workup—including contingencies if the first diagnostic test is negative—and how the diagnostic data would be captured.

How should applicants complete the Human Subjects and Clinical Trial section of the application?

You are not required to propose a study for this application. The preliminary design of the Vanguard Study has been provided to you in the RFA. This study will be the initial protocol designed by the CSRN and is anticipated to occupy the bulk of the 4-year funding cycle.

In addition, the electronic application section “R&R Other Project Information Form” will require selection of “Delayed Onset Study.” As described in the RFA, applicants should write "Multiple Delayed Onset Studies" in the Study Title section and select “Anticipated Clinical Trial.” For the “justification attachment” applicants may use or slightly modify the following language in the RFA based on their institutional needs: “Indicate that the clinical trials will be designed and conducted by the CSRN with NCI assistance during the Project Period. Each clinical trial protocol developed will be subject to approval through the standard NCI procedure that involves an initial concept submission and subsequent review. If the concept receives approval, the next stage will be development of the full clinical trial protocol, which will be subject to review and approval by NCI prior to activation through the CSRN.” Applicants are not required to propose a design for a delayed onset study.

Should ACCESS Hub applicants include specific study outcomes in their proposals?

This is not required. The actual outcomes will be specified in each CSRN protocol which will be written by the Steering Committee and appropriate CSRN working groups after the Network is funded. An ACCESS Hub applicant may include in their application specific outcomes that they anticipate collecting for the Vanguard Study. ACCESS Hubs should define how data will be collected to assess common health outcomes (examples may include: cancer diagnosis, cancer stage, cancer type, adverse events, mortality) at their institution(s) to demonstrate infrastructure and capacity.

Principal Investigator(s) and Leadership Teams

What are the expectations for expertise within the ACCESS Hub multidisciplinary leadership teams?

ACCESS Hubs are expected to have multi-disciplinary teams to recruit participants to CSRN trials and studies, conduct the screening protocols, and participate in the scientific development and implementation of those trials and studies. Ideally, the investigators will include a diverse group of medical specialties.

If an ACCESS Hub applicant has substantial experience, funding, and publications in cancer screening research and trials, is it necessary to also include investigators who do other (non-cancer) screening research in their application?

No. Each applicant should determine the composition of their team based on the requirements and description in the RFA.

Budget

Does the $750,000 cover participant compensation or incentives?

Yes. Applicants may include participant compensation or incentives funds as part of their overall budget request, which cannot exceed the limit of $750,000 direct costs per year.

For ACCESS Hub applicants, should the cost of the diagnostic workup for screen positive participants be included in the application budget?

Applicants may include an estimate for diagnostic workups that may not be covered by insurance in their budget (with a limit of $50,000 in direct costs over the 4 year period). We anticipate that some of the diagnostic imaging/procedures will be covered by insurance providers. The Vanguard is a pilot study to assess feasibility. Funding for the diagnostic workup is one of the operational issues that will be assessed and addressed over time.

The RFA-CA23-020 says, “Available funds may increase after year 1, dependent upon accrual to the Vanguard Study.” How should ACCESS Hubs budget for participant accrual to the Vanguard Study over the four-year funding period?

ACCESS Hub applicants should budget for the number of asymptomatic participants that they anticipate accruing to the Vanguard Study. The overall CSRN funding is expected to increase in years 2 and 3 because the majority of study accrual will occur in those years.

On average, ACCESS Hubs will accrue 1,600-2,400 participants into the Vanguard Study, primarily over two years (project years 2-3). It is expected and acceptable that ACCESS Hubs will not contribute equal numbers of participants to the study given the size and scope of their individual subaffiliate consortium and the demographic characteristics of their unique catchment areas.

For budget purposes, do the ACCESS Hubs need to include the collection of samples and the MCD assays in their budget?

ACCESS Hubs should budget for blood collection, but not shipping or the cost of running the MCD assay, in their applications.

Do ACCESS hubs need to budget for data deposit to Cancer Data Access System (CDAS)?

No. ACCESS Hubs do not need to budget for data deposit to CDAS.

Should applicants include funds for local auditing in their budgets?

The Coordinating and Communication Center will be primarily responsible for auditing costs. ACCESS Hubs may include costs for the auditing process at the local level (e.g., document redaction or staff milage from affiliate sites) in their budgets. ACCESS Hubs must provide data quality control for their sites and should include data quality control and monitoring costs in their budgets.

Vanguard Study Recruitment and Procedures

What participant accrual characteristics do you want to see in a successful application?

Overall, CSRN studies will seek to accrue participants who reflect the population that would benefit from cancer screening and include individuals who are traditionally underrepresented in clinical trials. Each ACCESS Hub will contribute to this goal by reflecting the diversity of their communities and catchment areas in their participant accrual demographics.

Will ACCESS Hubs be expected to focus on specific populations to recruit to the Vanguard Study?

Each ACCESS Hub will be expected to recruit participants representative of the diversity in their catchment area. The intent of the Vanguard Study is to enroll a broad spectrum of asymptomatic, average-risk participants who are representative of the population that would benefit from cancer screening. It is important that specific populations that are traditionally medically underserved or have historically low representation in clinical trials are effectively recruited into the Vanguard Study.

How many participants are ACCESS Hubs expected to enroll per year and over the entire grant period?

If 10-15 ACCESS Hubs are awarded as expected, each ACCESS Hub would recruit approximately 1,600 to 2,400 participants over two years to the Vanguard Study. This is an estimate and Hubs may not contribute equal numbers of participants. Based on the Vanguard Study concept, as described in the RFA, NCI expects that the network would accrue 24,000 participants in about two years (approximately 8,000 individuals per arm, three arms total).

When the RFA states “minority populations,” how are minority populations defined?

NIH uses the minority racial and ethnic groups defined by Office of Management and Budget (OMB Directive 15), which are: American Indian or Alaska Native, Asian, Black or African American, and Native Hawaiian or other Pacific Islander. The ethnicity used is Latino or Hispanic. Although these minority racial and ethnic group categories are required, the mixed or multiple race category should also be included if possible.

It is expected that CSRN trials will address questions related to health disparities and social determinants of health (SDOH). The Department of Health and Human Services defines SDOH as the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect health, functioning, and quality-of-life outcomes and risks. For NIH, populations that experience health disparities include racial and ethnic minority groups (OMB Directive 15), people with lower socioeconomic status (SES), underserved rural communities, and sexual and gender minority (SGM) groups. Applicants may identify unique populations of interest in their catchment area not listed above.

Note that evaluation criteria specific to this RFA includes reviewer consideration of the following:

• To what extent does the team have a history of successful accrual of recruitment of minority, underserved, and uninsured populations?
• How well do the research plans demonstrate the potential to overcome critical barriers for robust accrual to cancer screening clinical trials across large populations, including minority and/or underserved populations?

Will participants in the Vanguard Study be given results of their MCD tests? Will ACCESS Hubs be required to provide follow-up?

Yes. Participants in intervention arms of the Vanguard Study will receive their MCD test results. ACCESS Hubs must offer participants the appropriate follow-up diagnostic workup, as described in the study protocol.

Participants will be followed for cancer and mortality endpoints through the initial four year CSRN funding cycle.

Other

What are NCI expectations for the ACCESS Hub Administrator role?

The NCI does not have specific requirements for the role of the research administrator. The applicant organization should define the role of the research administrator based on the needs of the proposed ACCESS Hub and availability of existing resources. Roles and responsibilities may include leading clinical research operations, program management, communication, finance, quality assurance, regulatory compliance, etc.

Are there specific certifications required to become an ACCESS Hub?

No. There are no certifications required to become an ACCESS Hub.

Previous Next