Affordable Cancer Technologies (ACTs) Program

The ACTs Program encourages investigators to adapt, engineer, and apply new technologies for global cancer control. All ACTs Program supported projects explicitly consider affordability and cost-effectiveness in local health settings. 

The ACTs Program requires investigators to focus on preventable and/or treatable cancers in an LMIC setting and demonstrate utility of the proposed technology to improve cancer outcomes. This requires focus on real-world implementation with critical considerations for end-user design and implementation science. 

Some examples of new technologies might include

• platforms for risk assessment, early detection, and in vitro diagnosis (e.g., lab-on-a-chip and biosensor technologies that allow performance of chemical and biological assays outside of labs at point of care or point of need) 
• imaging modalities (e.g., optical imaging, spectroscopy, and portable, hand-held ultrasound) 
• treatment modalities (e.g., cryotherapy and photodynamic therapy) 
• decision tools (e.g., machine learning and artificial intelligence, image analysis, and robotics) 

Furthermore, environmental conditions, such as heat, humidity, and erratic electricity, pose significant challenges for medical devices outside of clinical laboratory settings. ACTs-supported technologies seek to address challenges by focusing on design-supported usability at the point of need. Such characteristics include

• ease of use (the device, technology, or assay must be suitable for use in the chosen setting by frontline health care workers or caregivers with minimal training in its operation and maintenance)
• operability in locations with limited clinical infrastructure (e.g., limited access to electricity, landline communication, refrigeration, or central water supply) 
• design for use at the community level or nontraditional health care settings 

Desirable attributes for ACTs technologies may also include

• rapid results (e.g., for diagnostic technologies) 
• risk-stratified approaches for risk assessment, early detection, or screening technologies 
• connectivity to the internet or telephone network (e.g., for telemedicine) 
• modular design to increase reliability and ease-of-use, and to simplify maintenance 
• internal performance checks, self-calibration, and error diagnosis 
• open-source hardware or software 
• standard readily available off-the-shelf components, such as power supplies, software, or approved imaging probes 

What is an low- and middle-income country (LMIC)?
The NCI uses the World Bank Country and Lending Groups to categorize LMICs for potential research sites and partnerships. Each ACTs grant must propose work in at least one LMIC project site and include LMIC investigators in the key personnel.

Can I propose work in an upper-middle-income country?
While work in upper middle-income countries is permitted, it will not count towards the requirement for an LMIC project site.

Should I include LMIC site personnel in the application?
Research equity and parity in research collaboration is an essential aspect of the ACTs Program. All ACTs projects must conduct research in an LMIC and include LMIC investigators in the senior personnel. For projects including scientists in both high-income countries (HICs) and LMICs, key personnel should contribute intellectually to the development of the research proposal and planned research activities.

Does the ACTs Program support traditional hypothesis-driven research?
No. ACTs supports pragmatic translational technology research only.

What is meant by the term “technology”?
In general, technology refers to instruments, devices, platforms, tools, and associated techniques or methods.

How much emphasis does the ACTs Program place on innovation?
The ACTs Program is focused on end-user design and the development of affordable and cost-effective technologies studied in local health care settings. Innovation for this program should be demonstrated through these design components, as well as the ultimate functionality and usability of the device or assay at the point of need.

Can multiple HIC institutions be part of the application?
Yes. We recognize that multidisciplinary teams needed for a successful ACTs application may require key personnel and experts from a variety of institutions.

Can multiple LMIC institutions be part of the application?
Yes. Multisite validation requiring sites in multiple LMICs can be an important component of some ACTs projects. When including multiple LMICs, it is essential that individuals from those institutions are represented in the key personnel and contribute intellectually to the research studies. 

How should the Milestones and Timelines section of the application be structured?
ACTs applications must include a specific section labeled Milestones and Timelines as a part of the Research Strategy portion of the application. Specific aims may not be regarded as milestones (unless they include quantitative end points). Specific aims describe the goals and intended path of the research, while milestones are a way of determining whether an applicant has successfully reached the specified goals. Milestones should be clearly stated and presented in a quantitative manner (e.g., numerical specifications of sensitivity and specificity or a count of some desired detection target), and include all of the following:

• timeline (Gantt chart) identifying milestones throughout the duration of the project is required
• milestones are goals that create go/no-go decision points in the project and must include clear and quantitative objective criteria for success
• annual milestones should function as indicators of a project's continued progress, revealing emergent difficulties, and will be used to evaluate the application in peer review and in consideration of continued funding for awarded projects in noncompeting award years
• milestones should be well described, quantitative, and scientifically justified

Examples of possible milestones/quantitative performance measures:

• detection of a targeted cancer cell in 109 normal cells
• demonstration that the measured analyte is highly correlated (Pearson correlation coefficient r >0.95) for a cancer question in a given human biospecimen when analyzed on different days; this should include mean, standard deviation, and relative standard deviation for repeatability targets superior to next best approach (if applicable)
• reduction of sequence read errors to one in 5,000,000 base pairs
• demonstration that the technology gives the same result in 95 out of 100 assays
• demonstration that the technology has >95% analytical and clinical sensitivity and specificity
• demonstration that the technology has high positive and negative predictive value
• demonstration that the technology can be n-fold faster, n-fold more sensitive, or n-fold more specific than the current "gold standard" technology

Applications lacking quantitative milestones, as determined by NCI program staff, will be returned to the applicant without review.

For applications including both HIC and LMIC investigators, is it expected that the HIC project director (PD) or principal investigator (PI) have worked in an LMIC?
No. Previous work in LMICs is not expected for the HIC PD/PI in applications including both HIC and LMIC investigators. Nevertheless, in such instances, evidence of past collaborations will strengthen the application.

What is the impact of 2 CFR 200.216 (prohibition on certain telecommunication and video surveillance services or equipment) on international collaborations and direct foreign awards?
NIH Guide Notice NOT-OD-21-041 summarizes new requirements for grant and contact recipients regarding use of federal funds prohibited for telecommunications providers. Please also refer to the FAQs for the guide notice and the Office of Management and Budget FAQs on these requirements.

For all awards at NIH, please note the following points:

• This requirement applies to grants and contracts and both direct and indirect costs.
• A grantee can use a prohibited provider as part of their grant; however, they cannot use NIH or US government funds to pay for their services or equipment. Grantee organizations must rebudget funds accordingly.
• There is no waiver process, nor exemptions or exceptions.

Who can apply to this request for applications (RFA)? Are industry applicants welcome? Are foreign institutions eligible?
Eligibility is addressed in Section III of the funding opportunity announcement (FOA). Eligibility is inclusive of applications from industry and foreign institutions.

What is the guidance for travel expenses?
Please refer to the Travel Expense Guidance from the NIH Grants Policy Statement.

Is new technology development allowed or encouraged?
Investigators are required to adapt, apply, and/or engineer an existing prototype or existing device, assay, or treatment for use in a low-resource setting. Projects making use of technologies for which an initial proof-of-concept has not already been demonstrated in cancer-relevant biological system or technologies not ready for advanced development and validation without substantial further developmental efforts are not responsive to this RFA.

Are technologies that have been commercialized eligible? 
Investigators are required to adapt, apply, and/or engineer an existing prototype or existing device/assay/treatment for use in a low-resource setting. This may include devices that have already been commercialized.

Can you comment on level of validation required for something to “count” as a validated biomarker?
Validation data should be sufficient to convince a peer review panel that the proposed translational technology research with the device or assay can go forward without the need for additional validation of new biomarkers.

What is the expectation for showing path to future commercialization, Food and Drug Administration (FDA) clearance, etc.? Is a detailed plan expected or a high-level approach?
Because this initiative is translational in nature and the goal of the program is ultimately high uptake of interventions in the community, addressing the path to commercialization and regulatory clearances is valuable and will be considered at a high level by reviewers, but this program will ultimately be primarily judged on the core design and engineering components of the project as well as the clinical validation studies in LMICs, not on proposed commercially driven activities.

Do applicants have to address FDA Investigational Device Exemption (IDE) requirements even though work is taking place at foreign sites? Is demonstration of regulatory approvals in the LMIC setting sufficient?
This is project-specific and should be discussed with local institutional review boards (IRBs), regulatory agencies, and key stakeholders. The ACTs-supported technology must comply with the applicable regulations and international standards/guidelines (such as Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP), WHO guidelines, FDA Investigational New Drug (IND), FDA Investigational Device Exemption (IDE) or local regulations in LMICs).

The ACTs Program management team includes representatives from many divisions, offices, and centers of NCI. The transdivisional, interdisciplinary nature of the management team is a unique feature and strength of the ACTs Program that promotes a more consolidated and balanced representation of technology interests and needs across NCI.

Click on any project title for a more detailed description of the project.

Additional Previously Funded Research:

• RFA-CA-15-024
• RFA-CA-15-001
• RFA-CA-13-015