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Issued by

National Cancer Institute (NCI)

Purpose

Through this Notice of Request for Information (RFI), the US National Cancer Institute (NCI) is soliciting input about how to increase high-quality cancer therapeutic clinical trials in low- and middle-income countries (LMICs) as well as the key research priorities for such clinical trials. This RFI is part of the US NCI Center for Global Health’s (CGH) effort to further the conduct of cancer therapeutic clinical trials in LMICs.

Background

Cancer is increasingly a major public health issue worldwide, including in LMICs, as premature deaths from infectious diseases and other causes decline. By 2040, approximately 70% of all global cancer deaths will occur in LMICs. In high-income countries (HICs), cancer therapeutic clinical trials including a large portfolio supported by the NCI have contributed to significant mortality declines for many cancers and new standards of care that have been rapidly incorporated into guidelines and practice. However, relatively few cancer therapeutic clinical trials have been conducted to date in LMICs either with NCI support or with support from other international funders. In addition to this clinical need, potentially unrealized scientific opportunities for cancer clinical trials in LMICs include the ability to investigate specific types of cancer which occur with high frequency in LMICs, potential genomic or other cancer biology differences in LMICs, diverse patient and population characteristics in LMICs including differing comorbidity burden as compared with HICs, and marked variations in health system and sociocultural contexts.

In HICs, the conduct of clinical trials has become increasingly more complex and costly with major data and regulatory requirements, often with inclusion of numerous specialized outcomes and endpoints that depend on advanced imaging or novel biomarkers. In addition to the ability to answer novel research questions through well conducted cancer therapeutic clinical trials in LMICs, such efforts might also provide opportunities to develop and test new models for delivering clinical trials that increase efficiency, reduce cost, reduce patient and provider burden, and generate clinically meaningful results sooner for patients globally.

CGH helps to lead and coordinate global health efforts at NCI. A priority of the 2021-2025 NCI CGH Strategic Plan is to explore how NCI might contribute to increasing impactful cancer clinical trials conducted in LMICs to accelerate progress and increase knowledge for people affected by cancer globally, including in the US. Further details about NCI CGH, the strategic plan and currently funded programs can be found at https://www.cancer.gov/about-nci/organization/cgh

Information Requested

NCI seeks information and recommendations that will help identify best practices, challenges, and strategies to overcome them, resources, and opportunities to enhance cancer therapeutic clinical trials specifically in LMICs. In the context of this RFI, cancer therapeutic clinical trials include surgical, radiotherapy, chemotherapy, immunotherapy, or other interventions that target a specific cancer type after it develops.

NCI requests broad public input from, but not limited to, the extramural research community, professional organizations, advocates, cancer survivors, healthcare practitioners, and research participants. NCI is especially interested in receiving comments from investigators and institutions in LMICs and those in the US and who have successfully partnered with investigators and institutions in LMICs.

NCI seeks comment on any of the subjects listed above and offers the following topics for response:

1. Primary challenges or barriers to conducting cancer therapeutic clinical trials in LMICs.
2. Successful strategies to overcome or mitigate these challenges.
3. Other strategies that might be tried to help address these challenges.
4. The role of national and local cancer control priorities in planning and implementing cancer therapeutic clinical trials in LMICs.
5. Cultural, ethical or country-specific obstacles that may impact advancing cancer therapeutic clinical trials in LMIC.
6. Components and key characteristics of a highly effective cancer therapeutic clinical trials network in an LMIC setting.
7. Specific scientific or disease areas that should be the focus of clinical trial efforts in LMICs.
8. Ways in which cancer therapeutic clinical trials in LMICs can impact clinical care and/or reduce cancer mortality.

How to Submit a Response

Responses to this RFI must be submitted electronically at NCICGHClinTrialsinLMIC@mail.nih.gov . We request that responses are limited to a maximum of 10 double-spaced pages.

Responses will be accepted through 11:59 p.m. Eastern Standard Time on March 10, 2023.

Responses to this RFI are entirely voluntary and may be submitted anonymously. If willing, you may indicate your background (e.g., academic institution, US researcher, non-US researcher, private sector, and the public) and/or country of origin. Do not include any personally identifiable information or any information that you do not wish to make public, unless you are interested in participating in a follow-up interview, in which case please provide your name and email address. The NIH is committed to learning from the responses to this RFI and will share a summary of the information collected from all respondents who provide their name and email address.

Do not include any proprietary, classified, confidential, trade secret, or sensitive information in your response. The responses will be reviewed by NIH staff, and individual feedback will not be provided to any responder except as described above. The Government will use the information submitted in response to this RFI at its discretion. Any identifiers (e.g., names, institutions, e-mail addresses, etc.) will be removed when responses are compiled. The Government reserves the right to use only the processed, anonymized results on public NIH websites, in reports, in summaries of the state of the science, in any possible resultant solicitation(s), grant(s), or cooperative agreement(s), or in the development of future funding opportunity announcements.

This RFI is for information and planning purposes only and shall not be construed as a solicitation, grant, or cooperative agreement, or as an obligation on the part of the Federal Government, the NIH, or individual NIH Institutes and Centers to provide support for any ideas identified in response to it. The Government will not pay for the preparation of any information submitted or for the Government’s use of such information. No basis for claims against the U.S. Government shall arise as a result of a response to this RFI or from the Government’s use of such information.

NIH looks forward to your input and we hope that you will share this RFI document with your colleagues.

Inquiries

Please direct all inquiries to:

Ophira Ginsburg, MScMD
Senior Advisor for Clinical Research
Center for Global Health
National Cancer Institute (NCI)
Email: Ophira.Ginsburg@nih.gov