News & Insights

GHTC submitted the below response to a request for information (RFI) on proposed changes to reporting outcomes from US National Institutes of Health (NIH) Peer Review, urging the agency to maintain a rigorous, transparent, and effective peer review process through any reforms to the process.The Global Health Technologies Coalition (GHTC), a coalition of more than 50 nonprofit organizations, academic institutions, and aligned businesses working to accelerate the development and delivery of new drugs, vaccines, diagnostics, and other health technologies, is committed to ensuring the NIH sustains a strong, predictable environment for scientific discovery to advance global health research and development (R&D). GHTC supports NIH’s goal of ensuring funding decisions reflect the full substance of scientific peer review. If NIH moves toward broader categories for reporting review outcomes, it should ensure that qualitative feedback is sufficiently clear and actionable to help researchers understand the scientific strengths and weaknesses identified through peer review and, where appropriate, improve future applications.  Peer review enables global health R&D NIH’s investments in early-stage biomedical research are critical for the global health R&D ecosystem. NIH support has helped advance more than 45 new global health technologies since 1999, including Lenacapavir for long-acting HIV prevention, monoclonal antibodies to treat Ebola, and new drugs to combat drug-resistant tuberculosis. The science leading to each of these transformative innovations moved through the NIH peer review process. For global health R&D, where promising discoveries often move through long and interconnected development pathways, GHTC’s primary interest is ensuring that NIH maintains a rigorous, predictable, and scientifically independent research environment that enables strong ideas to advance and researchers to continue improving the science. Transparency for researchers As NIH simultaneously implements a more flexible approach to funding decisions under the Unified Funding Strategy, transparency regarding how scientific merit is considered alongside programmatic priorities, portfolio needs, workforce considerations, and available resources will be important. Clear and consistently applied processes can help preserve confidence in the independence of scientific review while giving NIH appropriate flexibility to steward its research portfolio.  Researchers should be able to understand the substantive scientific feedback on their applications and use that feedback to inform future research and applications. Historically, scores, percentiles, and paylines have provided researchers with useful reference points in the review and funding process. If NIH moves away from this traditional system, the qualitative feedback provided through peer review becomes even more important. Written critiques and panel discussion summaries should provide researchers with sufficient information to understand the scientific strengths and weaknesses identified during review and assess whether and how to revise and resubmit an application.  Maintain scientific independence  Researchers and institutions have experienced significant changes to NIH funding policies, priorities, and grantmaking practices over the past year. Additional reforms should be implemented in a measured and thoughtful manner and clearly communicated to stakeholders to minimize unnecessary disruption to the research ecosystem. As the peer review and funding processes evolve, NIH should continue to provide clear safeguards and transparency regarding the respective roles of scientific peer review and programmatic considerations in final funding decisions. Preserving confidence in the independence and integrity of peer review is essential to maintaining researcher participation and ensuring that NIH investments continue to support high-quality science. A rigorous, transparent, and effective peer review process will help ensure that NIH resources continue to support scientific discovery and that today’s research can become tomorrow’s health technologies. 

GHTC submitted the below response to a public hearing on a proposed reorganization of the National Institute of Allergy and Infectious Diseases (NIAID), warning of potential implications and urging the need for transparency throughout any future restructuring efforts.The National Institute of Allergy and Infectious Diseases (NIAID) is one of the world’s leading funders of global health research and development (R&D) and plays a unique role within the National Institutes of Health (NIH). The Institute’s mandate requires it to anticipate and respond to emerging and persistent infectious disease threats, advance understanding of disease mechanisms, and support the development of critical countermeasures. As the Global Health Technologies Coalition (GHTC), a coalition of more than 50 nonprofit organizations, academic institutions, and aligned businesses working to accelerate the development and delivery of new drugs, vaccines, diagnostics, and other health technologies, we are committed to ensuring that NIAID’s structure and mandate sustain this work.The Division of Clinical Research (DCR) is a key component of the research ecosystem, providing the infrastructure, oversight, expertise, and standards needed to translate scientific discoveries into safe and effective interventions for patients. DCR’s centralized structure within NIAID has supported patient safety, scientific integrity, clinical trial operations, and the advancement of medical innovation. These functions are essential for moving promising discoveries from the laboratory into products that can improve and save lives.This is particularly important for global health R&D. Clinical research increasingly spans borders, disease areas, and institutions, with universities, academic medical centers, nonprofit product development partnerships, and other partners contributing essential expertise and infrastructure. International clinical research is necessary to ensure that new tools are effective across diverse populations and can ultimately be developed into affordable, fit-for-purpose products for communities facing the greatest disease burdens. DCR provides multi-disciplinary services across NIAID to help facilitate high-quality clinical trials across the globe. Maintaining strong coordination between domestic and international research efforts is therefore essential to US leadership in biomedical innovation and global health.The proposed reorganization of NIAID, including the dissolution of DCR and redistribution of its core functions, risks undermining this coordination by creating new silos, fragmenting clinical research expertise and oversight, and weakening integration across domestic and international research activities. It could also introduce unnecessary disruption at a time when the United States must strengthen, not weaken, the infrastructure needed to respond rapidly to infectious disease threats and translate scientific advances into effective countermeasures.Additionally, it is critical to ensure that with any restructuring, NIAID maintains transparency, consistency, and strong oversight of clinical operations. Disruptions to established systems and expertise should not contribute to funding and administrative delays, increase burdens on clinical research partners, or jeopardize the timely, safe, and effective conduct of clinical trials. Ultimately, we ask NIAID to ensure these changes do not slow the development of new interventions against some of the world’s most pressing health challenges.NIAID’s ability to connect basic science, clinical research, and product development is a critical component of US biomedical leadership. Preserving the infrastructure and coordination that make this possible—including a strong, centralized clinical research function within NIAID—is essential to protecting research participants, maintaining scientific rigor, advancing global health R&D, and ensuring that US investments in discovery translate into health technologies that reach the people who need them most.