Federal policy shapes the landscape of cancer research, influencing the speed of scientific discovery and the development of new treatments. The Donald Trump administration (2017 to 2021) saw a dynamic interplay between executive budget proposals and congressional appropriations concerning the nation’s biomedical research enterprise. Policy actions focused on financial support for federal science agencies and regulatory changes intended to accelerate patient access to investigational therapies. This environment defined the trajectory of several large-scale federal initiatives aimed at combating cancer.
NIH and NCI Funding Levels
The administration’s budget requests for the National Institutes of Health (NIH) and the National Cancer Institute (NCI) consistently proposed significant reductions. For example, the 2018 budget proposal sought to cut NIH funding by approximately $6 billion, an 18% decrease from the enacted level. This proposal included a near $1 billion reduction for the NCI, the primary federal agency for cancer research.
This pattern continued throughout the four-year period, culminating in the Fiscal Year 2021 request proposing a 7% cut for the NIH and a 9% cut for the NCI. These proposed reductions were often criticized by the biomedical research community and members of Congress. The rationale was generally tied to a broader strategy of reducing non-defense discretionary spending.
Congress consistently rejected these proposed cuts and instead provided annual increases for both the NIH and the NCI. This bipartisan support resulted in a steady upward trajectory for cancer research funding. Over the four-year period, the NIH received consecutive increases, adding billions of dollars to its budget and insulating grants from the proposed austerity measures.
Regulatory Reforms Affecting Clinical Trials
A primary focus of policy reform centered on accelerating the timeline for patients with life-threatening conditions to access experimental medicines. The most significant action was the signing of the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Public Law 115-176) into federal law in May 2018. This legislation established a new pathway for patients diagnosed with an imminently life-threatening disease, such as cancer, to obtain investigational drugs.
The law requires eligible patients to have exhausted all approved treatment options and be unable to enroll in a clinical trial. The drug must have successfully completed a Phase I clinical trial, confirming its initial safety profile. This mechanism allows manufacturers to provide the drug directly to the patient, bypassing the need for approval from the Food and Drug Administration (FDA) through its traditional Expanded Access program.
The intent was to streamline the administrative burden, placing the decision among the patient, their physician, and the drug manufacturer. Manufacturers must report annually on the use of their products under the new pathway. This approach aimed to increase patient autonomy while maintaining basic safety standards.
Legislative Focus on Pediatric and Rare Cancers
Specific legislative action focused on defined patient populations, particularly children and adolescents with cancer. The Childhood Cancer Survivorship, Treatment, Access, and Research (STAR) Act (Public Law 115-180) was signed into law in June 2018. It became the most comprehensive federal legislation to specifically address pediatric cancer, designed to enhance research, improve surveillance, and support survivors.
A primary provision of the STAR Act authorized the National Cancer Institute (NCI) to expand efforts in collecting biospecimens from children, adolescents, and young adults (AYAs) with cancer. This initiative focused on subtypes with the least effective current treatments, aiming to better understand their causes and progression. The collection of these biological samples and corresponding clinical data bolsters biorepositories for research.
The legislation also reauthorized and strengthened the national childhood cancer registry. It granted the Centers for Disease Control and Prevention (CDC) the ability to issue grants to state registries for improved tracking and reporting of pediatric cancer cases. Furthermore, the STAR Act mandated increased research into the late effects of childhood cancer treatments, such as secondary cancers, heart problems, and cognitive issues. It also called for research on methods to improve survivorship care and reduce health disparities.
Strategic Approach to Existing Research Initiatives
The administration maintained the framework of the Cancer Moonshot initiative, originally launched in 2016 to accelerate a decade of research progress into five years. This program was funded through a mandatory appropriation via the 21st Century Cures Act, a mechanism that provided insulation from annual budget negotiations. This dedicated funding stream allowed the initiative’s strategic goals to continue uninterrupted.
The National Cancer Institute (NCI), which managed the initiative, continued to prioritize research in areas such as immunotherapy, precision medicine, and enhanced data sharing. Efforts focused on building a robust national cancer data ecosystem, like the NCI Cancer Research Data Commons, allowing researchers to pool and analyze complex data sets. This strategic continuity emphasized collaborative science and the rapid translation of basic research findings into new clinical applications.
A specific strategic initiative supported was the Childhood Cancer Data Initiative (CCDI), which aimed to create a centralized data platform for pediatric cancer research. This initiative concentrated on aggregating clinical, molecular, and imaging data to help scientists better understand the unique biology of childhood cancers. Ongoing support for these data-intensive projects reflected a commitment to leveraging national resources for high-priority areas in oncology.