Today, the National Institutes of Health (NIH) stands at a crossroads. While the agency continues to receive bipartisan support and continued increases in funding, the NIH has long faced structural challenges related to the grant-making process, the pace of research, and the work of translating discoveries into clinical practice. The COVID-19 pandemic has shed more light on the highs and lows of the National Institutes of Health. On the other hand, the agency has sponsored critical science underlying diagnoses, treatments, and vaccines. However, at the same time, the National Institutes of Health lacked sufficient speed when it came to addressing scientific questions (for example, for Long COVID) and frequently faced hurdles with sharing data and studying redundancy in relation to clinical trials. In the wake of a global pandemic and in the midst of the first national search for a director in more than a decade, the present moment presents a unique opportunity to transform the National Institutes of Health to meet the public health challenges of the twenty-first century.
While many drawbacks in scientific policy are often attributed to a lack of funding, the challenges for the National Institutes of Health relate more to implementation than expenditures. In fact, despite the National Institutes of Health’s dedication to generating evidence for the greater good, very few of the agency’s core operations are actually evidence-based and developed over time based on internal experience. As a result, today, we simply don’t know the answers to countless basic questions about how an influential agency like the National Institutes of Health can work to achieve its mission more effectively. For example, which is better: individual-based financing or project-based financing? What is the ideal time frame for grants? What is the best way to stimulate high-risk and rewarding research? Despite the profound implications, these questions have yet to be explored. If the National Institutes of Health are able to try and test more innovative ideas, they may be able to significantly speed up the pace of scientific innovation.
This problem is not unique to the National Institutes of Health. A similar conclusion – that we have a lot to learn about how science is best funded and nurtured – was reached by a recent international commission on scientific funding commissioned by the Canadian government. Answering these basic science-policy questions will require the NIH to apply the same rigor that they apply to traditional scientific research.
So how can the National Institutes of Health “run the scientific method” [itself]Historically, the agency has experimented with using its mutual fund to pilot new funding streams, such as a high-risk research program and a rewards return. However, this mechanism likely would not apply to performance improvement initiatives, as the laws governing the agency make it clear that NIH funds It should go toward scientific research, not necessarily science research.Furthermore, one-off pilot projects are likely not enough to force the agency to adopt a comprehensive shift in its grantmaking and program evaluation practices.
Instead, the NIH needs the mandate to reinvent itself, and the authority to use the agency itself as a laboratory for experimentation.
Consider Medicare and Medicaid Innovation Center
Although this concept may seem foreign to science policy makers, there is a rich tradition of using experimentation to drive performance improvement in the United States government. The most prominent example today is the Medicare and Medicaid (Innovation Center) Innovation Center, established under the Affordable Care Act. The law authorized the innovation center to waive traditional health care regulations to conduct experiments on the health care system. The act also allocated the agency $10 billion in revolving funding each contract to design, implement, and evaluate pay-and-delivery reforms. Trials that meet specific criteria for cost and quality of care can then be approved by the Secretary of Health and Human Services for permanent implementation within our national health care policies and programs.
Between 2010 and 2020, the Innovation Center launched 54 pilots involving nearly 1 million physicians and 26 million patients nationwide. These trials varied in their design, from randomized controlled trials to prospective studies. For example, the Million Hearts Cardiovascular Risk Reduction Model enrolled nearly 400,000 patients in a randomized trial to assess the effects of a new cardiovascular risk assessment tool. Nearly one in five dialysis centers in the United States have participated in the Innovation Center’s End-Stage Comprehensive Kidney Care model, which has catalysed coordination of care and generated savings of more than $200 million while reducing hospitalizations by 3 percent over five years.
As another example, consider Medicare’s Universal Joint Replacement Model Care, which requires hospitals in randomly selected metropolitan statistical areas to participate in a specialized payment model for hip and knee replacement surgeries. Although not every innovation center trial was successful, many achieved significant savings (eg, accountable care institutions) and improvements in patient health outcomes (eg, Medicare’s Diabetes Prevention Program), while illustrative models helped Empty results in informing subsequent information. Experiments and fixes.
Notably, the Innovation Center’s offerings have also yielded insights to support process improvements in health policy research and health services. For example, with the expansion of demonstration models, the voluntary nature of participation has raised concerns about the risk of selection bias, prompting policy makers to explore the use of prescriptive models. In addition to program operations, the emergence of demonstration models has also led to the generation of a large body of data, which is available for independent analysis by academics and external entities, the evaluations of which, in turn, have helped stimulate discussion of critical aspects about model design (for example, benchmarking). Furthermore, data sharing and performance measurement in turn helped drive process improvements at the provider level, particularly around health IT use. Taken together, the work of the Innovation Center has not only spurred innovation in healthcare delivery but has also fostered innovation in how academics, service providers, policy makers, and other key stakeholder groups are addressing the challenge of transforming healthcare in the first place.
Lessons for the future of the National Institutes of Health
We believe Medicare provides a model for how the NIH addresses an effort to improve the science of science. Here are two key lessons from the innovation center’s experience for policy makers to consider.
First, experiments in government would be more successful with a legal mandate that is at least somewhat off the political winds. The innovation center had the authority to experiment beyond the confines of traditional systems; It had funding isolated from the policies of the annual budget process; And he had a clear process for translating trial results into changes in health care policy. In order for a similar “National Institutes of Health Innovation Center” to experiment with new approaches to funding science (for example, peer review processes), Congress must give the agency new powers to waive normal operations. For example, while federal law requires the National Institutes of Health to conduct peer review, an innovation center could experiment with giving NIH program administrators more powers to bypass peer review, to award grants that have only one strong support voice, or to conduct a limited lottery as a breaker tie.
Likewise, given how the results of scientific research—such as changes in health care spending and outcomes—require many years before they can be measured, Congress must provide funding that is shielded over an extended period. In addition, the NIH will need to develop clear protocols for how the results of a “successful” science policy trial will be disseminated and adopted into standard practice across the agency, mimicking Medicare’s own process for obtaining form certification.
Second, purposeful experiments require rigorous designs and evaluation support. The Innovation Center experience demonstrated the feasibility of conducting well-powered randomized trials in government practice and also provided lessons on how to design such models (eg, reduce model interactions and repetition). Furthermore, the Innovation Center has invested significantly in developing rapid cycle assessments and supporting independent assessments to expand the evidence base for healthcare reform.
Likewise, effective NIH trials will require thoughtful designs. For example, the ability to test experiments in science funding across different institutes and centers can provide insight into whether grantmaking models are generalizable or better suited to specific use cases. When considering evaluation mechanisms for NIH trials, officials will need to develop criteria that identify important outcomes. Although it is a challenge for an area where progress is often measured over decades, the NIH could consider setting specific goals, such as the percentage of grants that go to younger or more diverse researchers, translating preclinical research into Phase 1 trials or Phase 2, or the relative failure rate of so-called “high-risk” research projects.
Achieving this NIH vision will require congressional action. Although the director’s office has staff dedicated to program evaluation and portfolio analysis, it lacks both the authority and resources to advance system-wide trials in NIH operations. Other contemporary NIH reforms, such as the newly established Advanced Research Projects Agency for Health (ARPA-H), do not solve structural challenges within the agency (in fact, some policymakers have suggested separating ARPA-H’s staff and operations entirely from NIH).
The selection of a new director for the National Institutes of Health positions the agency uniquely for evaluating opportunities for bold action and innovative thinking. Although the National Institutes of Health currently funds many innovative projects in areas ranging from cancer biology to climate change, we believe that investment in the science of science itself will be a multiplier for the nation’s leading institution of biomedical innovation. By applying Medicare lessons, policymakers can provide the NIH with a toolkit to reinvent itself and help maximize returns on investment in scientific research for the American people.
Originally published at San Jose News Bulletin
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