FDA
Expanding Menopause Research to Advance the Health of All Women
Posted on by Janine Austin Clayton, M.D., FARVO, NIH Office of Research on Women’s Health
Since 2017, NIH’s Office of Research on Women’s Health (ORWH) has hosted the Vivian W. Pinn Symposium during National Women’s Health Week (NWHW) in May. This event honors the first full-time director of the office, Dr. Vivian W. Pinn, and serves as a critical forum for experts across sectors to communicate and collaborate for the advancement of women’s health.
This week marks the beginning of the 2023 NWHW, and on May 16, ORWH will host the 7th Annual Vivian W. Pinn Symposium. It’s titled: Menopause and Optimizing Midlife Health of Women.
Topics to be discussed include: the menopausal transition (also known as perimenopause), the accumulation of morbidity after menopause, menopause in special populations, the influence of social determinants of health on the experience of menopause, the use of menopausal hormone therapy (MHT), and interventions to promote healthy aging.
This year, JoAnn Manson, Harvard Medical School, Cambridge, MA, will deliver the keynote speech, titled “Menopausal Hormone Therapy: 30 Years of Lessons from the Women’s Health Initiative.” I encourage everyone with an interest in women’s health to register for the event.
In 1992, NIH’s National Heart, Lung, and Blood Institute launched the Women’s Health Initiative (WHI), seeking to improve the health of women through research on prevention of serious health conditions in postmenopausal women. Over three decades later, WHI remains an extraordinary example of centering research around the health needs of women, and WHI research results “definitively established that menopausal hormone therapy should not be used to prevent heart disease, stroke, and other chronic diseases.” These results were practice-changing and led to a dramatic decline in the use of MHT.
Menopause is a natural and irreversible life course stage marked by the cessation of menstrual cycling for 12 consecutive months. Common symptoms associated with menopause include hot flashes, sleep disturbances, mood changes, headaches, and heart palpitations. An article, co-authored by Dr. Manson, summarizes effective hormonal and non-hormonal treatments to manage menopausal symptoms [1].
The WHI’s longer-term follow-up of the treatment of these women, however, has demonstrated many nuanced findings [2]. For example, MHT’s risks and benefits are complex and vary based upon patient-level characteristics, including the age at which the therapy is initiated and the formulation of the MHT prescribed. Importantly, WHI was designed to assess the efficacy of MHT in preventing chronic disease, not to assess the efficacy or safety of MHT when used to treat menopausal symptoms. The average study participant was older, with over a decade since the start of their menopausal transition.
When considering any treatment, people should consult a health care professional, and MHT may be an option for some women, especially those who are experiencing menopausal symptoms and are at low risk for adverse events. The Food and Drug Administration (FDA) offers a fact sheet to answer questions and provide guidance about menopause and hormones, and has evaluated the risks and benefits of MHT for specific age groups of women [3].
In addition to WHI, there are two other valuable NIH-funded studies helping to make progress in our understanding of the health of midlife and older women:
• Study of Women’s Health Across the Nation (SWAN)
• Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH)
A major health concern for women during perimenopause, menopause, and post menopause is cardiovascular health. More research is needed to understand how different stages of menopause affect women’s cardiovascular health and how different doses and formulations of MHT may affect risk.
Among the many speakers at the Vivian W. Pinn Symposium will be Wendy Kohrt, a co-author on a recent comprehensive review of cardiovascular health and menopause [4]. She is director of the University of Colorado Specialized Centers of Research Excellence on Sex Differences (SCORE), Aurora. Also, a recent issue of ORWH’s Women’s Health in Focus at NIH discussed current NIH-funded research on menopause, resources, future menopause-related research, and more.
In response to a Congressional request to address NIH efforts related to women’s health research, ORWH hosted, along with the NIH Advisory Committee on Research on Women’s Health, “Advancing NIH Research on the Health of Women: A 2021 Conference.” The importance of menopause research as it relates to chronic debilitating conditions, which pose a significant burden on the health of women, was addressed during the conference, and the full report is available on the ORWH website.
Further, ORWH and partnering institutes released two notices of funding opportunities titled Understanding Chronic Conditions Understudied Among Women (R01 and R21), and ORWH sponsored the forthcoming Framework for the Consideration of Chronic Debilitating Conditions in Women from the National Academies of Sciences, Engineering, and Medicine.
I wish everyone a happy and healthy NWHW and look forward to gathering virtually for the 7th Annual Vivian W. Pinn Symposium. For more information and resources on menopause, visit the FDA’s Office of Women’s Health and NIH’s National Institute on Aging (NIA) websites. Also, My Menoplan, developed by NIA-funded researchers, offers information and personalized tools to help plan for perimenopause and menopause. Please stay connected to ORWH by visiting our website for updates; signing up for our monthly newsletter, The Pulse; liking us on Facebook; and following ORWH on Twitter.
References:
[1] Management of menopausal symptoms: A review. Crandall CJ, et al. JAMA. 2023 February 7: 329(5):405-420.
[2] Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women’s Health Initiative randomized trials. Manson JE, et al. JAMA. 2013 October 2: 310(13)1353-1368.
[3] Randomized trial evaluation of the benefits and risks of menopausal hormone therapy among women 50-59 years of age. Prentice RL, et al. Am J Epidemiol. 2021 February 1: 190(3):365-375.
[4] Body composition and cardiometabolic health across the menopause transition. Marlatt KL, et al. Obesity. 2022 January; 30(1)14-27.
Links:
Office of Research on Women’s Health (NIH)
7th Annual Vivian W. Pinn Symposium (ORWH)
Specialized Centers of Research Excellence on Sex Differences (SCORE) (ORWH)
National Women’s Health Week (Office on Women’s Health, U.S. Department of Health and Human Services, Rockville, MD)
Women’s Health Initiative (WHI)
Study of Women’s Health Across the Nation (SWAN)
Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) (Fred Hutchinson Cancer Center, Seattle)
Office of Women’s Health (U.S. Food and Drug Administration, Silver Spring, MD)
Note: Dr. Lawrence Tabak, who performs the duties of the NIH Director, has asked the heads of NIH’s Institutes, Centers, and Offices to contribute occasional guest posts to the blog to highlight some of the interesting science that they support and conduct. This is the 30th in the series of NIH guest posts that will run until a new permanent NIH director is in place.
10 Years of Protecting Public Health Through Tobacco Regulatory Research
Posted on by David M. Murray, Ph.D., NIH Office of Disease Prevention
“Kids are flocking to flavored, disposable e-cigarettes, study finds” – The Washington Post
“New ‘candy’ e-cigs catch fire after U.S. regulators stamp out Juul’s flavors” – Reuters
Headlines like these highlight a real challenge for people who want to protect kids from the harms of using tobacco products. While flavors, such as mint, menthol, watermelon, and apple pie are safe to consume in food products, inhaling them in tobacco products can be harmful and put the health of our kids at risk.+
A special kind of research is needed to help public health authorities keep up with the latest changes and trends in tobacco products. That includes studying how these flavored tobacco products are attractively marketed to children and how quickly many started using them.
In 2013, NIH and the Food and Drug Administration (FDA) launched a unique interagency partnership called the Tobacco Regulatory Science Program (TRSP), directed by Helen Meissner. It aims to reduce the public health impact of tobacco product use across the country. The NIH administers the research program through the Office of Disease Prevention (ODP), which I lead, to help inform FDA’s tobacco regulatory priorities.
This unique partnership also represents a new field of study called tobacco regulatory research. It informs proposed regulations for tobacco products based on strong scientific evidence. The TRSP brings together scientists from diverse fields, such as epidemiology, chemistry, toxicology, addiction, and psychology, to shed light on why people try and continue to use tobacco, how tobacco use affects health, and which policies might help reduce the risk of harm.
Now celebrating its 10th anniversary, this extremely productive partnership has resulted in more than 400 research grants, all peer-reviewed and designed to increase our understanding of existing and emerging tobacco products and their associated health risks.
Our research includes studies showing that menthol in cigarettes makes it easier to start smoking by reducing the harshness of tobacco [1]. People who smoke menthol cigarettes also show more signs of nicotine dependence and, therefore, are less likely to successfully quit. The research shows this is because menthol interacts with nicotine in the brain, making nicotine even more addictive.
Additionally, researchers have explored how marketing and promotion of menthol and flavored tobacco products have targeted Black and LGBTQ+ people, socioeconomically disadvantaged populations, and people with mental health challenges. These studies show that this direct marketing has contributed to the burden of tobacco-related disease among these groups and widened health inequities [2].
The TRSP also has a real-world impact on shaping tobacco policy. In April 2022, the program’s sponsored research was cited in FDA-proposed rules to prohibit menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (other than tobacco) in cigars [3]. These tobacco product standards will have a huge impact on public health by reducing youth experimentation with products like cigarettes, cigars, and cigarillos and increasing the number of people who quit smoking.
Many jurisdictions have already banned flavored tobacco products. Through our partnership with the FDA, TRSP-funded researchers have started evaluating the impact of these policies on tobacco use and public health. The need for research continues as we seek to understand how new tobacco products affect people’s use, attitudes, and health.
However, tobacco products that have the potential to addict a new generation to nicotine continue to be marketed. For example, new products that use “ice-hybrid” flavors which combine cooling and fruity/sweet properties, such as raspberry ice, are being used more often than either fruity/sweet or menthol/mint among young adult e-cigarette users [4]. Illegally marketed, but novel, flavored oral nicotine products, such as gummies and pouches, also are gaining appeal among young people. The dynamic nature of the tobacco market emphasizes the importance of TRSP to support research on tobacco products, directly informing tobacco regulation.
The success of TRSP over the past 10 years demonstrates how establishing a research pipeline that directly informs regulation can lead to effective, evidence-based health policies. The high output of research on the effects of new and emerging tobacco products, such as the appeal and addictiveness of flavored e-cigarettes, provides FDA with data to inform regulatory actions. This partnership is truly helping regulators and policymakers turn scientific discovery into actions designed to protect public health.
References:
[1] Use of menthol cigarettes, smoking frequency, and nicotine dependence among US youth. Leas EC, Benmarhnia T, Strong DR, Pierce JP. JAMA Netw Open. 2022 Jun 1;5(6):e2217144.
[2] Menthol smoking and related health disparities. Centers for Disease Control and Prevention, June 27, 2022.
[3] FDA proposes rules prohibiting menthol cigarettes and flavored cigars to prevent youth initiation, significantly reduce tobacco-related disease and death. FDA News Release, April 28, 2022.
[4] ‘Ice’ flavoured e-cigarette use among young adults. Leventhal A, Dai H, Barrington-Trimis J, Sussman S. Tob Control. 2023 Jan;32(1):114-117.
Links:
Smokefree.gov (U.S. Department of Health and Human Services, Washington, D.C.)
Office of Disease Prevention (NIH)
Tobacco Regulatory Science Program (ODP)
Director’s Messages (ODP)
Note: Dr. Lawrence Tabak, who performs the duties of the NIH Director, has asked the heads of NIH’s Institutes, Centers, and Offices to contribute occasional guest posts to the blog to highlight some of the interesting science that they support and conduct. This is the 29th in the series of NIH guest posts that will run until a new permanent NIH director is in place.
NIH HEAL Initiative Meets People Where They Are
Posted on by Rebecca Baker, Ph.D., NIH Helping to End Addiction Long-term® (HEAL) Initiative
The opioid crisis continues to devastate communities across America. Dangerous synthetic opioids, like fentanyl, have flooded the illicit drug supply with terrible consequences. Tragically, based on our most-recent data, about 108,000 people in the U.S. die per year from overdoses of opioids or stimulants [1]. Although this complex public health challenge started from our inability to treat pain effectively, chronic pain remains a life-altering problem for 50 million Americans.
To match the size and complexity of the crisis, in 2018 NIH developed the NIH Helping to End Addiction Long-term® (HEAL) Initiative, an aggressive effort involving nearly all of its 27 institutes and centers. Through more than 1,000 research projects, including basic science, clinical testing of new and repurposed drugs, research with communities, and health equity research, HEAL is dedicated to building a new future built on hope.
In this future:
- A predictive tool used during a health visit personalizes treatment for back pain. The tool estimates the probability that a person will benefit from physical therapy, psychotherapy, or surgery.
- Visits to community health clinics and emergency departments serve as routine opportunities to prevent and treat opioid addiction.
- Qualified school staff and pediatricians screen all children for behavioral and other mental health conditions that increase risk for harmful developmental outcomes, including opioid misuse.
- Infants born exposed to opioids during a mother’s pregnancy receive high-quality care—setting them up for a healthy future.
Five years after getting started (and interrupted by a global pandemic), HEAL research is making progress toward achieving this vision. I’ll highlight three ways in which scientific solutions are meeting people where they are today.
A Window of Opportunity for Treatment in the Justice System
Sadly, jails and prisons are “ground zero” for the nation’s opioid crisis. Eighty-five percent of people who are incarcerated have a substance use disorder or a history of substance use. Our vision at HEAL is that every person in jail, prison, or a court-supervised program receives medical care, which includes effective opioid use disorder treatment.
Some research results already are in supporting this approach: A recent HEAL study learned that individuals who had received addiction treatment while in one Massachusetts jail were about 30 percent less likely to be arrested, arraigned, or incarcerated again compared with those incarcerated during the same time period in a neighboring jail that did not offer treatment [2]. Research from the HEAL-supported Justice Community Opioid Innovation Network also is exploring public perceptions about opioid addiction. One such survey showed that most U.S. adults see opioid use disorder as a treatable medical condition rather than as a criminal matter [3]. That’s hopeful news for the future.
A Personalized Treatment Plan for Chronic Back Pain
Half of American adults live with chronic back pain, a major contributor to opioid use. The HEAL-supported Back Pain Consortium (BACPAC) is creating a whole-system model for comprehensive testing of everything that contributes to chronic low back pain, from anxiety to tissue damage. It also includes comprehensive testing of promising pain-management approaches, including psychotherapy, antidepressants, or surgery.
Refining this whole-system model, which is nearing completion, includes finding computer-friendly ways to describe the relationship between the different elements of pain and treatment. That might include developing mathematical equations that describe the physical movements and connections of the vertebrae, discs, and tendons.
Or it might include an artificial intelligence technique called machine learning, in which a computer looks for patterns in existing data, such as electronic health records or medical images. In keeping with HEAL’s all-hands-on-deck approach, BACPAC also conducts clinical trials to test new (or repurposed) treatments and develop new technologies focused on back pain, like a “wearable muscle” to help support the back.
Harnessing Innovation from the Private Sector
The HEAL research portfolio spans basic science to health services research. That allows us to put many shots on goal that will need to be commercialized to help people. Through its research support of small businesses, HEAL funding offers a make-or-break opportunity to advance a great idea to the marketplace, providing a bridge to venture capital or other larger funding sources needed for commercialization.
This bridge also allows HEAL to invest directly in the heart of innovation. Currently, HEAL funds nearly 100 such companies across 20 states. While this is a relatively small portion of all HEAL research, it is science that will make a difference in our communities, and these researchers are passionate about what they do to build a better future.
A couple of current examples of this research passion include: delivery of controlled amounts of non-opioid pain medications after surgery using a naturally absorbable film or a bone glue; immersive virtual reality to help people with opioid use disorder visualize the consequences of certain personal choices; and mobile apps that support recovery, taking medications, or sensing an overdose.
In 2023, HEAL is making headway toward its mission to accelerate development of safe, non-addictive, and effective strategies to prevent and treat pain, opioid misuse, and overdose. We have 314 clinical trials underway and 41 submissions to the Food and Drug Administration to begin clinical testing of investigational new drugs or devices: That number has doubled in the last year. More than 100 projects alone are addressing back pain, and more than 200 projects are studying medications for opioid use disorder.
The nation’s opioid crisis is profoundly difficult and multifaceted—and it won’t be solved with any single approach. Our research is laser-focused on its vision of ending addiction long-term, including improving pain management and expanding access to underused, but highly effective, addiction medications. Every day, we imagine a better future for people with physical and emotional pain and communities that are hurting. Hundreds of researchers and community members across the country are working to achieve a future where people and communities have the tools they need to thrive.
References:
[1] Provisional drug overdose death counts. Ahmad FB, Cisewski JA, Rossen LM, Sutton P. National Center for Health Statistics. 2023.
[2] Recidivism and mortality after in-jail buprenorphine treatment for opioid use disorder. Evans EA, Wilson D, Friedmann PD. Drug Alcohol Depend. 2022 Feb 1;231:109254.
[3] Social stigma toward persons with opioid use disorder: Results from a nationally representative survey of U.S. adults. Taylor BG, Lamuda PA, Flanagan E, Watts E, Pollack H, Schneider J. Subst Use Misuse. 2021;56(12):1752-1764.
Links:
SAMHSA’s National Helpline (Substance Abuse and Mental Health Services Administration, Rockville, MD)
NIH Helping to End Addiction Long-term® (HEAL) Initiative
Video: The NIH HEAL Initiative–HEAL Is Hope
Justice Community Opioid Innovation Network (HEAL)
Back Pain Consortium Research Program (HEAL)
NIH HEAL Initiative 2023 Annual Report (HEAL)
Small Business Programs (HEAL)
Rebecca Baker (HEAL)
Note: Dr. Lawrence Tabak, who performs the duties of the NIH Director, has asked the heads of NIH’s Institutes, Centers, and Offices to contribute occasional guest posts to the blog to highlight some of the interesting science that they support and conduct. This is the 28th in the series of NIH guest posts that will run until a new permanent NIH director is in place.
Advancing Access to Hearing Health Care
Posted on by Debara L. Tucci, M.D., M.S., M.B.A., National Institute on Deafness and Other Communication Disorders
By 2050, the World Health Organization estimates that more than 700 million people—or one in every 10 people around the globe—will have disabling hearing loss. In the United States alone, hearing loss affects an estimated 30 million people [1]. Hearing loss can be frustrating, isolating, and even dangerous. It is also associated with dementia, depression, anxiety, reduced mobility, and falls.
Although hearing technologies, such as hearing aids, have improved, not everyone has equal access to these advancements. In fact, though hearing aids and other assistive devices can significantly improve quality of life, only one in four U.S. adults who could benefit from these devices has ever used one. Why? People commonly report encountering economic barriers, such as the high cost of hearing aids and limited access to hearing health care. For some, the reasons are more personal. They may not believe that hearing aids are effective, or they may worry about a perceived negative association with aging. [2].
As the lead federal agency supporting research initiatives to prevent, detect, and treat hearing loss, NIH’s National Institute on Deafness and Other Communication Disorders (NIDCD) conducts and funds research that identifies ways to break down barriers to hearing health care. Decades of NIDCD research informed a recent landmark announcement by the Food and Drug Administration (FDA) creating a new category of over-the-counter (OTC) hearing aids. When the regulation takes effect (expected in 2022), millions of people who have trouble hearing will be able to purchase less expensive hearing aids without a medical exam, prescription, or fitting by an audiologist.
This exciting development has been on the horizon at NIDCD for some time. Back in 2009, NIDCD’s Working Group on Accessible and Affordable Hearing Health Care for Adults with Mild to Moderate Hearing Loss created a blueprint for research priorities.
The working group’s blueprint led to NIDCD funding of more than 60 research projects spanning the landscape of accessible and affordable hearing health care issues. One study showed that people with hearing loss can independently adjust the settings [3] on their hearing devices in response to changing acoustic environments and, when given the ability to control their own hearing aid settings, they were generally more satisfied with the sound of the devices than with the audiologist fit [4].
In 2017, the first randomized, double-blind, placebo-controlled clinical trial comparing an over-the-counter delivery model [5] of hearing aids with traditional fitting by an audiologist also found that hearing aid users in both groups reported similar benefits. A 2019 follow-up study [6] confirmed these results, supporting the viability of a direct-to-consumer service delivery model. A small-business research grant funded by NIDCD led to the first FDA-approved self-fitting hearing aid.
Meanwhile, in 2016, NIDCD co-sponsored a consensus report from the National Academies of Sciences, Engineering, and Medicine (NASEM). The report, Hearing Health Care for Adults: Priorities for Improving Access and Affordability, which was developed by an independent expert panel, recommended that the FDA create and regulate a new category of over-the-counter hearing devices to improve access to affordable hearing aids for adults with perceived mild-to-moderate hearing loss. These devices will not be intended for children or for adults with more severe hearing loss.
In sum, this targeted portfolio of NIDCD-funded research—together with the research blueprint and the NASEM consensus report—provided a critical foundation for the 2021 FDA rule creating the new class of OTC hearing aids. As a result of these research and policy efforts, this FDA rule will make some types of hearing aids less expensive and easier to obtain, potentially improving the health, safety, and well-being of millions of Americans.
Transforming hearing health care for adults in the U.S. remains a public health priority. The NIH applauds the scientists who provided critical evidence leading to the new category of hearing aids, and NIDCD encourages them to redouble their efforts. Gaps in hearing health care access remain to be closed.
The NIDCD actively solicits applications for research projects to fill these gaps and continue identifying barriers to care and ways to improve access. The NIDCD will also continue to help the public understand the importance of hearing health care with resources on its website, such as Hearing: A Gateway to Our World video and the Adult Hearing Health Care webpage.
References:
[1] Hearing loss prevalence in the United States. Lin F, Niparko J, Ferrucci L. Arch Intern Med. 2011 Nov 14;171(20):1851-1852.
[2] Research drives more accessible, affordable hearing care. Tucci DL, King K. The Hearing Journal. May 2020.
[3] A “Goldilocks” approach to hearing aid self-fitting: Ear-canal output and speech intelligibility index. Mackersie C, Boothroyd A, Lithgow, A. Ear and Hearing. Jan 2019.
[4] Self-adjusted amplification parameters produce large between-subject variability and preserve speech intelligibility. Nelson PB, Perry TT, Gregan M, VanTasell, D. Trends in Hearing. 7 Sep 2018.
[5] The effects of service-delivery model and purchase price on hearing-aid outcomes in older adults: A randomized double-blind placebo-controlled clinical trial. Humes LE, Rogers SE, Quigley TM, Main AK, Kinney DL, Herring C. American Journal of Audiology. 1 Mar 2017.
[6] A follow-up clinical trial evaluating the consumer-decides service delivery model. Humes LE, Kinney DL, Main AK, Rogers SE. American Journal of Audiology. 15 Mar 2019.
Links:
National Institute on Deafness and Other Communication Disorders (NIDCD) (NIH)
Funded Research Projects on Accessible and Affordable Hearing Health Care (NIDCD)
Adult Hearing Health Care (NIDCD)
[Note: Acting NIH Director Lawrence Tabak has asked the heads of NIH’s Institutes and Centers (ICs) to contribute occasional guest posts to the blog to highlight some of the interesting science that they support and conduct. This is the ninth in the series of NIH IC guest posts that will run until a new permanent NIH director is in place.]
RADx Initiative: Bioengineering for COVID-19 at Unprecedented Speed and Scale
Posted on by Bruce J. Tromberg, Ph.D., National Institute of Biomedical Imaging and Bioengineering
As COVID-19 rapidly expanded throughout the world in April 2020, many in the biomedical technology community voiced significant concerns about the lack of available diagnostic tests. At that time, testing for SARS-CoV-2, the coronavirus that causes COVID-19, was conducted exclusively in clinical laboratories by order of a health-care provider. “Over the counter” (OTC) tests did not exist, and low complexity point of care (POC) platforms were rare. Fewer than 8 million tests were performed in the U.S. that month, and it was clear that we needed a radical transformation to make tests faster and more accessible.
By February 2022, driven by the Omicron variant surge, U.S. capacity had increased to a new record of more than 1.2 billion tests in a single month. Remarkably, the overwhelming majority of these—more than 85 percent—were “rapid tests” conducted in home and POC settings.
The story behind this practice-changing, “test-at-home” transformation is deeply rooted in technologic and manufacturing innovation. The NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB), working collaboratively with multiple partners across NIH, government, academia, and the private sector, has been privileged to play a leading role in this effort via the Rapid Acceleration of Diagnostics (RADx®) initiative. On this two-year anniversary of RADx, we take a brief look back at its formation, impact, and potential for future growth.
On April 24, 2020, Congress recognized that testing was an urgent national need and appropriated $1.5 billion to NIH via an emergency supplement [1]. The goal was to substantially increase the number, type, and availability of diagnostic tests in only five to six months. Since the “normal” commercialization cycle for this type of diagnostic technology is typically more than five years, we needed an entirely new approach . . . fast.
The RADx initiative was launched just five days after that challenging Congressional directive [2]. Four NIH RADx programs were eventually created to support technology development and delivery, with the goal of matching test performance with community needs [3].The first two programs, RADx Tech and RADx Advanced Technology Platforms (ATP), were developed by NIBIB and focused on innovation for rapidly creating, scaling up, and deploying new technologies.
RADx Tech is built around NIBIB’s Point of Care Technologies Research Network (POCTRN) and includes core activities for technology review, test validation, clinical studies, regulatory authorization, and test deployment. Overall, the RADx Tech network includes approximately 900 participants from government, academia, and the private sector with unique capabilities and resources designed to decrease inherent risk and guide technologies from design and development to fully disseminated commercial products.
At the core of RADx Tech operations is the “innovation funnel” rapid review process, popularized as a shark tank [4]. A total of 824 complete applications were submitted during two open calls in a four-month period, beginning April 2020 and during a one-month period in June 2021. Forty-seven projects received phase 1 funding to validate and lower the inherent risk of developing these technologies. Meanwhile, 50 companies received phase 2 contracts to support FDA authorization studies and manufacturing expansion [5]
Beyond test development, RADx Tech has evolved to become a key contributor to the U.S. COVID-19 response. The RADx Independent Test Assessment Program (ITAP) was launched in October 2021 to accelerate regulatory authorization of new tests as a joint effort with the Food and Drug Administration (FDA) [6]. The ITAP acquires analytical and clinical performance data and works closely with FDA and manufacturers to shave weeks to months off the time it normally takes to receive Emergency Use Authorization (EUA).
The RADx Tech program also created a Variant Task Force to monitor the performance of tests against each new coronavirus “variant of concern” that emerges. This helps to ensure that marketed tests continue to remain effective. Other innovative RADx Tech projects include Say Yes! Covid Test, the first online free OTC test distribution program, and Project Rosa, which conducts real-time variant tracking across the country [7].
RADx Tech, by any measure, has exceeded even the most-optimistic expectations. In two years, RADx Tech-supported companies have received 44 EUAs and added approximately 2 billion tests and test products to the U.S. capacity. These remarkable numbers have steadily increased from more than16 million tests in September 2020, just five months after the program was established [8].
RADx Tech has also made significant contributions to the distribution of 1 billion free OTC tests via the government site, COVID.gov/tests. It has also provided critical guidance on serial testing and variants that have improved test performance and changed regulatory practice [9,10]. In addition, the RADx Mobile Application Reporting System (RADx MARS) reduces barriers to test reporting and test-to-treat strategies’ The latter offers immediate treatment options via telehealth or a POC location whenever a positive test result is reported. Finally, the When to Test website provides critical guidance on when and how to test for individuals, groups, and communities.
As we look to the future, RADx Tech has enormous potential to impact the U.S. response to other pathogens, diseases, and future pandemics. Major challenges going forward include improving home tests to work as well as lab platforms and building digital health networks for capturing and reporting test results to public health officials [11].
A recent editorial published in the journal Nature Biotechnology noted, “RADx has spawned a phalanx of diagnostic products to market in just 12 months. Its long-term impact on point of care, at-home, and population testing may be even more profound [12].” We are now poised to advance a new wave of precision medicine that’s led by innovative diagnostic technologies. It represents a unique opportunity to emerge stronger from the pandemic and achieve long-term impact.
References:
[1] Public Law 116 -139—Paycheck Protection Program and Health Care Enhancement Act.
[2] NIH mobilizes national innovation initiative for COVID-19 diagnostics, NIH news release, April 29, 2020.
[3] Rapid scaling up of Covid-19 diagnostic testing in the United States—The NIH RADx Initiative. Tromberg BJ, Schwetz TA, Pérez-Stable EJ, Hodes RJ, Woychik RP, Bright RA, Fleurence RL, Collins FS. N Engl J Med. 2020 Sep 10;383(11):1071-1077.
[4] We need more covid-19 tests. We propose a ‘shark tank’ to get us there. Alexander L. and Blunt R., Washington Post, April 20, 2020.
[5] RADx® Tech/ATP dashboard, National Institute of Biomedical Imaging and Bioengineering, NIH.
[6] New HHS actions add to Biden Administration efforts to increase access to easy-to-use over-the-counter COVID-19 tests. U.S. Department of Health and Human Services Press Office, October 25, 2021.
[7] A method for variant agnostic detection of SARS-CoV-2, rapid monitoring of circulating variants, detection of mutations of biological significance, and early detection of emergent variants such as Omicron. Lai E, et al. medRxiV preprint, January 9, 2022.
[9] Longitudinal assessment of diagnostic test performance over the course of acute SARS-CoV-2 infection. Smith RL, et al. J Infect Dis. 2021 Sep 17;224(6):976-982.
[10] Comparison of rapid antigen tests’ performance between Delta (B.1.61.7; AY.X) and Omicron (B.1.1.529; BA1) variants of SARS-CoV-2: Secondary analysis from a serial home self-testing study. Soni A, et al. MedRxiv preprint, March 2, 2022.
[11] Reporting COVID-19 self-test results: The next frontier. Health Affairs, Juluru K., et al. Health Affairs, February 11, 2022.
[12] Radical solutions. Nat Biotechnol. 2021 Apr;39(4):391.
Links:
Get Free At-Home COVID Tests (COVID.gov)
When to Test (Consortia for Improving Medicine with Innovation & Technology, Boston)
RADx Programs (NIH)
RADx® Tech and ATP Programs (National Institute of Biomedical Imaging and Biomedical Engineering/NIH)
Independent Test Assessment Program (NIBIB)
Mobile Application Reporting through Standards (NIBIB)
Point-of-Care Technologies Research Network (POCTRN) (NIBIB)
[Note: Acting NIH Director Lawrence Tabak has asked the heads of NIH’s Institutes and Centers (ICs) to contribute occasional guest posts to the blog to highlight some of the interesting science that they support and conduct. This is the eighth in the series of NIH IC guest posts that will run until a new permanent NIH director is in place.]
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