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| 14863 | History of NIH and NASA Collaborations | NIH and NASA have collaborated since the Project Gemini era in the early 1960s. NASA has identified 33 medical health risks to humans who will engage in deep space travel and is interested in research in these areas. In 2017, NIH Director Francis S. Collins, M.D., Ph.D., and former NASA Deputy Administrator Dava J. Newman, Ph.D., signed a second NIH-NASA Memorandum of Understanding (MOU) (PDF - 410KB). The MOU enabled NIH and NASA to develop processes by which NIH grantees could access the International Space Station U.S. National Laboratory as well as NASA facilities for biomedical research projects designed to improve human health on Earth. As outlined in the MOU, NIH and NASA efforts include establishing a framework of cooperation to encourage interaction between NIH and NASA research communities and integrating results from that research into improved understanding of human physiology and health. In early 2018, Collins appointed NCATS’ director, Christopher P. Austin, M.D., as the new NIH liaison to NASA. This role was previously held by the directors of NIH’s National Institute of Arthritis and Musculoskeletal and Skin Diseases and NIH’s National Institute of Biomedical Imaging and Bioengineering. An integral part of this NIH-NASA collaboration includes the representation from over 20 of the 27 NIH Institutes and Centers on the NIH-NASA Scientific Potential/Actual Collaborative Efforts (SPACE) group. The SPACE Group meets quarterly to discuss, share and brainstorm biomedical research activities that are of relevance to human and astronaut heath. The goals of the group are to: Explore areas of potential synergy for biomedical scientific research that fulfills the mandates of both NIH and NASA. Facilitate communications among researchers to instigate and support collaborative efforts. Explore possibilities for joint efforts between NIH and NASA to support research into synergistic biomedical interest areas and implement appropriate joint exercises. In December 2018, Deputy Secretary of the U.S. Department of Health and Human Services (HHS), Eric. D. Hargan appointed Austin to lead the advancement of human health research between HHS agencies and NASA. An interagency agreement (PDF - 273KB) was signed with the objectives to: Share innovative ideas for addressing science and tech challenges. Promote collaboration and cooperation in research and development related to human and public health. Leverage shared resources including expertise, access to facilities and scientific resources. The HHS-NASA team has engaged with a number of HHS components to help build collaborative efforts. For more information, email Danilo A. Tagle, Ph.D., NIH-NASA liaison point of contact. | History of NIH and NASA Collaborations | History of NIH and NASA Collaborations | ||||||
| 14815 | 2019 CCIA Administrative Supplements Projects | Developing Infrastructure and Harmonized Metrics to Study the Impact of Opioid ECHO Programs Patient Engagement with Health Coaching to Address Health Disparities Accelerating Rural Research Engagement Through a Biorepository Approach Community Reviewer Training Program in the CTSA Program Dissemination and Implementation of the Science Café Model to Engage Communities in Science, Health and Research A Collaborative Approach to Advancing Clinical Research Workforce Development Through Standardized Training, Implementation, and Evaluation Developing Infrastructure and Harmonized Metrics to Study the Impact of Opioid ECHO Programs The University of Utah Principal Investigators: Rachel Hess, M.D., and Willard H. Dere, M.D. The University of Utah proposes to partner with the University of New Mexico, the University of North Carolina, University of Pittsburgh, and Boston University CTSA Program hubs to assess the dissemination of the ECHO (Extension for Community Healthcare Outcomes) model on improving patient-level outcomes associated with opioid use disorder (OUD). This project will: Disseminate evidence-based OUD treatment in local communities via telementoring of primary care providers of patients with opioid use disorder; Assess this approach by measuring patient-level outcomes (hospital utilization associated with comorbidities relevant to injection drug use, rates of HIV and HCV infection, overdose deaths, and patient mortality); and Leverage and develop the data infrastructure within the five CTSA Program hubs to measure patient-level outcomes. This project is expected to result in a national model to guide practice by OUD-ECHO centers that could have a high impact on the retention and treatment of OUD patients in underserved and rural areas. It is a demonstration project that could be applied to other ECHO content on how to assess the impact of telementoring on patient outcomes. Patient Engagement with Health Coaching to Address Health Disparities Emory University Principal Investigators: William Robert Taylor, M.D. Contacts: Priscilla Pemu, M.D., and Elizabeth Ofili, M.D. Despite higher rates of chronic disease burden, African Americans and underserved populations are consistently underrepresented in clinical research. This results in gaps in the evidence base for clinical care, leading to persistent health disparities. Emory University proposes to collaborate with Harvard University to: Enhance a patient engagement tool, called “Health 360x,” via mobile and web applications with SMART on FHIR specification. This will enable interoperability of the app and web platform with the patient’s electronic health record (EHR). Using SMART on FHIR enables the use of various EHRs including Epic, Cerner, Allscripts and eClinical works. Provide health coaching for self-monitoring in chronic disease management and enable sharing of actionable health and research data from the patient to the doctor through the dissemination of the patient engagement tool. Use the Health 360x tool at 12 sites of the Association of Black Cardiologists Cardiovascular Implementation Study to test the dissemination of this approach to address health disparities. At the end of this project, it is expected that the results will demonstrate a unique approach to conduct research in health disparities and to increase participation of African Americans and other minorities in clinical research. Accelerating Rural Research Engagement Through a Biorepository Approach University of Iowa Principal Investigators: Patricia L. Winkour, M.D. and Marlan R. Hansen, M.D. Contact: Patricia L. Winkour, M.D. Website: https://clinicaltrials.gov/ct2/show/NCT03938129 The University of Iowa CTSA hub proposes to partner with the University of Alabama Birmingham and the University of Minnesota CTSAs to expand participation in the Iowa’s Maternal Fetal Tissue Bank by recruiting more rural and ethnically diverse populations within Iowa, Alabama and Minnesota. This project will: Acquire maternal blood and urine, cord blood, and placental tissue and the clinical data about the long-term health of the mother and child, providing the opportunity to conduct research across the lifespan; Develop novel tools such as e-consent and research education resources that can accelerate recruitment processes; Expand relationships with rural hospitals and clinics across the Midwest as well as other hubs to enhance representation of populations who traditionally may otherwise not be included in studies such as diverse and underrepresented populations, and Provide more information on best strategies for recruitment in rural populations and best strategies for e-consent for recruitment. This project has the potential to accelerate rural research engagement via e-consent methodologies and provide online site-agnostic educational materials that can be distributed to clinics and hospitals to accelerate common IRB and contracting processes. While this biorepository is initially focused on obstetrics, its approach to access rural populations. The outcomes of this project have the potential to be broadly applied and the biosample and data repository resource developed may be used to study long-term health of participants and enable the development of new technologies and therapies for various diseases. Community Reviewer Training Program in the CTSA Program University of Southern California Principal Investigators: Thomas A. Buchanan, M.D. and Michele D. Kipke, Ph.D. The immediate goal of the Community Reviewer Training Program (CTRP) is to implement and assess a scalable process that allows representatives of communities – whose primary affiliation is non-academic, non-research community-based organizations affected by a disease or condition – to meaningfully participate in reviewing pilot grant research proposals. The investigators will identify the most effective approaches to integrating community reviewers into the grant review process to create a culture of learning for academic and community reviewers that adds value to pilot grants. The CTSA CTRP will be implemented across a consortium of five CTSA Program hubs (University of Southern California, University of Arkansas for Medical Science, The Ohio State University, Virginia Commonwealth University, and University of California at Irvine). The project aims to: Implement an integrative and innovative community reviewer training program developed and validated at Arkansas; Increase the knowledge of community representatives regarding the meaning of research and how their participation in grant review enhances the rigor and impact of funded pilot grant applications; and Implement and evaluate the impact of this training on community reviewers’ knowledge of the grant review process and the qualitative contribution of the community reviewers to the quality and impact of work funded. The project has the potential to enhance the review process across the CTSA Program consortium and other funding agencies and change the culture of grant review, through the systematic integration of community perspectives on clinical and translational science research projects. Dissemination and Implementation of the Science Café Model to Engage Communities in Science, Health and Research University of Minnesota Principal Investigators: Bruce R. Blazar, M.D. and Daniel J. Weisdorf, M.D. Contact: Milton Eder, Ph.D. Website: https://www.ctsi.umn.edu/news-and-events/news/ctsis-community-engagement-office-receives-nih-support-science-cafe-event-series This project explores the Science Café as a way to engage communities from different linguistic and cultural backgrounds in discussions about science, health and research. In this project, Minnesota and Mayo – with community partners WellShare International and Community-University Health Care Center – seek to engage communities and stakeholders to enhance the translation of research into practice and to improve healthcare delivery across the lifespan and to diverse populations. They will: Determine whether Cafés improves attendee’s health and scientific literacy; Identify words and concepts that are difficult for community partners to translate and create new strategies to overcome translational challenges; and Iteratively translate and disseminate information learned from the Cafés to a digital platform. This project will create understanding of the linguistic processes used by different communities to develop key messages that could ultimately engage special populations in clinical and translational science research. The digital platform adds scalability and reach to the targeted populations. A Collaborative Approach to Advancing Clinical Research Workforce Development Through Standardized Training, Implementation, and Evaluation Pennsylvania State University Hershey Medical Center Principal Investigator: Lawrence I. Sinoway, M.D. The Pennsylvania State University CTSA Program hub and the University of Mississippi Medical Center, a partner of the University of Alabama at Birmingham CTSA Program hub, propose to adapt and implement standardized orientation and professional development programming for research support staff to support a variety of studies and trials that has been developed and tested in the Mayo CTSA Program hub. The project will provide: Programming aimed to increase knowledge and skills necessary to coordinate clinical research protocols while working cooperatively within a research team; An overview of the basics of clinical research including regulatory and compliance, roles and responsibilities, and activities related to the overall conduct and coordination of a research protocol; A mentorship program will encourage continuous learning for research support staff, and Resources to support the coordination of protocols, including introduction to key institutional research contacts and a platform through which staff can manage future educational needs and questions. The 10-day onboarding orientation consists of approximately 20 hours of online modules, 20 hours of facilitated topics and activities, and 40 hours of on-the-job training with a workplace mentor in the staff’s work unit. Standardized research support information and continued professional education to research staff will be delivered through a web-based platform and the DIAMOND portal for further dissemination beyond the three hubs. | 2019 CCIA Administrative Supplements Projects | 2019 CCIA Administrative Supplements Projects | ||||||
| 14785 | NCATS Director Statement in Support of Diverse and Inclusive Meetings and Conferences | NCATS Director Christopher P. Austin, M.D., stands in front of a high-throughput screening robot in NCATS' laboratory. (Daniel Soñé Photography, LLC)July 15, 2019A key to advancing the burgeoning field of translational science is a highly skilled, creative and diverse translational science workforce. NCATS is committed to ensuring that the translational science workforce is broadly representative across racial, ethnic, sex, gender, age, socioeconomic, geographic and disability status. There are many benefits that flow from a diverse scientific workforce. Key among them is the ability to enhance scientific innovation, something I often emphasize is critical to successful translation.I support the announcement from NIH Director Francis Collins to encourage more inclusion and diversity in speaking panels and to decline invitations to conferences or meetings when “attention to inclusiveness is not evident in the agenda.” Therefore, moving forward, I will accept speaking invitations only for events where the speakers, panelists and other key participants reflect the diversity of the field or interest area.Translation is a team sport. Working together to promote diversity in science contributes to our ultimate goal of delivering more treatments to more patients more quickly. | NCATS Director Statement in Support of Diverse and Inclusive Meetings | NCATS Director Statement in Support of Diverse and Inclusive Meetings | ||||||
| 14791 | CTSA Program Researchers Aim to Improve Health Care from All Sides | January 7, 2019Primary care doctors often used to spend their mornings visiting hospitalized patients, seeing patients in the office in the afternoons. In the 1990s, a new kind of doctor appeared in many hospitals—a general practitioner known as a hospitalist—who sees patients only in the hospital. David Meltzer, M.D., Ph.D., led the effort to establish the new specialty at the University of Chicago and to study how the introduction of hospitalists affected patient health.Today, Meltzer has grown that initial study into a thriving framework for conducting research on how health care is delivered. During the past two decades, Meltzer’s team has enrolled more than 100,000 patients and conducted dozens of studies on topics ranging from prostate cancer treatment to how a language barrier affects a patient’s health after release from the hospital. The research framework is integrated into University of Chicago Medicine’s electronic health record (EHR) system, and a team member discusses potential studies to join with every patient who is admitted to the hospital for illness.With support from NCATS’ Clinical and Translational Science Awards Program, the initiative includes funding for students to learn about research while enrolling patients in the studies. Meltzer leads the Learning Healthcare Systems Core at the Institute for Translational Medicine (ITM), a CTSA Program hub at the University of Chicago.The Shift to HospitalistsToday, hospitalists are standard across the country, but Meltzer’s early research showed that their introduction brought about only minimal improvements in patient outcomes—not enough of a change to justify the huge shift in how health care is delivered. Through further research, he and his colleagues found that hospitalists have become so common because doctors are busier now and have a much larger volume of patients."There has been an incredible increase during the past 20 years for things like cholesterol checks, mammograms—good preventive care," Meltzer said. "It’s not a bad thing; we just were not as attentive to those things in the past."Turning some of the work over to hospitalists made sense, but studies have suggested that the relationship between a primary care doctor and a patient is important to health; Meltzer and other researchers suspect that something was lost in the shift to hospitalists.Studying the Doctor-Patient RelationshipNow Meltzer is studying the value of returning to the way things used to be, with an idea called comprehensive care practice (CCP). In CCP, the same primary care doctor sees patients in or out of the hospital. Each doctor cares for only 200 patients, much less than the usual load, and the doctors are on call all the time. Through this approach, the doctors get to know each of their patients well.Meltzer’s Ph.D. is in economics, and he calls this model for health care "basic social science," similar to the approach to basic biomedical research that is conducted in a laboratory."It was a fundamental insight into a mechanism," he explained. "The question now is how to translate that into practice." The study of CCP represents that next step.The research team enrolls only very unhealthy people covered by Medicare. Each participant is assigned randomly either to receive standard care, involving hospitalists, or to have a CCP doctor. Preliminary results from the first 5 years of the study show that patients are happier and healthier if the same doctor cares for them all the time. On average, CCP patients also are hospitalized fewer times, which shows that they are managing their health better, thus resulting in significant savings for the hospital and for Medicare.Meltzer and his colleagues are focusing on disseminating the work—another step in the translational process. They have funding from Medicare to work with other institutions on ideas for caring for very sick patients. Two other institutions have tried the program with their sickest patients, and like the University of Chicago, those institutions also have seen a decrease in hospitalizations. The New York Times recently published a story about CCP.Recruiting Patients for a Wide Range of StudiesThroughout the 20 years of building his study framework, Meltzer has worked with a variety of collaborators at ITM institutions and organizations across the country to carry out studies on health care topics, such as how patients and providers communicate about health care costs; the risk of social isolation when an elderly patient is hospitalized; and whether text messages could help people manage their heart failure after they leave the hospital.The heart of the framework is a fleet of undergraduate students who speak with every patient who is admitted to the hospital for illness. Each student has a list of patients to approach and a list of studies in which each patient might be eligible to participate. If a patient is interested, they receive consent forms for the studies and are asked to give permission for researchers to review their EHRs.Meltzer noted that the trainees are integral to conducting the research."Our suite is full of students who are busy recruiting patients in the hospital and doing interviews and follow-up," he said. In addition to undergraduates, the trainees include high-school students, medical students, and CTSA Program Clinical Research KL2 Scholars. Many of them go on to lead similar research studies independently.Training the Next Generation of ResearchersDavid Meltzer, M.D., Ph.D., is all smiles in clinic with Comprehensive Care Practice team members (left to right) Shermeka Wilson, L.P.N.; Nicole Gier, L.C.S.W.; and Anitra Thomas, R.N. (Photo by Kathleen Ferraro/Chicago ITM)One of those former trainees is Micah Prochaska, M.D. Now an assistant professor at the University of Chicago, Prochaska first became interested in clinical research in 2002 when he started working for Meltzer as an undergraduate."Many undergrads were really interested in doing clinical research, and David realized he could organize that interest to collect data," Prochaska said. "In return, students get this incredible experience working with patients, learning how to administer a survey, and then publishing manuscripts and talking about it in medical school interviews."Now, Prochaska is collaborating with Meltzer to study blood transfusion and fatigue. Patients are sometimes given a blood transfusion if their levels of hemoglobin, a protein that helps transport oxygen in the bloodstream, are too low. What matters to the patients, however, is not the numbers but how they feel after the transfusion. His current study is about finding better ways to measure fatigue.Recruiting enough patients for a study is a key bottleneck for most clinical research, but Prochaska does not expect that to be a problem. In his grant application, he was able to show how efficiently Meltzer’s framework can recruit people to join studies. When awarding the grant, reviewers from NIH’s National Heart, Lung, and Blood Institute noted that they were confident that Prochaska would be able to find enough participants to accomplish his study’s goals.Meltzer thinks his framework points the way to a learning health system in which investigators can continually learn from experience, grow, and change. The hospital’s EHRs provide a huge volume of data that, if patients give their consent, can be used to find new ways to improve.Initiatives like CCP that strengthen the doctor-patient relationship also could increase research participation, according to Meltzer. "I think that restructuring care produces a real increase in trust," he explained. "Not only can we improve care, but we also can engage patients in the generation of much-needed knowledge." | CTSA Program Researchers Aim to Improve Health Care from All Sides | CTSA Program Researchers Aim to Improve Health Care from All Sides | ||||||
| 14794 | An Itch to Scratch: NCATS, NIDCR Scientists Identify Potential New Approach to Chronic Problem | Nerves that stimulate skin are grouped in structures next to the spinal cord. Here, nerves in such a structure—called a dorsal root ganglion—that are involved in detecting an itch are labeled green. Nerves involved in sensing pain, temperature and other stimuli are shown in magenta. (Hans Juergen Solinski, National Institute of Dental and Craniofacial Research)February 22, 2022Chronic itch goes beyond being just a simple annoyance; it can greatly affect a person’s quality of life. While scientists have some clues to its causes, effective therapies have been elusive.Now, using a technique called quantitative high-throughput screening to sort through more than 86,000 compounds at the same time, researchers at NCATS and the National Institute of Dental and Craniofacial Research (NIDCR) report a new strategy that may eventually help alleviate chronic itch. They’ve shown that blocking a receptor, or docking station, found on the surface of both mouse and human spinal cord neurons could be key.Several years ago, Mark Hoon, Ph.D., and his colleagues at NIDCR found a receptor, Npr1, on mouse spinal cord neurons for a protein associated with itch. The protein fit into Npr1 like a key into a lock, helping turn on the itch sensation. Npr1 appeared to be a potential target for drugs to halt itch.Hoon contacted NCATS scientist James Inglese, Ph.D., and his team for help in identifying compounds that could block Npr1 activity. The researchers developed a series of assays, or tests, and used robots to screen compounds in human cells, finding approximately 1,400 molecules worth examining more closely. They then developed additional assays to narrow the list to 15 compounds. They showed a subset of these compounds could halt both human and mouse versions of the receptor from working. A follow-up study in mice showed that blocking the receptor reduced scratching.Next, the scientists will examine more candidate compounds and determine how they block Npr1. They hope the findings will help them choose which compounds to study further and chemically modify as potential anti-itch drugs. Hoon, Inglese and their colleagues reported the results online July 10 in Science Translational Medicine."This is a proof-of-concept study and an important application of what NCATS does," Inglese said. "We wanted to show that by pharmacologically blocking the target receptor, the approach could be successful in finding a drug to treat chronic itch. Because it can take a long time to develop an ideal compound, the rationale behind the approach needs to be well-vetted." | An Itch to Scratch: NCATS, NIDCR Scientists Identify Potential New App | An Itch to Scratch: NCATS, NIDCR Scientists Identify Potential New App | ||||||
| 14668 | NCATS Innovation Continues Through Latest HHS Ignite Team Selections | June 12, 2019NCATS has done it again! The U.S. Department of Health and Human Services (HHS) Ignite Accelerator IDEA incubator program is supporting three NCATS teams to develop innovative ideas to translate research into better outcomes for people. Through Ignite, small teams receive access to a startup environment of design and entrepreneurship training and 3 months to develop and test their ideas with users. HHS’ recent Innovation Day on June 12 showcased Ignite Accelerator teams and highlighted HHS innovation practices.Christopher P. Austin, M.D., NCATS Director and Anne Pariser, M.D., NCATS ORDR Director, pose with the “No Disease Left Behind: Empowering Patients to Take Action” Ignite team at the HHS Innovation Day on June 12, 2019. Team members include Eric Sid, M.D., M.H.A., NCATS team lead; Christine Cutillo, MMCi, Health Science Policy Analyst; and Alice Chen, M.D., NCATS Medical Officer.In the previous round of Accelerator, NCATS personnel began an business development program for NIH grantees and explored agile software industry methods to accelerate drug development for rare diseases. In the current round, the three NCATS teams are working to emphasize happiness as an essential component of health, establish a system to track and coordinate clinical and translational science best practices and optimize NCATS’ Genetic and Rare Diseases (GARD) Information Center.Evidence shows that happiness can improve health and that the pursuit of happiness is declining in the United States. A team led by NCATS Division of Clinical Innovation (DCI) Program Director Olga Brazhnik, Ph.D., will foster research on interventions that empower people to choose happiness. The team will further investigate the link between health and happiness, identify simple lifestyle changes that increase happiness, and explore the motivating factors for individuals to make and maintain these changes in their lives. The team will identify federal and non-federal stakeholders that aspire to benefit from enhancing happiness and will propose a new NIH program accordingly.Olga Brazhnik, Ph.D. and Timothy Hsiao, Ph.D. lead NCATS teams to develop innovative ideas to translate research into better outcomes for people.Currently, the decentralized nature of the U.S. clinical and translational science ecosystem presents a challenge for the federal government to track and coordinate the nation’s R&D capacity in response to public health crises whose solutions require timely and robust research. DCI Program Director H. Timothy Hsiao, Ph.D., and his team aim to improve the information management process by establishing a searchable, web-based knowledge integration system. This tool would enable the U.S. clinical and translational science enterprise to collaboratively and dynamically disseminate their solutions to translational research challenges.The GARD program provides comprehensive information about rare and genetic diseases to patients, their families, health care providers, researchers and the public. A team led by NCATS Office of Rare Diseases Research Presidential Management Fellow Eric Sid, M.D., M.H.A., aims to modernize GARD’s workflows, database and website, using elements of human-centered design and lean process improvement. The team is working to improve access for patients and caregivers to accurate and plain-language information about rare and genetic diseases, as well as to resources and support services. Finally, the team plans to make its database available through an open application programming interface (API) to foster data sharing with public and private-sector scientists and to facilitate research on the collective impact of rare diseases.“These awards exemplify NCATS’ strong focus on innovation and our key role as trans-HHS collaborators,” said NCATS Director Christopher P. Austin, M.D.Read more about the eighth round of Ignite Accelerator teams. | NCATS Innovation Continues Through Latest HHS Ignite Team Selections | NCATS Innovation Continues Through Latest HHS Ignite Team Selections | ||||||
| 14665 | Translational Science Skills | Your browser does not support JavaScript or it is not enabled. hr.fancy { overflow: visible; /* For IE */ padding: 0; border: none; border-top: medium double #333; color: #333; width: 66%; text-align: center; } hr.fancy:after { content: "§"; display: inline-block; position: relative; top: -0.9em; font-size: 1.5em; padding: 0 0.25em; background: white; } .card { /* Add shadows to create the "card" effect */ box-shadow: 0 4px 8px 0 rgba(0,0,0,0.2); transition: 0.3s; } /* On mouse-over, add a deeper shadow */ .card:hover { box-shadow: 0 8px 16px 0 rgba(0,0,0,0.2); } .modalBodyText { text-align: left; } area { cursor: pointer; } .verticalScroll { overflow-y: scroll; } The Role of Translational Scientists There is tremendous need for people to discover, develop and disseminate the next generation of science and technology to improve human health. This process is called translational science. Watch this video to learn more about it and the role of translational scientists. Credit: National Center for Advancing Translational Sciences Seven Characteristics of a Translational Scientist Translational scientists are innovative and collaborative, searching for ways to break down barriers in the translation process and ultimately deliver more treatments to more patients more quickly. NCATS and other members of an international group called Translation Together have identified qualities that distinguish translational scientists. The Fundamental Characteristics of a Translational Scientist includes an infographic (similar to the one below) that can be used by aspiring scientists, established practitioners and other stakeholders to learn more about the discipline and encourage careers in it. Click on the icons or characteristics to learn more! × Translation is the process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public—from diagnostics and therapeutics to medical procedures and behavioral changes. The professionals involved in this process, either developing interventions or improving the process itself, are TRANSLATIONAL SCIENTISTS. Conducts research at the highest level of rigor and transparency, possesses strong statistical analysis skills, and designs research projects to maximize reproducibility. Practices a team science approach by leveraging the strengths and expertise and valuating the contributions of all players on the translational science team. Breaks down disciplinary skills and collaborates with others across research areas and professions to collectively advance the development of a medical intervention. Seeks to better understand the scientific and operational principles underlying the translational process and innovates to overcome bottlenecks and accelerate that process. Possesses deep disciplinary knowledge and expertise within one or more of the domains of the translational science spectrum ranging from basic to clinical to public health research and domains in between. Communicates with understanding with all stakeholders in the translational process across diverse social, cultural, economic and scientific backgrounds, including patients and community members. Evaluates the complex external forces, interactions and relationship impacting the development of medical interventions, including patient needs and preferences, regulatory requirements current standards of care, and market and business demands. Close !function () { "use strict"; function a() { function a() { function a(a) { function c(a) { return a * b[1 === (d = 1 - d) ? 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| 14605 | CTSA Program Support Enables Development of Life-Saving Blood Loss Monitor | December 6, 2019A person can have dangerous internal bleeding but still appear to be healthy and stable, because the body compensates for blood loss by constricting blood vessels, taking bigger breaths, and making other changes to keep blood and oxygen flowing to the brain, heart, and other internal organs. These responses keep vital signs, such as blood pressure, from changing until a significant amount of blood has been lost. Because vital signs remain relatively stable despite significant blood loss, it often is difficult for medics and hospital staff to detect and appropriately treat internal bleeding before a patient goes into life-threatening shock.As a trauma surgeon at the University of Colorado (CU) Anschutz Medical Campus and Children’s Hospital Colorado in Aurora, Steven Moulton, M.D., knew firsthand what this delay could mean for his patients. With support from the NCATS Clinical and Translational Science Awards (CTSA) Program hub at CU Anschutz, Moulton worked with researchers in the CU Department of Computer Science to find an innovative way to detect when someone is losing blood and how close they are to collapsing. The resulting device, called the CipherOx CRI M1, received approval from the U.S. Food and Drug Administration (FDA) in July 2018 and is now on the market."No one had been able to predict how close a patient was to collapsing," Moulton said. "So when we tell people we have a noninvasive method to trend acute blood loss—heartbeat to heartbeat—from normal to unstable collapse, they inevitably say, ‘You can’t do that, there is no such thing!’"Uncovering Hidden Knowledge in the DataIn 2007, Moulton thought there must be information in patients’ vital signs that could provide an earlier warning signal of blood loss, but he needed a way to find that information and interpret it. He turned to two computer scientists at the University of Colorado and the Colorado Clinical & Translational Sciences Institute—Jane Mulligan, Ph.D., and Greg Grudic, Ph.D.—who were applying machine-learning techniques to enable robots to self-learn and navigate in unstructured outdoor environments. Moulton thought the same approach could be used to navigate the "unstructured data" from vital signs."At the time, people were working on this type of technology for autonomous vehicles but weren’t thinking about leveraging it to analyze vital sign waveform data in medicine," Moulton said. "But there are a lot of similarities between looking at raw visual data from a robot’s sensors and looking at noisy waveforms from vital sign sensors."The team decided to use an unsupervised machine-learning approach in which a computer tried to group the data based on patterns without knowing anything about the data, such as which patients were losing blood and when they became unstable. This unbiased method could identify patterns from large amounts of clinical data that would be impossible for a human to see.But first, the team needed data. Moulton contacted Victor Convertino, Ph.D., at the U.S. Army Institute of Surgical Research (USAISR). Convertino had brought a lower-body negative pressure (LBNP) chamber from NASA to the USAISR to mimic bleeding. Healthy volunteers lie with their lower body inside the chamber, and a vacuum pulls blood away from their upper body into their pelvis and lower extremities, thus starving the heart of blood flow and mimicking acute blood loss. Meanwhile, a sensor on the volunteer’s fingertip monitors blood oxygen levels and collects pulsatile photoplethysmography waveform data. Over time, the team applied their machine-learning approach to pulsatile waveform data collected from more than 200 volunteer LBNP subjects, which resulted in more than 2 million waveforms for analysis. This training data enabled a powerful set of feature-extraction and machine-learning algorithms to identify and learn how a select group of pulsatile waveform features predictably change from completely normal to collapsed (systolic blood pressure < 80 mmHg).The result was a mathematical model of how much someone is bleeding and how close they are to collapsing. The model evaluates the shape of each waveform of blood at a fingertip and knows how that waveform changes when the person is bleeding. The output is a new kind of vital sign that indicates how close someone is to collapsing, which the team has termed the compensatory reserve index (CRI).Validating a Pioneering ApproachMoulton and the team were excited, but a lot more work lay ahead before this technology could reach patients. Moulton received a CTSA Program pilot award in 2009—his first funding for the project—to develop the CRI algorithm and later port it to a small, battery-powered device that could be deployed on the battlefield.This diagram shows how data from the compensatory reserve index currently on the market correspond to a patient's health status. (Flashback Technologies Photo)"The CTSA Program funding allowed us to hire computer science graduate students to make faster progress on developing and validating the technology," said Moulton. This pilot support was followed by significant funding from the U.S. Army to develop the device into an easy-to-use monitor. Moulton and Grudic subsequently licensed the intellectual property from CU and launched a start-up company, Flashback Technologies, to commercialize the technology.To gain approval from the FDA to use the device in hospitals and other care settings, the team had to validate the model in a more real-world scenario. They collaborated with Dr. David MacLeod, at the Duke University School of Medicine Department of Anesthesiology, to conduct moderate human blood-loss studies. The laboratory allowed the researchers to temporarily remove and store up to 20 percent of a healthy volunteer’s blood while monitoring them with the CRI device. The CRI algorithm reliably predicted how close each subject was to collapsing, selecting those who were more sensitive to blood loss and showed symptoms much earlier than the volunteers who were more tolerant of the blood draw. Upon reviewing these data, the FDA approved the CipherOx CRI M1 for broader use.CipherOx CRI M1 with CRI “fuel gauge” to the right and 20-minute trend line to the left. The trend line allows practitioners to determine if their patient is continuing to bleed or if fluid resuscitation measures are effectively refilling the patient’s “fuel tank.” (Children’s Hospital Colorado Photo)Commercial adoption of the CRI has taken different and interesting turns, according to Moulton. For example, one medical center bought 16 devices to monitor trauma patients being transferred to the hospital by helicopter. Another center plans to use these devices to monitor children who come in with spleen, liver, or other solid-organ injuries instead of drawing routine laboratory studies.Several centers are interested in monitoring women after childbirth for evidence of postpartum hemorrhage, one of the leading causes of maternal death in the United States. "Too many young, healthy women around the world die every year following childbirth," Moulton said. "We believe CRI will provide a better, continuous noninvasive method to monitor these women and enable practitioners to know how near or far a woman is from collapse. It will enable doctors to intervene earlier, before these women become unstable and are much more difficult to treat.""It is great to see CTSA Program support at the beginning of a project culminate in a life-saving technology that makes it to market to benefit patients," said Michael G. Kurilla, M.D., Ph.D., director of the NCATS Division of Clinical Innovation. "It demonstrates the catalytic power of NCATS through the CTSA Program." | CTSA Program Support for Life-saving Blood Loss Monitor | CTSA Program Support for Life-saving Blood Loss Monitor | ||||||
| 14548 | PUBLIC NOTICE | NIH National Center for Advancing Translational Sciences (NCATS) Notice of Intent to Support a Phase III Clinical Trial for a Rare Disease or Condition Pursuant to the “NCATS Policy for Support of Phase III Clinical Trial Activities for a Rare Disease or Condition” (NOT-TR-18-025), NCATS provides a public notice period (defined as 120 calendar days) and opportunity for any public or private organization to submit a reply on the contemplation of NCATS to support a Phase III clinical trial activity for a rare disease or condition (as defined here). Specifically, NCATS seeks responses from any public or private organization with credible, timely plans to conduct Phase III clinical trials of a similar nature. Respondents must provide sufficient information to enable an accurate determination of whether the respondents’ clinical trial activities are timely and of a similar nature to the trial described below. NCATS is currently seeking comments for the following Phase III Clinical Trial(s) for a Rare Disease or Condition which NCATS is considering supporting: None at this time Responses should include a credible, timely plan and contact information. Please submit to NCATS_Phase_III_CT_P@mail.nih.gov. Please direct all inquiries to: NCATS Policy Officer Email: NCATS_Phase_III_CT_P@mail.nih.gov Prior Phase III Clinical Trial(s) for a Rare Disease or Condition for which NCATS Sought Public Comment NCATS previously sought public comments on the following Phase III Clinical Trial(s) for a Rare Disease or Condition: “STeroids to REduce Systemic Inflammation After Neonatal Heart Surgery (STRESS),” details of which can be found at NCT03229538. (Posted on May 24, 2019. Responses were due by 5 p.m. ET on September 20, 2019.) | This page provide the public notice that NCATS is considering funding a phase III clinical trial for a rare disease or condition and that the public has 120 days to provide a comment. | PUBLIC NOTICE | This page provide the public notice that NCATS is considering funding a phase III clinical trial for a rare disease or condition and that the public has 120 days to provide a comment. | PUBLIC NOTICE | ||||
| 14455 | New Method Could Help Find Potential Treatments for Rare Diseases | January 5, 2019Finding treatments for rare diseases is difficult: Because they affect such a small number of people, research funding and other resources may be limited. Even if researchers are interested in studying a rare disease, the methods for testing potential drugs may not yet exist. A major focus at NCATS is to identify ways to test compounds and therapies that could apply to a wide range of rare disorders.Scientists in NCATS’ Assay Development and Screening Technology (ADST) program are collaborating with rare disease organizations to find better ways to test possible drugs for rare diseases. Scientist Mike Iannotti, Ph.D., spent three years as an ADST postdoctoral fellow developing a new way to measure whether a potential drug is effective against the inherited disease alpha-1 antitrypsin (AAT) deficiency. His fellowship was funded by the Alpha-1 Foundation, an organization founded by people with AAT deficiency, a disease that can cause serious lung and liver problems.The work has not yet led to a new treatment for AAT deficiency, but it should help speed the process of finding treatments for that and many other diseases—both rare and common.New Tests for Potential DrugsA robot retrieves compound plates from storage incubators (right) and brings them to a transfer station (foreground) where compounds are transferred to assay plates.ADST scientists use a technique known as high-throughput screening, in which robots carry out many experiments at in hundreds or even thousands of tiny wells that fit on a plastic plate that is the size of an index card. Scientists refine the tests—called assays—used in high-throughput screening so that they meet specific needs.However, finding the right assays to use in testing for potential drugs against diseases can be difficult. Scientists often need to test large collections of thousands of compounds to see whether any of them affect a disease.“For many rare diseases, not only do we not have any drugs that work, we don’t even have any assays that can be used to search for such drugs,” said ADST Director James Inglese, Ph.D., who supervised Iannotti’s work. “Rare diseases sometimes don’t have obvious targets for compounds and drugs compared to many widely studied diseases, such as cancer and cardiovascular disease.”Many existing assays will not work for rare diseases because of their unique underlying biology. In some cases where rare diseases share a similar biology, scientists can develop new assays specific to several diseases at the same time. Such assays can tell scientists whether a compound or drug has a promising effect on a disease.A Focus on AATHealthy liver cells make the protein AAT and then secrete it into the blood. The protein travels through blood vessels to coat the lungs, protecting healthy tissue from potential attack by immune cells.In people who have AAT deficiency, the protein does not form properly. Some people get liver disease because the protein builds up and forms toxic clumps inside the liver cells. Others can develop lung disease because they do not have enough AAT to protect their lungs. Patients can receive AAT intravenously, but this only slows the progression of lung disease, and no treatment currently exists for liver disease.Iannotti’s goal was to develop an assay to test the effects of small molecules as potential drugs on cells that model AAT deficiency. If a small molecule were to change how AAT is released, he would know that it is worth investigating. He needed to be able to measure how much AAT the cells were producing.Measuring the amount of protein coming from cells is straightforward if researchers test one potential drug at a time; however, NCATS’ high-throughput screening library contains approximately 400,000 small molecules, so Iannotti needed a way to test many of them at once.He began working with a kind of cell that is relatively easy to grow in the laboratory and can be altered with common genetic engineering tools to mimic a disease. He introduced AAT with a mutation found in many people with AAT deficiency and fused it with a protein that glows. By measuring the glow, he could see how much AAT protein was coming out of the cells.Measuring Protein with a New PlateThe technique worked, but Iannotti wanted a better way to measure the amount of protein coming from a cell.A new NCATS-designed assay plate allows protein samples to be measured through tiny dots of liquid.“It really bothered me that we couldn’t measure secreted protein in a straightforward, cost-effective way without modifying the cell with a glowing protein,” Iannotti said. “It’s like trying to compare how fast two people can move when one of them is dragging a suitcase.”To measure the unmodified AAT protein directly in a high-throughput setting, Iannotti realized that he needed an assay plate that could hold a sheet of nitrocellulose, a substance that is part of a common process for detecting individual proteins because proteins stick to it. Once the proteins are on a sheet of nitrocellulose, a researcher can cover it with molecules that bind only to the protein of interest. Those molecules, in turn, can be made to glow.The idea worked. NCATS’ Automation and Compound Management group stepped in to create a new prototype assay plate that snapped together to hold a nitrocellulose sheet. That allowed Iannotti to measure unmodified protein on the nitrocellulose sheet through 1,536 tiny dots of liquid to determine how much protein was in each dot. He and his colleagues recently described the method in the journal ACS Chemical Biology.A Method for Many DiseasesThe new method that Iannotti developed still has several steps to go before it can lead to a treatment for AAT deficiency. Iannotti still needs to run the tests with cells that are more like the liver cells of people with AAT deficiency. Through the Alpha-1 Foundation, he has access to stem cells developed from patients with AAT deficiency to test potential drugs.Researchers at NCATS and elsewhere also could use the new method to study many other diseases. “Cells that secrete proteins include everything from insulin-producing cells to cells shedding viruses,” said Inglese. “It would be great to be able to measure that process in a very effective, efficient way.”NCATS scientist Mike Iannotti, Ph.D.A New Research PathFor Iannotti, the Alpha-1 Foundation’s fellowship has opened up new translational research—and career—opportunities. “NCATS has provided me with translational research training in a unique environment, with its resources, expertise, and access to automation and compound screening facilities. It has enabled me to be innovative and design experiments in a different way than was possible as a graduate student,” he said.Iannotti and the foundation both benefit from the fellowship. “The foundation gets a rare disease champion who focuses on its disease. At the same time, I’ve been able to tackle a real-world problem and accomplish my research goals.”Working with rare disease patients and families has changed his perspective.“Sometimes as researchers we’re so focused on our work in the lab, we lose sight of the people with the rare disease we’re studying,” he said. “We started with a blank slate, and we worked together to establish a research path forward to eventually help those with a rare disease.” | New Method Aims to Help Find Treatments for Rare Diseases | New Method Aims to Help Find Treatments for Rare Diseases |
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