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Two New TIN Opportunities for Researchers: Efficacy to Effectiveness (E2E) Trial Design
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The national Trial Innovation Network, a new NIH entity to facilitate multi-center clinical trials utilizing existing national CTSC sites, has announced two new opportunities for researchers via Efficacy to Effectiveness (E2E) trial design.
Efficacy to Effectiveness (E2E) trial design is an approach whereby an effectiveness trial would commence seamlessly upon completion of the efficacy trial. E2E trials are prospectively designed to address the effectiveness and safety gaps that often occur in standard randomized controlled trials, and offer an opportunity for improved understanding of how a treatment will work in more usual real-world clinical settings. This paper by Selker et al, outlines this concept in more detail.
CTSA investigators can explore how an E2E Trial Design can improve their research in two different ways through the Trial Innovation Network.
- The the MIT NEWDIGS program, in collaboration with the JHU-Tufts Trial Innovation Center, are hosting a two-day E2E Design Lab in March 2018. This interactive multi-stakeholder event will provide a venue to discuss the considerations and challenges of designing a Phase 2 or Phase 3 E2E multi-site clinical trial that supports the generation of robust efficacy and effectiveness data. For more information on how to participate please visit:
https://trialinnovationnetwork.org/2017/07/20/two-day-e2e-design-lab-in-march-2018-hosted-by-mit-newdigs-program/. Deadline is Sept. 15, 2017.
- Investigators also may apply to the Trial Innovation Center for E2E Consultations, which offer a dedicated, protocol-specific approach to E2E trial design, focusing on the selection of suitable efficacy and effectiveness endpoints, advice on the statistical analysis plan, and the role of the DSMB in transitioning from the efficacy to effectiveness phase. We invite investigators interested in an individual consultation to submit a request through the website:
https://trialinnovationnetwork.org/e2e-consultations/?key-element=1602
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Any full-time faculty member at Case Western Reserve University is eligible to submit a study proposal to the Trial Innovation Network through the Trial Innovation Network Hub Liaison Team. To submit a proposal or for questions about the Trial Innovation Network, please contact Noreen Roman, Project Coordinator, at
[email protected]
or at
216-778-3130.
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KL2 Scholars, Drs. Fu and Knutson, Help Engineers Develop Innovative Rehabilitation Therapies
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Drs. Michael Fu, Ph.D. (left), and Jayme Knutson, Ph.D. (right), have been featured in the July 27, 2017 issue of the
NCATS Catalyzing Innovation newsletter!
Here, they are pictured with their Contralaterally Controlled Functional Electrical Stimulation video game therapy, an innovative method for training hand function in adults after stroke and in children with cerebral palsy. (Erika Woodrum/Cleveland Functional Electrical Stimulation Center Photo.)
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KL2 Scholar Receives Two Prestigious Awards for his Commitment to Mentoring Nursing Students
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Congratulations to Ronald Hickman, PhD, RN, ACNP-BC, FNAP, FAAN, associate professor of nursing at the Frances Payne Bolton School of Nursing and former CTSC KL2 scholar, on receiving the John S. Diekhoff Award for Excellence in Graduate Mentoring and the J. Bruce Jackson Award for Excellence in Undergraduate Mentoring!
“Mentoring has been a cornerstone approach to making a difference in the lives of undergraduate and graduate nursing students,” says Hickman. “The receipt of two of the university’s top honors for mentoring undergraduate and graduate students is a testament to my commitment to making sure that I pay it forward.”
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Erika Trapl, PhD, becomes PRCHN Acting Director until January 1, 2018
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PRCHN Director Elaine Borawski, PhD is taking a
six-month sabbatical to focus on her research and writing. In the meantime, Erika Trapl, PhD, and Assistant Professor of the Department of Population & Quantitative Health Sciences will be the PRCHN Acting Director until Dr. Borawski's return on January 1, 2018.
The PRCHN Monthly Seminar Series is on summer hiatus. The next seminar takes place
Wednesday, September 13, 2017
, at
noon
.
You can find more information on PRCHN seminars and programs
here.
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New BRFSS Data Available on PRCHN Website
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Curious as to how many Cleveland residents use tobacco products, how many feel safe in their neighborhood, or what Clevelanders think about the future?
The national BRFSS includes questions around quality of life; health care access and utilization; chronic conditions; health-related behaviors; and financial resources. Local questions also include perceptions of neighborhood food availability, price, and quality; neighborhood safety; quality of life and support; hopefulness for family and the city of Cleveland.
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News from the Urban Health Intiative
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Urban Health Happenings: Graduations, Presentations, and Publications
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Well-rested from our summer vacations, the Urban Health Initiative and friends have been busy!
Scott Frank, from the Department of Population and Quantitative Health Sciences, and I received a grant from the George Gund Foundation for continued support of Health Data Matters. I gave an invited keynote address to health care executives entitled “Data Mapping – The Geography of Health at a conference entitled Solving for Social Determinants of Health: The x-factor in effective population health management. Attendees were especially interested in learning about our data platform and also the HealthStead app developed by colleagues at MetroHealth System. Closer to home, we have been pleased to share our experience creating data use agreements, wrestling with data privacy and security issues, and evaluating data visualization software with people from other sectors that are interested in opening up civic data. These conversations are taking place at the Open Data Collaborative led by Councilman Brian Cummins and the Civic Insights Data Hub users group convened by DigitalC (formerly: OneCommunity) if you are interested.
Our article, Addressing Disparities in Diabetes Management Through Novel Approaches to Encourage Technology Adoption and Use (Amy Sheon, Shari Bolen, Adam Perzynski and others), was published in the Journal of Medical Internet Research Diabetes documenting the imperative of ensuring that all patients are digitally connected if we hope to reduce disparities in health and in clinical research recruitment. The article presents a strategy that involves using Community Health Workers to screen patients for digital literacy and connectivity, refer them to partners for basic digital skill training and for help accessing low cost internet service, and then train patients to use portals to the electronic health record. The photo shows students at the Cuyahoga Community College Community Health Worker Training Program learning these skills. We look forward to them helping us refine and test the model as they complete their clinical practicum assignments at MetroHealth System and at United Way 2-1-1. United Way has agreed to serve as a referral target for anyone seeking information on where they can get free digital skill classes and low cost internet. We hope to begin health portal training in the coming months with individuals who have completed basic digital skill training.
Finally, I’ve previously mentioned participation in the Network of Digital Evidence for Health (NODE Health), established by Dr. Ashish Atreja, currently at New York’s Mt. Sinai Hospital. Stay tuned for an announcement from CTSC about an opportunity to hear what NODEHEALTH can do for you when Dr. Atreja visits Cleveland in a few weeks. Together with the new Journal of Digital Biomarkers, NODE Health will host the first ever national meeting on generating evidence for digital medicine, December 4-5, 2017 in New York City. I will chair a track focused on digital health and underserved populations; I’ll circulate more information when available.
Mark your calendars for October 21-22, 2017 (Global Center), the 3rd annual Cleveland Medical Hackathon. If you want a jump start on using community health data to fuel apps or other innovations, please join our Public Health Innovation Meetup Group.
Please contact me if you would like further information about any of the above or have comments on our work!
Amy R. Sheon, Ph.D., M.P.H.
Executive Director, Urban Health Initiative
Case Western Reserve University School of Medicine
216-368-0915
http://urbanhealth.case.edu
www.healthdatamatters.org
@CLEhealthCUY
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Check out the NIH Extramural Nexus for important grant related news! Here are some important articles from this month:
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First-of-its-kind multicenter clinical trial to assess the long-term outcomes of bariatric/metabolic surgery compared to medical and lifestyle therapy for treating Type 2 diabetes
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A team of Cleveland Clinic doctors, John Kirwan, PhD, Philip Schauer, MD, and former CTSC KL2 Scholar, Sangeeta Kashyap, MD has been awarded $10.2M from NIDDK to lead The Alliance of Randomized Trials of Medicine versus Metabolic Surgery in Type 2 Diabetes (ARMMS-T2D) consortium.
Members of the consortium are Cleveland Clinic, Joslin Diabetes Center/Brigham & Women’s Hospital Boston, University of Pittsburgh and University of Washington. Each group completed previous studies that evaluated the short-term effectiveness of bariatric surgery compared to medical and lifestyle management on type 2 diabetes and body weight.
This new research will evaluate the long-term effectiveness of bariatric surgery compared to medical and lifestyle management on type 2 diabetes and body weight by merging the study participants, procedures, and outcome metrics from these centers; a total of 302 patients with type 2 diabetes and mild to moderate obesity will be re-enrolled into ARMMS-T2D.
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Vitamin D may improve sunburn, according to new clinical trial
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“We found benefits from vitamin D were dose-dependent,” said Kurt Lu, senior author on the study, assistant professor of dermatology at Case Western Reserve University School of Medicine, physician at University Hospitals Cleveland Medical Center, and former CTSC KL2 Scholar. “We hypothesized that vitamin D helps promote protective barriers in the skin by rapidly reducing inflammation. What we did not expect was that at a certain dose, vitamin D not only was capable of suppressing inflammation, it was also activating skin-repair genes.”
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OHRP Research Community Forum
September 6-7, 2017
Northern Kentucky Convention Center, Covington, KY
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The Cincinnati CTSA will be hosting a two-day human subject protection forum consisting of an academic conference and an applied workshop relevant for institutional review board (IRB) members, IRB administrators, clinical investigators, research scientists and support staff, sponsors, contract research organizations, government regulators, and members of the research community.
Representatives from the Office of Human Research Protection (OHRP) and other federal agencies as well as research experts will provide perspectives and resources for interpreting and applying human subject protections in an evolving regulatory landscape.
Tracks include:
- Social/behavioral research
- Biomedical research
- Innovative research
- Regulatory landscape
- Community engagement
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Clinical Research Forum 2017 Industry Roundtable
September 25, 2017
American College of Cardiology Conference Center
2400 N St NW, Washington, DC 20037
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Hear from leaders in the field about the 21st Century Cures Act and the future of industry-funded research. Enjoy unparalleled, intimate access to top decision makers at this exclusive member event. Free to CR Forum members as a member benefit!
Stellar Speaker Line-Up includes FDA, NIH, and Eli Lilly!
Learn more at http://www.clinicalresearchforum.org/page/IndustryRoundtable
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12th Annual Cleveland Clinic Obesity Summit
September 28-29, 2017
InterContinental Hotel - Cleveland, OH
Mississppi Gulf Coast Community College - Biloxi, MS
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The Cleveland Clinic Obesity Summit attracts a diverse mix of health care practitioners interested in discussing innovative solutions to the causes of obesity, preventive strategies, and therapeutic management approaches. This Summit features diverse sessions designed to engage you with colleagues as well as patient interviews, live surgeries, interactive workshops, case-based lessons, and question and answer sessions. Take advantage of the opportunity to learn from shared experts broadcast between two locations – Cleveland, OH and Biloxi, MS.
Who Should Attend?
Health care professionals (including physicians, nurse practitioners, nurses, physician assistants, and dietitians), researchers, hospital and corporate administrators, and others who have an interest in obesity-related fields, including endocrinology, family practice, internal medicine, pediatrics, psychiatry and psychology, bariatric surgery, and wellness.
Sign up today at www.ccfcme.org/ccfobesity17
ACCREDITATION: 13.5 AMA PRA Category 1 CreditsTM
Questions? Call 216-448-8710
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2017 Graft vs. Host Disease National Symposium
October 13, 2017
Grand Event Center, Columbus, OH
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This conference is intended to raise awareness about the signs and symptoms of GvHD, review cutting edge approaches to prevention and treatment, and highlight and promote research to further our understanding of its cause. The symposium has
two tracks: a scientifically rigorous one for physicians and practitioners, and a survivor track that will focus on challenges faced by BMT recipients and their families. The survivor track is intended to provide both education and the opportunity for individuals to interact with national leaders in the GvHD field. The afternoon "Meet the Expert" panel provides a unique opportunity for both physicians and survivors and their families to interact during the program.
ACCREDITATION:
Physicians
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Case Western Reserve University School of Medicine and the Meredith A. Cowden Foundation. Case Western Reserve University School of Medicine is accredited by the ACCME to provide continuing medical education for physicians. Case Western Reserve University School of Medicine designates this live activity for a maximum of
5.75 AMA PRA Category 1 CreditsTM. Physicians should only claim the credit commensurate with the extent of their participation in the activity.
Nurses
The Ohio Board of Nursing will accept at face value the number of contact hours awarded for an educational activity that has been approved for CE by a nationally accredited system of CE approval.
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3rd Annual Cleveland Medical Hackathon
October 21-22, 2017
Global Health Innovation Center - Cleveland, OH
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The Cleveland Medical Hackathon (#clemedhack) will bring together doctors, nurses, researchers, public health workers along with IT professionals over an intense 24-hour period at the Global Center for Health Innovation. Hackathon teams will identify challenges, propose solutions, and work on technological solutions that are poised to transform healthcare. Teams will then present their solutions for cash prizes and an opportunity to discuss their findings during the 15th Annual Medical Innovation Summit immediately following the Hackathon.
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2017 Medical Innovation Summit: Genomics & Precision Medicine
October 23-25, 2017
Huntington Convention Center - Cleveland, OH
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Cleveland Clinic Innovations hosts the Medical Innovation Summit each fall as a way to bring together all stakeholders in healthcare to build the relationships and ignite the technologies that will advance patient care. The Summit is part of Cleveland Clinic’s commitment to drive healthcare innovation and quality. Now more than ever, Cleveland Clinic believes it is essential that innovation remain at the core in the delivery of medical care.
Now in its 15th year, the Summit is renowned for thought-provoking panels, lively 1-on-1 discussions with influential CEOs, and the discovery of the latest market-ready technologies poised to shake up the status quo. Regardless of your field, Genomics and Precision Medicine is on the brink of revolutionizing the way we care for patients and the way we conduct business. Join us as we highlight the technologies, discuss the opportunities, and navigate the future challenges of this exciting new market.
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Meeting of the Minds 2017 Annual Summit
October 23-25, 2017
Global Health Innovation Center - Cleveland, OH
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The Meeting of the Minds Summit is a forward-looking conference for sharing strategies with scalable solutions in urban neighborhoods.The summit will include speakers and sessions that aim to share innovative sustainability and technology solutions between people from around the globe.
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New HHS, NIH Grant Programs
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Following in their long traditions of helping to support important scientific research, the National Institutes of Health and the Department of Health and Human Services have released information on new grant and award programs that we encourage members to take advantage of.
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Beckman Foundation accepting LOIs for Young Investigator Program
Letter of Intent due: August 14, 2017
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The
Arnold and Mabel Beckman Foundation is accepting Letters of Intent for its 2017 Beckman Young Investigator grant program.
The annual program is intended to provide research support to the most promising young faculty members in the early stages of an academic career in the chemical or life sciences and to foster the invention of methods, instruments, and materials with the potential to open up new avenues of research in science.
Projects proposed for this program should be truly innovative, high-risk, and show promise for contributing to significant advances in chemistry and the life sciences. They should also represent a departure from current research directions rather than an extension or expansion of existing programs. Proposed research that cuts across traditional boundaries of scientific disciplines is encouraged.
Projects are normally funded for a period of four years. Grants typically range around $600,000 over the term of the project, contingent on demonstrated progress after the second year of the award.
The BYI program is open to individual researchers within the first three years of a tenure-track position, or an equivalent independent research appointment, in an academic or nonprofit institution that conducts research in the chemical and life sciences. Candidates must be a citizen or permanent resident of the United States at the time of application.
For more information visit the
Beckman Foundation website.
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Microsoft Azure for Research
Application Deadline: August 15, 2017
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Cloud computing lets you spend more time on your research, providing all the computing you need, exactly when you need it Whether it’s a computer with more memory, a cluster with thousands of cores, a big data platform, an internet of things solution, or open-source machine learning at scale, you can achieve more using the cloud. Microsoft Azure for Research awards offer large allocations of cloud computing for your research project, and already supports hundreds of researchers worldwide across all domains.
What it is:
Azure cloud computing helps you accelerate your research by providing what you need, when you need it. The Microsoft Azure for Research program awards cloud computing time, training, and resources to help you achieve more.
Who it’s for:
Faculty, researchers, and graduate students are qualified to submit proposals for Azure awards for research projects. Masters and undergraduate students require a faculty project supervisor to submit their proposal.
Apply now for cloud computing resources for your research project. Proposals are evaluated every two months.
If you have any questions about the program, please contact [email protected].
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Stand Up To Cancer - $10 Million Dream Team of Top Investigators
Application Deadline: September 5, 2017
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Stand Up To Cancer (SU2C)
, in partnership with the American Association for Cancer Research, is inviting Letters of Intent for a new $10 million Dream Team of top scientific investigators searching for new strategies to prevent or treat cancer.
Unlike other Dream Team grants offered by SU2C in recent years that focused on specific types of cancer, such as colorectal cancer or lung cancer, the SU2C Dream Team Translational Cancer Research Grant program is open to any type of translational cancer research. The program will support a single translational cancer research project that will address critical problems in patient care and deliver near-term patient benefit through investigation by a multidisciplinary, multi-institutional, collaborative Dream Team of expert investigators.
Projects may focus on particular organ sites, patient populations (such as pediatrics), or on innovative methods of treatment. Projects must be designed to accelerate the application of new preventive, diagnostic, or therapeutic approaches to the clinic that lead to patient involvement within two to three years from the beginning of the grant.
In addition, through collaboration with the leading healthcare research and innovation center, OptumLabs, the team will have the opportunity to gain access to, and to conduct research using, OptumLabs’ proprietary database of de-identified medical claims and electronic health record clinical data, analytic tools, and research support to pursue the goals of the Dream Team.
To maximize creativity, innovation, and collaboration, the Dream Team must include laboratory and clinical researchers, senior and/or young investigators, and senior scientists who have not worked together in the past.
Invited Application Deadline: January 16, 2017
For more information visit the
SU2C website.
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American Skin Association - Calder Research Scholar Award in Vitiligo/Pigment Cell Disorders
Application Deadline: October 1, 2017
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The ASA invites the submission of applications for its Calder Research Scholar Award in Vitiligo/Pigment Cell Disorders in the amount of $60,000 to foster the career development of a young investigator working at the level of instructor through associate professor in the field of dermatology or cutaneous biology. The aim of the program is to provide bridge support for young investigators. Special consideration will be given to individuals without significant prior support. A second year of funding may be requested upon receipt and review of a final progress report and reapplication.
Preference will be given to those under the age of 45 as of June 30, 2018 with a rank of instructor up through associate professor (or the institutional equivalent). First preference will be given to those working in a department or division of dermatology, and second preference to those with a close working relationship to dermatology.
The individual must have a strong career goal within the field of dermatology and be dedicated to the furtherance of knowledge concerning vitiligo/pigment cell disorders. The research must be focused on new discoveries in the basic or translational medical sciences that impact the understanding or treatment of vitiligo/pigment cell disorders.
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NIH: Cellular and Molecular Biology of Complex Brain Disorders (R01)
Application Deadline: October 5, 2017
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This Funding Opportunity Announcement (FOA) encourages research grant applications directed toward the discovery of the impact of alterations associated with complex brain disorders on the fundamental cellular and molecular substrates of neuronal function.
For more information visit the Grants.Gov website.
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Special Funding Opportunities & Notices
Multiple Deadlines
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Tailoring Cardiac Rehabilitation to Enhance Participation of Older Adults (R01)
(RFA-AG-18-016)
National Centers for Translational Research in Reproduction and Infertility (P50)
(RFA-HD-18-008)
Implementing Genomics in Practice (IGNITE) II: Pragmatic Clinical Trials Clinical Groups (U01)
(RFA-HG-17-008)
Synthetic Biology for Engineering Applications (R01)
(PAR-17-334)
Discovery of in vivo Chemical Probes for Novel Brain Targets (R01)
(PAR-17-336)
Using Small Molecules and Molecular Genetics to Identify Novel Targets and Mechanisms Contributing to Tumor Immune Evasion (R01)
(PA-17-330)
First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01)
(PAR-17-327)
Discovery of Small Molecule Immunomodulators for Cancer Therapy (R01)
(PAR-17-331)
Exploratory/Developmental Investigations on Primary Immunodeficiency Diseases (R21)
(PAR-17-333)
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