Latest News from Around the CTSA Program Consortium

A pregnant woman and a man with his hand on her belly. Getty Images
Dads Matter: Moms Aren’t the Only Ones Who Impact Babies’ Health at Birth

University of Rochester Clinical and Translational Science Institute

Researchers at the University of Rochester School of Nursing have recently shown that dads can affect their babies' health - even before they're born. Their study, which was supported by the University of Rochester CTSI, shows that fathers’ education level, age, race or ethnicity can have a bearing on how healthy their children are at birth. “Paternal information is routinely collected during prenatal checkups, but this information has not been utilized to predict birth outcomes,” says study author Ying Meng, Ph.D., assistant professor at the University of Rochester School of Nursing and former UR CTSI Population Health Research postdoctoral fellow. “Our study suggests we might be able to make those predictions and prevent negative birth outcomes with programs that focus on – or at least include – fathers.”

June 20, 2019

NPRM HealthIT.gov
COMMENTS REQUESTED: Notice of Proposed Rule making to Improve the Interoperability of Health Information

CLIC / NCATS

The U.S. Department of Health and Human Services (HHS) recently proposed a new rule to support seamless and secure access, exchange, and use of electronic health information (EHI).

The proposed rule is designed to increase innovation and competition by giving patients and their healthcare providers secure access to health information and new tools, allowing for more choice in care and treatment. It calls on the healthcare industry to adopt standardized application programming interfaces (APIs), which will help allow individuals to securely and easily access structured EHI using smartphone applications.

The proposed rule places a strong focus on a patient's ability to access their health information through a provision requiring that patients can electronically access all of their EHI (structured and/or unstructured) at no cost. Finally, to further support access and exchange of EHI, the proposed rule implements the information blocking provisions of the Cures Act. The rule proposes seven exceptions to the definition of information blocking.

The public comment period is now open for the proposed rule, comments MUST be received by June 3, 2019

May 15, 2019

graphic depicting proteomics, genomics, metabolomics, and transcriptomics as methods of single-cell analysis Getty Images
The promises and pitfalls of omics in precision medicine.

University of Rochester Clinical and Translational Science Institute

Omics techniques that rapidly analyze large amounts of genomic and other data from an individual cell, tissue or patient could greatly benefit precision medicine, but not without challenges. The Regulatory Science to Advance Precision Medicine Working Group, led by scientists at the University of Rochester Clinical and Translational Science Institute, held a forum in 2017 to examine those possibilities and challenges. Members of the NIH, FDA, CTSA Program, foundations and industry explored how to apply omics techniques to precision medicine and revolutionize patient diagnosis and therapeutic interventions. Their findings were recently published in the Journal of Clinical and Translational Science.

February 20, 2019

Getty Images
We can grow a new ear, but how do we regulate it?

University of Rochester Clinical and Translational Science Institute

Technologies like 3D printing hold a lot of promise for precision medicine - even allowing scientists to grow new ears for children. As these technologies quickly advance, so does the need to regulate them. Scientists at the University of Rochester Clinical and Translational Science Institute established the Regulatory Science to Advance Precision Medicine Working Group and gathered experts from academia, government, industry and foundations at a forum in the fall of 2017 to discuss the emerging science and regulatory considerations of 3D printing. The group recently published their findings in the Journal of Clinical and Translational Science.

February 18, 2019

REP logo REP
Improving health globally by studying health locally

Mayo Clinic Center for Clinical and Translational Science

Mayo Clinic has been partnering with Olmsted Medical Center and several other regional health care providers for more than 50 years in an initiative called the Rochester Epidemiology Project. This collaboration stretches across 27 counties in Minnesota and Wisconsin, allowing researchers to study health and illnesses in the people living in the region or in specific counties. Most recent additions to the collaboration include Olmsted County Public Health Services, Zumbro Valley Health Center and several dental practices.

This collaboration and sharing of medical information makes the area of Minnesota and Wisconsin one of the few places in the United States where “population-based” research can be accomplished. The results inform both our understanding of diseases as well as how we prevent and treat them.

February 13, 2019

Reviewing research Getty Images
A Model for Accelerating Translational Research in Real Time

Clinical & Translational Science Institute of Southeast Wisconsin at the Medical College of Wisconsin

Before a clinical trial can begin, an institutional review board (IRB) must determine that the study is ethical and that participants’ rights are protected. This oversight step is crucial, but it can take a long time and delay studies from starting, particularly those at multiple sites. In response to numerous calls to reduce review times, the Clinical & Translational Science Institute of Southeast Wisconsin at the Medical College of Wisconsin devised "Real-Time IRB," a process that drastically reduces IRB review time.

In this, investigators and study staff attend the IRB meeting and make changes to the protocol while the IRB continues its meeting, so that final approval can be issued at the meeting. This achieved an overall reduction in time from submission to the IRB to final approval of 40%. While this process is time and resource intensive, and cannot address all delays in research, it shows great promise for increasing the pace by which research is translated to patient care.

January 03, 2019

NIAID logo NIAID
Physician-Scientists: Don’t Overlook This Novel Source of Funding

National Institute of Allergy and Infectious Diseases

We first told you about NIAID’s new program to increase and maintain a strong cohort of independent physician-scientists conducting biomedical research in our August 3, 2017 article “Physician-Scientists: NIAID Launches New Funding Opportunity Just for You.”

The grant is split into a one- to two-year K99 phase that supports mentored postdoctoral research training and career development followed by a two-year R00 phase that provides independent research support if the investigator obtains an approved, independent, tenure-track position at the end of the K99 phase.

Find the full funding opportunity announcement (FOA) at NIAID Physician-Scientist Pathway to Independence Award (K99/R00).

December 21, 2018

HEAL Logo NIH
NIH needs your innovative research ideas through our newly announced NIH HEAL Initiative funding opportunities

NIH

NIH leadership from across the agency has been working diligently over the past several months to identify areas of greatest opportunity for research to address the national opioid crisis. The result is more than 30 new funding opportunity announcements (FOAs) to solicit the best and brightest research ideas through the NIH HEAL (Helping to End Addiction Long-termSM) Initiative.

Through these and other investments, NIH plans to award more than $850 million in support of HEAL Initiative research in fiscal year (FY) 2019 (from funds appropriated in FY 2018 and FY 2019). This adds to a substantial investment made by NIH Institutes and Centers (ICs) in the areas of pain, addiction, complementary medicine, and much more.

The NIH HEAL Initiative is taking an “all-hands-on deck” approach to this crisis, garnering expertise from almost every NIH IC to attack the problem from all angles. New HEAL programs reflect the full spectrum of research from basic science to implementation research and across all disciplines.

December 10, 2018

Jeff Chen, Director, UCLA Cannabis Research Initiative, UCLA Semel Institute for Neuroscience and Human Behavior UCIPT
Hackathon Winners Develop Viable Solutions to Combat Opioid Addiction

UCI Institute for Clinical and Translational Science (ICTS)

The first ever “The Opioid Hackathon,” which was in part sponsored by the UCI Institute for Clinical and Translational Science (ICTS), demonstrated a new and rapid turn-turnaround approach to solving the opioid crisis through citizen engagement and led to 20 potential solutions in fewer than 24 hours.

On October 14th-15th, 2018, teams of computer and data scientists, public health officials, researchers, and patients/families affected by the opioid crisis traveled across the country to compete on finding software and big data-based solutions to the opioid crisis at the University of California Institute for Prediction Technology’s (UCIPT’s) “The Opioid Hackathon.” 

November 02, 2018

New DIAMOND Portal Allows CTSA Members to Access, Share Training and Assessment Materials

Michigan Institute for Clinical & Health Research (MICHR)

Translation of novel research interventions into clinical applications for improved human health requires a well-prepared, competent workforce. There is a critical need to provide high quality, accessible, competency-based training for research personnel conducting clinical trials.

To address the need for consistent training, assessment, and measures of competency, the Michigan Institute for Clinical & Health Research (MICHR) has collaborated with the Ohio State University, Rochester University, and Tufts University to launch the DIAMOND portal.

The DIAMOND portal is a pioneering digital collection that serves as a sustainable, federated database for members of clinical and translational research study teams to share and access training and assessment resources. It was developed as part of the Clinical & Translational Awards (CTSA) Development, Implementation, and AssessMent Of Novel Training in Domain-based competencies (DIAMOND) initiative.

October 16, 2018

UR Stars
UR Stars Doctoral Career Advancement Program Supports Research Career Advancement

UR CTSI

The new UR Stars Doctoral Career Advancement Program, which is supported by the UR CTSI, is an opportunity to enhance the faculty recruitment pipeline at the University of Rochester and establish meaningful connections with early career scholars. This two-day program serves as a career advancement opportunity for graduate students nearing the completion of their studies, post-doctoral scholars, and junior faculty.

Early career scholars of diverse backgrounds nationwide—with particular attention to historically underrepresented groups in the academy—will gain great insight about research and teaching opportunities at the University of Rochester, while exploring career and academic advancement. Scholars who participate in the program are strongly encouraged to apply for post-doctoral fellowships and faculty positions at the university.

June 27, 2018

BU_CTSI_Opioids
New Study Shows Medication-Based Treatment After Opioid Overdose Can Save Lives

Boston University CTSI

Survivors of opioid overdose have a higher risk of death than individuals who have not experienced an overdose. Effective strategies to lower that risk are critically important to combatting the opioid epidemic in the United States.

Medications to treat opioid use disorder (OUD) are one potential strategy, but research about the effect of medication use on survival after an overdose is limited. To address that gap, a team led by researchers from the Boston University CTSI reviewed medical records for more than 17,500 adults who had survived an opioid overdose. 

June 19, 2018

New Director of the NCATS Division of Clinical Innovation (DCI)

NCATS

Michael G. Kurilla, M.D., Ph.D. as the new Director of the NCATS Division of Clinical Innovation (DCI). Mike’s new role will include leading the CTSA program.

November 16, 2017

Do the Drugs that Keep HIV Patients Alive Damage Their Brains?

University of Rochester CTSI

Researchers from the University of Rochester Medical Center are studying whether drugs used to keep HIV patients alive could be damaging their brains. Early results from their clinical study, which was partially supported by the CTSA, suggest that these drugs do not pose a threat to the brain - at least in the short-term.

October 19, 2017

Twitter logoFollow CLIC
Twitter logoFollow NCATS