Goal 4: Innovate Processes to Increase the Quality and Efficiency of Translational Research, Particularly of Multisite Trials

Doctor examining patientThe CTSA Program is designed to strengthen and support the entire spectrum of translational research from scientific discovery to improved patient care. Read the latest in CTSA Program news about improving the quality and efficiency of translational research, particularly multisite clinical trials.

October 2019

CTSA Program-supported Study of Ketogenic Diet Intervention in Alzheimer’s Disease Shows Promise
CTSA Program-supported researchers tested the hypothesis that ketones could serve as a source of energy for the brain in people with Alzheimer’s disease (AD). The study found improved brain function in those with mild AD after a three-month ketogenic diet.

August 2019

CTSA Program Supports Research on Rapid Diagnosis of Genetic Diseases in Seriously Ill Children
NCATS-supported researchers have developed an automated approach to diagnosis of genetic diseases in seriously ill children to allow faster diagnosis and initiation of treatment, and, ultimately, better outcomes. The study appeared in the April 24, 2019, issue of Science Translational Medicine.

July 2019

CTSA Program Researchers Aim to Improve Health Care from All Sides
A research framework that enables the recruitment of hospitalized patients for a wide range of studies can help identify optimal care approaches during and after hospitalization. Undergraduate students play a valuable role in the studies at University of Chicago Medicine, where they recruit patients, conduct follow-up activities, and learn about clinical research.

June 2019

CTSA Program Support Enables Development of Life-Saving Blood Loss Monitor
NCATS-supported researchers used applied machine-learning to develop an innovative device that detects internal bleeding and monitors a patient’s response to blood loss. The monitor helps medical staff identify appropriate treatment before a patient goes into life-threatening shock. The device was approved by the U.S. Food and Drug Administration in 2018 and is in clinical use today.

February 2019

CTSA Program Supports Emerging Research on Health Effects of Plastics
An early-career investigator has developed techniques to study how chemicals used in medical devices affect the still-developing hearts of pediatric patients. Program support also enabled her to secure independent funding for larger studies.

December 2018

A Model for Accelerating Translational Research in Real Time
Investigators from the CTSA Program hub at the Medical College of Wisconsin have devised and piloted an innovative approach called Real-Time IRB that reduces the time between study submission to the institutional review board and final approval by 70 percent.

November 2018

NCATS-Supported Research Shows Potential for Altering Body Fat
CTSA Program-supported researchers at Columbia University have discovered a new way to take white fat from a mouse, turn it into brown fat and return it to the mouse. These findings could have implications for treating obesity.

August 2018

CTSA Program Researchers Shed Light on Improved Melanoma Treatment
Researchers at the University of California, Los Angeles, a CTSA Program hub, discovered four subtypes of melanoma — pointing to new treatment approaches.

July 2018 

NCATS-Supported Study Highlights Troubling Trend in Opioid Prescribing
Researchers at the University of California, Los Angeles, supported in part by NCATS' CTSA Program, discovered a troubling opioid prescribing trend. Patients who took a type of anti-anxiety medicine were more than twice as likely as the general public to receive new opioid prescriptions despite a higher overdose risk.

CTSA Program Support May Lead to Blood Test for Colon Cancer Screening
University of Alabama at Birmingham researchers, supported in part by NCATS’ Clinical and Translational Science Awards (CTSA) Program, teamed up with scientists from the HudsonAlpha Institute for Biotechnology to identify markers in the blood that could be used to detect precancerous polyps in patients.

June 2018

New Study Shows Medication-Based Treatment After Opioid Overdose Can Save Lives
Researchers from Boston University, a CTSA Program hub, have found a strong link between the use of medications to treat opioid use disorder and a reduced risk of overdose death. CTSA Program funding supported statistical analysis for this study, which also included support from NIH’s National Institute on Drug Abuse.

CTSA Program Researchers Advance Heart Condition Study Through Precision Medicine and Digital Health
Researchers at the Scripps Translational Science Institute in San Diego, a CTSA Program hub, are working to address the challenge of diagnosing atrial fibrillation, a common heart condition with complex causes. The team’s efforts can ultimately help advance precision medicine approaches to preventing and diagnosing other types of complex diseases.

April 2018

CTSA Program Support Enables Innovative Study of Brain Function
A CTSA Program-funded researcher tests innovative training to help people with schizophrenia “correct” disordered brain waves. Promising results suggest the training could potentially help improve memory.

December 2017

CTSA Program Supports Research on Translating Evidence into Practice
CTSA Program-supported researchers explore the dissemination and clinical implementation of therapies, interventions and policies to ultimately improve human health.

November 2017

CTSA Program-Supported Investigators Validate Biomarkers for NPC1 Treatment
With support from the Sharing Partnership for Innovative Research in Translation (SPIRiT) consortium, Daniel Ory, M.D., of Washington University in St. Louis, and Charles Vite, D.V.M., Ph.D., of the University of Pennsylvania, collaborated to validate biomarkers intended to monitor the response to therapy for Niemann-Pick diseases type C1 (NPC1).

October 2017 

CTSA Program-Supported Researchers Test Low-Cost Treatment for Deadly Illness
Virginia Commonwealth University researchers have discovered a low-cost and potentially lifesaving treatment for sepsis. Support from the CTSA Program helped streamline translation of this promising therapy to multisite clinical studies. 

July 2017

NCATS Supports Novel Methods to Improve Institutional Review Board Efficiencies
NCATS’ Clinical and Translational Science Awards Program support helped a University of Wisconsin–Madison Ph.D. student discover new ways of identifying factors affecting institutional review board (IRB) review times.

April 2017

NCATS Trial Innovation Network Investigators Tackling Clinical Trial Inefficiencies
Through NCATS’ new Trial Innovation Network, CTSA Program-supported investigators are working collaboratively to tackle inefficiencies in clinical trials.

March 2017

NCATS SMART IRB Platform Agreement
All CTSA Program sites have signed on to the NCATS Streamlined, Multisite, Accelerated Resources for Trials (SMART) Institutional Review Board (IRB) Platform agreement, which will enable all participating study sites to rely on one IRB for each study.

February 2017

North Carolina CTSA Program Hubs Create Regulatory Expertise Platform
Three North Carolina CTSA Program hubs collaborated to create a platform for sharing regulatory expertise. Regulatory Guidance for Academic Research of Drugs and Devices features a best practices website to help researchers better navigate the complex regulatory environment in translational science.

CTSA Program Good Clinical Practice Standards Published
Investigators leading the CTSA Program good clinical practice (GCP) standards initiative published three papers in the Journal of Clinical and Translational Science. GCP incorporates established ethical and scientific quality standards for the design, conduct, recording and reporting of clinical research involving human subjects.

Optimizing Translational Veterinary Trials to Advance Human Outcomes
The CTSA One Health Alliance has established a primary mission of creating an organized network of veterinary academic centers that will conduct translational clinical trials in veterinary patients with spontaneous disease.

SPARC: The Strategic Pharma-Academic Research
The Strategic Pharma-Academic Research Consortium aims to spark innovative collaborations between CTSA Program hubs and the biopharmaceutical industry. The vision is to establish a public-private partnership for patient-focused discoveries that generate greater knowledge and better approaches to next-generation and targeted therapies.

December 2016

NCATS Presents Early Plans for Trial Innovation Network, Solicits Project Proposals
Efforts to align and harmonize three Trial Innovation Centers and the Recruitment Innovation Center are underway within the NCATS Trial Innovation Network, a new collaborative initiative made possible through the CTSA Program.

October 2016

NCATS Launches Trial Innovation Network
NCATS launches its Trial Innovation Network, which features a single institutional review board system, master contracting agreements, quality-by-design approaches, and a focus on evidence-based strategies for recruitment and patient engagement.

NCATS Funds Collaborative Innovation Awards
In fall 2016, NCATS funded the first set of CTSA Program Collaborative Innovation Awards, which are designed to stimulate team-based research across the program’s network.

September 2016

CTSA Program Supports New Ultrasensitive Diagnostic Test Development
Stanford University researchers have developed a new test for diagnosing diseases, including thyroid cancer, HIV and type 1 diabetes. The method appears to be many times more sensitive than some traditional diagnostic tests, meaning that it potentially can detect illnesses earlier, enabling clinicians to treat patients sooner and possibly slow disease progression.

June 2016

CTSA Program Resources Help UCLA Scientists Visualize Key Enzyme in Cancer and Aging
With support from NCATS’ CTSA Program, scientists at the University of California, Los Angeles (UCLA), recently produced the clearest-ever image of telomerase, an enzyme involved in cancer and aging. This knowledge could inform the development of anti-cancer and anti-aging therapies.

May 2016

NCATS Introduces Plans for New Single IRB Reliance Platform
On May 2, 2016, NCATS held a workshop for CTSA Program representatives and other innovators in clinical research management to educate them about using its new single institutional review board (IRB) reliance platform for multisite clinical studies.

February 2016

CTSA Program Collaboration Provides Investigators with Access to High-Throughput Screening and Drug Discovery Expertise
CTSA Program hub researchers at the University of New Mexico, the University of Kansas Medical Center, and the University of North Carolina, Chapel Hill, collaborated to establish the Drug Rescue, Repurposing and Repositioning Network to more rapidly test existing drugs and advance those showing promise into clinical trials.

September 2015

Progress Toward a National CTSA Program Institutional Review Board Reliance Agreement
CTSA Program investigators made progress toward creating IRBrely, a national institutional review board (IRB) reliance agreement to streamline the review and approval of multisite clinical trials.

May 2015

Michigan CTSA Program Supports Development of Blood Analysis Device
A Michigan research team funded in part by NCATS’ CTSA Program and the National Heart, Lung, and Blood Institute has developed a life-saving diagnostic device that can test extremely small blood samples.

CTSA Program Supports Streamlined Clinical Trial Recruitment
Researchers at the University of New Mexico Clinical and Translational Science Center recently established the Participant Recruitment Service. Supported through NCATS’ CTSA Program, the goal is to streamline and improve recruitment rates for clinical trials while maintaining patient privacy.

February 2015

CTSA Initiative Yields Standard Agreement for Industry-Sponsored Clinical Trials
A standard agreement intended to reduce the contract negotiation time for industry-sponsored multisite studies, including Phase IIB and Phase III trials, is now available to download.

Creating Review Standards for Investigator-Initiated Research Studies
The NCATS Scientific Review Standards initiative aims to develop a consensus CTSA Program scientific review process that can ensure feasibility and scientific validity for research projects before reviews by institutional review boards.

Establishing Good Clinical Practices for Clinical Study Personnel
At the February 2015 CTSA Program principal investigators meeting, Thomas Shanley, M.D., of the University of Michigan shared progress and next steps for the CTSA Program’s Good Clinical Practice initiative.

May 2014

IRB Reliance: A New Model for Accelerating Translational Science
Within the CTSA Program, several institutions are participating in institutional review board (IRB) reliance networks to streamline this complicated process.

October 2013

Five CTSA Program Hubs Enable NIH-Funded Research on Innovative Allergy Therapy
Finding a new way to treat and possibly prevent the severest food allergy reactions could improve the lives of millions. A consortium of scientists at five institutions that receive NIH funding, including through NCATS’ CTSA Program, took up this challenge.

January 2013

Pitt Researchers Work to Restore Function in Paralysis Patients
A team of researchers at the University of Pittsburgh and its medical center have published breakthrough brain-computer-interface research that provides hope to nearly 6 million paralyzed individuals and another 1.7 million amputees nationwide.

March 2012

Converting Brain Signals into Action
A multidisciplinary team of researchers at the University of Pittsburgh received critical help from CTSA Program regulatory experts to develop a micro-electrocorticography grid that may help paralyzed individuals move again.

Designing Solutions to Improve Health for All
A team in Stanford University’s Biodesign program designed the OneBreath ventilator for use in emergency pandemic situations and for patient care in resource-poor countries.