Research

Study timeline:       8/10/2023-7/31/2028
Investigators:         Barnhart, K; Schisterman, E
Funding:                  Eunice Kennedy Shriver National Institute of Child Health and Human Development

This is a parallel assignment, randomized, double blind clinical trial of double low-dose aspirin (162 mg/day) begun no later than 6 weeks 6 days gestation, through delivery, to investigate the effects of early initiation of prophylactic aspirin therapy compared to standard of care (placebo through 12 weeks’ gestation, 81 mg aspirin thereafter through delivery) on reducing risk of both pregnancy loss and preeclampsia in pregnant people with one or more risk factors.

Veeva Vault: an FDA 21 CFR Part 11 compliant clinical data management tool used to manage projects requiring FDA oversight, such as trials of an Investigational New Drug (IND) or New Drug Applications (NDA). 

Access to our current list of Veeva Vault projects.

Funding: NHLBI
Investigator(s): Ramachandran, V

The Risk Underlying Rural Areas Longitudinal (RURAL) Cohort Study, coordinated by Vasan Ramachandran, MD, at The University of Texas at San Antonio (UTSA) and funded by the National Heart, Lung, and Blood Institute (NHLBI), is a six-year research project seeking to understand why people born in rural communities in the South live shorter and less healthy lives than do their counterparts elsewhere in the country. 

Funding: NHLBI
Investigator: Foglia, E

The DIVA Trial is a National Heart, Lung and Blood Institute funded multicenter randomized comparative effectiveness trial comparing 2 FDA-approved modes of respiratory support to prevent extubation failure among extremely preterm infants. The preterm (23-28 weeks gestation) babies will be randomly placed into either a non-invasive neurally adjusted ventilatory assist or non-synchronized nasal intermittent positive pressure ventilation treatment for bronchopulmonary dysplasia.  Bronchopulmonary dysplasia is the most common complication for premature babies and is the leading respiratory cause of death.

Funding: NHLBI
Investigator(s): Bonafide, C

The EMO effectiveness deimplementation trial, funded by the National Heart, Lung, and Blood Institute is a four-phase project seeking to eliminate monitor over use in children with bronchiolitis and to identify a de-implementation strategy.  Bronchiolitis is the leading cause of infant hospitalization.  There are over 100,000 admissions and 1.7 billion dollars in hospital charges.  Pulse oximetry is a common intervention but does not improve outcomes for patients during hospitalization when supplemental oxygen is being administered.  This study discourages the continuous use of monitoring SPO2 for children who are in room air which will maximize quality and minimize waste in our health care. 

Funding: Agency for Healthcare Research and Quality
Investigator: Mukhopadhyay, SM

The primary objective of the VRP study is to reduce unnecessary vancomycin use in preterm infants by implementing/re-enforcing VRP across multiple NICUs. Additional objectives of the study are to determine the effect of external facilitation on the fidelity of VRP use and to identify barriers and facilitators to implementation of the VRP across NICUs.

This project started in April 2024. The CRCU supports the study with project management and data management services.

Funding: NIDDK
Investigator: Lewis, J

The URBI study is a multicenter parallel group clinical trial. The primary objective is to determine if high-definition white light colonoscopy (HDWLC) using a limited biopsy strategy is non-inferior to HDWLC with a random 4x10cm biopsy strategy to detect dysplasia or sessile serrated adenoma (SSA) in patients with inflammatory bowel disease (IBD). Additional objectives of the study are to determine if HDWLC with a limited biopsy strategy is superior to HDWLC with a random 4x10cm biopsy strategy to detect one or more dysplastic or SSA lesion in patients with IBD, determine whether the number of targeted biopsies differs based on the number of random biopsies obtained and to define the molecular characteristics of the progression of colitis-associated dysplasia.

The URBI study started in July 2024. The CRCU supports the study with project management and data management services.

Clinical trials.gov NCT06560021

Funding:  Patient-Centered Outcomes Research Institute (PCORI)
Investigator:  Neuman, MD

Implementation and Evaluation of a Strategy to Improve Pre-Anesthesia Care Discussions - My Anesthesia Choice (MAC) is an implementation study to improve pre-anesthesia care discussions between care providers and patients who are undergoing hip replacement surgery.  The objective of this research study is to assess the implementation process for and the effectiveness of a quality improvement (QI) strategy to increase shared decision-making around anesthesia options for hip fracture surgery at 6 US hospitals. The QI strategy is to be facilitated by a clinician-administered 1-page bedside conversation aid designed to improve the quality of physician-patient communication.

Study timeline: 9/1/2023-5/31/2030
Funding: National Institutes of Health (NIH)
Investigator: Mumford, S

The ECHO Study is a National Institutes of Health (NIH) funded longitudinal study to seek the impact of broad range early environmental influences on child development and health.  In 2016, the NIH established the Environmental influences on Child Health Outcomes (ECHO) Program, an innovative and collaborative research initiative whose mission is to enhance the health of children for generations to come. The overarching scientific goal of ECHO is to advance understanding of the effects of a broad array of early environmental exposures on children’s development and health outcomes with high public health impact.

Funding: NIH/NIDDK
Investigator(s): Dember, LM; Flythe, JE; Crews, D

The focus of this study is on vascular access for hemodialysis. This is a randomized clinical trial testing 3 educational approaches to help patients with advanced chronic kidney disease prepare for placement of hemodialysis vascular access. Study participants will each be assigned to one of the 3 approaches...

Funding: PCORI
Co-Principal Investigator(s):  Flythe, JE; Dember, LM

The SMaRRT-HD Study, also known as “Comparative Effectiveness of Two Approaches to Symptom Monitoring in Hemodialysis” compares two approaches for monitoring and addressing symptoms among adult patients with kidney failure who are treated with hemodialysis.

Funding: NCI
Investigator(s): Mason, N; Long, Q

The mission of the Pre-medical Cancer Immunotherapy Network for Canine Trials (PRECINCT), supported by grants from the National Cancer Institute, is to provide infrastructure and oversight to a highly collaborative and interactive network of researchers and clinician scientists working to accelerate the application of next generation immunotherapies through comparative oncology. Pet dogs spontaneously develop cancers that share remarkable similarities in biology, genetics, treatment response and outcome to human patients. Evaluating next generation immunotherapies and combination immunotherapies in immune competent canine patients aims not only to provide more effective treatments for these pets but also unparalleled insight into response and response prediction through correlative biomarker discovery. This work will aid human clinical trial design and accelerate the translation of novel immunotherapies and immunotherapy protocols into the human clinic.

Funding: VA Office of Research and Development
Investigators: Kaplan, DE; Taddei, TH

The SACRED Study is a prospective phase 3, double-blind, randomized, placebo-controlled, multi-center study. The study is being conducted at 10 VA centers across the country. The primary objective is to test the effectiveness of simvastatin in reducing the incidence of hepatic decompensation, hepatocellular carcinoma, or all cause mortality in patients with cirrhosis at high risk. Secondary objectives include looking to explore the interaction of SLCO1B1 and KIF6 polymorphism on safety and clinical efficiency of statin therapy in patients with compensated cirrhosis, and to assess the impact of statin exposure on health related quality of life.

The Scientific and Data Coordinating Center at Penn receives data and provides ongoing support for a number of Ancillary Studies supported by the CRIC Cohort utilizing both CRIC study participants and biological samples obtained from CRIC study participants. Through the CRIC data sharing policy, investigators have an opportunity to tap into the rich CRIC data to pursue their own research goals.

In addition to the CRIC Clinical Centers listed on the Participating Institutions page, collaborative research partnerships are currently conducted at a number of institutions across the country including, but not limited to, University of Utah, University of Miami, University of North Carolina, George Washington University, University of Alabama, as well as at international sites in China, Japan, Peru, and Germany 

A selection of CRIC Ancillary Studies managed by the CRCU appears below:

Funding: NIDDK
Investigator: Dember, L.

The HOPE Trial is an NIDDK-funded randomized clinical trial to evaluate approaches to reducing pain and opioid use among patients with chronic pain who are receiving maintenance hemodialysis for end-stage renal disease.

Funding: NIDDK
Investigator: Landis, JR

The Clinical Research Computing Unit (CRCU) in its role as the Data Coordinating Core (DCC) for the MAPP Research Network, provides overall coordination, logistical support, and implementation for all aspects of the study protocol including data collection, data processing, tracking of participant recruitment, tracking of specimens, training, quality assurance, and statistical analysis, through its clinical data management, project management, and software systems development teams.

Funding: NIDDK
Investigators: Dember, L.M.

The CRIC study is an NIDDK-funded longitudinal cohort study established in 2001 with the Scientific and Data Coordinating Center (SDCC) located at Penn (Dember, L.M., PI). The original aim of CRIC was to establish a clinical research laboratory designed to (a) identify novel predictors of CKD progression, and (b) characterize the manifestations of CVD and identify its risk factors among individuals with CKD.

Funding: NIDDK
Investigator: Reese, P; Schaubel, D; Goldberg, D

The CRCU serves as the Data Coordinating Center for the THINKER-NEXT trial. The THINKER-NEXT trial, led by Peter Reese, MD and Douglas Schaubel PhD at The Perelman School of Medicine and David Goldberg, MD at the University of Miami in Florida, is a single arm open-label NIDDK-funded clinical trial.  The main objective of the study is to estimate the hepatitis C virus (HCV) cure rate after transplantation, using kidneys from HCV-infected deceased donors for HCV-negative recipients, followed by treatment with direct acting antivirals

Funding: NIDDK
Investigators: Dember, LM; Landis, JR

The CRCU serves as the Data Coordinating Center for the Hemodialysis Novel Therapies Consortium (HDNT) - a partnership between four highly-regarded clinical centers, the University of Pennsylvania, and the National Institutes of Diabetes, Digestive, and Kidney Diseases (NIDDK). The HDNT Consortium was established by the (NIDDK) to design and conduct pilot and feasibility studies of novel therapies to reduce morbidity and mortality for patients treated with maintenance hemodialysis.

Funding: PCORI
Investigator: Neuman, MD

The University of Pennsylvania, with funding from the Patient-Centered Outcomes Research Institute (PCORI), has designed the Regional vs. General Anesthesia for Promoting Independence after Hip Fracture Surgery (REGAIN) clinical research trial to determine whether one type of standard care anesthesia given to patients undergoing surgery for a hip fracture leads to better outcomes in recovery of walking, overall health and disability, pain, and survival.  This trial will enroll more than 2000 patients in over 25 cities in the United States and Canada.

Funding: NICHD
Investigators: Kirpalani, HM; Ratcliffe, SJ

The CRCU functions as a Data Coordinating Center for the Sustained Aeration of Infant Lungs (SAIL) Trial, a multi-national prospective randomized controlled study. SAIL consists of 21 participating Neonatal Intensive Care Units (NICUs) in the USA, Canada, Italy, Germany, Netherlands, Australia, Singapore and South Korea.

Funding: NHLBI
Investigators: Schmidt, BK; Bellamy, SL; Ellenberg, JH

The primary goal of the PROP studies (single center and multicenter protocols) is to identify biomarkers (biochemical, physiological and genetic) and clinical variables that are associated with and thus potentially predictive of pulmonary status in preterm infants up to 1 year corrected age.  An objective and validated measure of pulmonary outcome at 1 year does not currently exist.   Some promising measures are in development but not yet ready for use in a multi-center large clinical study.

Funding: National Eye Institue
Investigator: Maguire, MG

The DREAM study is a set of two multicenter randomized placebo controlled clinical trials designed to evaluate the effectiveness and safety of omega 3 fatty acid supplementation for treatment of patients with mild to moderate dry eye disease (DED).

Investigator: June, C

The Clinical Research Computing Unit (CRCU) was contracted by Dr. Carl June in 2012 to provide a 21 CFR Part 11 compliant Data Integration System in support of the Engineered T Cells for Cancer Project. The goals of this project was to develop an integrated, personalized medicine data system incorporating a comprehensive set of clinical, manufacturing and biomarker data from an extensive array of data sources.

Funding: NIA
Investigators: Snyder, PJ; Ellenberg, SS

The CRCU collaborated with the Testosterone Trial Steering Committee for four years in the development of this randomized, placebo-controlled, double-blind study of seven coordinated trials. This preliminary period included a feasibility pilot study and a validation study of several standard instruments using the interactive voice response system. The multi-center set of trials include 12 clinical sites geographically distributed across the United States, a central laboratory, investigational drug service, cognitive function reading center, interactive voice response calling center and prostate biopsy reading center, and pharmacogenomic laboratory.

Funding: NIAID
Investigators: Hoxie, JA; Ellenberg, SS

The Penn Center for AIDS Research (Penn-CFAR) is one of 18 NIH-funded CFARs, and includes HIV and AIDS investigators at the University of Pennsylvania, the Children's Hospital of Philadelphia (CHOP), and the Wistar Institute.