Virginia Commonwealth University researchers have collaborated on a clinical trial that identifies indicators for nonalcoholic fatty liver disease — a typically asymptomatic disease caused by fat buildup in the liver and the leading cause of liver disease in the United States.
Mohammad Siddiqui, M.D., an associate professor in the VCU School of Medicine, and researchers with expertise in cardiology, hepatology, and exercise physiology have been conducting research with a focus on the link between heart and liver damage. Their efforts have resulted in a study in which they draw a connection between patients with aggressive types of fatty liver disease and limitations in exercise capacity.
Infants born very preterm, at or before 28 weeks gestation, are at high risk for developmental impairments. Physical therapy and medical specialists from Virginia Commonwealth University are leading a study in collaboration with colleagues from the University of Virginia to determine how early, evidence-based physical therapy intervention can enhance physical, social and cognitive outcomes.
The team of researchers was awarded a $2.84 million grant from the National Institutes of Health to facilitate the multi-site clinical trial, “Efficacy of Motor and Cognitive Intervention for Infants Born Preterm (SPEEDI2).”The program is based on two smaller studies using Supporting Play, Exploration and Early Developmental Intervention (SPEEDI) developed through a series of studies at Children’s Hospital of Richmond at VCU. Stacey Dusing, Ph.D., a board-certified pediatric physical therapy specialist and associate professor in the Department of Physical Therapy at VCU and the Department of Pediatrics at CHoR, is the principal investigator for the project and the impetus behind the study concept. Read More
During recent workshops, she reviewed a summary of the 2017-2018 changes, delved into case studies to better understand NIH’s expanded interpretation of the definition of a clinical trial, and provided resources for researchers to use as they develop their proposals.
What are the takeaways you want from these workshops?
The main takeaways are these: NIH has implemented many policy changes over the past year to improve transparency and accountability in human subject research, especially clinical trials. NIH uses a broad interpretation of the definition of a clinical trial. This includes certain mechanistic studies, which are designed to explore or understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.
What are the major changes?
The funding opportunity announcement (FOAs) will specify whether clinical trials are required, optional, or not allowed.
NIH has revised their proposal form to consolidate and streamline human subjects information. Investigators must use the new Form E.
Multi-site studies must use a single IRB.
What are some of the questions you are getting?
Many investigators are asking whether their particular study qualifies as a clinical trial. Research administrators at VCU can provide guidance on this, but with so many changes occurring at once, the best source of truth is the NIH program officer.
What is your role at the Wright Center for changes like these?
My specific role is ensuring that VCU is compliant with ClinicalTrials.gov regulations, which require outreach and education, as well as input from the research community. The influence of ClinicalTrials.gov over research will likely continue to grow as long as transparency and accountability remain a priority. My goal is to make sure that we’re meeting our important reporting obligations in a way that is as painless as possible.
The Wright Center for Clinical and Translational Research will provide funding and research infrastructure for this opioid clinical trial. Dr. Moeller, the Center’s director, will serve as principal investigator on the trial!
Monday, Dec. 4, 2017
Virginia Commonwealth University today announced that it is leading a clinical trial to test SUBLOCADE™ (buprenorphine extended-release) injection for subcutaneous use (CIII), a once-monthly injectable formulation of buprenorphine for the treatment of moderate-to-severe opioid use disorder.
The VCU-led clinical trial will test innovative methods to prevent repeat opioid overdose by recruiting patients into treatment immediately after they recover from an overdose. During the 18-month clinical trial, VCU researchers will study SUBLOCADE-assisted intervention in adults diagnosed with opioid use disorder who have been successfully treated for an opioid overdose in the emergency department and immediately brought to outpatient treatment.
The research will involve collaboration with Virginia Tech Carilion Research Institute and Inova Fairfax Hospital.
“The main goal of the research is to develop a new treatment paradigm for patients after an overdose,” said F. Gerard Moeller, M.D., professor of psychiatry, pharmacology and toxicology, and neurology at VCU School of Medicine and director of the VCU Institute for Drug and Alcohol Studies. Moeller will serve as principal investigator on the trial. He will be joined by Robert Lipsky, Ph.D., director of translational research in the Department of Neurosciences at Inova Fairfax Hospital, and Warren Bickel, Ph.D., professor of psychiatry and director of the Addiction Recovery Research Center at Virginia Tech Carilion Research Institute.
The clinical trial is jointly funded by the Virginia Biosciences Health Research Corporation, Virginia Commonwealth University and Indivior Inc., which is headquartered in Richmond. Indivior has been developing medications to treat opioid use disorder for more than 20 years and is providing SUBLOCADE for use in the trial. Funding for the clinical trial is housed at the C. Kenneth and Dianne Wright Center for Clinical and Translational Research, where Moeller serves as director. The Wright Center will also provide research infrastructure for the clinical trial.
“We look forward to collaborating with VCU, Inova Fairfax Hospital and Virginia Tech Carilion Research Institute to study the effects of SUBLOCADE in the emergency environment together with behavioral therapy in outpatient treatment to possibly prevent repeat opioid overdoses and potentially change the standard of care for those who are recovering from opioid overdose,” said Christian Heidbreder, Ph.D., chief scientific officer at Indivior.
Standard treatment for an overdose until this point has started with first responders administering an opioid overdose reversal drug to a patient following an overdose. The reversal drug saves the patient’s life, but it also puts the patient into withdrawal as they are transported to a hospital, where they are typically monitored for a few hours before being sent home with a referral for outpatient addiction treatment.
“Unfortunately, the relapse rate is high,” Moeller said, adding that patients typically are not receptive to a referral for addiction treatment when they are in withdrawal.
The proposed new paradigm would allow treatment to begin in the emergency room, with an active referral and immediate transportation to the outpatient clinic. At the outpatient clinic, patients would receive SUBLOCADE and meet with a behavioral therapist.
“We know that treatment programs work when they combine medication with continuing addiction health care and support,” said Bickel, whose research since 1983 has helped lead to opioid replacement therapies that are currently in use.
“It would be a new treatment paradigm for patients after an overdose.”
Patients will be recruited for the trial from VCU Medical Center’s Emergency Department and will receive follow-up care at the VCU Health MOTIVATE Clinic. Virginia Tech is collaborating on development of behavioral biomarkers of addiction related to impaired decision-making. Inova is contributing research on personalized medicine and pharmacogenomics of opioid overdose.
“This research could have a major impact on a public health emergency,” Moeller said. “It would be a new treatment paradigm for patients after an overdose, with the goal of reduction of repeat overdoses and deaths.”
Virginia Commonwealth University is a major, urban public research university with national and international rankings in sponsored research. Located in downtown Richmond, VCU enrolls more than 31,000 students in 220 degree and certificate programs in the arts, sciences and humanities. Seventy-nine of the programs are unique in Virginia, many of them crossing the disciplines of VCU’s 13 schools and one college. The VCU Health brand represents the health sciences schools of VCU, the VCU Massey Cancer Center and the VCU Health System, which comprises VCU Medical Center (the only academic medical center and Level I trauma center in the region), Community Memorial Hospital, Children’s Hospital of Richmond at VCU, MCV Physicians and Virginia Premier Health Plan. For more, please visit www.vcu.edu and vcuhealth.org.
NIH and FDA develop and release a clinical trials protocol template.
NIH and FDA collaborated with the research community to develop a common Phase 2 and Phase 3 IND/IDE clinical trial protocol template. The goal is to support investigators and speed up FDA review of NIH clinical trials. The document is consistent with International Council for Harmonisation E6 (R2) Good Clinical Practice Guidance.
At the same time, NIH released an electronic protocol writing tool that allows investigators to work together in a common platform to develop their protocol. NIH anticipates future releases of the e-Protocol Writing Tool will include templates for Phase 1 and behavioral studies.
Please note that the use of these tools is optional. Individual Schools/Centers/Departments may already have protocol template requirements in place.
NIH and FDA Release Protocol Template for Phase 2 and 3 IND/IDE Clinical Trials
The National Institutes of Health (NIH) and Food and Drug Administration (FDA) developed a clinical trial protocol template with instructional and example text for NIH-funded investigators to use when writing protocols for phase 2 and 3 clinical trials that require Investigational New Drug application (IND) or Investigational Device Exemption (IDE) applications. In March 2016 a draft template was released for public comment generating nearly 200 comments from 60 respondents. All comments were carefully considered and many were incorporated into the final template. The agencies’ goal is to encourage and make it easier for investigators to prepare clinical trial protocols that are organized consistently and that contain all of the information necessary for the review of the protocol. The template follows the International Conference on Harmonisation (ICH) E6 (R2) Good Clinical Practice and is available as a Word document
The NIH also released a secure web-based e-Protocol Writing Tool that allows investigators to generate a new protocol using the NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template. The e-Protocol Writing Tool fosters protocol writing collaboration by allowing multiple writers and reviewers to participate in the protocol development process. The e-Protocol Writing Tool allows the author to assign writers and collaborators and the tool assists the author with tracking progress and document version control.
The NIH expects to expand the development of the e-Protocol Writing Tool by adding instructional text and sample text for other types of studies, such as a behavioral and phase 1 trials. Future releases of this e-Protocol Writing Tool will have improvements and enhanced tool functionality.
CAMBRIDGE, Mass., May 24, 2017 – Virginia Commonwealth University (VCU) has joined the TriNetX health research network, which is comprised of healthcare organizations representing over 84 million patients globally, biopharmaceutical companies and contract research organizations (CROs) who are working together to improve protocol design, site selection, patient recruitment, and collaborative research across a range of therapeutic areas and development stages. As a member, VCU will leverage the network to support cohort discovery, facilitate cross-institutional research collaborations and increase industry-funded clinical trial opportunities for the health system.
“We see membership on the TriNetX network as an opportunity to help facilitate an increase in clinical trials from biopharma and CROs, as well as remove some of the barriers associated with investigator-initiated multi-site collaborative research,” said Tim Aro, Manager of Clinical Research Informatics at Virginia Commonwealth University’s C. Kenneth and Diane Wright Center for Clinical and Translational Research.
Utilizing TriNetX’s cloud-based, health research platform, members can analyze patient populations with search criteria across multiple longitudinal data points, and TriNetX’s advanced analytics modules provide intelligence on which criteria have the most impact as well as the rate at which new patients present. Each data point in the TriNetX network can be traced to healthcare organizations who have the ability to identify individual patients, allowing clinical researchers to develop virtual patient cohorts that can be found in real-world clinical trial settings. Patients can be discovered for industry-sponsored and investigator-initiated studies, as well as for collaboration with peer research institutions. Data in the TriNetX network is fully de-identified to the user.
“To help support VCU’s strategic initiatives around cohort discovery and advances in precision medicine, we needed a searchable and extensible local data structure that included oncology and genomic data,” said Aro. “We now have the capability to do cohort discovery of complementary patient populations within the TriNetX network to obtain adequate representation across the demographic spectrum, elucidation of rare disease populations and other challenging cohorts such as those with extensive inclusion/exclusion criteria.”
About Virginia Commonwealth University
Virginia Commonwealth University is a major, urban public research university with national and international rankings in sponsored research. Located in downtown Richmond, VCU enrolls more than 31,000 students in 225 degree and certificate programs in the arts, sciences and humanities. Seventy-nine of the programs are unique in Virginia, many of them crossing the disciplines of VCU’s 13 schools and one college. VCU Health represents the VCU Health System, which comprises five health sciences schools (Allied Health Professions, Dentistry, Medicine, Nursing, Pharmacy), VCU Medical Center (the only academic medical center and Level I trauma center in the region), Community Memorial Hospital, Children’s Hospital of Richmond at VCU, VCU Massey Cancer Center and Virginia Premier. For more, please visit www.vcu.edu and vcuhealth.org.
TriNetX is the global health research network enabling healthcare organizations, biopharma and contract research organizations (CROs) to collaborate, enhance trial design, accelerate recruitment and bring new therapies to market faster. Each member of our community shares in the consolidated value of our global, federated health research network that connects clinical researchers in real-time to the patient populations which they are attempting to study. For more information, visit http://www.trinetx.com.
The Wright Center for Clinical and Translational Research sponsored the International Clinical Trials Day event on May 19th at the VCU Gateway Building. Visitors, patients, and staff learned about the history of clinical trials, how to navigate StudyFinder-the central point for enrolling in clinical trials, and discovered how research is changing patients lives! “I have seen so many patients being positively impacted by Clinical trials and everyone in VCU Health systems works hard to make sure that is always the reality. Happy International Clinical trials day.” Sofanit Almaw DessieOur staff and clinical trial participants are true heroes-making advances every day in research to improve patient outcomes! To make a difference, get involved in research, or find out about exciting clinical trials go to: https://studyfinder.cctr.vcu.edu/
Jonathan P. DeShazo, Ph.D., M.P.H., associate director for the Wright CCTR’s Enterprise Informatics and co-director of the Biomedical Informatics Core, and Megan Blumenthal, lab manager for the VCU School of Medicine’s Department of Health Behavior and Policy, led the discussion on strategies and tools for designing an effective research participant recruitment plan.
“It’s important to understand the different types of studies because the type will determine what approval you need for patient information and consent,” said DeShazo. “The CCTR has resources to help with this process, even when it comes to obtaining de-identified data or contact information for patients.”
The seminar reviewed factors that determine a recruitment strategy, such as the study design, sample size, and sample frame, in addition to the process of obtaining informed consent.
“Informed consent is always present,” said DeShazo. “Even if the IRB doesn’t require you to document it.”
To learn more about the CCTR’s resources for researchers, please visit www.cctr.vcu.edu/resources.
First image up top: Megan Blumenthal (left), lab manager for the VCU School of Medicine’s Department of Health Behavior and Policy, and Jonathan P. DeShazo, Ph.D., M.P.H., associate director for the Wright CCTR’s Enterprise Informatics and co-director of the Biomedical Informatics Core
Whether you’ve taken a medication today to manage a chronic disease or simply to keep a headache at bay, you know that medical innovations have the power to change lives.
But these breakthroughs don’t just happen. Developing new medicines is a lengthy and complex process, relying heavily on volunteer participation to evaluate potential therapies for safety and effectiveness in clinical studies. Without the patients who volunteer to participate in clinical trials, the development of new medicines would not be possible.
During Clinical Trials Awareness Week, May 2 – 6, 2016 we recognize the individuals who have made new, innovative treatments a reality for patients worldwide – clinical trial researchers and participants. By shining a spotlight on these unsung heroes, we can raise awareness about the importance of participating in a clinical trial.
Clinical trials may benefit participants by providing them the opportunity potentially to receive an investigational drug that is not available to people outside the trial. In addition, they may receive treatment from a clinical research team that provides careful oversight of their medical condition. Also, many participants report great satisfaction playing a key role in advancing medical science and helping scientists find new treatments that will help more people live longer, healthier lives. The Center for Information and Study on Clinical Research Participation (CISCRP) reports that 95 percent of clinical trial participants would consider joining a future clinical trial.
Everyone should have access to helpful information about clinical trials and the opportunity to determine if participating in a clinical trial is the right choice for them. Visit our VCU Clinical Trials Facebook page and join the CCTR in spreading the word about the importance of clinical trial participation.