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.
Wednesday, Nov. 22, 2017
A pioneering European research project with assistance from a Virginia Commonwealth University clinician aims to lead to new diagnostic tests to assess patients with non-alcoholic fatty liver disease and identify those most at risk for developing severe inflammation and liver scarring.
The $40 million (€34 million) project, Liver Investigation: Testing Marker Utility in Steatohepatitis, is funded by the European Innovative Medicines Initiative 2 Joint Undertaking and brings together clinicians and scientists from prominent academic centers across Europe with companies from the European Federation of Pharmaceutical Industries and Associations. Their common goals are developing, validating and qualifying better biomarkers for testing NAFLD.
The project is coordinated by Newcastle University, UK, working closely with the lead EFPIA partner, Pfizer. LITMUS will include 47 international research partners based at leading international universities and some of the world’s largest pharmaceutical companies.
Through his appointment as a visiting professor at Newcastle University, VCU Health hepatologist Arun Sanyal, M.D., is an adviser to the LITMUS project.
“This is a very important project which will allow physicians to diagnose those who have this dangerous kind of fatty liver disease,” he said. “Currently the only way to do that is with a liver biopsy, which is painful, invasive and carries some risk.”
Affecting 20 to 30 percent of the population worldwide, NAFLD is caused by a build-up of fat in liver cells, which leads to inflammation, scarring of the liver and ultimately cirrhosis. It is strongly linked to obesity and Type 2 diabetes.
Quentin Anstee, a professor at Newcastle University’s Institute of Cellular Medicine and a consultant hepatologist at Newcastle Hospitals NHS Foundation Trust, is coordinating the LITMUS consortium.
“Non-alcoholic fatty liver disease is already the most common underlying cause of liver transplant in the United States and, with the obesity epidemic in Europe, we are very close behind,” he said. “LITMUS will unite clinicians and academic experts from centers across Europe with scientists from the leading pharmaceutical companies, all working together to develop and validate new highly-accurate blood tests and imaging techniques that can diagnose the severity of liver disease, predict how each patient’s disease will progress and monitor those changes, better or worse, as they occur.”
“Lack of easy and accurate diagnostic tests means that many patients go undiagnosed until late in the disease process. It has also held back efforts to develop new medical treatments for NAFLD,” Anstee said. “Availability of better diagnostic tests will help us to target care at an early stage of disease to the people who are going to be most severely affected. It will also help us to develop more effective medical treatments for NAFLD and to run the clinical trials that the regulatory agencies need so that they can license these medicines to be prescribed by doctors.”
Chris Day, vice-chancellor and president of Newcastle University and a consultant hepatologist, added, “Tackling non-alcoholic fatty liver disease is a major public health challenge and the award of such a large grant from the EU, allowing us to bring together pharma and academia in this way, gives us real hope of making significant advances in the diagnosis and treatment of this increasingly common and often devastating disease.”
If studies in Europe identify noninvasive methods that properly recognize patients at risk for developing liver cirrhosis, those results will need to be validated in the United States. VCU Health will be one of two sites where that will happen, Sanyal said.
Julia Brosnan, senior director of external collaborations and scientific alliances at Pfizer, who also serves as the industry project lead for LITMUS, expressed enthusiasm about the good the collaboration will do.
“This is an exciting project and we look forward to working with the other LITMUS partners to develop new diagnostic tests for NAFLD, which is too often undiagnosed in patients,” she said. “We hope the results of this project will help change that.”
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777377. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
NOTES FOR EDITORS
Professor Quentin Anstee:
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777377. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA and 47 Associated Partners: AMC Amsterdam, Antaros, Antwerp University Hospital, Boehringer-Ingelheim, Center for Cooperative Research in Biosciences, Ellegaard Göttingen Minipigs, European Association for the Study of the Liver, Exalenz Bioscience, Faculdade de Medicina de Lisboa, Genfit, Hôpital Beaujon, APHP, Institute of Cardiometabolism And Nutrition, Integrated Biobank of Luxembourg, Intercept, iXscient, Lilly, Linköping University, Medical University of Vienna, National & Kapodistrian University of Athens, Newcastle University, Nordic Bioscience, Novartis Pharma AG, Novo Nordisk, Örebro University, OWL, Perspectum Diagnostics, Pfizer Ltd., RWTH Aachen University Hospital, Sanofi, Servicio Andaluz de Salud, Seville, Somalogic, Takeda Pharmaceuticals International GmbH, UMC Utrecht, Università Cattolica del Sacro Cuore, Università degli Studi di Milano, Università degli Studi di Palermo, University Hospital of Angers, University Hospital Würzburg, University Hospitals Birmingham NHS Foundation Trust, University Medical Center Mainz, University of Bern, University of Cambridge, University of Helsinki, University of Lisbon, University of Nottingham, University of Oxford, University of Torino
This release is the author’s view and that neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.
Monday, November 13th- 12 PM- 1 PM, Main Hospital, Learning Center
Please join us for the Wright Center for Clinical and Translational Research’s Discovery Dialogues seminar, “Discovering ways to make cost-effective medicines: A case study with ciprofloxacin”, presented by Dr. Perrer Tosso, Post-doctoral Fellow, Chemical and Life Science Engineering, on Monday, November 13 from noon – 1PM in the hospital’s Learning Center (Main Hospital, first floor, across from the cafeteria).
Faculty, staff, students, patients, and families are invited to attend. Light refreshments will be served. For more information, contact Pam Dillon at firstname.lastname@example.org.
Tuesday, November 14th- 9 AM- 12 PM, BioTech One
Learn how to communicate your research!
Scientists are increasingly called to share their research outside of traditional academic spheres. Engagement with non-academic audiences can help increase the public’s science literacy and shape impactful policy decisions. How can we share science in a way that both engages non-experts and accurately presents complex topics? To register, click here: http://vcu.libcal.com/event/3676022.
This event is sponsored by: VCU Center for Clinical and Translational Research, VCU Libraries, and Office of Research.
9 – 9:50 a.m. “Teaching journalism to scientists — and science to journalists,” Dr. Jeff South, VCU Robertson School of Media and Culture
10:00 – 10:50 a.m. Perspectives in Publishing: A Panel Presentation
11 a.m. – 12:30 p.m. Keynote Presentation: “Be Such a Scientist: Improving How We Communicate and Connect with Public Audiences,” Holly L. Menninger, PhD. Director of Public Science, College of Sciences, NC State University
Wednesday, November 29th-12 PM-1 PM
The Wright Center for Clinical and Translational Research and Tompkins-McCaw Library present the next in their lunch research seminars, “NIH Clinical Trials 2018: New Definition, New Policies,” on Wednesday, November 29, from noon – 1PM in the Tompkins-McCaw Library, Room 109.
Ms. Alanda Perry Jones, CCTR, will discuss changes to human subjects’ research for the January/February funding cycle. During this session, she will review a summary of the 2017-2018 changes, delve into case studies to better understand NIH’s expanded interpretation of the definition of a clinical trial, and provide resources for researchers to use as they develop their proposals.
Participants may bring lunch, drinks will be provided. For more information or to register, contact Pam Dillon (email@example.com).
Come to the Research Expo and find out how the Wright Center for Clinical and Translational Research can help you! The sessions are divided into two tracks that will run concurrently. The Wright Center’s Lydia Klinger and Tim Aro will be presenting the following sessions that day. Come and check it out!
Session Title: First Look: Wright Center Clinical Research Coordinator Education & Training Program
Presenters: Meghan Wright – IRB Training & Education Manager; Lydia Klinger –Director of Business Operations, Wright Center for Clinical and Translational Research
“I’m excited the Wright Center is taking such a central role in establishing programs that will promote the role of clinical research coordinators, both by providing them with standardized and robust training opportunities, and by being an advocate for their professional development and recognition.”
Session Description: While clinical research coordinators at VCU share many of the same responsibilities, training and education has historically varied from department to department. This session offers you a first look at the Wright Center’s CRC Education & Training Program, a collaborative initiative designed to provide a comprehensive, standardized approach to support quality clinical research at VCU. With robust resources, multiple training mechanisms, and tools to support clinical research coordinators and their supervisors, this program is designed to meet everyone’s needs. Come get a sneak peek at what the CRC Taskforce has up its sleeve for 2018!
Session Title: Informatics Tools and Services Supporting the Clinical Research Life Cycle
Presenters: Tim Aro, Manager – Clinical Research Informatics; Bobby Moulden, Manager – OnCore Clinical Trial Management
“Our goal is to provide the tools and services to allow investigators to focus on the science. Let the Wright Center help you with the technical aspects so scientists can focus on their research and bring new treatments to patients.”
Session Description: The Wright Center for Clinical and Translational Research will present a variety of informatics tools and services and describe how they can help support the clinical research life cycle. This pragmatic presentation will discuss technologies that can be leveraged during various phases of the clinical trial life cycle. Find out how informatics resources can help with study design/feasibility, multi-site collaborations, work flows, recruitment and trial management, electronic data capture solutions, and more.
Please read the full announcement here:
Message to NIH grant applicants/awardees, contractors, researchers and research administrators:
If you are conducting NIH-funded research that involves human subjects, or are considering applying to NIH for support of such research, we want to call your attention to important changes that may affect how you:
- select the right NIH funding opportunity announcement
- write the research strategy and human subjects sections of your application
- comply with appropriate policies and regulations
First, familiarize yourself with the new PHS Human Subject and Clinical Trial Information form.
For application due dates of January 25, 2018, and beyond, you will be required to use an updated application forms package (FORMS-E), which includes the new human subject and clinical trial form. This form requests human subject and clinical trials information at the study level using discrete form fields, which is a change from current practice. Contract proposals will also require this information. Learn about the new form here.
Second, take a moment to answer these four questions about your current or proposed research:
1) Does the study involve human participants?
2) Are the participants prospectively assigned to an intervention?
3) Is the study designed to evaluate the effect of the intervention on the participants?
4) Is the effect that will be evaluated a health-related biomedical or behavioral outcome?
If the answer to all four questions is yes, then your proposed research meets the NIH definition of a clinical trial. Clarified and broadened in 2014, the definition encompasses a wide range of trial types: mechanistic, exploratory/developmental, pilot/feasibility, behavioral, and more. NIH expanded the clinical trial definition in response to widespread calls from diverse stakeholders for improved reporting of research milestones and outcomes, and for assuring maximal transparency.
Need help determining whether your study would be considered by NIH to be a clinical trial? See our webpage on the definition that includes case studies, FAQs and other resources that can help. Still unsure? Contact your NIH program official or the scientific point of contact listed on the funding opportunity announcement to which you are applying.
Third, familiarize yourself with NIH policy changes related to enhancing stewardship of clinical trials.
NIH made a number of policy changes to improve the stewardship of clinical trials across the life cycle of the trial. We encourage you to familiarize yourself with all that is changing, including:
- the requirement to apply to an FOA that specifically allows for the submission of clinical trial applications for due dates beginning January 25, 2018.
- Good Clinical Practice training expectations for NIH staff, grantees, and contractors that went into effect January 2017.
- updated peer review criteria that will be included in FOAs for clinical trial applications and solicitations for due dates on/after January 25, 2018.
- new Human Subject Information form requirements for clinical trials that will be included in updated application forms (FORMS-E) for due dates on/after January 25, 2018, and contract solicitations published as of January 25, 2018.
- use of a single IRB for non-exempt, multi-site clinical trials for application due dates on/after January 25, 2018.
- expanded ClinicalTrials.gov registration and reporting to include all NIH supported clinical trials.
Improving the design, efficiency, and transparency of clinical trials is important because it:
- respects our ethical obligation to participants to maximize the use of the knowledge from the trials in which they participate
- facilitates design of clinical trials while reducing unnecessary duplication
- promotes broad, timely, and responsible dissemination of research information and results
- fosters responsible stewardship of the public’s investment in biomedical research
We have developed a new Clinical Trial Requirements for NIH Grantees and Contractors web page to bring together all the information you need to know. Please review this information carefully. Your attention to detail will be critical to ensuring successful funding of your clinical trial awards.
The success of clinical trials relies on the public trust in scientific rigor and ethical oversight. We all play a critical role in this process. We are most grateful to you for your help and support.
Michael S. Lauer, MD
Deputy Director for Extramural Research, NIH
One Center Drive, Building 1, Room 144
Bethesda, MD 20892
By: Krista Hutchins
July 12, 2017
Hovering over a computer, VCU Data Science Lab Director, Timothy P. York, PhD, and Wright Center Bioinformatics Specialist, Aaron Wolen, PhD, scrutinize, analyze, and interpret the emerging and rapidly growing field of big data. Much of their day is spent digging deep into data in an effort to make research more transparent and reproducible.
“The Data Science Lab is an idea that grew out of conversations Tim and I were having about how the data science movement has produced amazing solutions to some of the most common pain points researchers experience while working with their data,” Wolen said.
“One of our passions, York added, “is facilitating moving raw data to publication more efficiently while ensuring the robustness of the research product.” York, also an Associate Professor for VCU Departments of Human and Molecular Genetics and OB/GYN and the Virginia Institute for Psychiatric and Behavioral Genetics, believes this is the wave of the future.
What is Data Science?
Data Science is both the science and art of working with data. The VCU Data Science Lab supports best practices for reproducible research using modern computational tools. The program, sponsored by the Office of the Vice President for Research and Innovation, and supported by the Wright Center for Clinical and Translational Research, aims to help researchers manage their projects and workflows.
“Reproducibility of research is key to advancing knowledge and maintaining public trust in science,” said Francis Macrina, PhD, Vice President for Research, Office of Research and Innovation.
Collaborating and sharing your research matters, according to York and Wolen. “These techniques can dramatically improve the reproducibility and transparency of your research, which helps others understand exactly what you did to produce a result,” Wolen said.
So what exactly is Data Science? According to a recent Harvard Business Review article, it is The Sexiest Job of the 21st Century and according to Glassdoor, it is one of the ‘Best Jobs in America’. But it is much more than that according to York. The Data Science Lab hopes to solve the ongoing problem of managing, tracking and sharing your research with easy to use storage, data analysis and collaboration.
Open Science Framework
One of the tools in the scientific computing toolbox is the Open Science Framework (OSF). It is a free, open source application built to help researchers manage their projects and workflows. “The OSF is a great, free tool that provides an entry point to researchers, regardless of their technical background, to learn and adopt best practices for reproducible research, York said. The OSF is part collaboration tool, part version control software, and part data archive.
A recent workshop, as part of an on-going OSF educational and hands-on series, provided an overview of Open Science Framework. The workshop also demonstrated how VCU researchers can use it for securely storing data and materials, organizing projects, coordinating with collaborators and making all or part of their data public and citable.
Workshop attendee, Michael Broda, PhD, Assistant Professor, Department of Foundations of Education, found the information extremely helpful, “A deeper understanding of reproducibility in research is absolutely critical for education researchers. The OSF training provided by the VCU Data Science Lab is a wonderful introduction to these issues, as well as an invaluable tool for research management and dissemination.”
Roxann Roberson-Nay, PhD, Associate Professor of Psychiatry, thought the workshop contained the ideal balance of content depth and efficiency. “I now feel much more confident in my ability to use the OSF to manage the research activity of my NIH funded grants.”
Other participants reflected on the value of sharing data, “to be able to have access to all of your data and analyses, as well as sharing, it is amazing. I wish I had the Open Science Framework when I started 20 years ago,” Rita Shiang, Associate Professor, Human and Molecular Genetics said.
Rigor and Reproducibility
The OSF module also falls in line with new National Institutes of Health (NIH) guidelines for Rigor and Reproducibility. The NIH Guidelines advocate a commitment to promoting rigorous and transparent research in all areas of sciences…it is key to the successful application of knowledge toward improving health outcomes.
“The VCU Data Science Initiative is a university-wide solution that aims to educate and assist our community of researchers in implementing and sustaining best practices in data science,” Macrina said.
The next workshop, with participants learning how to create a reproducible project from start to finish, will be July 25th, at the Molecular Medicine Research Building from 10 am-12 pm, and is aimed at faculty, graduate students, postdocs, across disciplines, who are actively engaged in research. If you would like to attend, please register here: https://training.vcu.edu/course_detail.asp?ID=16013.
By: Krista Hutchins
July 12, 2017
Clinical and Translational Research Mentoring Workshop
The Wright Center for Clinical and Translational Research invites you to become a more effective mentor.
August 8th from 8 am-4 pm – The Wright Center for Clinical and Translational Research will host a research mentor training workshop facilitated by master facilitators from the National Research Mentoring Network (NRMN) in the Robert Ball Conference Room of the BioTech One building. The NRMN is an initiative supported by the National Institutes of Health (NIH) to diversify the biomedical workforce through mentoring.
This workshop is based on the published curriculum of Mentor Training for Clinical and Translational Researchers that was developed by the University of Wisconsin-Madison Institute for Clinical and Translational Research (ICTR). Through a process-based approach, participants will explore an intellectual framework for research mentoring, have opportunities for reflection on mentoring skills, participate in a forum to solve mentoring dilemmas, and share strategies for success. Core competencies such as maintaining effective communication, aligning expectations, and promoting research self-efficacy will be addressed.
Last year, more than 35 faculty attended the first translational research mentoring workshop sponsored by the Wright Center in partnership with ICTR. Facilitated by Dr. Kelly Diggs-Andrews, NRMN master facilitator and Stephanie House, Co-Director of the Master Facilitator Initiative at ICTR, the workshop was geared for developing mentoring relationship skills of early career, mid-level, and senior clinical and basic biomedical faculty. Attending faculty members represented a diverse assemblage of clinical and basic research departments at VCU.
This year’s mentoring workshop will be facilitated by both Dr. Diggs-Andrews and Dr. Angela Byars-Winston, Associate Professor of Medicine at University of Wisconsin and co-investigator of the NIH grant that funded the National Research Mentoring Network.
RSVP is required for this event at:
For registration questions, please contact T’Keyah Johnson at 804-628-5414 or firstname.lastname@example.org
For content questions, please contact Dr. Teraya Donaldson at email@example.com
Dr. Angela Byars-Winston
University of Wisconsin-Madison
Counseling psychologist and Associate Professor in the UW Department of Medicine, And Director of Research and Evaluation in the UW Center for Women’s Health Research.
Dr. Byars-Winston investigates cultural influences on academic and career development, especially for racial and ethnic minorities and women in the sciences, engineering, and medicine with the aim of broadening their participation in these fields. Dr. Byars-Winston was Principal Investigator on an NIH R01 grant to measure and test critical factors in research training interventions for mentors of ethnically diverse mentees in biological science. She is currently co-leading (multi-PI with Dr. Christine Pfund) a renewal of that R01 grant to investigate and intervene on research mentors’ cultural diversity awareness. She is co-investigator on the National Research Mentoring Network (NRMN) grant from the NIH in the Mentor Training Core in which she leads the Culturally Aware Mentorship (CAM) team that is launching innovative training interventions nationwide to build capacity of research mentors to effectively navigate cultural diversity matters in their research mentoring relationships. Dr. Byars-Winston was selected as a 2011 Champion of Change by the White House through President Obama’s Winning the Future initiative for her research efforts to diversify science fields, received the University of Wisconsin’s 2014 Outstanding Woman of Color Award, and is an elected Fellow in the American Psychological Association.
Dr. Byars-Winston is a member of the National Academy of Sciences’ Board of Higher Education and Workforce (BHEW) and the STEM Equity Pipeline National Advisory Board. She is a graduate of San Diego State University (bachelor’s and master’s degrees) and Arizona State University (doctoral degree).
Dr. Kelly Diggs-Andrews
Diggs-Andrews Consulting, LLC
Kelly Diggs-Andrews, PhD is the founder and CEO of Diggs-Andrews Consulting, LLC, a consulting and media company who goals is to broaden accessibility to science careers through science outreach, diversity training, and professional development. Dr. Diggs-Andrews is a trained neuroscientist and cell biologist who earned her PhD in Biology and Biomedical Sciences from Washington University in St. Louis. She was also the recipient of the NIH-Ruth L. Kirschstein National Research Service Award, Chancellor’s Diversity Graduate Fellowship, and a National Cancer Institute Postdoctoral Supplement. In her previous role, she served as the Education and Mentoring Fellow with the American Society for Microbiology (ASM) and spearheaded an NSF-funded program to develop ASM’s mentoring capacity, to advance investigator-educator collaborations and interdisciplinary research, and to broaden participation of underrepresented individuals in science, technology, engineering, and math (STEM) fields. She is also a Master Facilitator with the National Research Mentoring Network (NRMN) and has organized and co-facilitated Research Mentor Training workshops for graduate trainees, postdoctoral fellows, and junior and senior faculty.
NRMN Email: firstname.lastname@example.org
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
Notice Number: NOT-OD-17-064
Release Date: May 2, 2017
National Institutes of Health (NIH)
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.
Please direct all inquiries to:
NIH Office of Science Policy
The Wright Center for Clinical and Translational Research hosts nationally and internationally known speakers for heart symposium!
Heart failure is a complex clinical syndrome in which the heart function is impaired to the point that the patient becomes limited by shortness of breath and fatigue.