IU-CTO is now the Office of Clinical Research

We are delighted to announce that our office is changing its name from the Indiana University Clinical Trials Office to the Office of Clinical Research, effective September 1, 2017.

This name change reflects our commitment to expand our support for the entire Research Community.

We look forward to serving you under our new banner.

The Office of Clinical Research (OCR) was created to serve as a hub for Clinical Research connecting Indiana University, its strategic partner IU Health, and its other partners across the research community. Efforts are underway to enhance the clinical research engagement process, streamline contracting for industry sponsored clinical research, optimize budgeting and study facilitation processes, create an optimal environment and workforce for clinical research, increase clinical research participation and the number of clinical research studies across the research community, and to engage key stakeholders to enhance our partnerships. The Office of Clinical Research will continue to develop community-wide approaches to enhance the efficiency, effectiveness, and quality of Clinical Research conducted throughout the entire state of Indiana.

For any questions about our office, or any of our services, we encourage you to please contact our office at our main inbox: ocr@iu.edu

Clinical Research Coordinator Tools Now Available

As a result of the responses to the Research Survey several weeks ago, we are now able to share examples of study visit checklists used by research coordinators across the research community. The documents are now posted in the Private Documents section of the Office of Clinical Research (OCR) website. There are a variety of styles of checklists available. All of the documents are editable, making it possible for you to modify them to suit your needs. By sharing examples across the research community, our goal is to reduce the length of time spent by coordinators in creating these documents. Hopefully, this will help!

You can find the documents in the Private Documents section of our website. To navigate to the documents, take the following steps: On the main page, click to log in. Log in through the usual CAS method. Once you’re logged in, look at the bottom right corner of the page and click on Private Documents. Once you’ve entered Private Documents, click on the folder called Coordinator Resources to locate the shared checklist examples. Should you have trouble locating the documents, or gaining access to the Private Documents section of the website, please contact the Office of Clinical Research by email at CTO@iu.edu for assistance.

Naga Chalasani named IU School of Medicine associate dean for clinical research

June 30, 2017

INDIANAPOLIS – Indiana University School of Medicine will enhance research that explores whether medical treatments or therapies are effective in humans with the appointment of a new associate dean for clinical research, Naga Chalasani, MD, an international leader in gastroenterology and hepatology research with extensive experience in patient-oriented research, clinical trials and drug development.

As the associate dean for clinical research, Dr. Chalasani will help IU School of Medicine grow the number of researchers engaged in clinical trials, encourage faculty participation and leadership in industry-sponsored clinical trials, promote the clinical trials resources of the IU Clinical Trials Office (CTO) and the Indiana Clinical and Translational Sciences Institute (CTSI), liaise with hospital partners and pharmaceutical companies, and implement best practices to improve clinical research across the school.

The new position will be an addition to Dr. Chalasani’s current roles as David W. Crabb Professor of Medicine at IU School of Medicine, division chief of gastroenterology and hepatology in the Department of Medicine and adjunct professor of cellular and integrative physiology. He joined IU School of Medicine in 1997 and became division chief in 2007.

Dr. Chalasani is internationally known for his expertise in nonalcoholic fatty liver disease and drug-induced liver injury, and he is the lead author for the multisociety practice guideline on the diagnosis and management of nonalcoholic fatty liver disease, as well as the American College of Gastroenterology practice guideline on the diagnosis and management of drug-induced liver injury.

Dr. Chalasani has also consulted on drug development activities and regulatory matters related to fatty liver disease and drug safety for pharmaceutical companies and the United States Food and Drug Administration. He currently serves as the academic chair for the International Consortium for Innovation and Quality in Pharmaceutical Development’s initiative on drug-induced liver injury.

Anantha Shekhar, MD, PhD, IU associate vice president of research for university clinical affairs and IU School of Medicine executive associate dean for research affairs, said Dr. Chalasani’s scientific expertise, experience and industry connections make him an ideal fit for the position of associate dean for clinical research.

“Naga brings a deep knowledge of our institution and our hospital partners to this position, with proven experience in clinical trials, corporate relationships and corresponding regulatory issues,” Dr. Shekhar said. “I look forward to working with him to advance this extremely important area of research at IU School of Medicine.”

Dr. Chalasani said he is excited to serve in this new role and believes the university and school are well positioned to succeed in their goal to enhance clinical research.

“IU possesses an unprecedented opportunity to dramatically increase our patient-oriented research portfolio because of our extensive clinical footprint throughout the state of Indiana and very large physician workforce through key hospital partners, as well as our growing clinical trials infrastructure through our CTO and the Indiana CTSI,” Dr. Chalasani said. “I believe a robust clinical research portfolio is essential for the school to fulfill its mission of dramatically improving the health and well-being of the residents of Indiana.”

Dr. Chalasani will begin his new duties on July 1, 2017.

 

Click to view the full article

Raghu Mirmira named director of Herman B Wells Center for Pediatric Research

Indiana University School of Medicine will continue its nationally recognized work in the scientific discovery of innovative medical treatments and care for children with the appointment of Raghu G. Mirmira, MD, PhD, as director of the school’s Herman B Wells Center for Pediatric Research, which is associated with Riley Hospital for Children at IU Health.

 

For more information click here.

IUH Recruitment Policy Training

The new IUH Recruitment Policy Training Materials and Documents are now available on our website in the Private Documents section. To access the Private Documents section of our website please log in using your CAS Credentials and then click on the Private Documents button to enter the Private Documents section of our site.

Also, if you would like to view the video of the IUH Recruitment Policy Training Presentation then there are instructions posted in the Private Documents section.

For assistance gaining access please contact our main mailbox at cto@iu.edu

Indiana University to provide paid parental leave for staff

Effective July 1, IU will begin offering fully paid parental leave for all staff employees of the university.

 

Read more

Eskenazi Health: New Medical Director of Smith Level I Shock Trauma Center

Indianapolis, Dec. 19, 2016 – Eskenazi Health announces that Ben L. Zarzaur Jr., M.D., MPH, has been appointed to the position of medical director of the Smith Level I Shock Trauma Center at Eskenazi Health. He is also currently an associate professor, director of the Center for Outcomes Research in Surgery and vice-chair for Clinical Research in the Department of Surgery at the Indiana University School of Medicine.

“Dr. Zarzaur is a highly credentialed leader in his field and poised to make a tremendous contribution here at Eskenazi Health,” said Dr. Lisa E. Harris, chief executive officer at Eskenazi Health. “We’re all very pleased to welcome him to our team.”

Prior to joining the IU School of Medicine in 2014, Dr. Zarzaur was an associate professor of Surgery at the University of Tennessee Health Science Center in Memphis, Tennessee where he worked at one of the busiest trauma centers in the United States. Dr. Zarzaur started his professional career as an assistant professor of Surgery at the University of North Carolina – Chapel Hill in 2004.  While at Chapel Hill, he completed a Masters in Public Health in Epidemiology at the School of Public Health at the University of North Carolina. In 2006, he moved to the University of Tennessee Health Science Center as an assistant professor of Surgery where he rose through the academic ranks to obtain tenure and the rank of associate professor. While in Memphis, Dr. Zarzaur also served as an assistant professor in the Department of Preventive Medicine and he as an adjunct professor at the University of Memphis School of Public Health.

Originally Published by Eskenazi Health: Read full article here.

Washington Post: Obama Signs 21st Century Cures Act

Paying tribute to both bipartisanship and his vice president — who was galvanized by his own son’s death to change the way the United States combats cancer — President Obama signed legislation Tuesday that aims to increase funding for medical research, speed the development and approval of experimental treatments and overhaul federal policy on mental health care.

“We are bringing to reality the possibility of new breakthroughs to some of the greatest health-care challenges of our time,” Obama said. “It is wonderful to see how well Democrats and Republicans in the closing day of this Congress came together around a common cause. And I think it indicates the power of this issue and how deeply it touches every family across America.”

The 21st Century Cures Act had wide bipartisan support and has been held up as an example of what Congress can accomplish by working together. After a previous version of the bill stalled in the Senate for more than a year, a new version — cheered by the drug and medical device industry, patient advocates and universities — made a swift passage through the lame-duck session.

The measure’s critics — mainly consumer watchdog groups and health policy experts — have argued that the popular funding provisions mask a worrisome loosening of regulations at the Food and Drug Administration that could put patients at risk.

The bill contains several provisions that the White House has championed, including $1 billion for opioid abuse prevention and $4.8 billion for biomedical research funding, including Obama’s Precision Medicine initiative and the BRAIN initiative. A hefty chunk of that funding — $1.8 billion — is dedicated to cancer research, a part of the bill that was renamed the “Beau Biden Cancer Moonshot” in honor of the vice president’s late son, who died of a brain tumor. The bill also aims to strengthen mental health services and access.

Originally Published in the Washington Post: Read full article here.

InScope: Don Brown, MD, Donates $30 Million for Immunotherapy Center

One of the largest gifts ever to Indiana University School of Medicine will enable researchers to harness the power of the immune system to cure cancer and other devastating diseases — propelling Indiana’s standing as an engine for biomedical discovery and innovation.

Indianapolis entrepreneur Donald E. Brown, MD, announced a $30 million gift to establish the Brown Center for Immunotherapy at the IU School of Medicine. The center will discover new ways to deploy immune-based therapies to treat cancers and pioneer use of this powerful technology in other diseases. Researchers will also study how to make this highly specialized therapy accessible to large numbers of patients.

“Immunology is the right place for a big investment. It is clear to me that this is the most exciting area in all of science,” said Dr. Brown, a 1985 graduate of IU School of Medicine who has founded three successful software companies. “It has tremendous potential for long-sought breakthroughs in cancer, but also autoimmune diseases, neurodegenerative diseases and a whole range of conditions. We have tremendous resources and talent in Indiana. Hopefully my contribution can push us over the top to do some really exciting things.”

Originally published in InScope: Read full article here.

Vice President for Research Administration: IU Annual Report on Research for FY16 Now Available Online

The 2016 Annual Report offers a brief overview of the breadth of IU’s research collaborations and creative activities. Access the full report.

Wall Street Journal: New U.S. Rule to Expand the Requirements for Publication of Clinical Trials

Federal health officials will soon be requiring scientists and companies to make public more details of a broader range of medical research studies, even if the results are disappointing to the researchers or to companies sponsoring the research.

A rule published Friday from the Department of Health and Human Services will expand the requirements for clinical trials’ publication to include most studies of products not yet licensed by the Food and Drug Administration. Bolstered by a companion policy announced Friday by the National Institutes of Health, the government beginning next year will require more types of bad side effects to be reported and will set out legal penalties for scientists or companies that don’t comply.

The NIH will now plan to cut off future research funding to institutions that don’t comply.

Francis S. Collins, the director of the NIH, said that while there are more than 224,000 clinical studies listed on the website ClinicalTrials.gov, researchers have “a disappointing track record” in making the results of studies available when the results are unfavorable. He called this situation “simply not acceptable.”

The NIH’s complementary policy will apply to all NIH-funded studies. The NIH will generally require that results of such research be posted on ClinicalTrials.gov, and Dr. Collins said failure to do so “may jeopardize future grant funding” for the university or institution, not just the individual researcher. The idea, he said, is to “maximize the value of clinical trials.”

Dr. Collins said one of the factors leading to the Friday announcement was Vice PresidentJoe Biden’s Cancer Moonshot effort to encourage faster cures for cancer. Mr. Biden has spoken extensively, and passionately, about the need for scientists to make their research findings broadly and quickly available to other researchers and to patients.

Jerry Avorn, a Harvard University medical professor and chief of pharmacoepidemiology at Brigham and Women’s Hospital, called the steps “an important and much-needed development. Most people don’t realize that if a company runs a clinical study of a drug and finds that it doesn’t work, or that it has dangerous side effects, until now it’s been possible for them to bury those findings and never let them see the light of day.”

Originally published by the Wall Street Journal, full article here. Author Thomas M. Burton.

Additional information on the final rule regarding 42 CFR Part 11

 

Journal of Clinical Research Best Practices: Implementing NIH Single IRB Policy Using the National Center for Advancing Translational Sciences (CTSA) Program

The NIH has mandated the use of a single IRB for NIH-funded clinical research. In response, 62 CTSA members have joined together to create the SmartIRB initiative. Initially, Johns Hopkins, University of Utah, and Vanderbilt University IRBs will perform reviews for consortium members. SmartIRB has created a standard reliance agreement and is now creating software to facilitate communications between referring and reviewing institutions. Any healthcare facility or IRB with an FWA number can join SmartIRB. In addition, reviewing IRBs must be AHHRPP-accredited. Referring IRBs must be accredited or pass a quality assessment by a qualified external party. Eventually, any qualified IRB will be able to review any study from willing IRBs, so SmartIRB could be the framework for all sorts of consortia and network reviews. Reviewing IRBs will use their own software, forms and business processes. NIH has issued guidance on allowable budgets for IRB reviews, but further clarification will be required. Schulman IRB has already joined SmartIRB, and more independent IRBs are sure to follow. It remains to be seen how the competition between local and independent IRBs will play out.

Originally published in the Journal of Clinical Research Best Practices, Vol.11, No.12, December 2016 

Indiana CTSI: Comprehensive Drug Database Established with Support from Indiana CTSI, Lilly and NCATS

The Integrative Data Science Laboratory at Indiana University Bloomington, and Data2Discovery Inc., an IU spinoff company, have partnered with Eli Lilly and Co. to create a public database that links multiple data resources to 2,500 drugs tested by Eli Lilly.

The database, Phenotypic Drug Discovery Resource, was funded by grants from the Indiana Clinical and Translational Sciences Institute and Eli Lilly.

The work was overseen by David J. Wild, PhD, director of data science academic programs and CEO of Data2Discovery.

“The research has demonstrated a radically new approach to translational drug repurposing,” said Dr. Wild. “We expect it to catalyze scientific and research discoveries in both clinical and preclinical applications.”

The Integrative Data Science Laboratory and Data2Discovery developed technology to pull data about the drugs from multiple sources to create the comprehensive database. The goal is to advance drug discovery and health care intelligence.

To gather and organize the information, Data2Discovery created a data mining tool, Semantic Association Predication, based on research by the Integrative Data Science Laboratory. This work can be used to find new connections between drugs and their potential uses.

Already, the Semantic Association Predication method has created a list of drugs that could potentially be repurposed to treat mycobacterium tuberculosis. Planning is underway for these drugs to be laboratory tested.

Indiana Clinical and Translational Sciences Institute awarded a $50,000 grant to Data2Discovery. Eli Lilly matched the Clinical and Translational Sciences Institute grant, and the National Center for Advancing Translational Sciences provided $97,300 for development of the list of potential mycobacterium tuberculosis drugs.

Originally published here.

InScope: IUPUI research awards increased by $40.5 million in 2016

The IUPUI Office of the Vice Chancellor for Research has released funding results for fiscal year 2016 showing research awards campuswide totaled $428.9 million, a $40.5 million increase over 2015.

Counting only non-IU School of Medicine awards, the campus received $67.2 million in research awards in 2016, compared to $58.1 million in 2015, a 16 percent increase.

The increase in research awards reflects, in part, the support of the Office of the Vice Chancellor for Research to advance innovative research and creative activity.

Funding awards for 2016 show an increase in National Science Foundation awards, one of the office’s strategic goals. NSF funding rose from $5.2 million in 2015 to $7.9 million in 2016.

http://news.iupui.edu/releases/2016/10/research-awards-for-iupui-2016.shtml

Members of the IU-CTO Attend the Onsemble Conference

Members of the Indiana University Clinical Trials Office (“IU-CTO”) recently attended the Onsemble conference held in Chicago, Illinois. During the conference, the team gained valuable training and information on recent developments with OnCore technology.  Conference presentations ranged from data interpretation of regulatory, contracts, budget and enrollment metrics to advanced reporting and notification techniques. Among the conference presenters was IU’s own Matt Edison, OnCore Projects Specialist IU Simon Cancer Center, who taught participants how to create effective and engaging OnCore “how to” videos.  The IU-CTO team is looking forward to sharing the knowledge they gained at the conference with IU’s clinical research enterprise.

According to IU CTO’s OnCore Enterprise Manager, Lindsay Mann, “The tools we gained at this conference will help us improve the functionality and implementation of OnCore across the research enterprise. As more researchers and study coordinators receive OnCore training and start to utilize this resource, we’ll continue to see the positive impact it has on clinical trial efficiency and accessibility.”

Conference materials can be accessed by research professionals by contacting Onsemble and requesting a username and password.

InScope: IU Clinical Trials Office launches new website

The  Indiana University Clinical Trials Office website is featured in the IUSM InScope newsletter.    Take a moment to read and learn about all of the clinical trial information and resources available!

http://inscope.medicine.iu.edu/issues/2016/2016-09-29.html

 

 

IU-CTO Website Webinar Video and Materials are now available

The slides from the presentation are available below:

IU-CTO Website Webinar Slides

Please click the link below in order to view the IU-CTO Website Webinar:

IU-CTO Website Webinar

In addition, all of the materials from the IU-CTO Website Webinar are now posted to the IU-CTO Website on the Additional Resources page under the Internal Resources Training Tab.

IU-CTO Website Launch Webinar

Indiana University’s Clinical Trials Office (“IU-CTO”) is excited to announce the launch of its new website!

The IU-CTO is offering the following webinars to demonstrate the information and guidance related to clinical trials that can be accessed through the website. You do NOT need to sign up for the webinar. All you need is the link detailed below. On the date and time you prefer, just click the link and it will take you to the webinar.

 

Webinar Dates and Times

DATE TIME WEBINAR LINK
Tuesday, September 13th 12:00 p.m. to 1:00 P.M. https://connect.iu.edu/ctowebsite/
Tuesday, September 13th 3:00 p.m. to 4:00 p.m. https://connect.iu.edu/ctowebsite/
Friday, September 16th 10:00 a.m. to 11:00 a.m. https://connect.iu.edu/ctowebsite/
Friday, September 16th 2:00 p.m. to 3:00 p.m. https://connect.iu.edu/ctowebsite/

 

The IU-CTO hopes you will attend a webinar and offer your suggestions to further improve the performance of the website.

If you have questions, please contact the IU-CTO at cto@iu.edu.

 

Thank you,

Kenneth H. Carlson

Director, IU Clinical Trials Office

PowerTrials Implementation to Improve Patient Safety

Now that most research groups are actively using OnCore to track protocol and subject information for their clinical studies, it is important to begin the next steps in assuring the safety of all Indiana University Health (IUH) patients who participate in clinical trials.  A key step in this assurance of patient safety is using the OnCore RPE Admin functionality which sends protocol and subject information to Cerner PowerTrials for those studies meeting the criteria to be sent.  Sending this information to PowerTrials allows IUH clinicians to access details about their patient’s participation in the clinical trial, lets identified study contacts receive notification about subject admissions to IUH facilities, and facilitates study recruitment through use of PowerTrials’ screening tools (future functionality.)

Research coordinators/nurses and other key research personnel received a checklist of preparation activities to begin working through as soon as possible.  Completing these activities will insure that research groups have the training, Cerner system access, and the quality data needed to support a successful PowerTrials activation.

Once the checklist is complete, research groups can reach out to the PowerTrials project team to schedule an activation session specifically tailored to their protocols.  To schedule a PowerTrials activation session or for questions and concerns, please contact Cheryl Yacone via email at cyacone@iuhealth.org or by phone at (317) 963-0545.

If you need assistance with OnCore or have questions about which trials need to be sent to PowerTrials, please contact the OnCore support team by email at oncore@iupui.edu or by phone for more urgent issues at (317) 278-2600.

 

Standard Pricing Schedule for Industry Sponsored Clinical Research Studies

The Indiana University Clinical Trials Office has collaborated with research leaders in various departments throughout Indiana University School of Medicine and Indiana University Health to develop a schedule of recommended fees for industry funded clinical research studies.  The standard fees will be available in the OnCore within the Charge Master Console.  Check out our Project Collaborations page for more details.

OnCore Version 14.1 MU1 Release

Coming in August! Refer to the OnCore Upgrades and Future Functionality section for details.

 

Changes to IRB Initial Submission and Review Questionnaire

The Office of Research Compliance is updating the IRB Initial Submission and Review Questionnaire to facilitate identification of clinical studies that meet the eligibility criteria for entry into OnCore. Changes will take place on new studies and renewals submitted on or after March 31, 2016.

 

Interface with Cerner PowerTrials

In December, the interface enabling the link between OnCore and Cerner PowerTrials was released and 60 studies from OB/GYN, Cardiology and Methodist Research Institute were transmitted. Training of additional Indiana University and IU Health research groups in the use of Cerner/PowerTrials is proceeding on an aggressive schedule during 2016. For additional information visit our Cerner PowerTrials page or contact oncore@iupui.edu or 317-278-2600.

 

OnCore: Implementation Update

Since May 2015, research teams across IU Health and IU Schools of Medicine and Dentistry have focused on completing training and entering basic protocol information into OnCore. These concerted efforts resulted in 80.7% of required studies being entered by year end. Achieving this milestone is a modest, but necessary, first step towards our ultimate goal to have all relevant IU Health and IU clinical studies managed within OnCore.