New federal policies issued on clinical trials

The NIH is the largest funder of clinical trials in the U.S., investing over $3 billion each year. Standards for scientific rigor and ethical oversight must be exceptionally high because the health and safety of human subjects are at stake. But challenges in the design, efficiency, and reporting of clinical trials are well documented–and may even threaten the progress of biomedicine.

Clinical trials journey and NIH stewardship reforms Taken from Sept. 16 NIH Extramural Nexus blog post

Clinical trials journey and NIH stewardship reforms. From Sept. 16 NIH Extramural Nexus.

In a recent JAMA article,  Kathy Hudson, Ph.D., deputy director for Science, Outreach and Policy at NIH, Michael Lauer, M.D., deputy director for extramural research, and NIH Director Francis Collins describe several new initiatives for improving clinical trials. Their aim is to catalyze more innovative and robust trial design and accelerated access to discoveries. Several new policies are being rolled out to this end.

1. The Department of Health and Human Services issued a new regulation and the National Institutes of Health rolled out a new policy to increase availability of information about clinical trials. The DHHS regulation, known as The Final Rule, implements existing FDA requirements to register and report clinical trials on ClinicalTrials.gov. The NIH policy complements The Final Rule and applies to all clinical trials funded by NIH, regardless of whether they are subject to the regulation. Both the NIH policy and the Final Rule will take effect Jan. 18, 2017. Here are some resources to help you better understand the changes:

2. A new NIH policy requires all applications involving clinical trials be submitted through a Funding Opportunity Announcement specifically designed for clinical trials. NIH will no longer accept applications through parent FOAs or other announcements not specific to clinical trials. The aim is to ensure that key trial protocol information will be included in a standard way across clinical trial applications. The target effective date for this policy is Sept. 27, 2017.

3. A policy issued in June, 2016 requires use of a single institutional review board for multi-site studies in order to streamline and expedite IRB review. The first applications that will incorporate the new requirements will be for those with due dates of May 25, 2017. Resources are still under development – stay tuned for more information and guidance.

4. A policy that goes into effect Jan. 1, 2017 requires all NIH-funded investigators and clinical trial staff who are responsible for the conduct, management and oversight of NIH-funded clinical trials to be trained in Good Clinical Practice. GCP  training includes the Principles of the International Conference on Harmonisation and can be achieved through a class, academic training program, or certification from a recognized clinical research professional organization. The good news for OHSU investigators is that OHSU’s Responsible Conduct of Research training through the CITI program qualifies under this new policy.

5. A clinical trial protocol template is being developed with input from the research community. An updated template should be released this fall to be used as a way to organize and standardize key details that should be included in clinical trial protocols.

 

Inaugural Art of Neuroscience competition accepting submissions

The inaugural “Art of Neuroscience” competition is now accepting entries. All OHSU staff, faculty, and students/trainees are invited to submit an original image that explores the aesthetics of brain and mind as a broad topic.

Voting will be open to OHSU staff, faculty, and students/trainees from November 7 through November 16. A special category and prize are designated for high school students. Prizes for First Place, Honorable Mention, and First Place in the high school category will be awarded at the OHSU Brain Institute Annual Forum on Friday, November 18.

Submission requirements:

  • Format: JPEG
  • Include the title of image, description of image (<100 words), artist’s name, and department or school
  • Deadline: Monday, October 31

Submit images to stoutk@ohsu.edu.

Reminder: Applications for University Shared Resources pilot funding due Friday, Oct. 7

This is the final week to submit your applications for the OHSU University Shared Resources Core Pilot Awards program. These awards support OHSU faculty and USR cores by providing pilot funding for principal investigators, especially to support generation of data for new grant applications, as well as to support core development.

Applications must be filled out online through OHSU’s Competitive Application Portal (CAP). Full RFA is provided on CAP and can also be found here.

Please note: Applicants must consult with the director of the designated core prior to application submission. An email from the core director(s) acknowledging a consultation must be received by USR Program Director Andy Chitty before applications can be moved forward for review. Applications are due Oct. 7, 2016, and awards will be announced in late fall.

 

Groundbreaking study opens door for treating congenital disease before birth

Congenital diseases account for nearly a quarter of perinatal deaths and are important causes of childhood illness and long-term disability. Prenatal screening techniques now make early diagnosis possible, presenting the opportunity to intervene in disease processes before birth. The rapid proliferation of stem cells in the fetus and its immature immune system make in utero gene therapy an attractive target for gene therapy, but ethical considerations and the consequences of disrupting fetal development have so far prohibited human trials.

A breakthrough study by a team of researchers at OHSU and collaborators suggests it may be possible to deliver prenatal gene therapy safely and efficiently in the womb, using the amniotic cavity as a drug reservoir. The study, published in the journal Nucleic Acids Research on Sept. 28, opens the door to potential therapeutic treatments.

The team used a mouse model to determine whether antisense oligonucleotides (ASO), synthetic molecules engineered to target and alter RNA sequences, could be delivered to the amniotic cavity to target gene expression in utero.

A well-characterized ASO was injected into the amniotic fluid and successfully altered expression of a targeted RNA transcript in the liver, kidney, and inner ear of postnatal mice for up to four weeks after birth. The treatment was well tolerated, with 94% of injected mice surviving. The team successfully demonstrated the general ability of ASOs to deliver gene therapy by testing a second ASO.

Further investigation is needed to better understand ASO transport in order to maximize fetal uptake and broaden distribution, but this work establishes that the amniotic cavity has the necessary characteristics to serve as an efficient reservoir for sustained ASO delivery to the developing fetus.

Authors included Lingyan Wang, Ph.D., Han Jiang, Ph.D., and John Brigande, Ph.D., of OHSU’s Oregon Hearing Research Center; Frederic F. Depreux, Ph.D., Francine M. Jodelka, Ph.D. and Michelle L. Hastings, Ph.D., with the Department of Cell Biology and Anatomy, Chicago Medical School, Rosalind Franklin University of Medicine and Science in Chicago; Frank Rigo, Ph.D., of Ionis Pharmaceuticals in Carlsbad, California; and Robert F. Rosencrans, Ph.D., and Jennifer J. Lentz, Ph.D., with the Neuroscience Center and Department of Otorhinolaryngology, LSU Health Sciences Center in New Orleans.

This research was funded by the National Institutes of Health [R01-DC012596 to M.L.H., R21-DC012916 to J.V.B., R01-DC014160 to J.V.B., P30-DC005983 to J.V.B., 1 U54 GM104940 to J.J.L., P30-GM103340 to J.J.L.]; and Foundation Fighting Blindness (to J.J.L., M.L.H.)

Applying for foundation funding? Check out the President’s List!

Just a friendly reminder that if you plan to submit a grant to a foundation or corporation on the OHSU President’s List, you are required to submit a Notice of Intent form to the OHSU Foundation. The purpose of the President’s List is to ensure that OHSU maintains coordinated communication with these organizations. Additionally, some organizations are reserved for top institutional priorities as determined by senior OHSU leadership.

Things to keep in mind:

  • If you’re interested in applying to one of these organizations, please submit a Notice of Intent form. The Notice of Intent Form is only required for organizations on the list.
  • If Office of Proposal & Award Management needs to contact one of these organizations or receives communications from them, please let someone on the Office of Foundation Relations team know.
  • The OHSU President’s List is updated about once a year.

Questions? Contact the OHSU Foundation.

Who’s new at OHSU? Sivaraman Prakasam

Sivaraman Prakasam, B.D.S., M.S.D., Ph.D., is an assistant professor in the Department of Periodontology, OHSU School of Dentistry. In addition to his research program, Prakasam is a clinical educator and a practicing clinician, limiting his practice to periodontics and dental implant placement.

prakasam_family

Prakasam and family

Where are you from originally?
I was born and raised in India. I got my dental degree there – a B.D.S. as it’s known in India – and as soon as I was done with that, I knew I wanted to pursue research. I went to the Stony Brook University in New York for my Ph.D. and was fortunate to work under the mentorship of Dr. Chris Cutler an innate immunologist and periodontist. This helped shape the direction of my research career. Though I knew I wanted to do research, I found I missed the clinical side of things while I was completing my Ph.D., so I decided to go back and pursue advanced clinical training. I went to Indiana University School of Dentistry and did my periodontal residency for my specialty training. I stayed as a clinical faculty member for another four years. This was sort of an unofficial postdoc. Because of the projects I developed there, I was then able to apply for a position here at OHSU, which is also part research, part clinical. Though there are similarities, I find I have access to a lot more resources here.

What’s the focus of your research?
Understanding periodontal disease. The pervading thought on what this disease is that the biofilm or tooth plaque is the primary etiology and that some people are more susceptible to developing a response to it. Also, there are certain bacteria that are commonly associated with disease process. So, one of the things I worked on as a clinical professor at Indiana was salivary diagnostics. I was able to incorporate the focus of my Ph.D. work – innate immunology – but in terms of translational research. The goal was to try and identify salivary markers that we see in periodontal disease. In developing that project, I came across something called Peptidoglycan recognition proteins, a group of innate immune receptors. It’s unique in the sense it’s a secreted receptor that does two things: kill bacteria and modulate inflammation. Up to now, I’ve been studying this receptor mostly in mice models. But my goal is to understand the relevance of this molecule in terms of human diseases, particularly inflammatory diseases like gum disease. In addition to figuring out what role the receptor plays in periodontal disease, I want to see if it can be used as a biomarker for identifying disease.

Another avenue I’m exploring is that this receptor may have a role to play in other systemic diseases. One of the emerging concepts is that oral disease may be a risk factor or causative agent for distant diseases such as cardiovascular disease and diabetes. There are varied hypotheses about the connection between oral health and say, cardiovascular disease. The controversy lies in causality. Are these people who have poor gum health alongside cardiovascular disease, generally prone to reduced immunity or hyper inflammation? Or is it the type or amount of oral bacteria itself that’s the cause?periodontal-disease

The cause may, in fact, be direct. There is a large build-up of bacteria when people don’t brush regularly so that when they do brush or have dental work done like a tooth extraction, this can cause the abnormal levels of bacteria to enter the circulation system, which can eventually precipitate changes in the cardiovascular system. Studies have identified traces of these bacteria in atherosclerotic plaque. These are dead oral bacteria that are not supposed to be in the heart but are often found in people who die of cardiovascular disease. These bacteria have also been found in dead fetuses in certain cases of pregnancy that don’t go to term. So, investigators are trying to establish the connection, and one of my goals is to find out if this receptor could be the link. There is some proteomic data that suggest this molecule may be relevant in various systemic inflammatory diseases.

So this is my primary focus of my research, but I also do a lot of small projects. One of them is my work with a collaborator in Iowa – we do a lot of data mining of a health insurance data base, trying to find links between oral diseases and systemic diseases. We’ve published a few papers published from this line of research. I’m also interested in safety. When I was in Indiana, inspired by Atul Gawande’s pioneering work on WHO Surgical Safety checklist, we developed a safety checklist for implant placement, and that’s been published. Though this is not my main research focus, I feel it’s very important work. Most states have very lax laws in terms of who gets to perform what types of procedures. In the case of dental implant placement, a dentist who has taken minimal training (two to three weeks) may be allowed do the same procedure as someone who’s had two or three years’ worth of training. Developing safety protocols is one way to protect the patient and guide inexperienced practitioners.

What do you do when you’re not at work?
I read a lot of books, mostly non-fiction, about self-improvement, leadership, and communication. But mostly I spend time with my family. My wife is at home now with our son who’s two and a half, and she’s also an aspiring pastry chef. Trying not to eat pastries keeps me plenty busy!

Learn more about NIH peer review in upcoming online briefings

Have you ever wondered what goes on inside an NIH Study Section and what’s most important to reviewers? The NIH Center for Scientific Review is hosting a series of online briefings in November and December to help you navigate the peer review process and increase your chances of getting funded. The first two briefings will provide fellowship and R01 grant applicants  information on how applications are reviewed for scientific and technical merit. The third briefing will offer information to help basic research grant applicants and reviewers better do their part in proposing and reviewing basic research.

8 Ways to Successfully Navigate NIH Peer Review and Get a Fellowship Grant
Wednesday, Nov. 2, 2016

8 Ways to Successfully Navigate NIH Peer Review and Get an RO1 Grant
Thursday, Dec. 1, 2016

NIH Peer Review Briefing for Basic Research Applicants and Reviewers
Friday, Dec. 2, 2016

All briefings will run from 11 a.m. to 12 p.m., including a 30 minute Q&A period.

Register here by Oct. 31 for the November briefing and by Nov. 30 for the December briefings.

Recruitment begins for emergency medicine career development program

The OHSU Department of Emergency Medicine was recently selected as one of three sites for the new national K12 Training Program in Emergency Care Research. The purpose of this award is to promote multidisciplinary clinical research training programs in emergency care that prepare clinician-scientists for independent research careers and academic leadership roles.

The program runs for five years and supports five scholar’s comprehensive research training to evaluate innovative approaches in the diagnosis and clinical management of patients with acute, life-threatening manifestations of cardiovascular, pulmonary, hematologic, traumatic, and mental health emergencies. The scholar recruitment process will begin this fall with the first two scholars starting July 2017.

If you’re interested in applying, visit the program website for more information or contact program co-directors Craig Newgard, M.D., M.P.H., or Cynthia Morris, Ph.D.

New drug discovery program provides access to AstraZeneca resources

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Do you have an innovative idea for a drug discovery project? AstraZeneca is seeking opportunities to work with like-minded scientists in academia and organizations with the common goal of discovering and developing novel medicines for the treatment of patients with diseases of high unmet need. The AstraZeneca Open Innovation platform has been created to help identify and establish research partnerships that will lead to the discovery and development of new medicines.

AstraZeneca is looking to collaborate with partners across all stages of drug discovery – from the early idea through to early clinical development. For partners and collaborators, working with AstraZeneca means access to optimized compounds, compound libraries, technologies, multi-disciplinary science, services and know-how, with the prospect of joint publications in high profile journals and, most importantly, the opportunity to see their ideas develop into treatments for patients.

Go to openinnovation.astrazeneca.com for additional details.

New scientific review requirement for some clinical research studies

Concerns have been raised that some human subject scientific protocols that do not receive external peer review have limitations that slow their progress through the IRB.  As the IRB is charged with protecting human subjects, rather than as a scientific review committee, this lack of review slows the process and adds work for researchers and regulators alike.  And this problem is not just local, but nationwide.  In response to several recent examples here at OHSU, the Senior Vice President for Research has committed to addressing this problem by convening a new scientific review committee under the auspices of the Oregon Clinical and Translational Research Institute.  

Beginning October 1, 2016, if your full board human subjects protocol was not otherwise externally peer-reviewed–including unfunded studies and studies conducted under some career development grants–they will be required to undergo internal scientific review by the new OHSU Clinical Research Scientific Review Committee. This committee will review full board human subject protocols prior to IRB review. It is chaired by Mary Samuels, M.D., professor in the Division of Endocrinology in the School of Medicine and director of the Clinical and Translational Research Center. The goal of this review is to improve quality without delaying approval, and committee will work hard to satisfy this goal. Protocols for FDA-regulated studies, NIH-funded research grants, and studies receiving scientific review through other means, such as the Knight Cancer Institute Clinical Research Review Committee, will not require additional review. 

Protocols meeting the criteria to require committee review will be automatically triaged upon submission to the IRB in the eIRB system, so you do not need to submit anything separately. The committee will let you know through the eIRB system of the result of the review.

Serendipitously, at the same time, OCTRI has been invited to participate in a nationwide trial of prior scientific review of scientific protocols to determine whether this could improve overall turnaround time and ease of processing. It is hoped that the data derived from this trial will inform NIH policies in the future. 

OHSU is also soliciting applications for investigators to join the committee as reviewers; please contact Dr. Samuels (samuelsm@ohsu.edu) or Darlene Kitterman (kitterma@ohsu.edu) if you are interested or have further questions.

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