About six years ago, the NIAMS, as part of a larger National Institutes of Health (NIH) effort to revamp clinical research, reviewed our mechanisms and processes for funding clinical trials. As a result of that review, we instituted a number of new clinical trial policies and processes. Over the years, we’ve monitored the progress of those efforts to assess whether changes or additional measures are needed. This month’s letter focuses on new ways that the NIAMS and the NIH are enhancing support for clinical research.
Image: Stephen I. Katz, M.D., Ph.D.
The NIH has issued a new policy to streamline the review process for NIH-funded, multi-site clinical research studies in the United States. The NIH Policy on the Use of a Single Institutional Review Board (IRB) for Multi-Site Research [PDF – 57 KB] sets the expectation that multi-site studies conducting the same protocol use a single IRB to carry out the ethical review of the proposed research.
In a study of patients with rheumatoid arthritis (RA) in knee and hip joints, scientists learned that the disease mechanisms of RA may differ from joint to joint—in any one person. Supported in part by the NIAMS, the study team developed a method for analyzing genes and the molecular pathways that affect different joints in one person—and confirmed that genes and pathways differ between the joint locations. This analytical method could form the basis for developing precision medicine approaches to rheumatoid arthritis.
Image: Molecular differences between knee and hip joints with RA may inform more personal treatment strategies. Photo credit: Sebastian Kaulitzki/Hemera/Thinkstock.
We all know that exercise is important for a strong and healthy body. Less appreciated is that exercise seems also to be important for a strong and healthy mind, boosting memory and learning, while possibly delaying age-related cognitive decline. How is this so? Researchers have assembled a growing body of evidence that suggests skeletal muscle cells secrete proteins and other factors into the blood during exercise that have a regenerative effect on the brain. Now, an NIH-supported study has identified a new biochemical candidate to help explore the muscle-brain connection: a protein secreted by skeletal muscle cells called cathepsin B.
Image: After running in a wheel, adult mice form new neurons (green) in the brain’s dentate gyrus. Photo credit: Henriette van Praag, Ph.D., and Linda Kitabayashi.
A recent study funded in part by the NIH’s National Institute of Biomedical Imaging and Bioengineering (NIBIB) tested whether epidural stimulation could restore some hand strength and control in people with tetraplegia, also known as quadriplegia (the loss of use of all four limbs).
Image: Restoring hand and arm function would have a major impact on quality of life for patients with cervical spinal cord injuries.
Photo credit: Thinkstock.
Evidence shows that the best way to boost the chance of living a long and active life is to follow the advice you likely heard from your parents: eat well, exercise regularly, get plenty of sleep and stay away from bad habits.
The U.S. Food and Drug Administration (FDA) finalized its efforts to streamline the process used by physicians to request expanded access, often called “compassionate use,” to investigational drugs and biologics for their patients. The new form, Form FDA 3926 [PDF – 88 KB], can be used by physicians to request expanded access to investigational drugs for individual patients who suffer from serious or immediately life-threatening diseases and for whom no comparable or satisfactory alternative therapy is available.
Two skin cells of a mouse indicate the flow of calcium into the cell in response to a dose of histamine. The image on the left shows the cell before the dose of histamine, with a low level of calcium. The image on the right depicts the higher level of calcium in response to the histamine dose. Duke researchers have demonstrated that an ion channel called TRPV4 triggers a rush of calcium into the cell, causing a chain of messages that ends up signaling "itch" to the brain. This pathway may be a promising target for topical medications to suppress itch and inflammation. This image is courtesy of Yong Chen, Ph.D., and Wolfgang Liedtke, M.D., Ph.D., of Duke University.
This information from the National Cancer Institute (NCI) raises awareness that anyone can get skin cancer—whether you consider your skin light, dark or somewhere in between. Skin cancer can affect both men and women. Even teenagers, and rarely, younger children, can develop skin cancer.
The NIAMS Advisory Council Meeting will be held September 13, 2016, in Building 31, 6th Floor, C Wing, Conference Room 6, NIH Campus. A meeting agenda will be posted as soon as it is available. This Council meeting will be available for live viewing via the NIH videocasting service as well. As a reminder, you can watch an archived version of the June 7, 2016 Advisory Council meeting in its entirety until the September meeting.
FDA Public Workshop: Scientific Evidence in the Development of Human Cells, Tissues and Cellular and Tissue-Based Products Subject to Premarket Approval
Thursday, September 8, 2016
8:30 a.m. to 5:00 p.m.
Location: FDA White Oak Campus, 10903 New Hampshire Avenue
Building 31 Conference Center, Great Room
Silver Spring, MD 20993-0002
Registration is required by August 1.
NIH Science Lectures and Events Available Online
The NIH hosts a number of science seminars and events that are available online through real-time streaming video (videocast). The NIH calendar notes these videocast events with a video icon .