NIH Establishes Genetic Testing Registry

An online tool launched today by the National Institutes of Health will make it easier to navigate the rapidly changing landscape of genetic tests. The free resource, called the Genetic Testing Registry (GTR), is available at http://www.ncbi.nlm.nih.gov/gtr/.

“I’m delighted that NIH has created this powerful, new tool. It is a tremendous resource for all who are struggling to make sense of the complex world of genetic testing,” said NIH Director Francis S. Collins, M.D., Ph.D., who unveiled GTR at NIH’s observance of international Rare Disease Day. “This registry will help a lot of people — from health care professionals looking for answers to their patients’ diseases to researchers seeking to identify gaps in scientific knowledge.”

Genetic tests currently exist for about 2,500 diseases, and the field continues to grow at an astonishing rate. To keep pace, GTR will be updated frequently, using data voluntarily submitted by genetic test providers. Such information will include the purpose of each genetic test and its limitations; the name and location of the test provider; whether it is a clinical or research test; what methods are used; and what is measured. GTR will contain no confidential information about people who receive genetic tests or individual test results.

Genetic tests that the Food and Drug Administration has cleared or approved as safe and effective are identified in the GTR. However, most laboratory developed tests currently do not require FDA premarket review. Genetic test providers will be solely responsible for the content and quality of the data they submit to GTR. NIH will not verify the content, but will require submitters to agree to a code of conduct that stipulates that the information they provide is accurate and updated on an annual basis. If submitters do not adhere to this code, NIH can take action, including requiring submitters to correct any inaccuracies or to remove such information from GTR.

In addition to basic facts, GTR will offer detailed information on analytic validity, which assesses how accurately and reliably the test measures the genetic target; clinical validity, which assesses how consistently and accurately the test detects or predicts the outcome of interest; and information relating to the test’s clinical utility, or how likely the test is to improve patient outcomes.

“Our new registry features a versatile search interface that allows users to search by tests, conditions, genes, genetic mutations and laboratories,” said Wendy Rubinstein, M.D., Ph.D., director of GTR. “What’s more, we designed this tool to serve as a portal to other medical genetics information, with context-specific links to practice guidelines and a variety of genetic, scientific and literature resources available through the National Library of Medicine at NIH.”

GTR is built upon data pulled from the laboratory directory of GeneTests, a pioneering NIH-funded resource that will be phased out over the coming year. GTR is designed to contain more detailed information than its predecessor, as well as to encompass a much broader range of testing approaches, such as complex tests for genetic variations associated with common diseases and with differing responses to drugs. GeneReviews, which is the section of GeneTests that contains peer-reviewed, clinical descriptions of more than 500 conditions, is also now available through GTR.

The GTR database was developed by the National Center for Biotechnology Information (NCBI), part of NIH’s National Library of Medicine, under the oversight of the NIH Office of the Director and with extensive input from researchers, testing labs, health care providers, patients and other stakeholders. To view video tutorials on how to use GTR, go to http://www.youtube.com/playlist?list=PL1C4A2AFF811F6F0B.

Source: NIH News Release

Feb. 28 Lecture Highlights Medical Education Research

The next lecture in the 2011-2012 Translational Research Lecture Series is scheduled on Tuesday, Feb. 28, from 6:00-8:00 p.m. in Room 120 White Hall. The series is presented by the WSU Medical Student Research Club. All BSOM faculty and students are invited to attend.

The lecture will survey “Medical Education Research at WSU” with a panel of faculty and medical student investigators led by Nicole Borges, Ph.D. (above left), professor of community health and assistant dean of medical education research and evaluation. Faculty presenters also include Brenda Roman, M.D., professor and director of medical student education in psychiatry and assistant dean for curriculum development; Barbara Kraszpulska, Ph.D., assistant Professor of neuroscience, cell biology and physiology; and Raymond P. Ten Eyck, M.D., M.P.H., F.A.C.E.P., professor of emergency medicine and Simulation Center director. Student presenters include Ryan Whitt (M4), Julie Popritkin M4), and Robbie Beaulieu M2). Download the agenda (MS Word).

Dinner will be provided on Feb. 23. Please RSVP to Adam Deardorff (deardorff.2@wright.edu) if you plan to attend.

Related links:

• Research Learning Community homepage
• 2011-2012 Translational Research Lecture Series

NIH Launches New Website About “Clinical Research Trials and You”

The National Institutes of Health has created a new website, NIH Clinical Research Trials and You to help people learn more about clinical trials, why they matter, and how to participate. From the first cure of a solid tumor with chemotherapy to the use of nitroglycerin in response to heart attacks, clinical research trials — or research studies involving people — have played a vital role in improving health and quality of life for people around the globe.

Clinical trials are essential for identifying and understanding ways to prevent, diagnose, and treat disease. Research has shown that among the greatest challenges to recruitment of volunteers is the lack of general knowledge about what trials involve, where they are carried out, and who may participate.

“The ability to recruit the necessary number of volunteers is vital to carrying out clinical research that leads to health and medical advances,” said NIH Director Francis S. Collins, M.D., Ph.D. “This new, centralized resource will make it much easier for the public and health professionals to learn about clinical trials and how people can participate in them.”

Visitors to the website will find information about:

• The basics of clinical trial participation
• First hand experiences from actual clinical trial volunteers
• Explanations from researchers
• Links on how to search for a trial or enroll in a research matching program

In addition, health care professionals can read about evidence-based strategies for talking with patients about trials, print audience-tested posters to help promote trials in clinics and offices, and find other educational materials.

Source: NIH News Release

Robert Fyffe Appointed Wright State VP for Research

Robert E. W. Fyffe, Ph.D. (left), formerly Associate Dean in the BSOM Office of Research Affairs, has been named Vice President for Research and Graduate Studies at Wright State University effective February 6, 2012. He holds a faculty appointment as professor of neuroscience, cell biology, and physiology at WSU.

He will replace Jack Bantle, Ph.D., who has retired.

“Dr. Fyffe has a proven record of administering programs that support research activities and will provide the leadership necessary to maintain our excellence in research, scholarship, and graduate programs,” said Provost Steven Angle. “He will also be a strong advocate for the diverse constituencies involved in the university’s research enterprise.”

Fyffe was appointed associate dean for Research Affairs at the Boonshoft  School of Medicine in April 2001. He was responsible for overseeing programs that supported the medical school’s research activities in the basic and clinical sciences. Read more.

WSU & PHP Announce Clinical Trials Research Alliance (CTRA)

Wright State University Boonshoft School of Medicine, Wright State Research Institute and Premier Health Partners announced today the formation of the Wright State University & Premier Health Partners Clinical Trials Research Alliance to increase medical research opportunities for physicians and clinicians and boost access to clinical trials in the Dayton region.

This major public-private initiative partners the Dayton region’s strongest biomedical research institution with the clinical resources of the region’s leading hospital system. Premier Health Partners is making a major investment of $4 million over five years to support the infrastructure of the alliance. It is expected to build a $5 million to $7 million annual clinical research portfolio over five years, roughly doubling the total of what the medical school and Premier have today.

The National Institutes of Health, other federal sources and pharmaceutical, biotechnology and medical device companies spent $94 billion on research and development in 2008, according to Center Watch, the leading source of clinical trials information for both clinical research professionals and patients.

The Wright State Research Institute will lead the alliance’s development, providing business infrastructure and administrative support, as well as building a pipeline for new research projects. The administrative support will free doctors and researchers at both Wright State and Premier from much of the extensive paperwork and bureaucracy that can discourage doctors from pursuing clinical research projects, said Ryan Fendley, institute director.

The alliance will be established from existing facilities at Wright State and initially with Miami Valley Hospital and Good Samaritan Hospital as the Premier hospitals, but will be available to all PHP hospitals and practices in the future.

Arthur S. Pickoff, M.D., professor and chair of the medical school’s Departments of Community Health and Pediatrics, and assistant dean for clinical research, will direct the alliance.

“We anticipate this will be a game-changer for clinical research in the Dayton region,” Pickoff said. “This research alliance will give the residents of the Dayton region and beyond the opportunity to participate in a large number of cutting-edge clinical trials, which will result in the development of the medical treatments and cures of tomorrow.” Read more.

For more information about clinical trials, see ClinicalTrials.gov.