CR and FDA News
Four new NIH centers in alternative medicine
Four new Centers of Excellence for Research on Complementary and Alternative Medicine (CERCs) have been added by the National Institutes of Health's National Center for Complementary and Alternative Medicine (NCCAM).
The new centers are as follows:
- Wisconsin Center for the Neuroscience and Psychophysiology of Meditation: Located at the University of Wisconsin in Madison, WI, the center's research team, headed by Richard J. Davidson, PhD, will examine the impact on the brain and body of two forms of meditation: loving-kindness/compassion meditation and mindfulness meditation. Potential health applications include biological and behavioral processes linked with emotions and stress, including recurrent depression.
- Metabolic and Immunologic Effects of Medicine: Located at the University of California, San Francisco, the site will study a program combining mindfulness meditation, mindful eating, and a diet and exercise program for use in obesity and metabolic syndrome. Frederick M. Hecht, MD, will lead the research team as it tests whether this program helps alter participants' hormonal responses to stress and helps enhance and maintain weight loss.
- CAM as Countermeasures Against Infectious and Inflammatory Disease: Principal investigator Mark A. Jutila, PhD, at Montana State University in Bozeman, MT, will head a project that focuses on the effects of botanical extracts from apple polyphenols, which are located in apple skins, and from yamoa, which comes from the bark of an African gum tree, on white blood cells. The project will use models of infection and inflammation of the intestinal mucosa.
A second project will examine two models of influenza and stomach virus, and a third project will focus on bacterial products to see how they treat autoimmune diseases, such as arthritis.
- Center for Herbal Research on Colorectal Cancer: At the University of Chicago in Illinois, principal investigator Chun-Su Yuan, MD, PhD, and colleagues will examine the anti-tumor effects of different preparations of the herbs American gingseng and notoginseng. Their goal is to learn more through laboratory and animal studies of how these herbs act upon cellular and molecular pathways of the mechanisms of cancer inhibition.
The NCCAM grants are for five years, and there now are 11 CERCs. For more information, visit the Web site: nccam.nih.gov/training/centers/, or call 888-644-6226.
ACRP comments on FDA draft guidance
The Association of Clinical Research Professionals (ACRP) of Alexandria, VA, wrote to the Food and Drug Administration (FDA) on Sept. 26, 2008, to address questions about the FDA's draft guidance on FAQ - Statement of Investigator (Form FDA 1572).
Thomas L. Adams, CAE, president and chief executive officer of ACRP questioned the wording in four items, including the following:
- Item #5: What are the minimum qualifications of an investigator?
According to Adams' letter, ACRP believes mentioning a concreted example of achievement, such as a physician investigator certification, would provide an example of the "general recognition that this would include familiarity with human subject protection requirements…"
- Item #17: How should an investigator's name appear on the 1572?
"The guidance mentions the use of the legal name on Block #1. Some believe that the name must match exactly how their name appears on their medical license (i.e., "James A. Smith, M.D." versus "James Smith, M.D."). Is this the case?" Adams writes.
- Item #30: Who should be listed as a subinvestigator in Block #6?
Adams' letter recommends deleting the sentence in lines 321-323, which reads, "In general, if an individual is directly involved in the treatment or evaluation of research subjects, that person should be listed on the 1572." Adams makes this recommendation because the sentence seems to be inconsistent with the clarity of "direct and significant contribution to the data" as it implies that many people, including hospital nurses who pass the study drug or a radiology technician, would need to be on the 1572 as they are involved in the treatment of the individual, the letter states.
- Item #31: Should research nurses, other nurses, residents, fellows, office staff, or other hospital staff be listed in Block #6?
Adams' letter asks the FDA for an example of what kind of statement should be made with regard to lines 337-338, which state that if there are staff residents on rotation, a general statement can be made regarding their planned participation.
"Additionally, many settings such as psychiatric hospitals or specialty clinics, contract with physician groups to perform physical exams and care which may be used as data for the study," Adams writes. "Under these arrangements, it is not easily predictable as to which physician in the group will show up that day to perform the care."