On Friday, September 16, in an effort to make information about clinical trials widely available to the public, the US Department of Health and Human Services (HHS) issued a final rule specifying requirements for registering and reporting summary results information to ClinicalTrials.gov. The new rule expands the legal requirements for submitting registration and results information for certain clinical trials involving US Food and Drug Administration (FDA)-regulated drug, biological and device products to ClinicalTrials.gov.

At the same time, the National Institutes of Health (NIH) issued a complementary policy for registering and submitting summary results information to ClinicalTrials.gov for all NIH-funded clinical trials, including those not subject to the final rule. These actions are important steps to honor our commitments to clinical trial participants to share the knowledge gained from their participation in order to achieve the greatest benefit to human health.  

Since many of you are likely to be affected by these changes, we encourage you to read the NIH news release along with related materials (including a summary) to learn more about these important developments. 
 

Interested in integrating human, animal, and environmental health? Want to meet collaborators and develop grant proposals? Join Tufts CTSI for a One Health Workshop on Tuesday, October 4, 9:00AM-1:45PM at Tufts University School of Dental Medicine, Rachel's Amphitheater (1 Kneeland Street, 15th Floor, Boston). A live webcast will also be available. The link to the webcast will only be available to people who register for the event.

The workshop will help project teams develop proposals for future grant submission, including:

• Development of a Safe, Inexpensive, Easily Administered EHEC Vaccine for Cattle
  Project team: John Leong, MD, PhD; Abraham L. Sonenshein, PhD; Saul Tzipori, DVM, PhD, DSc
• A Novel Approach to Asthma Therapy: Decreasing Airway Smooth Muscle Mass – A One Health Approach Using Naturally Occuring Models of Disease in the Horse and Cat
  Project team: Melissa R. Mazan, DVM; Heber Nielsen, MD
• Antibiotic Stewardship and Infection Control: Sharing Approaches from Tufts Medical Center and the Foster Hospital for Small Animals at the Cummings School of Veterinary Medicine, and the Effects of the Human Microbiota Due to Pet Antimicrobial Therapy
  Project team: Shira Doron, MD; Kirthana R. Beaulac, PharmD; Tine Vindenes, MD; Annie Wayne, DVM
• Cohabitation with Production Animals, Gut Microbiota, and Stunting in Children
  Project team: Janet Forrester, PhD; Honorine Ward, MD; Marieke Rosenbaum, DVM

To attend, please register here by Friday, September 30.

Congratulations to the 29 junior faculty members chosen to participate in the 2016-2017 Junior Faculty Research Career Development Forum. They will meet monthly to discuss research activities such as specific aims, grant applications, grant re-submissions, and manuscript preparation and revision.

Forum members represent Tufts CTSI partner institutions including Brandeis University, Cummings School of Veterinary Medicine, Institute for Clinical Research and Health Policy Studies, Jean Mayer USDA Human Nutrition Research Center on Aging, Maine Medical Center, Northeastern University, Tufts Medical Center, Tufts University School of Arts and Sciences, Tufts University School of Dental Medicine, and Tufts University School of Medicine.

Medford Phone Office Hours Start September 30

Please click on the links below for event information and registration. To view all upcoming Tufts CTSI events, visit our calendar.