Tag Archives: Clinical Research

FASEB Responds to NIH’s Call for Information on Age Inclusion in Clinical Research

The National Institutes of Health (NIH) on April 26 published a Request for Information (RFI) inviting comments on “the appropriate inclusion of pediatric and older populations in research studies involving human subjects.” Responses are due June 30. The RFI provides an opportunity for the scientific community and the public to express their views, while feedback… Read More »

Council considers strategies to strengthen NIH peer review

On September 26, the National Institutes of Health (NIH) Center for Scientific Review (CSR) Advisory Council met to discuss key issues for peer review—and the NIH grant application and award process more broadly—as the agency plans for FY 2017 and beyond. Lawrence Tabak, DDS, PhD, NIH Principal Deputy Director, reviewed the current status of the… Read More »

New rules on registering and reporting clinical trials

The Department of Health and Human Services (HHS) issued new rules on announcing clinical trials and reporting their results. On September 16, HHS released the Final Rule on clinical trials registration and summary results information submission on the ClinicalTrials.gov website. The Final Rule mirrors the Notice of Proposed Rulemaking (NPRM) published in November 2014. At… Read More »

FASEB welcomes new president and officers

On July 1, the Federation of American Societies for Experimental Biology (FASEB) welcomed its new President, Hudson H. Freeze, PhD. Dr. Freeze is Professor of Glycobiology and Director of the Human Genetics Program at the Sanford-Burnham-Prebys Medical Discovery Institute in La Jolla. “I am honored to lead FASEB—the policy and advocacy voice of 125,000 scientists. Today,… Read More »

FASEB Provides Feedback on NIH Principles and Guidelines for Reporting Preclinical Research

Building on the expertise of four subcommittees of its Science Policy Committee, the Federation of American Societies for Experimental Biology (FASEB) submitted feedback to the National Institutes of Health (NIH) on its Principles and Guidelines for Reporting Preclinical Research. Released by NIH in November 2014, the Principles and Guidelines were developed by journal editors and… Read More »

FASEB Outlines Concerns on Proposed Changes to Reporting of Clinical Trial Information

In comments on proposed changes governing the registration and reporting of clinical trial results, the Federation of American Societies for Experimental Biology (FASEB) noted the importance of having standardized, transparent, and publicly available information about clinical trials available to avoid unintended duplication of studies and detect adverse events. FASEB also raised concerns about certain aspects… Read More »

IOM Report Describes Strategies for Responsible Sharing of Clinical Trial Data

The Institute of Medicine (IOM) of the National Academies released the report “Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk” on January 14, 2015. It concludes that data sharing is in the public interest, but an effort on the part of many stakeholders is needed “to develop a culture, infrastructure, and policies that will foster… Read More »