Category: Clinical Trials
New Draft Guidance Regarding Data Sharing on ClinicalTrials.gov and Civil Money Penalties
On September 21st, the U.S. Food and Drug Administration (“FDA”) published a draft guidance document titled “Civil Money Penalties Related to the ClinicalTrials.gov Data Bank” (“Draft Guidance”) regarding the imposition of civil money penalties (“CMPs”) for failure to submit required clinical trial information to ClinicalTrials.gov or improperly certifying compliance with […]
FDA Issues First of Four Draft Guidances Related to Patient-Focused Drug Development
Today, the U.S. Food and Drug Administration (FDA) released guidance titled, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input (Guidance 1), to address how stakeholders can collect and submit patient experience data from patients, caregivers, clinicians and patient advocacy groups for product development and regulatory decision-making. “Patient experience data” is defined as data that is “collected by […]
JAMA: Study Shows “Significant Positive Progress” in Managing Conflicts of Interest Among IRB Members, But More Work Needed
JAMA Internal Medicine published a report this week titled, Industry Relationships Among Academic Institutional Review Board Members: Changes From 2005 Through 2014, which is an update to a similar study conducted in 2005. The study found that although there were no significant changes in the percentage of institutional review board (IRB) members […]
NIH Releases Final Guidance on Genomic Data Sharing
The National Institute of Health (NIH) recently released its final policy related to sharing human and non-human genomic data (GDS Policy). The GDS Policy applies to all NIH-funded research, regardless of the level of funding, that generates large-scale human or non-human genomic data, including the use of the data for […]
Additional Transparency for Clinical Trials Announced by Industry Groups
On July 24, 2013, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) announced joint endorsement of the “Principles for Responsible Clinical Trial Data Sharing: Our Commitment to Patients and Researchers.” These principles applicable to biopharmaceutical companies take effect January 1, […]
