This week in transparency news: June 22 – June 28, 2019

by Staff writer,
Posted on 6/28/2019

Transparency in clinical trials is continually changing, and to stay on top of the news, TrialAssure brings a weekly round-up of some of the key stories surrounding disclosures in clinical trials. This week’s stories are as follows:

PHUSE obtains two TransCelerate guidance tools to help promote clinical data transparency and patient privacy – PHUSE

PHUSE announced its successful transition of two guidance papers from TransCelerate BioPharma Inc. The guidance documents address clinical data transparency and data anonymization.

Read the full press release here

Statement on agency’s efforts to increase transparency in medical device reporting – U.S. Food & Drug Administration

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health is updating its Medical Device Reporting (MDR) Program. The FDA uses this program to monitor device performance, safety concerns, and other factors.

View the full statement on the FDA newsroom

Postmarketing commitments for novel drugs and biologics approved by the U.S. Food and Drug Administration: a cross-sectional analysis – BMC Medicine

Researchers studied how often postmarketing commitments agreed upon by pharmaceutical companies at first FDA approval lead to new clinical trials. The researchers found that while only 15% of postmarketing commitments agreed to by pharmaceutical companies at the time of FDA approval were for new clinical trials, these trials were nearly always registered with reported results on ClinicalTrials.gov. However, only half were published, and despite FDA public reporting requirements.

Access the full study here

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