November 2019

1 - 10-Year Update on Study Results Submitted to

Zarin DA et al. Read the full paper here

Abstract: A decade after launched a database for reporting results of clinical trials, the database includes results of approximately 36,000 trials. The authors discuss laws, regulations, and policies relevant to results reporting, trends over time in the frequency of reporting, and adherence to requirements for the completeness and quality of the results reported.

2 - Data Quality in Registries Remains an Issue

This Nov 2019 StatNews article shows that although more data are being posted, the quality of the data does not necessarily hold up.

3 - FDA Guidance 'Certificates of Confidentiality'.

FDA have issued DRAFT guidance ‘Certificates of Confidentiality’ (November 2019) intended to help protect the privacy of human subject research participants from whom identifiable, sensitive information is being collected or used in furtherance of the research. Comments are open for 45 days.

JAMA Editorial on Data Sharing Challenges

This November 2019 JAMA Editorial by Howard Bauchner and Phil Fontanarosa titled 'The Challenges of Sharing Data in an Era of Politicized Science' provides thoughtful commentary on data sharing and the associated processes, and cautions that scientific process must prevail no matter what challenges are faced.

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