Outcome Sciences,
Inc. today announced that the
Agency for Healthcare Research and Quality
(AHRQ) has published the second edition of, “Registries for Evaluating Patient Outcomes: A User’s Guide,” a Federal publication that provides information on designing, implementing, and evaluating patient registries.
The second edition of the User’s Guide, which reflects the work of more than 80 contributors from government, academic and private sectors, includes:
* New methodological developments;
* Emerging topics in registry science, including updates on safety;
* Technological advances; and
* Operational examples and case studies from around the world.
Updates to the original 11 chapters from the 2007 version of the handbook are included, as well as four new sections:
* Use of Registries in Product Safety Assessment
* Planning for the End of a Patient Registry
* Interfacing Registries and EHRs
* Linking Registry Data
OUTCOME was selected by AHRQ in 2005 to lead the effort to create the patient registries guide. OUTCOME’s Drs. Richard Gliklich and Nancy Dreyer served as the guide’s senior editors and authors for several chapters. The second edition includes 38 case studies, which illustrate real-life challenges in the design and conduct of registries. Contributors came from industry, academia, and government, with representation from various agencies in the U.S., as well as the National Institute for Health and Clinical Excellence in the U.K. The work was performed under contract to OUTCOME through its role as an AHRQ DEcIDE Research Center, a component of AHRQ’s Effective Health Care Program.
The guide will be available in on AHRQ’s website (
www.effectivehealthcare.ahrq.gov
) and will also be available in print.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.