Are we making progress in streamlining drug development?

  

Wednesday, June 26

 

Collaborating to Streamline Drug Development: Are We Making Progress?
In this forum, leaders of two of the best known initiatives – TransCelerate Biopharma Inc (TransCelerate) and the Clinical Trials Transformation Initiative (CTTI) – will provide a status report on current projects, with additional perspectives provided by representatives of the FDA, CROs, and research sites.

 

TransCelerate’s Collaborative Approach to Risk-based Monitoring: The Methodology
TransCelerate BioPharma Inc. (TransCelerate) developed a methodology for monitoring that shifts monitoring processes from an excessive concentration on source data verification to comprehensive risk-driven monitoring. This philosophical shift in monitoring processes employs centralized and offsite mechanisms to identify and monitor important study parameters holistically, and uses adaptive onsite monitoring to further support subject safety and data quality.

Better quality hurts patient experience

It may seem counterintuitive, but adopting mandated quality measures could hurt patient experience--at least in the short-term, according to a study scheduled for publication in Manufacturing & Service Operations Management.

Calling it a "tradeoff," Ohio State University research shows a negative link between clinical quality and a patient's hospital experience after implementing quality strategies to meet state or federal requirements.

Researchers surveyed directors of quality or chief nursing officers at 284 hospitals in 44 states about their adherence to guidelines from the Centers for Medicare & Medicaid Services, as well as state patient safety guidelines, mandated in 2003. The researchers weren't surprised to find that implementing techniques to reduce medical errors and improve patient safety did, in fact, improve outcomes. However, they unexpectedly found that "these improvements sometimes came at the expense of the quality of the patient experience," according to a research announcement.

Read more: Better quality hurts patient experience - FierceHealthcare http://www.fiercehealthcare.com/story/quality-measures-can-worsen-patient-experience/2012-04-02?utm_medium=nl&utm_source=internal#ixzz1quh2p3r8
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