Applied Clinical Trials-08-01-2015

The "Cures" bill and PDUFA IV are the latest measures pushing for more systematic inclusion of patient views into drug development.

While still early days, key metrics can be collected in three broad areas

Officials tackle such areas as early diagnosis and treatment, patient access, and personalized medicine

Combining PRO data with clinical feasibility data can make a difference in diabetes care.

The number of site audits performed has grown significantly.

The four essential steps to ensuring optimal clinical deliverable specifications and process controls.

How to satisfy regulatory concerns about EDC data integrity and site controls over its source records.

Whether we are referring to CSRs or to IPD, the personal information of trial participants needs to be de-identified prior to release. This article will describe the available methods for de-identifying clinical trial data, and the relative strengths and weaknesses of each.

CRO/Sponsor: Logical Sourcing: Key Steps Clinical Technology: eSource Record-Keeping Data Sharing: De-identifying Trial Data Also in this issue: R&D Focal Points in Europe Patient Centricity: The Clinical Investment PRO Plusses for Diabetes Research