One Program, Four Stakeholders: An Overview of the Utilization of Patient-Reported Outcomes in Intervention Development to Meet the Needs of Regulators, Payers, Healthcare Professionals and Patients

Description

Pharmaceutical Medicine, March 2015 - This article briefly summarizes the perspectives of regulators, payers, HCPs and patients regarding PRO endpoints, and examines how a robust, comprehensive and systematic PRO endpoint strategy can be developed to meet the needs of all stakeholders in a single development program.

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Leveraging Centralized Data Surveillance

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Copyright, March 2015 - This white paper explores how the widespread availability of computers and the Internet is revolutionizing the clinical trial industry by creating an eClinical ecosystem of electronic data capture tools to facilitate the expansion of clinical trials to sites around the world. While these tools bring many advantages, they also produce new challenges by creating silos of information and limiting visibility into the clinical trial process. Several solutions that integrate fragmented study data and deliver operational intelligence are analyzed and compared.

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Best Practices for Streamlining Electronic Implementation of Established COAs

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Copyright, January 2015 - This paper addresses the best practices for building an electronic Clinical Outcome Assessment (eCOA) solution in support of clinical research as it relates to the operational and licensing compliance aspects of administering COAs on electronic platforms.

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Symptoms and Impact of COPD Assessed by an Electronic Diary in Patients with Moderate-to-Severe COPD: Psychometric Results from the SHINE Study

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International Journal of COPD; January 2015. This paper presents the results of psychometric assessment data from a COPD eDiary devel¬oped by Novartis to provide a more detailed assessment of symptom frequency and severity and their impact on patients with COPD.

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The Use of Ambulatory Blood Pressure Monitoring in Drug Development

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Copyright, January 2015 - How is Ambulatory Blood Pressure Monitoring (ABPM) leveraged in clinical trials? This white paper delves into the basics of blood pressure and why we measure it, along with the well-documented limitations of standard and digital office blood pressure measurements. ABPM device functionality is detailed, as well as example ABPM recordings and activity records. The paper reviews common drug classes where blood pressure monitoring comes into play and compares the advantages and disadvantages of different monitoring options in clinical studies.

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