ePRO Resource Center/Global Clinical Trial Regulations

As the use of Patient Reported Outcomes in global clinical trials is increasing, the regulations pertaining to the use of PRO are also evolving.  Click any link below to access recent information pertaining to US and European regulations surrounding PROs in clinical research, as well as other recent publications on global clinical development.

• Read ”ePRO Regulatory Inspections: Best Practices for Smooth and Successful Outcomes” (registration required), Craig, G., September 2010
  Summary: In this White Paper, members of invivodata’s ePRO Inspection Team review our experiences in supporting and participating in ePRO regulatory inspections by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), specifically BfArM (German Federal Institute for Drugs and Medical Devices), and the Japanese Pharmaceutical and Medical Devices Agency (PMDA), and outline best practices for ensuring smooth regulatory inspections of ePRO data collection systems.

• Download the “European Medicines Agency’s (EMEA) Reflection Paper on the Regulatory Guidance forr the use of Health Related Quality of Life (HRQOL) Measure in the Evaluation of Medicinal Products” (registration required)
  Summary:  The scope of this reflection paper is to discuss the place that a health-related quality of life (HRQL), a specific type of PRO, may have in drug evaluation process and to give some broad recommendations on its use in the context of already existing guidance documents.

• Read “Global Trials Draw Regulatory Scrutiny”, Wechsler, J., Applied Clinical Trials, Sep., 2008
  Summary:  The global expansion of pharmaceutical production and clinical research has put pressure on the FDA to step up its oversight of foreign drug development and production. This article reviews the steps FDA is taking to ensure that foreign clinical research meets GCP standards.

• Read “Create a Successful Project Plan for Global Trials”, Glancszpigel, D.,  Rácaro, G.,  Applied Clinical Trials, Nov., 2007.
  Summary:  The globalization of clinical trials has resulted in changes to clinical research regulations around the globe. Regulatory authorities, particularly in emerging regions, have continued to introduce changes to existing clinical trial legislation and requirements to ensure patient safety. This article addresses how global clinical trials can be successfully planned and managed within this increasingly complex environment.

• Read “Global Clinical Trials Activity in the Details”,  Getz, K., Applied Clinical Trials, Sep., 2007
  Summary:  This article identifies the Central and Eastern European countries that have significantly increased their number of FDA regulated investigators in recent years and reviews why sponsors and CROs need to constantly monitor these details in order to anticipate and manage more effectively their global clinical trial activities.