Safety Monitoring in Clinical Trials

Towards Research Equity – Challenges of Safety Monitoring During Clinical Trials in Resource- Limited Settings

Issue:

Vol 56, Issue 2 (2007)

Pages:

163–5

Synopsis:

Difficulties with safety monitoring during clinical trials in less-industrialized countries have hampered global research equity. Re-discussion of objectives and methods of safety monitoring and adapted general clinical practice guidelines may contribute to greater participation of these countries in the clinical trials industry.

INTRODUCTION

The safety and wellbeing of the volunteer participant is central to the clinical research process, making Adverse Events (AE) management a core function of clinical trials and Good Clinical Practice (GCP) (1). The ultimate aim is to protect the greater society in its exposure to the products of the clinical research, through clinical research practice and philosophy, by clearly defining the parameters within which the new intervention can and must be used after its licensure by regulatory authorities.

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