Journal of Molecular Biomarkers and Clinical Trials

Offshoring Clinical Trials

*Jo Ann LeQuang
Department Of Molecular Biomarkers, USA , United States

*Corresponding Author:
Jo Ann LeQuang
Department Of Molecular Biomarkers, USA , United States
Email:joannlequang@gmail.com

Published on: 2018-04-03

Abstract

As more and more American companies offshore large randomized clinical trials—a cornerstone of evidence-based medicine— considerable debate has occurred over this practice. Hosting clinical studies in certain foreign countries can be more costeffective and allow for easier, more rapid enrollment than studies in the U.S. However, concerns about potential exploitation of vulnerable populations as well as the integrity of data and processes have come to light. Many of these concerns apply to clinical trials in general, regardless of where they take place. Our overview considers the reasons for the trend to offshoring, potential benefits of offshored trials, and concerns as well as drawbacks to this practice. Offshoring trials has the potential of increasing the speed of completion of clinical trials, which may benefit patients if this can translate into the more rapid market clearance of important treatments.

Keywords

Clinical Trials; Offshoring Clinical Trials; International Clinical Trials

Introduction

Historically, pharmaceutical companies relied on a very simple albeit expensive business model: new drugs were discovered, developed, and launched to market, where patent protection afforded them monopolistic pricing for a specific window of time until lower-priced generics entered. Big Pharma was a viable business model as long as the pipeline was primed—that plenty of new drugs entered the market as the older namebrands were retired and replaced by less expensive generic versions[1]. A similar paradigm is in place for medical devices. This model is expensive: in 2008, it was estimated that it took about 12 years to go from drawing board to market for a new drug and the average cost was over $1 billion[1].