Abstract
The increasing amount of clinical research conducted outside the “traditional” countries raises questions about the benefits of hosting offshored clinical research. The extent to which trials contribute to the scientific knowledge base and, in particular, whether there are differences between different types of trials remain open questions. By examining a change in clinical trial regulations in India, a country often viewed as a first-choice offshoring location, we study how the relaxation of clinical trial regulations affects the number and the type of clinical trials as well as the domestic scientific knowledge base. Based on trial data from ClinicalTrials.gov and data on associated publication activities, our empirical analysis suggests that, despite an initial increase in the number of clinical trials, relaxing clinical trial regulations has a limited impact on the domestic scientific knowledge base. More specifically, the number of Indian researchers involved in the production of trial-related scientific knowledge remains modest. Furthermore, the potential to learn from the additional trials appears to be limited: the influx of phase 3 trials—mainly sponsored by Western-pharmaceutical firms—is accompanied by a lower likelihood that the trial results will be used in Indian researchers’ subsequent research activities when compared to phase 3 trials with preceding phase 2 trials, as was required before the regulatory change. Overall, our results contradict expectations that relaxing the regulatory requirements for conducting late-stage clinical trials is an appropriate means of supporting the development of the domestic scientific knowledge base.
Highlights
The geographical distribution of clinical research has changed considerably over time, such that clinical trials are increasingly conducted outside the “traditional” research centers in North America, Western Europe, and selected locations in the Asia-Pacific region
The average number of weighted trial-related publications by Indian authors is slightly higher for phase 3 trials that were not preceded by a phase 2 trial in India (0.053) than for phase 3 trials that were preceded by a phase 2 trial (0.045)
An understanding of the complex dynamics in this context is important for effective regulation and, in our case, for understanding the consequences of relaxing clinical trial regulations
Summary
The geographical distribution of clinical research has changed considerably over time, such that clinical trials are increasingly conducted outside the “traditional” research centers in North America, Western Europe, and selected locations in the Asia-Pacific region. Non-traditional countries, emerging economies in East Asia, Southeast Asia, and Latin America, have gained importance as locations for conducting clinical trials [1,2,3,4]. This rising importance of non-traditional countries coincides with an increase in intercontinental. Clinical trial regulation and pharmaceutical knowledge stock in India
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