Trends in the globalization of clinical trials

Abstract

Industry-sponsored clinical research has traditionally been carried out in relatively wealthy locations in North America, Western Europe and Oceania1. However, in recent years, a shift in clinical trials sponsored by the biopharma industry to so-called emerging regions, especially in Eastern European, Latin American and Asian countries, has been noted (for example, REFS 2–5). Reasons cited for this shift include the ability to reduce operational costs while recruiting a large number of patients in a timely manner; the establishment of contract research organizations focused on global clinical trials; the rapid pace of growth of market size, research capacity and regulatory authority in emerging regions; and the harmonization of guidelines for clinical practice and research1,2,4,6,7. It seems that these factors will continue to be prominent drivers of the globalization process, resulting in the solidification of trends and increased geographic dispersion of drug development operations6. Although these trends, and the associated regulatory, public health and economic implications, have been discussed qualitatively and extensively in the literature (for example, REFS 3,5,6,8), we are unaware of any recent Medline-indexed publications quantifying the globalization of biopharmaceutical clinical trials (BCTs; defined as trials assessing small-molecule pharmaceuticals and adjuvants, biologics and vaccines) based on publicly accessible data. This absence reflects in part historical difficulties in accessing comprehensive public data on the location of BCTs. However, owing to new mandates for clinical-trial registration from both the FDA and the International Committee of Medical Journal Editors9,10, there has recently been a substantial registration influx of ongoing and completed trials into ClinicalTrials.gov. As of January 2007, the site contains detailed descriptions of 36,249 recruiting and completed studies sponsored by the public and private sectors in more than 140 countries11. These data registry developments create the opportunity for a more detailed country and region-specific quantitative assessment of the globalization of BCTs, including clinical-trial capacity (the average number of sites per trial); trial density per population; size of trial; global span (regional versus global); and type of trial (early versus confirmatory versus post-marketing). Key results of such an analysis, conducted as described in Supplementary information S1 (box), are presented in FIG. 1 and TABLE 1, with extensive additional data available online (Supplementary information S2 (box), S3 (table), S4 (table), S5 (table), S6 (table)). This study has several limitations, especially concerning uncertainty about the evolving coverage ratio of ClinicalTrials. gov, incompleteness of the records of some trials and its US-centric nature. It is hoped that in the future, the public will have access to a database containing virtually complete coverage of global clinical development operations over time.