Globalization of Clinical Trials – Where are We Heading?

Abstract

The last decade has witnessed a greater transparency in clinical research with the advent of clinical trial registries. The aim of the study was to describe the trends in the globalization of clinical trials in the last five years. We performed an internet search using the WHO International clinical trials registry platform (WHO ICTRP) to identify the clinical trials conducted from January 2007 to December 31, 2011 among 25 countries. Among the 25 countries, the United States, Japan and Germany occupy the top positions in the total number of clinical trials conducted. Clinical trials in the US (36312) constituted 31.5% of the total number of trials performed during this period. However over a period of five years both US and Western Europe appear to show a decline, while the emerging countries show a rise in clinical trials registered. Among the emerging countries China, India and Republic of Korea are most active regions involved in clinical trials. Cancer, diabetes and respiratory diseases were most widely researched areas overall. Although the study confirms the transition in the clinical trials research towards emerging countries, the developed regions of the world still contribute to more than 70% of the trials registered worldwide.

AAN position statement: Ethical issues in clinical research in neurology

“…International clinical research in low-and middle-income countries (LMICs) has expanded dramatically over the last 2 decades, while the number of trials in the United States and Western Europe has declined. 35,36 Some of the newly globalized clinical research targets public health concerns specific to or shared by LMICs, areas of research that have historically received disproportionately low rates of attention and funding. However, some globalized clinical research is conducted by pharmaceutical, biotechnology, and device companies developing products intended for sale in high-income countries (HICs).…”

On the Feasibility of Distributed Process Mining in Healthcare

“…For the sake of conciseness, here we provide an overview of the main steps of the Alpha algorithm. In a nutshell, the steps indicated in Algorithm 1 aims: (1) to build the set of symbols adopted in the traces; (2) and (3) to build, respectively, the initial and final transitions; (4) by considering the Footprint Matrix, it is possible to find the groups of symbols which are in a relation among them and in a ← relation with all the subsequences (which, again, are in a relation among them); (5) to reduce the set of the previous set of groups and build the set of states; (6) to define the arcs between couples of items identified in the previous step; (7) to join the arcs with the states; (8) to compose the result and return the structure of the Petri net. The Petri net summarizes the process mined by the algorithm, and can then be exploited for the PM purposes.…”

“…The medical sciences generate an ever increasing amount of medical evidence and clinical variables potentially able to play a key role in controlling diseases or in predicting toxicities. For this reasons, due to the rising number of covariates but the limited number of patients that can be enrolled for each hospital or research center, the trend is to move towards multi-centric clinical trials [7,6]. A PM investigation exploiting multi-centric data sources would be able to extract more evidence and trends, to highlight organizational differences between participating centers, and to show different ways to cope with daily clinical and administrative issues.…”

A Trial Activation Initiative to Accelerate Trial Opening in an Academic Medical Center

“…Although the United States has always been the leading country in terms of worldwide clinical research volume, the growing interest of the pharmaceutical industry in globalization has led to an increase in the number of clinical trials in Asia, with Seoul now ranked as the top city for global clinical development. 3 Efforts to expedite the trial activation process have been undertaken by number of institutions in the United States and Europe, but there seems to be a relative lack of concerted effort in other geographic regions. 4 Barriers to trial activation arise from the number of processes required to open a clinical trial, and these include such steps as institutional review board (IRB) protocol submission and approval, as well as contract negotiation and conclusion by a contract team.…”