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The closure of Pfizer's research and development plant [1] may be
only the latest illustration of a global pharmaceutical industry under
economic stress. This trend may be reflected in the ClinicalTrials.gov
registry.
ClinicalTrials.gov is a registry of "clinical trials conducted in the
United States and around the world" [2]. Search of this database may
reveal trends in clinical trials of the past decade, such as in the
economic aspect.
Interventional trials were selected for this analysis because they
are generally more expansive than observational trials, and thus, probably
more sensitive to economic changes. The date when the clinical trial was
first submitted to the registry was used for annual data summaries.
Search on ClinicalTrials.gov was conducted on 13 January, 2011.
Interventional trials constituted 82.2% of all registered trials (101,448
trials). In 2005, a dramatic 7.4-fold increase in the absolute number of
interventional trials compared to the previous year was observed (Figure
1). This was due to the fact that as of 1 July, 2005, the International
Committee of Medical Journal Editors required the registration of any
clinical trial in public trials registry, in order to be considered for
publication in the medical literature [3]. Following that, an immediate
surge in registration of all types of trials, including a 75% increase in
registered interventional trials was observed [4]. However, during 2008-
2010, the growth of previous years reached a plateau.
The major contributor to interventional trials between 2000 and 2010
was the US with 51.1% (40,834 trials) of all interventional trials. A
refined search of interventional trials, in which the US participated or
was the only location of trial, revealed that the share of these trials
among all global trials declined from 50.6% in 2008 (7,083 trials) to
42.7% in 2010 (5,724 trials), which is a 19.2% decrease in the total
number of US-based interventional trials in this period.
The decline in the number of US interventional trials was mainly
contributed by the following trends: between 2008 and 2010, private
pharmaceutical industry-funded trials declined, in absolute number, by
29.2%, US National Institutes of Health-funded trials declined by 27.3%,
and other federally-funded trials by 15.3%; contrary, other-source-of-fund
US trials (e.g. funded by individual, university, organisation) [2]
increased by 5.1% but globally, a higher increase of trials funded by this
source, by 19.5%, was observed at the same period.
The observed cessation of global growth in interventional clinical
trials and the increased shift toward lower US participation in the past
two years, including the private industry, may well reflect an economic
recession effect.
References
1. Hawkes N. Pfizer closes Kent plant as it trims research spending
by $1bn a year. BMJ 2011;342:d771. (4 February.)
3. De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial
registration: a statement from the International Committee of Medical
Journal Editors. N Engl J Med 2004;351:1250-1251.
4. Zarin DA, Tse T, Ide NC. Trial Registration at ClinicalTrials.gov
between May and October 2005. N Engl J Med 2005;353:2779-87.
Figure 1. Total number of all global interventional clinical trials during 2000-2010, including private industry-funded trials, which are also presented in separate.
Industry-funded trials constituted 48-50% of all global interventional trials during 2005-2008. Between 2008 and 2010, this proportion fell from 49.8% to 42.1%.
*There is often a delay of a few days before trials are available on the ClinicalTrials.gov website [2]. Therefore, minimal changes to end of 2010 figures are possible, as search results are from 13 January, 2011.
Shifting trends in global and US interventional clinical trials, 2000-2010
The closure of Pfizer's research and development plant [1] may be
only the latest illustration of a global pharmaceutical industry under
economic stress. This trend may be reflected in the ClinicalTrials.gov
registry.
ClinicalTrials.gov is a registry of "clinical trials conducted in the
United States and around the world" [2]. Search of this database may
reveal trends in clinical trials of the past decade, such as in the
economic aspect.
Interventional trials were selected for this analysis because they
are generally more expansive than observational trials, and thus, probably
more sensitive to economic changes. The date when the clinical trial was
first submitted to the registry was used for annual data summaries.
Search on ClinicalTrials.gov was conducted on 13 January, 2011.
Interventional trials constituted 82.2% of all registered trials (101,448
trials). In 2005, a dramatic 7.4-fold increase in the absolute number of
interventional trials compared to the previous year was observed (Figure
1). This was due to the fact that as of 1 July, 2005, the International
Committee of Medical Journal Editors required the registration of any
clinical trial in public trials registry, in order to be considered for
publication in the medical literature [3]. Following that, an immediate
surge in registration of all types of trials, including a 75% increase in
registered interventional trials was observed [4]. However, during 2008-
2010, the growth of previous years reached a plateau.
The major contributor to interventional trials between 2000 and 2010
was the US with 51.1% (40,834 trials) of all interventional trials. A
refined search of interventional trials, in which the US participated or
was the only location of trial, revealed that the share of these trials
among all global trials declined from 50.6% in 2008 (7,083 trials) to
42.7% in 2010 (5,724 trials), which is a 19.2% decrease in the total
number of US-based interventional trials in this period.
The decline in the number of US interventional trials was mainly
contributed by the following trends: between 2008 and 2010, private
pharmaceutical industry-funded trials declined, in absolute number, by
29.2%, US National Institutes of Health-funded trials declined by 27.3%,
and other federally-funded trials by 15.3%; contrary, other-source-of-fund
US trials (e.g. funded by individual, university, organisation) [2]
increased by 5.1% but globally, a higher increase of trials funded by this
source, by 19.5%, was observed at the same period.
The observed cessation of global growth in interventional clinical
trials and the increased shift toward lower US participation in the past
two years, including the private industry, may well reflect an economic
recession effect.
References
1. Hawkes N. Pfizer closes Kent plant as it trims research spending
by $1bn a year. BMJ 2011;342:d771. (4 February.)
2. U. S. National Institutes of Health. ClinicalTrials.gov. 2011.
http://clinicaltrials.gov/ct2/home.
3. De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial
registration: a statement from the International Committee of Medical
Journal Editors. N Engl J Med 2004;351:1250-1251.
4. Zarin DA, Tse T, Ide NC. Trial Registration at ClinicalTrials.gov
between May and October 2005. N Engl J Med 2005;353:2779-87.
Figure 1. Total number of all global interventional clinical trials during 2000-2010, including private industry-funded trials, which are also presented in separate.
Industry-funded trials constituted 48-50% of all global interventional trials during 2005-2008. Between 2008 and 2010, this proportion fell from 49.8% to 42.1%.
*There is often a delay of a few days before trials are available on the ClinicalTrials.gov website [2]. Therefore, minimal changes to end of 2010 figures are possible, as search results are from 13 January, 2011.
Competing interests: No competing interests