Trends in Canadian respiratory clinical trials from 2001 to 2011

Abstract

Clinical research bridges patients' unmet medical need with innovative medicines, increases knowledge acquisition by clinicians, and creates solutions to improve the sustainability and quality of the Canadian health care system and economy. The Canadian Institutes of Health Research and the Canadian Lung Association have recently raised concerns over declining research activities within the Canadian respiratory community. While there are currently >3000 ongoing clinical trials in Canada, the number of trials investigating common respiratory diseases is unknown. The objective of the present study was to monitor the trends in industry- and non-industry-sponsored respiratory clinical trials in Canada from 2001 to 2011. Trialtrove 2012 (Citeline, an Informa UK business), a database containing summarized clinical trial information regarding pharmaceutical products, was searched using common chronic respiratory disease terms: "allergic rhinitis", "asthma", "chronic obstructive pulmonary disease (COPD)", "cystic fibrosis", "respiratory infections", "pulmonary fibrosis" and "smoking cessation". Over the past 10 years, the number of respiratory clinical trials conducted in Canada has increased (4.49 per year; P=0.004). From 2001 to 2011, the majority of trials were performed in asthma, followed closely by respiratory infections and COPD. Over the past decade, the number of trials investigating COPD and respiratory infections increased (P<0.05), while asthma trials showed a declining trend since 2007. Of the clinical trials performed during this 10-year period, the majority were in phase III, with a significant increase in the number of phase II trials (2.49 per year; P=0.008). However, certain trends observed are concerning and warrant further monitoring in the coming years.

Figure 1)

Total number of respiratory clinical trials conducted in Canada from 2001 to 2011

Figure 2)

A Trend in respiratory clinical trials conducted in Canada according to disease from 2001 to 2011. Disease type is based on Trialtrove’s (Citeline, an Informa UK business) ‘Disease Scope Statement’ for allergic rhinitis, asthma, chronic obstructive pulmonary disease and respiratory infections. B Trend in respiratory clinical trials conducted in Canada according to disease from 2001 to 2011. Disease type is based on Trialtrove’s ‘Disease Scope Statement’ for cystic fibrosis, pulmonary fibrosis and smoking cessation

Figure 3)

Respiratory clinical trials according to phase from 2001 to 2011. Phase I: Generally studies conducted in a small number of healthy volunteers. These studies are generally conducted to determine a drug’s safety profile as well as its pharmacokinetic and/or pharmacodynamic profile; Phase II: Typically dose-ranging studies including a larger group of subjects who have the disease, disorder or addiction of interest. These trials evaluate safety and efficacy of the drug at a range of doses; Phase III: Typically confirm the safety and efficacy of a drug at selected doses in a large group of patients. These studies may also compare the drug against the current ‘gold standard’ of treatment; Phase IV: Typically conducted after drug is approved and marketed and evaluates the safety and effectiveness of the drug in large numbers of patients or in subpopulations. In the present article, the trials reported by Trialtrove (Citeline, an Informa UK business) as phase I/II were included with phase II trials, those reported as phase II/III were included with phase III and those reported as phase III/IV were included with phase IV trials

Figure 4)

Respiratory clinical trial sponsors from 2001 to 2011. Nonindustry sponsors included government, not-for-profit or academic institutions. Collaborative sponsored trials included those sponsored by industry and nonindustry partners