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.

Evaluating the Completeness of ClinicalTrials.gov

“…We achieve these 2 objectives by comparing ClinicalTrials.gov data to a well-established and widely used information source: Informa Pharma Intelligence’s Trialtrove database. 29 Trialtrove is a commercially available resource, first introduced in 2004, that draws data on clinical trials from more than 70 country, regional, and multi-national trial registries in addition to trial listings from biopharmaceutical companies, registries published by patient advocacy groups, and clinical trials presented at major medical meetings and in medical journals. 30,31 This baseline assessment will prove useful in future assessments of ClinicalTrials.gov post January 18, 2017.…”

The efficacy and safety of the Timothy grass allergy sublingual immunotherapy tablet in Canadian adults and children

“…Although sublingual immunotherapy tablets (SLIT-T) have been in use in Europe for several years, the experience with Timothy grass immunotherapy tablet in Canadian and US subjects is limited. Given the prevalence of AR in Canada [ 2 ] and the relatively small number of AR clinical trials conducted in Canada from 2001 to 2011 [ 13 ], it was of interest to determine if SLIT-T would reduce AR symptoms and medication use in Canadian participants. The efficacy and safety of the Timothy grass 2800 BAU SLIT-T, which dissolves within seconds [ 14 ], has been investigated in 3 North American trials in which it was found to be effective and well tolerated for participants with grass-pollen–induced AR/C [ 14 – 16 ].…”

Respiratory Clinical Trials in Canada – Slow, Steady Progress Toward Effective, Evidence‐Based Health Care

“…Thankfully, in the past several years the numbers have increased and, in 2010/2011, an average of 61 respiratory trials per year were conducted in Canada, with an average of 16 per year being conducted independent of industry. Reassuringly, Tacon et al (1) found that the number of respiratory clinical trials conducted in Canada has increased at an average rate of 4.5 per year over the past decade.…”

“…In summary, the study by Tacon et al (1) suggests that our relatively terrible performance at the start of the millenium has improved this past decade, and more Canadian investigators and Canadian patients, have the opportunity to participate in respiratory and critical care clinical trials of new medicines and new treatment procedures. However, there are threats on the horizon.…”