Metrics Survey of Industry-Sponsored Clinical Trials in Canada and Comparator Jurisdictions between 2005 and 2010

Leclerc, Jean‐Marie; Laberge, Normand; Marion, J. E.

doi:10.12927/hcpol.2012.23130

Cited by 3 publications

(2 citation statements)

References 9 publications

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“…Nevertheless, there has been an increasing trend in respiratory clinical trials performed in Canada over the 10 years examined (4.49 per year; P=0.004). The data point toward a positive overall trend in phase II clinical trials (P=0.008), consistent with data presented by Leclerc et al (8), who observed a positive trend in phase II trials in Canada between 2005 and 2010, contrasting with a decreasing global trend over this five-year period. Finally, funding resource data clearly suggests that industry contribution and industry academic partnerships have played a critical role in respiratory medicine development over the past decade.…”

Section: Discussionsupporting

confidence: 90%

Trends in Canadian Respiratory Clinical Trials from 2001 to 2011

Tacon

Abbas

Zhang

et al. 2014

Canadian Respiratory Journal

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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.

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Section: Discussionsupporting

confidence: 90%

Trends in Canadian Respiratory Clinical Trials from 2001 to 2011

Tacon

Abbas

Zhang

et al. 2014

Canadian Respiratory Journal

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“…66 Signs of diminished site capacity were found in Canada as a consequence of activation delays. 67 Recommendations to accelerate study start-up emphasized greater coordination across study processes and trial sites. For instance, parallel processing reduced the time to complete trials' contracts and IRB reviews from 117 to 61 days in Korea 68 and a centralized IRB led to decreases in investigator and staff effort and faster protocol review times for phase 3 oncology trials in the United States.…”

Section: Key Finding 1: Delays In Trial Activation Persist and Impactmentioning

confidence: 99%

Conducting clinical trials—costs, impacts, and the value of clinical trials networks: A scoping review

et al. 2019

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Background A significant barrier to conducting clinical trials is their high cost, which is driven primarily by the time and resources required to activate trials and reach accrual targets. The high cost of running trials has a substantial impact on their long-term feasibility and the type of clinical research undertaken. Methods A scoping review of the empirical literature on the costs associated with conducting clinical trials was undertaken for the years 2001–2015. Five reference databases were consulted to elicit how trials costs are presented in the literature. A review instrument was developed to extract the content of in-scope papers. Findings were characterized by date and place of publication, clinical disease area, and network/cooperative group designation, when specified. Costs were captured and grouped by patient accrual and management, infrastructure, and the opportunity costs associated with industry funding for trials research. Cost impacts on translational research and health systems were also captured, as were recommendations to reduce trial expenditures. Since articles often cited multiple costs, multiple cost coding was used during data extraction to capture the range and frequency of costs. Results A total of 288 empirical articles were included. The distribution of reported costs was: patient management and accrual costs (132 articles), infrastructure costs (118 articles) and the opportunity costs of industry sponsorship (72 articles). 221 articles reported on the impact of undertaking costly trials on translational research and health systems; of these, the most frequently reported consequences were to research integrity (52% of articles), research capacity (36% of articles) and running low-value trials (34% of articles). 254 articles provided recommendations to reduce trial costs; of these, the most frequently reported recommendations related to improvements in: operational efficiencies (33% of articles); patient accrual (24% of articles); funding for trials and transparency in trials reporting (18% of articles, each). Conclusion Key findings from the review are: 1) delayed trial activation has costs to budgets and research; 2) poor accrual leads to low-value trials and wasted resources; 3) the pharmaceutical industry can be a pragmatic, if problematic, partner in clinical research; 4) organizational know-how and successful research collaboration are benefits of network/cooperative groups; and 5) there are spillover benefits of clinical trials to healthcare systems, including better health outcomes, enhanced research capacity, and drug cost avoidance. There is a need for more economic evaluations of the benefits of clinical research, such as health system use (or avoidance) and health outcomes in cities and health authorities with institutions that conduct clinical research, to demonstrate the affordability of clinical trials, despite their high cost.

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