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Approximately 40% of randomized controlled trials are not published, leading to publication bias and less informed clinical decision-making. Qualitative interviews were conducted to understand whether and how industry sponsors of clinical trials of drugs and biologics in Canada influence decisions to report trial results.Participants eligible for an interview included clinical trial investigators and research coordinators with experience in drug research, research ethics board members with at least 1 year of experience in ethical review of trials, research administrators with knowledge of dissemination of clinical trial findings or relations with trial sponsors, and trial participants who had taken part in a drug trial as an adult in the 5 years before their interview. Semi-structured interviews were held in person or by telephone between March 2019 and April 2021 with participants in Alberta, British Columbia, and Ontario, Canada. Qualitative analysis included coding of interview transcripts and identification of key themes.Interviews were conducted with 34 participants, including 17 clinical trial investigators, 1 clinical research coordinator, 3 research administrators, 3 research ethics board members, and 10 clinical trial participants. Participants involved in the conduct, administration, or ethical review of trials represented a range of medical disciplines. Interview participant accounts indicated that in some cases, industry sponsors influence whether results are reported. A core theme was that companies have a weaker incentive to publish trials with unfavorable findings and trials for products that they have decided not to develop further. Companies may influence reporting in various ways, including stopping trials early and not reporting results of stopped trials, owning and controlling access to data, and negotiating clinical trial agreements in multicenter trials that do not fully protect the ability of investigators to publish. Internal company trials represent an additional source of unpublished trials. More broadly, the research system creates a dependency on funding from industry sponsors that may weaken the ability of researchers and research institutions to negotiate terms with industry sponsors that would fully protect publication rights.Interviews with trial investigators and others connected to trial research indicate that in some cases, industry sponsors of clinical trial research in Canada influence whether results are reported. Policies aiming to bring about full reporting of trials could benefit from considering the commercial incentives of companies and the ways in which industry sponsors may influence clinical trial reporting. Future research could examine the generalizability of these findings to other jurisdictions.

Background Tablet splitting, in which a higher-dose tablet is split to get 2 doses, reduces patients' drug costs. Statins can be split safely. General practitioners (GPs) may not direct their patients to split statins because of safety concerns or unawareness of costs. Medical chart inserts provide cost-effective education to physicians. Objective The aim of this study was to assess whether providing GPs with statin-splitting chart inserts would increase splitting rates, and to identify predictors of splitting. Methods In 2005 and 2006, we faxed a statin chart insert to British Columbia GPs with a request for a telephone interview. Consenting GPs were mailed 3 statin chart inserts and interviewed by phone (the intervention). In an interrupted time series, we compared monthly rates of statin-splitting prescriptions among intervention and nonintervention GPs before, during, and after the intervention. In multivariate logistic regressions accounting for patient clustering, predictors of splitting included physician and patient demographics and the specific statin prescribed. Results Of 5051 GPs reached, 282 (6%) agreed to the intervention. Before the intervention, GPs' splitting rate was 2.6%; after intervention, GPs' splitting rate was 7.5%. The rate for the nonintervention GPs was 4.4%. Intervention GPs were 1.68 (95% CI, 1.12–2.53) times more likely to prescribe splitting after the intervention than were nonintervention GPs. Other predictors were a patient's female sex (odds ratio [OR] = 1.26; 95% CI, 1.18–1.34), lower patient income (OR = 1.33; 95% CI, 1.18–1.34), and a lack of drug insurance (OR = 1.89; 95% CI, 1.69–2.04). Conclusions An inexpensive intervention was effective in producing a sustained increase in GPs' splitting rate during 22 months of observed follow-up. Expanding statin-splitting education to all GPs might reduce prescription costs for many patients and payors.

Background: Rapid growth in prescription drug costs has compelled insurers to require increased patient cost-sharing. Objective: The aim of this study was to compare the effects of 2 recent cost-sharing policies on emergency hospitalizations due to chronic obstructive pulmonary disease, asthma, or emphysema (CAE), and on physician visits. Methods: We analyzed data from a large-scale natural experiment in British Columbia (BC), Canada. The cost-sharing policies were a fixed copayment policy ( fixed copay policy ) and an income-based deductible (IBD) policy with 25% coinsurance ( IBD policy ). Prescription, physician billing, and hospitalization records were obtained from the BC Ministry of Health. From the total population of BC residents ≥65 years of age, we extracted data from all patients dispensed an inhaled corticosteroid, β 2 -agonist, or anticholinergic from June 30, 1997, to April 30, 2004. Poisson regression was used to evaluate the impact of the policies in a cohort of patients receiving long-term inhaler treatment. An identically defined historical control group unaffected by the policy changes was used for comparison. Results: The study population included 37,320 users of long-term inhaled medications from the BC population of 576,000 persons ≥65 years of age. During the IBD period but not the fixed copay period, emergency hospitalizations for CAE increased 41% (95% CI for adjusted rate ratio [RR], 1.24–1.60) in patients ≥65 years of age. There was also a significant increase in physician visits of 3% (95% CI for adjusted RR, 1.01–1.05). No significant increases were observed during the fixed copay period. In a secondary analysis using a concurrent control group, we estimated a smaller but significant increase in emergency CAE hospitalizations of 29% (95% CI for adjusted RR, 1.09–1.52). This analysis also showed increases in physician visits (fixed copay period RR, 1.03 [95% CI for adjusted RR, 1.01–1.05]; IBD period RR, 1.07 [95% CI for adjusted RR, 1.05–1.08]). Conclusion: The results suggest that the IBD policy was likely associated with an increased risk for emergency hospitalization and physician visits in these users of inhaled medications who were aged ≥65 years.

Evaluations of drug cost-sharing policies within the same population are needed for a fair comparison of different options.The aim of this work was to analyze the impact of 2 changes in a public drug insurance plan on the use of inhaled medications in British Columbia (BC), Canada.Data for the period from 1997 to 2004 were used to assess whether changes in the use of steroid, beta2-agonist, and anticholinergic inhalers were associated with insurance-plan changes in a large, natural experiment involving all BC residents agedor=65 years. The 3 sequential policies included full coverage, fixed copayments at the beginning of 2002, and 25% coinsurance with an income-based deductible beginning May 1, 2003. Linkable prescription, physician billing, hospitalization, and mortality records were obtained from the BC Ministry of Health Services. From the total population of residents agedor=65 years, we extracted data for all patients to whom inhaled steroids, beta2-agonists, or anticholinergics were dispensed on or after January 1, 1997. Multivariable linear regression was used to estimate inhaler use during a 60-month baseline period and during implementation of the subsequent copayment and coinsurance plus deductible policies. We used logistic regression to identify predictors of initiation and cessation use of inhaled medications among older patients.Use declined for inhaled steroids (-12.3%; P0.001), inhaled anticholinergics (-12.2%; P0.001), and inhaled beta2-agonists (-5.8%; P0.001). Patients with new diagnoses of asthma or chronic obstructive pulmonary disease were 25% (95% CI, 14%-31%) less likely to initiate treatment with inhaled steroids when covered by the copayment or coinsurance plus deductible policies than when they had full coverage. Chronic users of inhaled steroids were 47% (95% CI, 40%-55%) more likely to cease treatment when they were covered by the copayment policy and 22% (95% CI, 15%-29%) more likely to cease when covered by the coinsurance plus deductible policy than when they had full coverage.The copayment and coinsurance plus deductible policies were associated with significant reductions in use of inhaled medications, mostly due to decreased initiation and increased cessation rates. However, the consequences of these policies on health outcomes have not yet been determined.

Background In the treatment of chronic obstructive pulmonary disease (COPD), tiotropium bromide has a longer duration of action than ipratropium bromide; however, tiotropium bromide is a more expensive alternative treatment. At issue is whether tiotropium reduces the risk for hospital readmissions for COPD compared with ipratropium. Objectives A population-based cohort study was conducted to assess whether tiotropium reduces the risk for hospital readmissions for COPD compared with ipratropium. Methods British Columbia (BC) linked provincial administrative health databases were used to identify new patients with COPD (aged ≥45 years) with a first hospital admission for COPD from 2003 to 2011. The study period was defined as the 30-day tiotropium or ipratropium treatment-initiation period after hospital discharge. Patients were followed up for ≤6 months from drug initiation to hospital readmission for COPD. In a subanalysis, the 2 treatment groups were matched on age, sex, and high-dimensional propensity scores derived from 200 empirically identified and predefined covariates. The risk for hospital readmission was estimated using multivariate Cox proportional hazards and logistic regression analyses. Results In total, 3723 patients with COPD were dispensed tiotropium (n = 992) or ipratropium (n = 2731) within 30 days from the index hospital admission for COPD. The mean age of these patients was 72.8 years, and 50.8% were women. Tiotropium-treated patients were more likely to be in a higher income category and were more likely to use a greater number of medications compared with ipratropium-treated patients. Among the subset of 1500 matched patients, 215 (14.3%) were readmitted to hospital within 6 months. There was no statistically significant group difference in hospital readmissions using either analytical approach (hazard ratio = 0.98 [95% CI, 0.72–1.34]; odds ratio = 0.97 [95% CI, 0.70–1.36]). Conclusions In this select group of patients, neither tiotropium nor ipratropium was effective in significantly decreasing the risk for rehospitalization for COPD within 6 months.