Reports of randomized trials in acute stroke, 1955 to 1995. What proportions were commercially sponsored? (9/161)

BACKGROUND AND PURPOSE: Research in acute stroke has expanded rapidly. Many potentially important interventions lack commercial potential (eg, admission to a stroke unit). We therefore wished to examine the frequency of reports of randomized trials of interventions for acute stroke over the past 40 years, the source of support for such trials, the reporting of the commercial involvement, and whether the proportion of commercially supported trials had changed. METHODS: Eligible trials were identified from the Cochrane Stroke Group's specialized register of controlled clinical trials. We included all randomized trials in patients with acute stroke which published a full text report, in English, between 1955 and 1995. Two reviewers independently extracted data on the involvement of the pharmaceutical industry in all eligible trials. RESULTS: There was a substantial increase in the number of acute stroke trials published per year between 1955 and 1995. The description of pharmaceutical industry involvement in each trial report was poor. Only a minority of supported trials made explicit statements about the role of the sponsoring company. The proportion of trials apparently supported by the pharmaceutical industry has increased substantially. CONCLUSIONS: The increasingly important role of the pharmaceutical industry in evaluating new treatments gives substantial scope for bias and may not be in the interests of public health. Poor reporting of the sponsor's involvement suggests that modifications to the guidelines for the reporting of randomized controlled trials to include more details of the sponsor's involvement in the design, conduct, management, analysis, and reporting of the trial are justified.  (+info)

Pharmacoeconomic evaluation of new treatments: efficacy versus effectiveness studies? (10/161)

The juxtaposition of economic and clinical evaluation raises new issues in the design of clinical trials. Recent pharmacoeconomic guidelines provide some direction, but do not deal with the appropriate timing of economic evaluations in the drug developmental process. Ideally, pharmacoeconomic data should be available at the time of the regulatory and formulary decision making. Current pivotal phase III trials do not provide these data; they are designed to test safety and efficacy (does the drug work under optimal circumstances?) and not to answer questions about the effectiveness of a drug, the more relevant question for economic analysis (does the drug work in usual care?). The use of more "naturalistic" designs for some phase III randomised trials has been suggested. These so called "effectiveness trials" more closely reflect routine clinical practice. They use a more flexible dosage regimen, and a "usual care" instead of a placebo comparator. Patients randomised are more representative of actual practice and outcomes include quality of life and utility measures. They are more suited to provide the data needed to estimate the real benefit of the treatment in actual care. When costs are applied and compared with these benefits, you can estimate the efficiency of allocating resources to this new drug. Increasing the use of effectiveness trials in phase III would decrease the need for economic modelling.  (+info)

Review article: economic issues in Crohn's disease--assessing the effects of new treatments on health-related quality of life. (11/161)

The advent of highly effective yet costly new treatments for Crohn's disease will force clinicians, patients, and society to make important choices regarding the allocation of resources. Pharmacoeconomic analyses can be useful in deciding whether new technologies are of good value in comparison to established treatment regimens. In Crohn's disease conventional cost-effectiveness analyses are of limited use because surgery, death, and disease-related complications occur relatively infrequently. Alternatively, cost-utility models relate the incremental cost of new treatments to improvements in health-related quality of life. These analyses require the collection of valid cost and utility inputs that have only recently become available. Ultimately, cost-utility models should allow decision makers to make sensible choices for patients and society. This article describes the techniques of pharmacoeconomic analysis and reviews existing data on the measurement of costs and quality-of-life outcomes in Crohn's disease.  (+info)

The cost-effectiveness of high dose chemotherapy in the treatment of relapsed Hodgkin's disease and non-Hodgkin's lymphoma. (12/161)

As part of an NHS Executive Trent regional initiative we considered the role and cost-effectiveness of high dose chemotherapy in the treatment of relapsed Hodgkin's disease and non-Hodgkin's lymphoma. The key trials and case series show an additional patient benefit of 0.8-1.1 life years over standard chemotherapy. We estimate incremental cost per life year gained of 12 800 pound silver-17 600 pound silver, which reduces further if long-term benefits are considered. High dose chemotherapy in these conditions is both life-saving and cost-effective.  (+info)

Just what the HMO ordered: the paradox of increasing drug costs. (13/161)

Drug companies argue that newer, more expensive drugs offset other medical costs; health plans counter that they increase pharmacy costs more than they offer a "pharmacoeconomic" benefit. Neither side is universally right or wrong, and neither has the data to support its case. Increasing drug costs for selective therapeutic classes represent the fulfillment of managed care's original promise. Certain therapeutic classes of drugs offer pharmacoeconomic benefit, while others represent induced costs in excess of this benefit. Health maintenance organizations (HMOs) should determine one from the other and incorporate these findings into their plan designs; multitier drug coverage is the best method to achieve this.  (+info)

Pharmacoeconomic analysis of liposomal amphotericin B versus conventional amphotericin B in the empirical treatment of persistently febrile neutropenic patients. (14/161)

PURPOSE: In a randomized, double-blind, comparative, multicenter trial, liposomal amphotericin B was equivalent to conventional amphotericin B for empirical antifungal therapy in febrile neutropenic patients, using a composite end point, but was more effective in reducing proven emergent fungal infections, infusion-related toxicities, and nephrotoxicity. The purpose of this study was to compare the pharmacoeconomics of liposomal versus conventional therapy. PATIENTS AND METHODS: Itemized hospital billing data were collected on 414 patients from 19 of the 32 centers that participated in the trial. Hospital length of stay and costs from the first dose of study medication to the time of hospital discharge were assessed. RESULTS: Hospital costs from the time of first dose to discharge were significantly higher for all patients who received liposomal amphotericin B ($48,962 v $43,183; P =.022). However, hospital costs were highly sensitive to the cost of study medication ($39,648 v $43,048 when drug costs were not included; P =.416). Using decision analysis models and sensitivity analyses to vary the cost of study medications and the risk of nephrotoxicity, the break-even points for the cost of liposomal therapy were calculated to range from $72 to $87 per 50 mg for all patients and $83 to $112 per 50 mg in allogeneic bone marrow transplant patients. CONCLUSION: The cost of liposomal amphotericin B and patient risk for developing nephrotoxicity play large roles in determining whether liposomal amphotericin B is cost-effective as first-line empirical therapy in persistently febrile neutropenic patients.  (+info)

Feasibility study of multicentre comparison of NHS hospital pharmacy computer data. (15/161)

AIMS: This study aims to determine the feasibility of collecting, collating and analysing drug expenditure data from a sample of acute hospitals in England. METHODS: The hospital pharmacy computer system was used to report on drug expenditure from 16 hospitals throughout England for a 2 year period. These data were analysed as a whole and hospital episode statistics were correlated to hospital drug costs. RESULTS: Hospital outpatient costs were found to be approximately one third of hospital inpatient costs. Cardiovascular drugs accounted for the greatest increase in expenditure for both inpatients and outpatients (25%). The most expensive therapeutic area of drug use across all sites was anti-infectives. The average daily number of occupied beds explained 55% of the variation in inpatient expenditure and the number of outpatient (including Accident and Emergency) attendances explained 60% of the outpatient drug expenditure. CONCLUSIONS: This project has confirmed the feasibility of collecting, collating and analysing hospital drug expenditure and identified some interesting patterns and trends in hospital drug use. Hospital activity is reflected in hospital drug costs.  (+info)

The FDA's regulation of health economic information. (16/161)

Section 114 of the Food and Drug Administration Modernization Act of 1997 was intended to increase the flow of health economic information from pharmaceutical manufacturers to managed care decisionmakers. But the legislation raises a host of complex questions and has provoked diverse opinions from inside and outside the pharmaceutical industry. Moreover, the Food and Drug Administration (FDA) has yet to issue interpretative guidance on the subject. The challenge in implementing Section 114 lies in developing a policy that improves health economic information exchange while protecting consumers from misleading claims and preserving incentives for manufacturers to conduct rigorous studies.  (+info)