Abstracts 119S 74P HEALTH ECONOMIC DATA COLLECTION WITHIN A MANAGEMENT TRIAL Snezana Bersinic and Angela Rocchi lnnovus Inc. Hamilton, Ontario, Canada Economic evaluations have become increasingly important m evaluating alternative therapies, particularly since formulary decision-makers have increasing informa~onal demands. It is both feasible and desirable to build economics into the design of clinical trials. Ideally this would be at a time of a management trial, where the effectiveness of a new therapy is compared to standard therapy and the treatments are adndnistered in a standard practice setting. Data collected for the conduct of an economic evaluation should include: use of key resources essential to the treatment (both in the hospital and the community sectors), such as drugs, physician time, other health professional time, medical tests and procedures, hospitalizations, loss of work time by patient and family during treatment, as well as benefits of u'eatment (e.g. improvement in patient's quality of life, resource savings, etc.). The type of d_At+a to be coilected and the amount of detail required depend on the policy questions, the available evidence of drug's effectiveness, the I~.-nellness, the costs, and the manageability. We have developed d_,t~ collection forms for use in various Phase llI and IV clinical trials, designed with the objectives of minimizing trial costs, physician, nursing and patient time, and complexity of d_~t+~ collection, but at the same time, ensuring that all the key components necessary for an economic evaluation were included. Sample d_,t~ collection forms will be presented, with an explanation of their use and applicability. We will present our experiences with these forms in terms of the time requirements on part of the patients, physicians, nurses, study coordinators, the usefulness of these data in the context of an economic evaluation, and the additional costs incurred as a result of collecting the economic data within the clinical trial. 75P DECREASING MORTALITY RATE WITH LATER ENROLLMENT TIME IN CIBIS Chantel Nemoz, Jean-Pierre Boissel, Philippe Lechat, Patrice Jaillon and the CIBIS Group Uni~ de Pharmacologic Clinique Lyon, France It is well known that a clinical trial is not a homogenous environment. For exaruple it has been observed that mortality as an indication of patients' characterislics varies across centers in multicenter clinical trials. CIBIS was an international randomized double-blindtrial of bisoprolol, a non selective beta-blocker, in patients with NYHA class III and IV heart failure. The endpoint was total mortality. Enrollment started in March 1989, and was terminated in August 1992. Over the successive interim analyses a decrease in the overall mortality rate was observed while the average duration of follow-up increased. At the end of the study we explored this trend by analysingthe results by dividing the total number of patient x years into classes corresponding to 100 patient x years, and determining the hazard rate for one-year overall mortality for each class. The hazard rate was found to decrease regularly from 0.15 down to 0.094 from the first 100 patient x years to the final 1250 patient x years. The one- year mortality was 14.1 ~ for the 199 patients enrolled from March 1989 to September 1990,

74P Health economic data collection within a management trial

Download PDF Report

Upload
snezana-bersinic
View
215
Download
2

Embed Size (px)

Citation preview

Abstracts 1 1 9 S

74P HEALTH ECONOMIC DATA COLLECTION

WITHIN A MANAGEMENT TRIAL

Snezana Bersinic and Angela Rocchi lnnovus Inc.

Hamilton, Ontario, Canada

Economic evaluations have become increasingly important m evaluating alternative therapies, particularly since formulary decision-makers have increasing informa~onal demands. It is both feasible and desirable to build economics into the design of clinical trials. Ideally this would be at a time of a management trial, where the effectiveness of a new therapy is compared to standard therapy and the treatments are adndnistered in a standard practice setting. Data collected for the conduct of an economic evaluation should include: use of key resources essential to the treatment (both in the hospital and the community sectors), such as drugs, physician time, other health professional time, medical tests and procedures, hospitalizations, loss of work time by patient and family during treatment, as well as benefits of u'eatment (e.g. improvement in patient's quality of life, resource savings, etc.). The type of d_At+a to be coilected and the amount of detail required depend on the policy questions, the available evidence of drug's effectiveness, the I~.-nellness, the costs, and the manageability. We have developed d_,t~ collection forms for use in various Phase llI and IV clinical trials, designed with the objectives of minimizing trial costs, physician, nursing and patient time, and complexity of d_~t+~ collection, but at the same time, ensuring that all the key components necessary for an economic evaluation were included. Sample d_,t~ collection forms will be presented, with an explanation of their use and applicability. We will present our experiences with these forms in terms of the time requirements on part of the patients, physicians, nurses, study coordinators, the usefulness of these data in the context of an economic evaluation, and the additional costs incurred as a result of collecting the economic data within the clinical trial.

75P DECREASING MORTALITY RATE WITH LATER

ENROLLMENT TIME IN CIBIS

Chantel Nemoz, Jean-Pierre Boissel, Philippe Lechat, Patrice Jaillon and the CIBIS Group

Uni~ de Pharmacologic Clinique Lyon, France

It is well known that a clinical trial is not a homogenous environment. For exaruple it has been observed that mortality as an indication of patients' characterislics varies across centers in multicenter clinical trials. CIBIS was an international randomized double-blind trial of bisoprolol, a non selective beta-blocker, in patients with NYHA class III and IV heart failure. The endpoint was total mortality. Enrollment started in March 1989, and was terminated in August 1992.

Over the successive interim analyses a decrease in the overall mortality rate was observed while the average duration of follow-up increased. At the end of the study we explored this trend by analysing the results by dividing the total number of patient x years into classes corresponding to 100 patient x years, and determining the hazard rate for one-year overall mortality for each class. The hazard rate was found to decrease regularly from 0.15 down to 0.094 from the first 100 patient x years to the final 1250 patient x years. The one- year mortality was 14.1 ~ for the 199 patients enrolled from March 1989 to September 1990,