PubMed Health⌕ Search

Biomedical subjects

Michael J Wonder

Publications and source records attributed to Michael J Wonder.

3 recordsLinked to original sources

Development of a predictive population survival model according to the cytogenetic response rate for patients with chronic myeloid leukemia in the chronic phase.

This study sets out to investigate whether the proportion of patients with chronic myeloid leukemia (CML) in the chronic phase who achieve a major cytogenetic response (MCR) can be used as the basis for estimating long-term survival through the use of modeling. Data from seven randomized controlled trials of drugs to treat patients with CML in the chronic phase were used to explore the association between MCR and survival by way of regression analysis. The estimated weighted odds ratio for the survival of those who achieved an MCR when compared with those who did not was 7 (95% CI 5 - 11) at 2 years and 5 (95% CI 3 - 8) at 4 years. Four long-term survival models were subsequently constructed. All models were found to be robust to variations in the data included. Model D was favored using the 'Ockham's razor' principle; it suggests that the median survival may be increased by 1.8 years for every 25 percentage point increase in MCR rate. The results support the use of the proportion of patients with CML in the chronic phase with an MCR to estimate overall long-term survival.

Clinical Trials as Topic↗

Are Australians able to access new medicines on the pharmaceutical benefits scheme in a more or less timely manner? An analysis of pharmaceutical benefits advisory committee recommendations, 1999-2003.

OBJECTIVE: Timely access to necessary medicines that Australians need is one of the four pillars of the Australian Government's National Medicines Policy. We were interested to determine whether there was a change in the time taken for medicines to be listed once recommended by the Pharmaceutical Benefits Advisory Committee (PBAC). METHODS: Descriptive statistics were used to show the pattern of recommendations for PBAC meetings from 1999 to 2003. For successful recommendations, we developed a linear regression model to analyze the time to list from the PBAC meeting to date of listing (time to list). The model determined whether this time had changed over the 4-year period, and the reasons for any changes. RESULTS: The PBAC made 307 positive recommendations at its 17 meetings over the study period. Ninety percent resulted in a Pharmaceutical Benefits Scheme (PBS) listing on or before April 1, 2005. Eighty-two percent of the recommendations made in 1999 and 2000 resulted in early or on-time listings. In 2001, 2002, and 2003, the comparable proportions were 67%, 68%, and 75%. Mean times to list for the years from 1999 to 2003 were similar (approximately 23 weeks), except in 2001 where it was 30 weeks. CONCLUSIONS: Over the study period, 90% of all PBAC recommendations resulted in a PBS listing. In 2001 there was a statistically significant increase in the mean time to list. In addition, it appears that recommendations for new listings and new indications (medicines that are likely to result in substantial Government expenditure) were associated with a longer time to list.

Advisory Committees↗

Drugs down under.

Explore the source record for details and available documents.

Australia↗