No abstract

Women are often underrepresented in randomized clinical trials (RCT) of HIV-1 drugs. As a result, determining whether women have different virologic outcomes compared to men is not always possible because the gender-related analyses usually lack statistical power. To address this important public health concern, the Food and Drug Administration's (FDA) Division of Antiviral Products (DAVP) created a database including 20,328 HIV-positive subjects from 40 RCTs in 18 New Drug Applications (NDAs) submitted to the FDA between 2000 and 2008. These RCTs were conducted for at least 48 weeks in duration and were used to support approval of new molecular entity, new formulation, or major label change. To delineate potential gender differences in antiretroviral treatment (ART), we evaluated the percentage of subjects with HIV RNA less than 50 copies per milliliter at 48 weeks. Analyses of the database represent the most systematic review of gender-related ART efficacy data to date. Overall, the meta-analyses did not demonstrate statistically or clinically significant gender differences in virologic outcome at week 48. However, the corresponding subgroup analyses appear to show several statistically significant gender differences favoring males.

BACKGROUND Colorectal cancer (CRC) screening tests (e.g., fecal occult blood testing [FOBT], flexible sigmoidoscopy [FS], etc.) are underused. Primary care providers (PCPs) play a critical role in screening, but barriers to and facilitators of screening as perceived by PCPs in managed care settings are poorly understood. The objectives of the current study were to describe current CRC screening practices and to explore determinants of test use by PCPs in a managed care setting. METHODS In 2000, a self‐administered survey was mailed to a stratified, random sample of 1340 PCPs in a large, network model health maintenance organization in California. RESULTS The survey response rate was 67%. PCPs indicated that 79% of their standard‐risk patients were screened for CRC. PCP‐reported median rates of recommendation for the use of specific screening tests were 90% for FOBT and 70% for FS. In logistic regression models, perceived barriers to the use of FOBT and FS included patient characteristics (e.g., education) and PCP‐related barriers (e.g., failure to recall that patients were due for testing). Perceived facilitators of the use of FOBT and FS included interventions targeting certain aspects of the health care system (e.g., reimbursement) and interventions targeting certain aspects of the tests themselves (e.g., provision of evidence of a test's effectiveness). Assignment of high priority to screening, integrated medical group (as opposed to independent practice association) affiliation, and the proportion of patients receiving routine health maintenance examinations were positively associated with reported test use. CONCLUSIONS CRC screening tests appear to be underused in the managed care setting examined in the current study. The perceived barriers and facilitators that were identified can be used to guide interventions aimed at increasing recommendations for, as well as actual performance of, CRC screening. Cancer 2004. © 2004 American Cancer Society.

Objective:To provide context for the malignancy experience in the rheumatoid arthritis (RA) abatacept clinical development programme (CDP) by performing comparisons with similar RA patients and the general population.Methods:Malignancy outcomes included total malignancy (excluding non-melanoma skin cancer (NMSC)), breast, colorectal, lung cancers and lymphoma. Comparisons were made between the observed incidence in patients within the abatacept CDP and RA patients on disease-modifying antirheumatic drugs (DMARD) identified from five data sources: the population-based British Columbia RA Cohort, the Norfolk Arthritis Register, the National Data Bank for Rheumatic Diseases, the Sweden Early RA Register and the General Practice Research Database. Age and sex-adjusted incidence rates (IR) and standardised incidence ratios (SIR) were used to compare events in the abatacept trials with the RA DMARD cohorts and the general population.Results:A total of 4134 RA patients treated with abatacept in seven trials and 41 529 DMARD-treated RA patients in the five observational cohorts was identified for study inclusion. In the abatacept-treated patients, the 51 malignancies (excluding NMSC), seven cases of breast, two cases of colorectal, 13 cases of lung cancer and five cases of lymphoma observed were not greater than the range of expected cases from the five RA cohorts. The SIR comparing RA patients with the general population were consistent with those reported in the literature.Conclusions:The IR of total malignancy (excluding NMSC), breast, colorectal, lung cancers and lymphoma in the abatacept CDP were consistent with those in a comparable RA population. These data suggest no new safety signals with respect to malignancies, which will continue to be monitored.

PMCV induces both humoral and cell-mediated immune responses to melanoma-associated tumor antigens, the type and strength of which appear to be directly related to its therapeutic efficacy.