An opinion and practice survey on the structure and management of data and safety monitoring boards

There is little to no empirical data available on how data and safety monitoring boards (DSMBs) are structured and how they operate. The purpose of this study was to provide data on this. To accomplish this goal, we administered a random survey on current structure and management practices and opinions as reported by principal investigators (PIs) and biostatisticians. We also surveyed Institutional Review Board (IRB) community members, as proxies for the public, as to their opinions on how DSMBs should be structured and managed. A final purpose was to compare opinions about what should be taking place to what is actually happening.     

Quantitative models for optimal rest period scheduling

Mathematical and simulation models studying work-rest schedules in a production process are developed to arrive at an optimal rest policy to maximize work output per unit time. A CSMP simulation study is used to test the sensitivity of the results for different specific cases.     

Who needs RDD? Combining directory listings with cell phone exchanges for an alternative telephone sampling frame

The traditional Random Digit Dialing method (list-assisted RDD using a frame of landline phone numbers) is clearly under threat. The difficulty and costs of completing telephone surveys have increased due to rising rates of refusal and non-contact. The completeness of coverage of list-assisted RDD samples has diminished due to the proliferation of cell-phone only households. The ability of list-assisted RDD to capture young, mobile, unmarried, and minority households is thus diminishing as well. Increasingly, survey researchers have been adding a cell phone component to their sampling frames for telephone surveys, despite the increased costs and other issues associated with RDD calling of cell phones.Recent research by Guterbock, Oldendick, and others has explored the extent to which “electronic white pages” (EWP) samples really differ from RDD samples. Oldendick et al. and Guterbock, Diop and Holian have emphasized that minority households are seriously underrepresented in EWP samples. Nevertheless, EWP samples have distinct advantages whenever a survey is aimed at a restricted geographic area.This paper considers the feasibility of combining EWP samples with cell-phone RDD, eliminating the ordinary RDD component from the sampling frame. We analyze the components of the telephone population, showing that the proposed method would fail to cover only one segment of the telephone population: unlisted landline households that have no cell phone. We analyze data from the 2006 National Health Interview Study to estimate the size of this segment, its demographic profile, the degree to which selected demographic and health behavior characteristics are different from those in the segments that this sampling strategy would capture, and what biases are present in the various sampling frames of interest. Trend data from the NHIS are used to assess how these biases are changing. A simple cost comparison is made among the RDD, RDD + cell and EWP + cell frames. The proposed alternative “EWP + cell” sampling frame provides relatively small bias compared to RDD + cell at costs comparable to RDD-only designs. The portion of the telephone universe that is excluded in the EWP + cell design is getting smaller all the time, therefore its bias relative to the RDD + cell design is decreasing over time. Overall, the EWP + cell design seems to be a useful alternative.     

Prevalence of Industry Support and its Relationship to Research Integrity

Most U.S. clinical trials are funded by industry. Opportunities exist for sponsors to influence research in ways that jeopardize research objectivity. The purpose of this study was to survey U.S. medical school faculty to assess financial arrangements between investigators and industry to learn about investigators' first hand knowledge of the effects of industry sponsorship on research.

Here we show first-hand knowledge that compromises occurred in: research participants' well-being (9%), research initiatives (35%), publication of results (28%), interpretation of research data (25%), and scientific advancement (20%) because of industry support. Financial relationships with industry were prevalent and considered important to conducting respondents' research.