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Who has used internal company documents for biomedical and public health research and where did they find them?

ABSTRACT: OBJECTIVE: To describe the sources of internal company documents used in public health and healthcare research. METHODS: We searched PubMed and Embase for articles using internal company documents to address a research question about a health-related topic. Our primary interest was where authors obtained internal company documents for their research. We also extracted information on type of company, type of research question, type of internal documents, and funding source. RESULTS: Our searches identified 9,305 citations of which 357 were eligible. Scanning of reference lists and consultation with colleagues identified 4 additional articles, resulting in 361 included articles. Most articles examined internal tobacco company documents (325/361; 90%). Articles using documents from pharmaceutical companies (20/361; 6%) were the next most common. Tobacco articles used documents from repositories; pharmaceutical documents were from a range of sources. Most included articles relied upon internal company documents obtained through litigation (350/361; 97%). The research questions posed were primarily about company strategies to promote or position the company and its products (326/361; 90%). Most articles (346/361; 96%) used information from miscellaneous documents such as memos or letters, or from unspecified types of documents. When explicit information about study funding was provided (290/361 articles), the most common source was the US-based National Cancer Institute. We developed an alternative and more sensitive search targeted at identifying additional research articles using internal pharmaceutical company documents, but the search retrieved an impractical number of citations for review. CONCLUSIONS: Internal company documents provide an excellent source of information on health topics (e.g., corporate behavior, study data) exemplified by articles based on tobacco industry documents. Pharmaceutical and other industry documents appear to have been less used for research, indicating a need for funding for this type of research and well-indexed and curated repositories to provide researchers with ready access to the documents.

SUBMITTER: Wieland LS

PROVIDER: S-EPMC4011692 | biostudies-other | 2014

REPOSITORIES: biostudies-other

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Who has used internal company documents for biomedical and public health research and where did they find them?

Wieland L Susan LS Rutkow Lainie L Vedula S Swaroop SS Kaufmann Christopher N CN Rosman Lori M LM Twose Claire C Mahendraratnam Nirosha N Dickersin Kay K

PloS one 20140506 5

<h4>Objective</h4>To describe the sources of internal company documents used in public health and healthcare research.<h4>Methods</h4>We searched PubMed and Embase for articles using internal company documents to address a research question about a health-related topic. Our primary interest was where authors obtained internal company documents for their research. We also extracted information on type of company, type of research question, type of internal documents, and funding source.<h4>Result ...[more]

PMID: 24800999

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Project description:BackgroundDetails about the type of analysis (e.g., intent to treat [ITT]) and definitions (i.e., criteria for including participants in the analysis) are necessary for interpreting a clinical trial's findings. Our objective was to compare the description of types of analyses and criteria for including participants in the publication (i.e., what was reported) with descriptions in the corresponding internal company documents (i.e., what was planned and what was done). Trials were for off-label uses of gabapentin sponsored by Pfizer and Parke-Davis, and documents were obtained through litigation.Methods and findingsFor each trial, we compared internal company documents (protocols, statistical analysis plans, and research reports, all unpublished), with publications. One author extracted data and another verified, with a third person verifying discordant items and a sample of the rest. Extracted data included the number of participants randomized and analyzed for efficacy, and types of analyses for efficacy and safety and their definitions (i.e., criteria for including participants in each type of analysis). We identified 21 trials, 11 of which were published randomized controlled trials, and that provided the documents needed for planned comparisons. For three trials, there was disagreement on the number of randomized participants between the research report and publication. Seven types of efficacy analyses were described in the protocols, statistical analysis plans, and publications, including ITT and six others. The protocol or publication described ITT using six different definitions, resulting in frequent disagreements between the two documents (i.e., different numbers of participants were included in the analyses).ConclusionsDescriptions of analyses conducted did not agree between internal company documents and what was publicly reported. Internal company documents provide extensive documentation of methods planned and used, and trial findings, and should be publicly accessible. Reporting standards for randomized controlled trials should recommend transparent descriptions and definitions of analyses performed and which study participants are excluded.

Project description:Amidst concerns regarding the capacity of the public health system to respond rapidly and appropriately to threats such as pandemics and terrorism, along with changing population health needs, governments have focused on strengthening public health systems. A key factor in a robust public health system is its workforce. As part of a nationally funded study of public health renewal in Canada, a policy analysis was conducted to compare public health human resources-relevant documents in two Canadian provinces, British Columbia (BC) and Ontario (ON), as they each implement public health renewal activities.A content analysis of policy and planning documents from government and public health-related organizations was conducted by a research team comprised of academics and government decision-makers. Documents published between 2003 and 2011 were accessed (BC?=?27; ON?=?20); documents were either publicly available or internal to government and excerpted with permission. Documentary texts were deductively coded using a coding template developed by the researchers based on key health human resources concepts derived from two national policy documents.Documents in both provinces highlighted the importance of public health human resources planning and policies; this was particularly evident in early post-SARS documents. Key thematic areas of public health human resources identified were: education, training, and competencies; capacity; supply; intersectoral collaboration; leadership; public health planning context; and priority populations. Policy documents in both provinces discussed the importance of an educated, competent public health workforce with the appropriate skills and competencies for the effective and efficient delivery of public health services.This policy analysis identified progressive work on public health human resources policy and planning with early documents providing an inventory of issues to be addressed and later documents providing evidence of beginning policy development and implementation. While many similarities exist between the provinces, the context distinctive to each province has influenced and shaped how they have focused their public health human resources policies.

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Who has used internal company documents for biomedical and public health research and where did they find them?

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Who has used internal company documents for biomedical and public health research and where did they find them?

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