Overzealous oversight
Research in the United States is “slowly grinding to a halt” because of excessive and ineffective regulatory oversight, according to a report from the Infectious Diseases Society of America (CID 2009; 49:328–35).
The report, Grinding to a Halt: The Effects of the Increasing Regulatory Burden on Research and Quality Improvement Efforts, states that although regulations are needed to protect people who participate in medical research, the existing regulatory system has too many redundancies and inefficiencies, which consume resources and delay research while providing no benefit to research participants.
Problems cited in the report include:
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Local reviews of protocols for multicentre studies, which delay research but rarely improve protocols or consent forms.
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A redundant system of adverse event reporting for multicentre trials.
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Overzealous efforts to protect children involved in medical research, which hurt research efforts and eventually leads to use of inappropriate medications or incorrect doses.
Among its recommendation, the society, based in Arlington, Virginia, suggests:
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Developing central institutional review boards for multicentre studies.
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Replacing local review boards with data monitoring committees to monitor adverse events in multicentre studies.
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Bringing together pediatric researchers, bioethicists and regulators to clarify “key definitions” for pediatric research.
“Patients and disease advocacy groups, as well as researchers and regulators, need to be part of this discussion,” the report concludes. “The need for research and the need for oversight are not competing agendas; they are two pillars that support the research enterprise. It is time to restore the balance.”
Getting noticed
Some health issues gain widespread support, while others are neglected, because of how the issues are communicated — regardless of objective measures of their importance, according to a paper published in the Bulletin of the World Health Organization (Bull World Health Organ 2009;87:608–13).
Quantifiable factors, such as mortality and morbidity, play little role in determining the variance in attention given to heath issues, says paper author Jeremy Shiffman, an associate professor at the Maxwell School of Citizenship and Public Affairs (Syracuse University, New York). Rather, it is how effective advocates for a particular health initiative communicate their message that determines how much attention and funding it receives.
Shiffman suggests that “the rise and fall of a global health issue may have less to do with how ‘important’ it is in any objective sense than with how supporters of the issue come to understand and portray its importance.”
The paper notes that HIV/AIDS received about a third of major donor funding for health in the early 2000s, even though it accounted for only about 5% of the mortality and morbidity burdens in low- and middle-class countries. Meanwhile, health issues with significantly higher rates of mortality and morbidity, such as pneumonia and malnutrition, received much less attention.
An issue will attract more attention, Shiffman suggests, if it can be effectively framed in different ways. HIV/ AIDS, for instance, has been framed in myriad ways, including: as a public health problem, as a development issue, as a humanitarian crisis and as a human rights issue.
Shiffman notes that some global health observers are calling for “a more rational global health architecture” that would turn away from issue-specific initiatives and focus on material factors, such as diseases burdens, which would be a more effective means of strengthening health systems.
List checking
An international group led by David Moher, a clinical epidemiologist with the Ottawa Hospital Research Institute in Ontario, has created a 27-item checklist and a four-phase flowchart to help authors of scientific literature improve the quality of their systematic reviews and meta-analyses.
The guidelines, called the PRISMA (preferred reporting items for systematic reviews and meta-analyses) Statement, were developed to help improve the quality of research used to aid health care decision-making
“The aim of the PRISMA Statement is to help authors report a wide array of systematic reviews to assess the benefits and harms of a health care intervention,” says a statement on the PRISMA website (www.prisma-statement.org/statement.htm). “PRISMA focuses on ways in which authors can ensure the transparent and complete reporting of systematic reviews and meta-analyses.”
The checklist is divided into seven sections, with descriptions: Title, abstract, introduction, methods, results, discussion and funding.
In July, the checklist was jointly published by 5 medical journals:PLoS Medicine, the British Medical Journal, Open Medicine, Annals of Internal Medicine and Journal of Clinical Epidemiology. — Roger Collier, CMAJ