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November 2011

Beyond trials and looking to prevention. Notes from AHA 2011

Ami Banerjee
Last edited 15th November 2011

Since the early trials of beta-blockers and thrombolysis, or “clot-busting” drugs, in cardiovascular disease, the American Heart Association Scientific Sessions and other international cardiology meetings have been dominated by highly-anticipated “late-breaking” or “hot trials” sessions. During these talks, thousands of conference attendees would clamour to hear the results of trials of new drugs reported for the first time. As well as being highly talked about, they greatly influence projections of how the drug will perform in the real market: akin to a stockmarket floor for pharma. Today new drug trials are still by the dozen, but difficult economic times, increased regulation of pharma and wider and quicker dissemination of results may be changing the role of these sessions.

Aside from the trials, three messages are coming through loud and clear from this year’s meeting in Orlando. First, although the best-attended sessions are still the trials of new interventions and drugs for the range of cardiovascular disease, the number of talks devoted to primary prevention and primordial prevention is growing. In other words, prevention of the development of disease and prevention of the development of risk factors of disease, respectively

Second, there is a shifting focus on risk factors as continuous exposures over the whole lifespan. For example, we have talked about “pack-years” of smoking for a long time, i.e. an individual’s lifetime exposure to cigarette smoke. Rather than looking at arbitrary cut-offs for risk factors such as hypertension or high cholesterol, it may make more sense to look at the burden of that risk factor over their lifespan, and in combination with other risk factors.

Third, in the aftermath of the September UN high-level meeting, there is an increasing recognition of the global health aspects of heart disease and stroke. In a session chaired by Professor Sir Magdi Yacoub, eminent cardiac surgeon and long-term activist for improved health services for heart disease in low-income countries, a researcher from Mozambique showed the huge disease burden how feasible screening for common heart diseases can be, even in rural settings.

All three of these changes are welcome and signal gradual, encouraging paradigm shifts among both researchers and health professionals to look at the bigger picture of prevention and population approaches to cardiovascular disease.

Astronomy and Evidence: StaR Gazing for Children's Trials

Peter Gill
Last edited 14th September 2012

On the eve of the 20th anniversary of the United Nations Convention on the Rights of the Child, which recognised the right of all children to "the enjoyment of the highest attainable standard of health", the editor of the Lancet Richard Horton was delivering a plenary address at the first summit of StaR Child Health in Amsterdam in 2009. In his address, he stated the:

“Lack of research, poor research, and poorly reported research are violations of children’s human rights.”

Individuals from various disciplines, including the World Health Organisation, the US Food and Drug Administration, and the European Medicines Agency, gathered together to discuss a topic of shared interest: the paucity and shortcomings of paediatric clinical trials.

The quality, quantity and relevance of data involving children are substantially lower than those involving adults. This problem persists despite knowledge that inadequate testing of medication in children may result in harmful or ineffective drugs being offered or beneficial drugs being withheld.

Indeed a systematic review sponsored by the World Health Organisation found that there were few guidelines relevant to the design, conduct and reporting of research in children. Most guidelines only seem to focus on what should be done, failing to address the important issue of how it should be completed.

The mission of StaR Child Health is to improve the design, conduct and reporting of "research with children through the development and dissemination of evidence-based standards."

How best to achieve this monumental task? The StaR Child Health group is using a "knowledge to action" process that involves using a systematic process to review the current knowledge base, identify gaps, develop guidance and implementation strategies. An ambitious agenda that is gaining tremendous momentum.

Based the results of a systematic review and survey of key stakeholders, they have identified 10 priority issues. Each issue will be systematically addressed by a standard development group that will produce evidence summaries, identify gaps and develop a dissemination strategy. The priority issues include recruitment and informed consent, risk of bias, sample size, age-specific dosage and administration, safety and global health.

But more guidelines and standards will not change the conduct of trials unless they are implemented. StaR Child Health is leading in knowledge translation by involving multiple stakeholders from the beginning and is working with international partners, such as the GRIP Project, a global research network in paediatrics.

For the quality of health care for children across the world to improve, trials must be conducted that address the complexity of child health and provide reliable evidence-based answers. Now we can be confident that we have a bright StaR illuminating the path forward.

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