Applied Clinical Trials - August 2010 - (Page 27)
To see more Technology Viewpoint articles, visit appliedclinicaltrialsonline.com
Turning to Baseball for a Better Perspective
How game statistics can help inform the U.S. outlook on comparative effectiveness research.
fans revel in the Wrigley experience—but it’s best we don’t look too closely to the comparative effectiveness of the Cubs payroll to win ratio vs. that of the competition. Then again, at least the data is there for us, even if we choose to ignore it while dreaming wistfully of next year.
or some of us, the heart of the summer brings to mind the desire for cold drinks, warm books, Arcadian vacation sites, and baseball. Now while baseball is an antiquated nineteenth-century sport to some and often a pretty dull one at that, it holds a special attraction for the statistically-inclined—even those in clinical research—since it’s such a rich source of precise data about what players and teams have done in the past under specific circumstances. In many ways, baseball is all about data, which analysts like the venerable Bill James (not to mention many more real and amateur statisticians—aka fans) study at great length. These data help us imagine whether our team has a ghost of a chance this year; whether our favorite players are on the upswing, plateau or denouement of their careers; and eventually lead us to determine the effectiveness of team management in putting together the best teams for the money. Ultimately, it’s this access to data that allows us to justify or at least rationalize the high cost of game attendance (not to imagine the often higher cost of passionate team loyalty). Of course, I carry a particular bias in this regard since I live in Chicago, home of the lovable, tragicomic Chicago Cubs. Here we absorb the hope and promise of our baseball statistics with a healthy dose of fatalism. Cubs
And this brings me to the timely topic of Comparative Effectiveness Research (CER). Like baseball, CER is all about data. In this case, it’s the study of health data to identify which therapies may provide the best outcomes. To be more exact, the Department of Health and Human Services defines CER as “the conduct and synthesis of research comparing the benefits and harms of different interventions to prevent, diagnose, treat, and monitor health conditions in “real world” settings...about which interventions are most effective for which patients under specific circumstances.”1 For many reasons, CER has long been a taboo topic in America, where many of our political leaders and their innumerable influencers somehow feel that exposure to such information will inevitably lead to the rationing of health care and the curtailment of personal liberties. This is odd—one wouldn’t imagine it would be possible Wayne R. Kubick
is Senior Vice President and Chief Quality Officer at Lincoln Technologies, Inc., a Phase Forward company based in Waltham, MA. He can be reached at wayne.kubick@ phaseforward.com.
to build a very good baseball team if the general manager didn’t know the performance statistics and salaries of each of his players. CER is certainly not a new concept among pharmacoepidemiologists—they’ve been performing such research for years, though it has not always been easy to translate their findings to bedside except among some pioneering physician advocates of evidence-based medicine. But the audience for this research has changed—now there’s substantial involvement by government (in the form of a $1.1 billion dollar allocation as part of the American Recovery and Reinvestment Act), increasing interest among venture capitalists, and even, as Jeff Goldsmith recently put it, 2 a burgeoning desire for such practical information by the family’s Chief Health Officer, Mom. The unavoidable conclusion is that health care costs can’t continue to rise as they have been—we need to get a better return on investment for our health care dollars. CER is not such a novelty in Europe—the European Medicines Agency has previously stated the importance of conducting active comparator (i.e., CER) trials as part of marketing applications when “an established pharmacological treatment is available.” 3 And the UK National Institute for Health and Clinical Excellence (NICE) conducts CER research, defines health care standards, and even provides an Internet tool known as NHS Evidence, which is described as “a Google-style device that allows NHS staff to search the Internet for up-to-date evidence of effectiveness and examples of best practice in relation to health and social care.” As discussed by an extraordinary panel of experts including Goldsmith, Michael Rawlins of NICE, Mark McClellan, and many others at a thoughtprovoking 2010 DIA Annual meeting session on CER,4 we need to get past the misplaced fears that have been
APPLIED CLINICAL TRIALS
Table of Contents for the Digital Edition of Applied Clinical Trials - August 2010
Applied Clinical Trials - August 2010
From the Editor
Letters to the Editor
View from Washington
View from Brussels
Considerations for Medical Device Trials
Automate Phase I Trials
Business and People Update
Calendar of Events
A Closing Thought
Applied Clinical Trials - August 2010