Transforming Clinical Research in the United States Challenges and Opportunities: Workshop Summary (2010) / Chapter Skim
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5 Clinical Trials in Depression
5 Clinical Trials in Depression
Pages 39-48
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From page 39... ...
The ISIS trial changed the study of ACS in that future trials sought larger sample sizes to appropriately answer the main outcome questions of interest in cardiovascular disease. However, the fact that the ISIS trial did not pay investigators makes its duplication in any country today impossible, according to Califf.
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From page 40... ...
As illustrated in the table below, in 2006 acute decompensated heart failure lacked evidence-based guidelines, whereas acute MI had a robust base of scientific evidence based on large randomized trials.
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From page 41... ...
Califf highlighted a recent positive development -- the development of a large clinical trial to answer the question of whether a marketed drug, nesiritide, is effective against heart failure. Nesiritide originally gained market approval based on the results of a number of small clinical trials, but a subsequent meta-analysis of patient data called the drug's per formance into question and suggested an increased mortality risk.
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From page 42... ...
In response to a question from Califf, Sabatine described TIMI's studies as being relatively complex, having case report forms that are more than one or two pages, and seeking to answer a variety of questions. Strong academic support for the trial activities listed above is important to the group as a whole and would be very difficult to maintain through government funding alone.
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From page 43... ...
As a result, the phase III CLARITY TIMI 28 trial involving nearly 3,500 patients was launched. The trial showed that administering clopidogrel to patients receiving a thrombolytic therapy for their heart attack decreased the odds of their having a blocked artery and translated to a decreased rate of clinical events.
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From page 44... ...
According to Sabatine, the company was confident of the positive results of a number of RCTs comparing pravastatin with placebo and believed pravastatin offered patients additional benefits that atorvastatin lacked. However, PROVE-IT TIMI 22 showed that atorvastatin outperformed pravastatin in helping patients achieve lower LDL.
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From page 45... ...
THE OCCLUDED ARTERY TRIAL Lauer discussed OAT as a case study that highlights a number of common obstacles encountered in conducting a large clinical trial with significant ramifications for clinical practice. Acute MI (heart attack)
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From page 46... ...
As a result, there was a widespread increase in the use of cardiac catheterization to open the arteries of heart attack patients, and, despite the lack of robust scientific evidence supporting PCI, it became conventional medical wisdom to use this procedure for patients with chronically occluded arteries after a heart attack. OAT, an NHLBI-supported experimental trial, eventually revealed that health outcomes were worse among those subjects randomized to receive stents, dispelling the belief that opening arteries through PCI is always desirable.
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From page 47... ...
. NOTE: NHLBI = National Heart, Lung, and Blood Institute; OAT = Occluded Artery Trial; OAT-NUC = Occluded Artery Trial Nuclear Study; TOSCA-2 = Total Occlusion Study of Canada-2.
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From page 48... ...
Federally sponsored research -- The federal government plays an • important role in funding and conducting large clinical trials to test the effectiveness of clinical practices that are in widespread use but do not have an evidence base. Biases -- Physicians and patients often have strong preferences for • and biases toward certain procedures or levels of care they believe to be appropriate, regardless of the evidence supporting them.
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