Data from multiple trials have shown that patients who enter treatment with more severe cocaine withdrawal symptoms as measured by the CSSA scores do poorly (Kampman et al, 2001; Kampman et al, 2002; Mulvaney et al, 1999).
Use of these definitions at the FDA has enhanced the ability to aggregate data within and across medical product development programs, conduct meta-analyses to evaluate cardiovascular safety, integrate data from multiple trials, and compare effectiveness of drugs and devices.
By pooling data from multiple trials addressing the same or very similar thing, you generate the power of large numbers ― and can often replace suggestions about some association with some degree of statistical reliability.
For clinical trial data, meta-analysis of summary-level efficacy and safety data from multiple trials provides a quantitative framework for comparative efficacy and safety assessment.
44 45 To increase power and reduce the opportunity for false negatives, we recommend that meta-analyses based on individual participant data from multiple trials are facilitated (recommendation 17).
When data from multiple trials are synthesized, such as in a meta-analysis, a negative study does not trump a positive study of similar quality.
A caveat is that it cannot be proved whether this assumption applies to each individual trial as the results from Experiment 1a reflect cumulative data from multiple trials, while the objects, by necessity, were different from those in Experiment 1b.
With ever-larger trials, and meta-analyses of data from multiple trials, we have the statistical power to demonstrate quite small mean differences in these outcome measures that are unlikely to have arisen by chance.
In fact, given the strength of the data from multiple trials, most experts would advocate that arginine therapy in the perioperative period should be the standard of care in high-risk surgical patients [ 19].
As a result, the majority of studies derived primary clinical inputs from single trials [ 8, 13, 16, 23, 26, 33, 37, 45] or via simple pooling of data from multiple trials [ 9, 28, 31, 40], or a combination of single trials, pooled analyses, indirect comparisons and meta-analyses [ 11, 12, 18- 25, 27, 27].
