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It’s time for true transparency of clinical trials data

What makes a health professional science-based? We advocate for evaluations of treatments, and treatment decisions, based on the best research methods. We compile evidence based on fair trials that minimize the risks of bias. And, importantly, we consider this evidence in the context of the plausibility of the treatment. The fact is, it’s actually not that hard to get a positive result in a trial, especially when it’s sloppily done or biased.  And there are many ways to design a trial to demonstrate positive results in some subgroup, as Kimball Atwood pointed out earlier this week. And even when a trial is well done, there remains the risk of error simply due to chance alone. So to sort out true treatment effects, from fake effects, two key steps are helpful in reviewing the evidence.

1. Take prior probability into account when assessing data. While a detailed explanation of Bayes Theorem could take several posts, consider prior probability this way: Any test has flaws and limitations. Tests give probabilities based on the test method itself, not on what is being tested. Consequently, in order to evaluate the probability of “x” given a test result, we must incorporate the pre-test probability of “x”. Bayesian analysis uses any existing data, plus the data collected in the test, to give a prediction that factors in prior probabilities. It’s part of the reason why most published research findings are false.

2. Use systematic reviews to evaluate all the evidence. The best way to answer a specific clinical question is to collect all the potentially relevant information in a structured way, consider its quality, analyze it according to predetermined criteria, and then draw conclusions. A systematic review reduces the risk of cherry picking and author bias, compared to non-systematic data-collection or general literature reviews of evidence. A well-conducted systematic review will give us an answer based on the totality of evidence available, and is the best possible answer for a given question.

These two steps are critically important, and so have been discussed repeatedly by the contributors to this blog. What is obvious, but perhaps not as well understood, is how our reviews can still be significantly flawed, despite best efforts. In order for our evaluation to accurately consider prior probability, and to be systematic, we need all the evidence. Unfortunately, that’s not always possible if clinical trials remains unpublished or are otherwise inaccessible. There is good evidence to show that negative studies are less likely to be published than positive studies. Sometimes called the “file drawer” effect, it’s not solely the fault of investigators, as journals seeking positive results may decline to publish negative studies. But unless these studies are found, systematic reviews are more likely to miss negative data, which means there’s the risk of bias in favor of an intervention. How bad is the problem? We really have no complete way to know, for any particular clinical question, just how much is missing or buried. This is a problem that has confounded researchers and authors of systematic reviews for decades. (more…)

Posted in: Clinical Trials, Politics and Regulation

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The Need for Transparency

A recent editorial in PLOS Medicine discusses the need for transparency in the medical literature, specifically with regard to comparative effectiveness research (CER). The editorial makes many excellent points, but also puts into clear relief the double standard that is consciously being fabricated by proponents of non-science-based medicine.

I wrote previously about another editorial that took a very different approach. Speaking for The Kings Fund, Professor Dame Carol Black said.

“The challenge is to develop methods of research that allow us to assess the value of an approach that seeks to integrate the physical intervention, the personal context in which it is given, and non-specific effects that together comprise a particular therapy.”

The editorial essentially defended the use of CER and other forms of evidence to bolster the evidence base for so-called CAM (complementary and alternative medicine) in order to promote its use.

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Posted in: Science and Medicine

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