Problems with clinical trials

Clinical trials are at the heart of our progress in medicine. If we have a new therapy, clinical trials tell us whether it is better than the current one. They measure outcomes, but also look out for side effects and unexpected consequences of taking the therapy. They are absolutely essential to our progress, and it is vital that they are carried out properly and transparently.

In recent years there has been an increasing awareness that our current mechanism to ensure this happens has been failing miserably. This has led to the formation of the All Trials initiative, which is campaigning for reform of the system. A paper this week in F1000Research emphasises the extent of the problems with clinical trials at the moment.

The authors took a look at trials in the clinicaltrials.gov database. This is a database run by the National Institutes of Health in the US, and the FDA require that all clinical trials report a summary of their results there within 12 months of completion. What the authors of this study did was pretty simple: they mined the data for trials that were finished and also for those that had published their results. By comparing the two, they could figure out who was failing to share their trial results, and who was publishing.

trialresults2The study looked as far back as 2006, when it became a legal requirement for trial results to be published, so had a list of nearly 26,000 trials to analyse. The results were pretty stark. Over 45% of trials had not reported their results. This is a shocking but not unexpected finding. Previous studies had suggested such a high level of non-reporting, but this was the most thorough analysis to date.

So why is it so important that results be published? Simply put, we need all the evidence about a treatment to understand its risks and benefits. The AllTrials campaign put it like this:

“If you tossed a coin 50 times, but only shared the outcome when it came up heads and you didn’t tell people how many times you had tossed it, you could make it look as if your coin always came up heads. This is very similar to the absurd situation that we permit in medicine, a situation that distorts the evidence and exposes patients to unnecessary risk that the wrong treatment may be prescribed.”

This is not an unfounded fear. In 1980, nine men died during a trial for a drug called Lorcainide, compared to only one in the placebo arm of the study. The manufacturer stopped the drug’s development (for commercial reasons rather than safety reasons), but crucially the researchers never managed to published the study. Over time other companies developed similar drugs, and they were prescribed throughout the 1980s. In 1993, the original researchers published their results, and the drug was removed from the market. Tragically, an estimated 20,000 to 75,000 people died every year from Lorcainide. It is essential that all the information is available when people’s health is on the line.

A deeper look at the data published in this paper shows that some companies and institutions are a lot worse than others. This tool developed by the authors allows you to visualise this. The pharmaceutical company Sanofi, for example, has only published 150 of their 435 completed trials (35%). The Mayo Clinic, a prestigious Minnesota hospital and research centre, has not published 157 of their 312 trials (50%).

Unfortunately, this issue has not been getting better with time. The most recent year that was analysed in this study was 2014, and in that year only 50% of trials were reported (see graph below), which is obviously unacceptable.

trialsgraph

This is a major issue in medicine at the moment, and one it is vital to be aware of. I would urge you all to sign this petition on the AllTrials website. The sooner this situation is rectified, the better.

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