Every year, millions of people are treated for head injury. A substantial proportion die or are permanently disabled. The theory goes that aside from the direct damage at the time of the injury, the inflammation that follows leads to further problems. Fortunately, corticosteroids can reduce this inflammation so have been used to treat head injury for more than 30 years. This makes perfect sense, right?
This is about trials, I promise, but first, let’s start with the music of David Bowie. One thing that many commentators said following his recent death was that he never followed trends, he created them. Every few years he would unveil his latest creation, sometimes to the horror of his fans, as when he killed off Ziggy Stardust at the height of his fame, but always creating something new. Right until the end, the same artist, but creating new art to surprise us. And that’s what I’ll miss, that in the next couple of years through the banal beats, he won’t suddenly reappear with his latest creation. Now compare Bowie with the Spice Girls. Massively successful yes, a prominent icon of a specific era, but firmly grounded in that time.
This is streptokinase. It was first isolated from bacteria in the 1930s and in the lab was shown to breakdown blood clots (by converting plasminogen to plasmin). When a purified version became available in the 1950s there was great interest to find out if it might increase survival if given after a person had suffered a heart-attack. This resulted in the first randomised trials being undertaken at the end of the 1950s, so what did they show? If streptokinase was given after a person had a heart-attack was survival increased?
One thing that ICH-GCP emphasises is collecting “high-quality” data. It then goes on to spell out the considerable efforts that are required to achieve this focusing on having complete data and having that data verified against the patient’s medical notes. This is usually done by the trial sponsor sending a trained person called a monitor (aka CRA, Clinical Research Associate) to the site, say a hospital, to track down the missing data and to compare the data collected in the trial with the original data recorded in the patient’s notes. These are done every few months so not surprisingly these monitoring visits are a major cost component of the trial along with all of the other checking of data that is involved. Again, it sounds sensible doesn’t it? But, it’s not.