MoreTrials

MoreTrials: A public campaign to make it much easier to do randomised trials

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News: RICERC@ supports MoreTrials campaign

RICERC@ website

 

Welcome to the Italian Network of Ethics Committees, Researchers and Citizens, RICERC@ who have joined the MoreTrials campaign to make it much easier to do better randomised trials.

An article from Marina Ferri on the RICERC@ website with the fantastic – wish I’d thought of that – title, “Less (GCP) is More (Trials)”  points out the various problems with ICH-GCP, which have not been addressed in the recent update proposed by ICH.

Our letter pointing out these problems and what needs to be done to fix them will be considered by the ICH working group, whose membership we are not allowed to know (why, we don’t have a clue?), when it meets next in Lisbon in June. ICH then plans to finalise the update to GCP at its next meeting in Osaka in November.

Turning to the EMA, we’ve still not heard anything back from them, which is kind of ironic, given that they’ve recently announced a consultation on how they better collaborate with the academic community.Their briefing says that the EMA wants to “channel Academia’s advanced knowledge into the regulatory environment”, which I think in everyday language means, that experts in universities know a thing or two about developing drugs, so it might be sensible to listen to what they have to say.

Again, kind of ironic.

Trials that matter: Treating TB faster

Treating TB Faster

 

Today is world TB day.

Our colleagues at the MRC Clinical Trials Unit at University College London, including Professors Sarah Meredith and Di Gibb, who are supporters of MoreTrials, are hosting a symposium in London today on the global fight to eradicate TB. It will cover a number of the trials they are currently running to tackle pressing health issues from TB. For example, there are around half a million new cases of multiresistant TB each year. Current treatment takes around two years to complete, with only around half of those treated having a positive outcome. Fortunately, the STREAM trial is testing whether newer shorter treatments lasting 6-9 months might be more effective. You can read more details of all of the CTU’s TB trials here.

What is interesting to note is that randomised trials really started in medicine more than sixty years ago with the MRC trial of streptomycin in 1948. What disease was the trial in? TB.

 

 

Trials that mater: Turning conventional wisdom in the treatment of major injury to the head on its head

Ambulance ER

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?

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Fundamental problems with ICH-GCP: #2 A lot has changed in 20 years

Spice Girls 1996

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.

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