The success or not of a trial ultimately depends upon two key groups: The participants who take part and the clinic staff that take care of them, so training these staff well really matters.
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.
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.
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?