The West African Ebola epidemic is still raging, but the race is now on to fast track the trials of possible treatments. The WHO has set out the ground rules to try and ensure that these highly unusual drug trials still produce safe and valid results.
Last week, the World Health Organization set out its criteria for the conduct of clinical trials on experimental drugs and other therapies for the treatment of Ebola. First and foremost, they stressed that great care must be taken to ensure the safety of any product before efficacy testing is done on humans.
Several possible candidates have been suggested – including vaccines, plasma and blood from survivors, and other treatments. However, none of these have been tested for efficacy.
There are several factors that are confusing the picture, for instance the extent to which the recovery of repatriated foreign Ebola sufferers is a result of better healthcare standards rather than any novel treatments they may also have received.
To eliminate this factor, the WHO insists that novel drugs are tested in a situation where care is standardized. Unfortunately, this is not going to be easy, as there are only a few centres in the hardest-hit areas where care is sufficiently consistent and high quality for them to take place in such trials.
The sad situation is that there are currently more candidate treatments than there are facilities in which they could be tested. The WHO has received details of over 120 untested potential treatments and yet they have identified less than ten possible test sites.
Of course, prioritising the IMPs is going to be the key first step but it is even more crucial than usual that every trial counts – which bring me to the second issue…
It seems that there is little consistency in the way data is being collected – making it difficult if not impossible to compile the results from several small trials into a single usable data set.
The solution was to introduce a standardized data collection form to be used by different sites.
Treatments using blood and plasma from survivors present further challenges because blood must be drawn under highly controlled conditions to prevent other diseases being transmitted.
The first trials under this regime are set to begin in December.
