I may have led a sheltered life, but until this week it had never really occurred to me that bones and joints get infected, and how hard it is to treat them when they do. Yet, for about 7,000 people in the UK every year, complex, prolonged and expensive treatment is required to alleviate what can be a painful and potentially crippling problem.
So I was pleased to help when one of our PAIR members got in touch for advice about a clinical trial that is currently recruiting patients. OVIVA stands for Oral versus Intravenous Antibiotics and is comparing whether it is as effective to treat bone and joint infection by “tabs as jabs.”
In the study, antibiotics are given either orally (swallowed as tablets) or intravenously (injected into a vein). And the reason for the trial is that no-one knows know whether one route is better than the other.
The team is not testing any experimental drugs – all the antibiotics being used are already licensed to treat these conditions – they are simply trying to find out, in the biggest ever trial of its kind, how best to give them. They enrolled the first patients in March 2013, and will enrol the last on or before October 31st this year, aiming for a total of 1050 patients.
As with so many trials, recruitment has not been easy, and they contacted me in part to see whether I could help raise awareness of the study. I was particularly pleased to help because the request came directly from a patient member of the trial steering committee* (the simple fact that such a person existed made me sit up and take notice) but also because, if I’m honest, the condition itself (and the thought of intravenous treatment) made me think “ouch.”
On a more professional level, I was also pleased to have a chance to remind the trial leads of the importance of having really good patient information available – they developed theirs with patient involvement – and less pleased to have a little sigh as so often about what is said about the trial on the supposedly patient-friendly UK Clinical Trials Gateway (UKCTG – an issue I have written about before here).
The OVIVA lay summary is not at all bad, but I was able to nudge the leads to take a look at their UKCTG page where there is a broken link to the patient information sheet and a reference to the trial website that says: “Sorry, not currently available.” Such a shame, when OVIVA has such a good one – but so easy to understand how such things go out of date: amid the bustle of doing the work, details like webpages can get forgotten.
Huge efforts are being made by many organisations and individuals to get more patients involved in more trials, and (the bit that really concerns me) to ensure that these trials are truly “right” for the patients who will join them, both in terms of the questions that they ask and how they are designed. OVIVA seems to be a bit of a trail blazer, what with having a very involved patient on the steering committee, and a lay summary that cuts the mustard. I wish them well.