Clinical Trials
Do we need more collaboration and less competition in primary care clinical trials?
I’ve been delivering clinical trials for almost 20 years. It used to be a niche area and few practices did it. During covid there was a dip in commercial studies (apart from vaccine ones). Over the last year or so - there appears to be an explosion of interest. More clinical trials are coming, NIHR and others are strongly pushing primary care to get involved and indeed more practices than ever before are seeing doing clinical trials as a potential income source so are interested in how they get involved but struggling to deliver. RRDNs to be fair are doing a good job, funding and educating and supporting new practices but I think we need to think of a different model.
Loads of practices in the last 6m have contacted me asking for advice. What do they need to do - how do they get involved, what staff, skills, equipment do they need? - I tend to offer advice but basically I’m shooting myself in the foot by doing so. Most studies seem to want 20/30/50 sites across the UK. Site selection can be quite a competitive affair and quite frustrating from our side but that’s another post. If I train up (or the RRDNs help) loads of sites get research active - it just generates competition and means that any one site is less likely to get a study. That in itself means that any investment in people/equipment/time is harder to justify and while sponsors might like the eagerness - they are dealing with lots of inexperienced sites all recruiting small numbers. multiple contracts, multiple contacts, lots of questions, lots of issues.
A collaborative model seems to make more sense to me? Let an experienced site like mine - work with a number of less experienced sites - not as PIC sites where all they do is feed in recruits but as satellite sites with trial deliver from each base or each locality - where perhaps staff and resources are shared and knowledge and expertise can improve recruitment, retention, data quality etc..
You agree Im sure but.. the system doesn’t seem to allow this. We need model contracts both between the practices and between the sponsors and the lead practice provider. we need sponsors to understand this model (they keep wanting to set everyone up as a separate site) and to build their IT and IP management around it. At the moment particularly for double blinded RCTS - IP dispensing systems don’t seem to want to cope with IP on multiple sites. Monitoring also tends to be site specific but with some easy IT enhancements a lot of that could be done centrally or even remotely.
Keen to hear your views? have you got multi-site working? do you use a central workforce? central PIs? what models/agreements are you using? some of the big commercial players are getting into this game (or already there) and they are taking the fees and passing on chicken feed to the practices - done right practices could be getting a real income from this.