licensing and what meds work better

RE: licensing and what meds work better

Jo Dyer — Fri, 06 Sep 2019 20:33:24 GMT

[quote user="robloxley"]The EMEA guidelines for NSAID applications are here https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-conduct-efficacy-studies-non-steroidal-anti-inflammatory-drugs_en.pdf and it seems you don't need a non-inferiority trial or positive (rather than placebo) control group[/quote]

Exactly. It's not seen as ethical for humans, but it is for animals.

RE: licensing and what meds work better

Rob Loxley — Fri, 06 Sep 2019 20:10:34 GMT

[quote user="Jo Dyer"]Researchers are very unlikely to get ethical approval to do the trial if that is the case, and as far as I am concerned it should be the same for animals. [/quote]

The EMEA guidelines for NSAID applications are here https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-conduct-efficacy-studies-non-steroidal-anti-inflammatory-drugs_en.pdf and it seems you don't need a non-inferiority trial or positive (rather than placebo) control group

RE: licensing and what meds work better

Thomas Johnson — Fri, 06 Sep 2019 16:25:34 GMT

[quote user="Jo Dyer"]

According to the Declaration of Helsinki it is regarded as unethical in human studies in the UK to use a placebo instead of an active control in efficacy trials. They can be used for testing for side-effects. Researchers are very unlikely to get ethical approval to do the trial if that is the case, and as far as I am concerned it should be the same for animals.

I will personally disregard evidence where the control group of animals in pain did not receive a effective treatment, as in eg the Rausch-Derra et al (2016) grapiprant study.

[/quote]

I was led to believe by the Elanco rep that the FDA in the USA prefer placebo controlled trials whereas the EU medicines authorities prefer comparison with an already proven alternative, and the grapiprant trials were done in the USA hence being placebo controlled.

RE: licensing and what meds work better

Jo Dyer — Fri, 06 Sep 2019 16:22:29 GMT

I will personally disregard evidence where the control group of animals in pain did not receive a effective treatment, as in eg the Rausch-Derra et al (2016) grapiprant study.

RE: licensing and what meds work better

Sarah Keir — Thu, 05 Sep 2019 12:54:47 GMT

SAMSoc is very much involved in first-opinion practice research. We already have several projects under way and more are going to be launched at our Autumn meeting - come along and find out more.

Getting ethical approval for projects is not as hard as you would think. Mark Dunning gets SAMSoc projects through the Uni of Nottingham ethics committee, also the BSAVA I think have a route for getting approval. I think I read something else recently that another group was setting up an easy access for ethical approval of in practice research (RCVS Knowledge?).

I agree, there isn't enough research done at the level where it makes a difference to the greatest number of patients i.e. primary care. But the way to change this is to get everyone involved in it, even if it is just collecting data/cases (e.g. via SAVsNET). I am finding the greatest problem for my project is that people say they want to help and sign up to the project but then don't then actually action it.

The biggest barriers to research are that negative results are withheld or at least have a bias against being published, published results are not freely accessible without paying money and research needs to be funded as as no NHS in the vet world, this means that pharmaceutical companies pay for the research. But things are changing - CEBVM, RCVS Knowledge, the BSAVA research masters....

Be the change you want to see.

RE: licensing and what meds work better

Andreas Ege — Thu, 05 Sep 2019 10:49:55 GMT

[quote user="Evelyn Barbour-Hill"](...)It gets a licence if it works. What's wrong with that?[/quote]

IMO whats wrong with that is exactly what I said - if we got something we don't really need something else that's better than nothing. What we need is something that's better than what we got.
Besides, call me a cynic, but just because it got licensed doesn't even mean it's working. In a worst case it only means that the manufacturer published the couple of studies (or how many are needed for licensing) that show a positive effect but not the dozen that didn't. Wouldn't be the first time that a medication got removed from market again because it was eventually figured out it's not working or has more severe adverse reactions than originally shown (or maybe than originally published...).

[quote]It's for clinical researchers and you to work out which works better (if either), (...) [/quote]

I absolutely disagree with that for multiple reasons.
1. Choice of profession. I did spent 3 years in basic and clinical research including taking part in developing a cattle vaccine that's been marketed for a few years now. If wanted to do research, I would have stayed a researcher. I would assume similar choices have been made by a lot if not most vets in practice.
2. Practical reasons: time, money, and procedural issues.

I assume we can agree that personal impressions and experiences are not the most reliable kind of information. So you would have to run some kind of study to compare products.
As long as you do that informally and only use it in-house you're likely fine without an ethics commitee. But as soon as you want to share that data it becomes a proper animal experiment and you'll need an ethics committees approval (ironic that just doddling on without knowing what works better is considered ethical without needing approval while sharing data that's on the system anyway needs approval even if anonymized - but that's a different kettle of fish).
That all boils down to cost: money and time. Between work, family and things in house and garden needing sorting I personally struggle finding the time to keep up to date (or close to it) with my medical interests. I wouldn't see where the time for additional work in research would come from. Being employed confounds that, as you can't necessarily freely choose to spend time or money on side projects.
Organizing can be a barrier as well. I would think not a lot of practitioners have experience getting a study ethically approved, so you're looking at even more time and hassle at least, more cost potentially.
One practice alone might not to see enough patients to get a statistically sound result, so more time to get other practices in the boat if you want to do it right.
Finally, not one practice (or research centre, for that matter) could do that work for every medication where we got multiple options themselves. There simply are too many.

In summary I think generally it would be a good idea to do more clinical research involving general practice.
But I don't quite see that coming easily in the future due personal disposition, investment in time and money and organisational issues.
And I certainly don't think the onus should be on practitioners to do that work.

I admit, I do think the whole licensing procedure and the cascade system is deeply flawed with putting the pharmaceutical industries interests way before patients, owners and (veterinary) doctors interests.