The next focusIR Investor Webinar takes places on 14th May with guest speakers from WS Blue Whale Growth Fund, Taseko Mines, Kavango Resources and CQS Natural Resources fund. Please register here.
London South East prides itself on its community spirit, and in order to keep the chat section problem free, we ask all members to follow these simple rules. In these rules, we refer to ourselves as "we", "us", "our". The user of the website is referred to as "you" and "your".
By posting on our share chat boards you are agreeing to the following:
The IP address of all posts is recorded to aid in enforcing these conditions. As a user you agree to any information you have entered being stored in a database. You agree that we have the right to remove, edit, move or close any topic or board at any time should we see fit. You agree that we have the right to remove any post without notice. You agree that we have the right to suspend your account without notice.
Please note some users may not behave properly and may post content that is misleading, untrue or offensive.
It is not possible for us to fully monitor all content all of the time but where we have actually received notice of any content that is potentially misleading, untrue, offensive, unlawful, infringes third party rights or is potentially in breach of these terms and conditions, then we will review such content, decide whether to remove it from this website and act accordingly.
Premium Members are members that have a premium subscription with London South East. You can subscribe here.
London South East does not endorse such members, and posts should not be construed as advice and represent the opinions of the authors, not those of London South East Ltd, or its affiliates.
Very interesting discussion Burble and Bermuda.
Where do you think human challenge studies fit in where healthy volunteers are infected with Covid 19 within a secure respiratory viral unit.
Obviously you are limited to smaller numbers but my understanding carrying out these trials can generate valuable data and speed up the Approval process.
Thanks in advance
Burble - that's great, thanks very much, appreciated
LochinvarLass - thanks for your earlier heads up and links
Bermuda
I think possibly the way I phrased it was wrong and I apologise if it came across in this manner. At the moment a clinical trial for any C-19 vaccine is useless if cases of infection are dropping - you will not be able to tell whether a vaccine is working quickly if people aren't being infected - hence you'd be unable to tell if the investigational arm was seeing less infections.
Obviously a challenge trial doesn't require community infections as you are giving people C-19 in a hospital situation, so actually diminishing rates of community infection in the UK wouldn't matter for a challenge trial. There are a number of reasons why the UK may acutally be a better place than the US for this type of thing - firstly treatment at point of care is free meaning if you got taken seriously ill in a challenge situation it wouldn't bankrupt you. Secondly, you have a network of NHS hospitals which all talk to each other. In the US hospitals don't generally talk to each other, hence getting a trial of any size set up in the US is more difficult than here in the UK.
I think where my mind was going was in relation to Covidity. It would be easier to test under standard trial protocols in the US at the current moment in time because there are many active community infections ongoing. Hence it would be quicker to get a readout (positive or negative) as to whether it was working or not. If you wanted to go down the challenge route, then you would be better to do it in the UK but most likely at a higher cost.
Great insights, thank you.
Uni of Notts is a site for the Oxford vaccine clinical trial. I understand that they have revamped many processes to get this lead on competitors. Flaskdata (Israel) has developed ways to collect data points directly from participants to help ensure the right data is collected at the right time. This also helps with the collation and reporting of that data, and thus submissions to regulatory authorities.
Burble,
Thanks for the comprehensive replies. I was trying to understand why you feel the US would be a better place to run a challenge trial. ie. Your comment 'You'd want to try this in somewhere like the US at the moment'. Are you saying that the regulatory environment is easier in the US?
Yes to a point, the problem you run into is to get a clinical trial off the ground internationally is that you have to have protocols that are approved by individual countries, each ethics committee will have certain criteria to go through before they will sign off on something. Hence, it'd be easier to get a challenge trial signed off in the UK than it would to get it signed off in the US from a distance.
Currently colleagues are trying to open a trial across Europe, the US and the UK and are having an absolute nightmare because each country is wanting something slightly different and so protocols are being drafted, redrafted, as are patient information leaflets, consent forms etc. It's definitely easier opening a trial in a single country. Then you would want a multi-site model, which means that once approved by ethics you would need to get each individual R&D department to sign up to and sign off on a trial. Depending on the trust, this can take weeks or months or longer.
If they applied to the MHRA for ethical approval then yes. But as with any clinical trial, you've got to have the thing fully costed, with a clinical trials unit to back you, all the necessary paperwork in place (consent, patient information leaflets, protocols etc). Then you have to go through each individual NHS R&D department to get them to sign off on the trial, allocate staffing time etc to it.
The number of processes and things that have to be in place prior to a clinical trial opening are tremendous. A standard clinical trial probably takes upwards of a year to be designed, approved and signed off and that's multiple people working on it full-time. It's not as simple as just asking people to sign a piece of paperwork.
As somebody who has sat on MHRA ethics committees, and submits to them regularly, the time it takes to get a trial started (even a very basic trial) is colossal. Generally for our ethics for a non-CTIMP trial, in 20 hospitals across the UK takes routinely 6-12 months to get everything signed off. For a CTIMP trial this could be longer and for CTIMP challenge trial it wouldnt surprise me if timelines are stretched even further. Though I would add the caveat that currently ethics committees are prioritising all C-19 trials, hence it may take less time to go through than we would appreciate normally.
Burble,
Re. your 12.45, isn't the whole point that challenge trials can be carried out anywhere? ie. They don't require high levels or even any COVID-19 in the community and so there would be no advantages in carrying out a trial in the US rather than the UK. Apologies if I have misunderstood your post.
I'm going to wait until Q1 2021 to find out more about Scancell's trial before volunteering.
So could SCLP as for shareholders to volunteer to take COVIDITY to save money. Any volunteers or nominations on here?
If ethics approve it then yes it is ethical. We have challenge trials going on all the time with the likes of FluCamp etc.
Generally the population that are exposed will be screened for underlying health conditions, but as with any clinical trial there are risks involved and the disclaimers for this can be as long as your arm. The problem here in the UK currently is that there are relatively low numbers of actively infected C-19 patients so trials are unable to actually get significant data to see whether they are effective. You'd want to try this in somewhere like the US at the moment, but there is obviously difficulties getting ethical agreements over there at short notice. One thing I would add, is that if I were to do a challenge trial, I'd rather do it in a hospital in the UK - at least it wouldn't bankrupt you if you ended up in ICU!
https://www.bbc.com/news/health-53426367
To deliberately expose people to a potentially deadly illness.