clinical trial

Here you will find news updates, papers and links from the Clinical Trial Team in Birmingham.
15 July 2018(Publish Date)
Clinical Trial Update from Prof Tim Barrett
Dear friends,

I want to provide a brief update on our progress towards a clinical trial in Wolfram. I am pleased to say that we are finally getting some progress with the medicine issues that we had been having.
The first hurdle to mention is that we now have regulatory approval to go ahead with the trial, from the Health Regulatory Agency. This means the clinical trial protocol, participant information sheets, consent forms, and so on, are all approved and ready to go.

The second hurdle is stability testing. You remember that we need to show that the medicine we would like to use, is stable outside manufacturer's packaging for at least 12 months. Our pharmacy partners had great technical difficulty in dissolving the tablets, extracting the active ingredient, and showing it had not degraded. Part of the problem was that the tablets had been coated with a chemical that interfered with the assays. I am pleased to say that after several modifications, our partners now have a method for completely dissolving the tablets. They have gone ahead and tested the stability of tablets that have been kept in study containers for 12 months, and I am relieved to say that initial results show the medicine is indeed stable. These methods are now being validated to regulatory standards; then the tests will be repeated, before allowing us to progress with medicine and placebo manufacture.

The third hurdle is recruitment. The medicine stability issue has caused a delay to recruitment of about 12 months. I know this must be incredibly frustrating to you, and indeed it is to us. We are trying to keep in close contact with you through Tracy, Jody, and in the multidisciplinary clinics, to keep you updated. We are confident that you will help us by participating once the trial is open. Our clinical trials unit, local investigators, and nurses are working hard to be ready to go as soon as the medicine and placebo are made.

The fourth hurdle is international sites. Our colleagues in Poland, France and Spain are being fantastic, and we are working with their national coordinating centres to get their sites open to recruitment as soon as possible after the UK sites open. This may allow us a bit of catch-up time.

I hope this helps for now, and I will send another update in August

Sincerely

Tim
30 April 2018(Publish Date)
Clinical Trial Important Update from Prof Tim Barrett
Dear friends and colleagues,

I wanted to update you about the TREATWOLFRAM clinical trial. Rebecca Storey, our clinical trials coordinator, has done a fantastic job in writing all the regulatory documents. These include things like patient information sheets, consent forms, ethics submission, clinical trial reporting documents, insurance and adverse event notification. She submitted the whole package in January. We had the ethics committee interview in February, the ethics approval in March, and last week we finally received the UK Health Research Authority approval letter. This means all the approval documents are in place! This has been a fantastic amount of work, and I am really grateful to Rebecca and the clinical trials team in Birmingham for pulling these all together. I am now sending the whole package to our partners in Spain, France, and Poland, so that they can get their own country regulatory approvals in place to start the trial.

The next rate limiting step is production of the medicine. As you know, we have had great difficulty in proving the medicine remains stable when outside its manufacturers' packaging. Our pharmacy production unit at Guy's and Thomas's hospital in London have been working hard to find a method to prove stability; they have made some progress over the last 2 weeks. At the same time, I have been in touch with bulk medicines suppliers, who have found a couple of alternative sources of the medicine that come in old fashioned glass bottles. This could be interesting as the medicine could stay in its original container.

We have a telephone conference about this next week and I remain hopeful that we can solve this problem in the near future. I will keep you all updated through Tracy as soon as I have more information

In the meantime, I am spending the next 2 days with Susan Gleeson meeting some wonderful families at our children's Wolfram clinic here in Birmingham. I hope you all have a relaxing (and sunny) May bank holiday

With best wishes

Tim
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