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Roche’s Sunfish Clinical Trial – why didn’t it happen here/what about access to future trials?

28 June 2018

At SMA Support UK, we shared the community’s frustration when Roche announced this month that, due to the rapid increase of recruitment into the study, all available screening slots had been allocated by study centres which were already up and running. This meant that no new sites and countries, including the UK would be able to offer this Sunfish clinical trial.

We followed this up with GOSH and learned that staff there were equally disappointed and frustrated. They had been working to a timeline agreed with Roche for different sites in different countries to open. GOSH was due its first site visit by the company this month with a view to opening the trials. The news this wasn’t going to happen came to them at the same time as it reached the wider community.

Roche commented to GOSH: ‘This will be bitterly disappointing for you and your patients. However, we do not think it make sense to ask you and your staff to continue to invest more time and effort when the probability of you being able to enroll patients is so low. On behalf of Roche, I thank you all for your efforts to ensure the success of the Sunfish trial.’

As Professor Muntoni said to us in answer to our query: ‘So what has happened is outside our control as we are not in a position to dictate how many patients are recruited in other countries. This is the first time in the last decade that a clinical trial close recruitment significantly ahead of schedule. From our side we clearly had invested in the possibility to start recruitment imminently, so we share your frustration, although I do appreciate your level of frustration will be significantly higher than ours, I am sorry for this.’

From our perspective, next time round, in order for us to be involved in one of these studies in the future, I will need assurance by the Sponsor that we are in a position to recruit early, and not late in a trial, as the implication of not having been able to recruit – apart the frustration- is also an immense waste of time from multiple members of my team, who attended training days in order to be accredited to participate. This is not a good use of the time of our team.

On a positive note, this leaves us now more spare capacity to participate in other upcoming SMA trials. We have already been in touch to express our availability to other sponsors.’

What to do if you would like to be considered for a clinical trial?

To date, SMA clinical studies have involved very small patient numbers. The clinical leads from GOSH and Newcastle have been able to recruit from their own known group of patients and, if required, have been able to reach out to colleagues in different centres. Therefore, in a sense, the possibility of inclusion in a trial has been largely influenced by who a person’s clinician is and their ability and means to travel. This is of course hugely frustrating and an inequitable ‘postcode lottery’, but is possibly difficult to avoid due to the limited number of centres of excellence that have been clinical trial sites and the small numbers of participants.

Clinicians are very aware of how this must feel to families.

If you are interested in trials, do make sure your medical team knows about this. There is a robust National Network of Neuromuscular Clinicians and Physiotherapists. Upcoming trials are communicated to the Network in a timely way to give the possibility for your team to refer you if you are potentially eligible.

It’s also important to have your name and details recorded with the SMA Patient Registry.  They may also be asked to help identify potential recruits should the inclusion criteria be very specific and limited.  You can register here but please do note that being registered does not mean a guarantee you will be invited for screenings for trials.

Also, if you are aware of a study coming up and you think you would meet the criteria, you can contact the centre involved in it directly. They, in turn, will then contact your local doctor whose involvements is essential.

On a final note, the demand for SMA trials has been very high and cannot be fulfilled with only two clinical trial centres in the UK (GOSH and Newcastle).  Other centres would also like to offer trials, with further work needed on how this can be to done.

Keep up-to-date

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