Documents from the SMILE trial

University of Bristol has created a website with the documents from the SMILE trial.

http://www.bristol.ac.uk/ccah/resea...bility/chronic-fatigue/smile/smile-documents/

Note that does not include the data, of course.

 

I notice that they have not included information about the two amendments just the letters saying they were accepted.

The two lines

refer to the same document which appears to be a convenient mistake.

So as far as I can tell by scanning through the documents they have not said what the amendments they applied for were. I notice that one amendment was approved by a two person sub committee. The second went to the full committee so I assume that is upgrading the study from a feasibility study to a full trial.

 

From this letter

http://www.bristol.ac.uk/media-libr...hics - REC Review of SMILE Project Letter.pdf

I thought that he was promoting the fact the trial was being done by the NHS.

 

Amendment 2.0 seems to have been reviewed by the R&D committee which I assume is the full thing?

It includes

So it looks like the ethics committee did approve the conversion to a full study. But I still think that seems dodgy. In that I would question whether they gave it their full attention in the way they would a new study. I remember at the time the first papers (from the feasibility study) came out it looked like they were optimizing the primary outcomes to get good results. I wonder if such issues were considered by the ethics committee. The inclusion of the earlier data after such outcome switching also seems dodgy.

What we haven't seen with the release of the documents is the case that Bristol University presented to the ethics committee.

 

I don't think I am write and I think they are trying to mislead. The letter I quoted suggesting they had ethical approval for the change:
http://www.bristol.ac.uk/media-libr...cs - Amendment 2 - 20 August 2012 - Reply.pdf
Is from the hospitals R&D committee not the ethics committee. Although its placement on the Bristol university website is misleading. Then as you say the next 3 letters concerning amendment 2 look identical and seem to come from the ethics committee. They appear to approve a new protocol because it is listed in the document list along with "Notice of substantial amendment". I assume this is the one that is missing and replaced by an earlier document. Then the letter of approval for amendment 2 does as you say suggest that it was approved by just 2 people on a subcommittee.

The cynic in me believes that the information is deliberately not there and in a misleading order with duplicates. Which makes me think there is more to find out.

@JohnTheJack have you made any sense of the documents or do you have additional ones.

 

There are websites setting out the process but they are confusing,

From https://www.myresearchproject.org.uk/help/hlpamendments.aspx#1

The boundaries don't seem clear around converting a feasibility study to a full study.

This link also seems relevant
https://www.myresearchproject.org.uk/help/hlpamendmentsresearch.aspx

It would be interesting to know what category amendment they considered it,

 

[QUOTE="
@JohnTheJack have you made any sense of the documents or do you have additional ones.[/QUOTE]

I haven't looked through them properly. I don't have any additional documents.

 

I have today received the result of the review undertaken by Bristol about the SMILE trial data.. They still claim an exemption. I'll refer it to the ICO. It usually takes about 4 months to get a decision.

 

We've tried many times to involve Goldacre but for some reason the former student of Simon Wessely refuses to look at it. He's too busy, apparently. Though not too busy to tweet about harassment of researchers by ME militants.