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Could be that was the intent. But the words in the document are the words in the document and no reason not to cite them at face value.

Yes but they would be considered "substantial amendments" rather than new protocols, and can therefore be approved by a two-person sub-committee of the REC. So it's not a high bar.

I have made my concerns known to Carol Monaghan. She's on the committee with Norman Lamb.

I'm ordering this...

yup, that's what it stands for. I never heard of this degree before going to Berkeley. In US it's considered a "professional" doctorate rather than an "academic" doctorate. Like we have PsyD as well as a PhD in psychology, or an EDD as well as a PhD in education. Theoretically, the academic...

DrPH to you!

oh, I didn't realize that. I sometimes can't tell what's behind a wall or what I've gotten through library access.

I've just written about that: http://www.virology.ws/2019/02/12/trial-by-error-bmj-amends-last-weeks-pace-article/?fbclid=IwAR1buck-DYPy_3bSYli0jLEI_Q3WEsEjvzlzpI7-nKHNazYBNEI2sQUiZrc

yeah, I had a lot of exchanges with him but just didn't remember that particular criticism. I kept offering to discuss things in private conversations and he only wanted me to say things publicly. Then he blocked me. Then at some point I noticed that he'd unblocked me. I assume if an article is...

I'm happy to post this or other responses if it seems they're not getting posted at BMJ. Also the story has been tweaked to add my academic credential and also a sentence about academics also being concerned, with a link to BMJ's own coverage of last summer's open letter to Lancet. However, I am...

I didn't see this particular criticism. When did he say that?

helpful to see this all in one place. thanks.

I would interpret it to mean the opposite--the one current in 1998. But the phrase is certainly ambiguous. Anyway, it should be a moot point because the protocol promised to adhere to Helsinki, and when the consent forms were signed the version clearly called for the disclosures. Unfortunately...

MRC Guidelines for Good Clinical Practice in Clinical Trials (1998) 5.4.1 The principles of informed consent in the current revision of the Helsinki Declaration and those laid out in the 13 principles at the beginning of this document should be implemented in all RCTs. That's very...

I agree this is a critical need that I need to pay more attention to going forward, and yes, this current situation has distracted me from getting further along on that topic. I can't speculate about people's motivations--well, I can, but in this case I won't publicly.

It came out of the science integrity (or lack of) hearing. I'm not sure if there was a specific request and I don't know if it came directly from Monaghan--could have been the committee.

The recovery criteria were also not mentioned. So was that tantamount to allowing them to drop them as secondary outcomes? They have described their recovery paper as a "secondary analysis," as if it were a secondary analysis of an existing data set--not a report of secondary outcomes form a...

were their industry ties disclosed in the protocol? I don't remember seeing that in it but the HRA report seems to claim that it was.

I would call their logic and level of integrity to be Trump-like.

yes, and here's the issue with that. At the time, there were no prevailing UK requirements that these links be disclosed--the HRA is right about that. However, I have always made the argument not based on the fact that they didn't disclose but that they violated their own protocol in not...