200 page parliamentary report on RCTs and problems with spin

[Esther12]

I've not read it all... just been going through looking at bits related to protocols. A lot of protocol stuff, but almost nothing on what to do when researchers deviate from their protocols.

I've had to correct the format a lot, but there could still be glitches- sorry:

http://www.publications.parliament.uk/pa/cm201314/cmselect/cmsctech/104/104.pdf

61. Witnesses were unanimous in their support of trial registration. The Wellcome Trust stated that registration was “the most important” way in which clinical trials could be made more open to scrutiny, while Dr Fiona Godlee, editor-in-chief of the British Medical Journal (BMJ), claimed to “only see benefits”, explaining that “if prospective trial registration were working [...], it would ensure that we
would have a full record of all the ongoing trials and, therefore, the potential to chase up and obtain the full results of those trials”. 215
Tracey Brown, Sense about Science, agreed that, at present: We do not even have the contents list, if you like, of what has been done, never mind being able to track down some of the results. That is something that reviewers who are looking across a whole range of studies really struggle with; they spend a lot of
time just trying to find out what has actually been done but been left in a cupboard somewhere. Registration is about knowing what the trial is for and registering the protocols. 216
Dr Elizabeth Wager, a freelance writer and publications consultant, noted the particular importance of registering design details before a study began, in order to “help to reduce, or at least identify, the selective reporting of outcomes, or changes in study design occurring between initiation and publication”.217
...
64.
Since the trials of treatments currently in use often occurred many years ago, retrospective disclosure is important if the benefits of clinical trial transparency are to be realised in the short to medium-term. Although retrospective trial registration will incur some cost, we consider that this will be outweighed by the public health benefit of having a complete picture of the trials conducted on treatments currently available to patients. The Government should support the retrospective registration of all trials conducted on treatments currently available through the NHS and should actively pursue policies to bring this about.

p37-38
ON problems with relying only on peer reviewed journals for publication:

67. However, there are several limitations to academic journals as a source of summary-level trial results, the most significant of which, according to the advoca
cy groups Healthy Skepticism UK (HS-UK) and Health Action International (HAI), is the potential for
journal articles to “not only misrepresent the actual results or conclusions of that study but also skew the larger body of evidence”. 227
HS-UK and HAI stated that misrepresentation
could come in the form of several types of reporting bias, which affect how, when and where a trial is published, based on the natureand direction of its results.228 The most frequently highlighted bias was publication bias, where by “positive” results—those which suggest that a treatment is effective—are placed in the public domain more frequently than “negative” results. Dr Wager, an ex-employee of the pharmaceutical industry, agreed that “under-reporting” was a problem, particularly for negative results, and put this down to a number of causes including:
•clinical investigators being uninterested in unexciting
or unfavourable results;
• journal space constraints and the rejection
of papers detailing “negative” results;
•deliberate omission of unfavourable or inexplicable outcomes; and
•resources being transferred away from drugs that were no longer being developed, making publication of the results of related trials a low priority.229
The Global Alliance of Publication Professionals (GAPP) agreed with Dr Wager that “publications do not write themselves” and suggested that many studies remained unpublished simply because researchers “lack the resource s to write up their results”.230 Dr Godlee, BMJ, however, criticised researchers who kept trial results “in their bottom drawer” if they did not “come up with the results that they wish[ed] for”.231
Dr Godlee agreed that in the past journals had also been at fault in failing to publish “negative” results, but claimed that the introduction of “open access journals an d online journals that have lots of space to publish negative and neutral results” meant that this was no longer the case.232
BioMed Central, an academic publisher, concurred, suggesting that rejection by journals was no longer avalid reason for non-publication since “many peer-reviewed journals [...] strongly encourage publication of negative results” and “at least one journal makes publication of negative results its mission”: the Journal of Negative Results in Biomedicine. 233

p39

Tracey Brown:
The thing that should have been added
on the end of everything is, “or equivalent”. Once we
had that discussion with the Medical Research
Council, I think it was happy. As I understand it, its
concern was, “We do not want to start asking
academics to prepare a regulatory marketing
authorisation document that they have no need for,”
and quite clearly that is not the case. They should not
have any problem, because under requirements
already in operation, they are supposed to publish
their protocols and the primary and secondary
outcomes of their trials, so it should not present a
problem for them to do that. It might not look like a
similar format

p110

Tracey Brown:
I am not quite sure how it came about
that people were thinking that non-commercial
researchers would be producing clinical study reports.
Clearly, it would be strange to produce a regulatory
document, if you were not seeking regulatory
approval. If it were the case, I would imagine that it
would take that time, but I cannot ever see a situation
in which anyone would realistically be calling for the
production of those. However, it is absolutely not
unrealistic at all to expect anyone involved in clinical
research to be able to publish the primary and
secondary outcomes and the protocols of their
research—effectively, publish their results. They are
required to do so. It is not as though this is
requirement that does not already exist in the running
of clinical trials. I know that you have the HRA
speaking to you later this morning, and they, I am
sure, have something to say about the ethical
component of running clinical trials, requiring that
people undertake those responsibilities. It is just a
question of the fact that no one has actually enforced
it

2.2 The signatories to the letter asked the EMA to put in place measures to ensure that the protocols for all clinical trials from now on—and all clinical trials since the 1980s—are posted on a public register; and that the primary and secondary outcomes measured in all these trials and the clinical study reports are publish

p135 (written Sense About Science testimony)

Academics are already required, according to the Helsinki Declaration, to make the results of trials available:
“Authors, editors and publishers all have ethical obligations with regard to the publication of the results of research. Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. They should adhere to accepted guidelines for ethical reporting.”
This means all results according to what was planned in the trial protocol, not just a summary of the results (we already know that summaries of results are generally highly misleading, see, for example: Gøtzsche PC. Believability of relative risks and odds ratios in abstracts: cross-sectional study. BMJ 2006;333:231–4).
March 2013

p144 (further SAS written testimony)

 

[alex3619]

Hmmm, should we make a checklist? Then show for each of these points the PACE trials succeeded or failed? Because at first read it looks like PACE is a fail, fail, fail.