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<li><a href="https://doi.org/10.1186/s13063-019-3173-2">A prospective cohort study correcting and monitoring 58 misreported trials in real time</a></li>
<li><a href="https://doi.org/10.1186/s13063-019-3172-3">Qualitative analysis of researchers’ responses to critical correspondence on a cohort of 58 misreported trials</a></li>
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Tracking switched outcomes in clinical trials
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Resistance and misunderstanding from the journal editors on
outcome switching – What does the FDA say?
</h1>
<p class="entry-meta">
<time
class="entry-time"
itemprop="datePublished"
datetime="2016-02-12T16:28:34+00:00"
>February 12, 2016</time
>
- by
<span
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><span class="entry-author-name" itemprop="name"
>Carl Heneghan</span
></a
></span
>
<span class="entry-comments-link"
><a href="fda/index.html#comments">1 Comment</a></span
>
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<h4>
<span style="font-weight: 400"
>There seems to be some resistance and misunderstanding from
journal editors and the academic community on outcome
switching, so we thought it would be useful to give an
overview of what various authoritative bodies have to say on
the topic. In this series, we will cover </span
><span style="color: #0000ff"
><a
style="color: #0000ff"
href="blog/outcome-switching-what-does-the-icmje-say/index.html"
><span style="font-weight: 400">ICMJE</span></a
></span
><span style="font-weight: 400"
>, CONSORT, the FDA, and the Word Of God. Today, we look at
the FDA.</span
>
</h4>
<p><span id="more-312"></span></p>
<p>
<span style="color: #000000"
><span style="font-weight: 400"
>In the US, the Food and Drug Administration (FDA)
regulate drugs. Some background is required to understand
what the FDA say on drug regulation and to make it clearer
for everyone I have bolded the </span
><b>MUST</b><span style="font-weight: 400"> or</span
><b> MANDATORY </b
><span style="font-weight: 400"
>items required to comply with these regulations.</span
></span
>
</p>
<p>
<span style="color: #000000"
><span style="font-weight: 400"
>The legislation that new drugs have to comply with is the
FDA Amendments Act (FDAAA), </span
><span style="color: #0000ff"
><a
style="color: #0000ff"
href="https://clinicaltrials.gov/ct2/manage-recs/fdaaa"
><span style="font-weight: 400">Section 801</span></a
></span
><span style="font-weight: 400">
. This important piece of legislation states that either
the sponsor or the PI is responsible for registering the
clinical study. There </span
><b>MUST</b
><span style="font-weight: 400">
be a responsible party for each applicable clinical trial,
who is accountable for what appears in the registry, and
for each clinical trial they </span
><b>MUST</b
><span style="font-weight: 400"> register the trial </span
><i><span style="font-weight: 400">and</span></i
><span style="font-weight: 400">
submit the results within one year of the trial being
completed.</span
></span
>
</p>
<p>
<span style="color: #000000"
><span style="font-weight: 400"
>The Act applies to trials with one or more sites in the
US; conducted under a new drug or device application; or
involving an intervention manufactured in the US. On the
FDA website, the</span
><span style="color: #0000ff"
><a
style="color: #0000ff"
href="https://prsinfo.clinicaltrials.gov/definitions.html"
>
<span style="font-weight: 400"
>Protocol Data Element Definitions</span
></a
></span
><span style="font-weight: 400">
specifies the elements that </span
><b>MUST</b
><span style="font-weight: 400">
be reported in the registry to comply with the Act.</span
></span
>
</p>
<p>
<img
class="wp-image-313 aligncenter"
src="wp-content/uploads/2016/02/Screen-Shot-2016-02-12-at-16.19.27-300x78.png"
alt="Screen Shot 2016-02-12 at 16.19.27"
width="673"
height="175"
srcset="
wp-content/uploads/2016/02/Screen-Shot-2016-02-12-at-16.19.27-300x78.png 300w,
wp-content/uploads/2016/02/Screen-Shot-2016-02-12-at-16.19.27.png 743w
"
sizes="(max-width: 673px) 100vw, 673px"
/>
</p>
<p>
<span style="color: #000000"
><span style="font-weight: 400"
>Importantly, the primary outcome measure is a </span
><b>MANDATORY </b
><span style="font-weight: 400"
>requirement of the registry, and is required to comply
with FDAAA Section 801. And even more important, as this
issue has come up many times in response to COMPare, is
the </span
><b>MANDATORY</b
><span style="font-weight: 400">
requirement for the time-point at which the outcome is
assessed to be included in the registry entry. This is
only required by</span
><span style="color: #0000ff"
><a
style="color: #0000ff"
href="https://clinicaltrials.gov/"
>
<span style="font-weight: 400"
>ClinicalTrials.gov</span
></a
></span
><span style="font-weight: 400">
for records first released on or after December 1,
2012.</span
></span
>
</p>
<p>
<img
class="wp-image-316 aligncenter"
src="wp-content/uploads/2016/02/Screen-Shot-2016-02-12-at-16.21.26-300x102.png"
alt="Screen Shot 2016-02-12 at 16.21.26"
width="842"
height="286"
srcset="
wp-content/uploads/2016/02/Screen-Shot-2016-02-12-at-16.21.26-300x102.png 300w,
wp-content/uploads/2016/02/Screen-Shot-2016-02-12-at-16.21.26-768x262.png 768w,
wp-content/uploads/2016/02/Screen-Shot-2016-02-12-at-16.21.26-1024x349.png 1024w,
wp-content/uploads/2016/02/Screen-Shot-2016-02-12-at-16.21.26.png 1200w
"
sizes="(max-width: 842px) 100vw, 842px"
/>
</p>
<p>
<span style="color: #000000"
><span style="font-weight: 400"
>Further to this, the secondary outcomes measure is also a </span
><b>MANDATORY </b
><span style="font-weight: 400"
>requirement, along with the time-point and
description.</span
></span
>
</p>
<p>
<img
class="wp-image-317 aligncenter"
src="wp-content/uploads/2016/02/Screen-Shot-2016-02-12-at-16.22.12-300x40.png"
alt="Screen Shot 2016-02-12 at 16.22.12"
width="1006"
height="134"
srcset="
wp-content/uploads/2016/02/Screen-Shot-2016-02-12-at-16.22.12-300x40.png 300w,
wp-content/uploads/2016/02/Screen-Shot-2016-02-12-at-16.22.12-768x102.png 768w,
wp-content/uploads/2016/02/Screen-Shot-2016-02-12-at-16.22.12-1024x136.png 1024w,
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"
sizes="(max-width: 1006px) 100vw, 1006px"
/>
</p>
<p>
<span style="color: #000000"
><span style="font-weight: 400"
>It is also worth noting that the FDA website tells us
that staff members at</span
><span style="color: #0000ff"
><a
style="color: #0000ff"
href="https://clinicaltrials.gov/"
>
<span style="font-weight: 400"
>ClinicalTrials.gov</span
></a
></span
><span style="font-weight: 400">
review study records after they are released and before
publication. Apparently – as I don’t
</span></span
><span style="color: #000000"
><span style="font-weight: 400"
>know if what comes next actually happens – this
review focuses on “apparent validity,</span
>
<span style="font-weight: 400"
>meaningful entries, logic and internal consistency, and
formatting.”</span
>
<span style="font-weight: 400"
>Now if all this happened, then it would ensure outcome
measures were correctly defined in the trial registry
entry.
</span></span
>
</p>
<p>
<span style="color: #000000"
><span style="font-weight: 400"
>Therefore, to comply with FDA regulations, which is
pretty stiff in its penalties, you </span
><b>MUST</b
><span style="font-weight: 400">
register and report the primary outcomes with adequate
time-points and descriptions.
</span></span
>
</p>
<p>
<span style="color: #000000"
><span style="font-weight: 400"
>However, a word of caution: section 801 also requires
that drug and device clinical trials, done in the US, </span
><b>MUST</b
><span style="font-weight: 400">
report their results within 1 year of completion on the
website</span
><span style="color: #0000ff"
><a
style="color: #0000ff"
href="https://clinicaltrials.gov/ct2/home"
>
<span style="font-weight: 400"
>ClinicalTrials.gov</span
></a
></span
><span style="font-weight: 400"
>. And if you don’t report your results, you will be fined
for every day that you don’t. However, to date this fine
has </span
><span style="font-weight: 400">never</span
><span style="font-weight: 400">
been imposed. This is odd when you consider that at least
half of all trials don’t report their summary results in
this window of opportunity.</span
></span
>
</p>
<p>
<span style="font-weight: 400; color: #000000"
>It is likely that registry entries which are incorrect,
fuzzy or missing details are not being noted or corrected at
the outset by the FDA; adding to the confusion and possibly
undermining the value of the registry entry, which can’t be
helping the ongoing issue of outcome switching.
</span>
</p>
<p><strong>Carl Heneghan</strong></p>
<p> </p>
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<div class="entry-comments" id="comments">
<h3>Comments</h3>
<ol class="comment-list">
<li class="comment even thread-even depth-1" id="comment-1709">
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<span class="says">says</span>
</p>
<p class="comment-meta">
<time
class="comment-time"
datetime="2016-10-17T19:09:17+00:00"
itemprop="datePublished"
><a
href="fda/index.html#comment-1709"
class="comment-time-link"
itemprop="url"
>October 17, 2016 at 7:09 pm</a
></time
>
</p>
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<div class="comment-content" itemprop="text">
<p>
Dr. Bernard Carroll, MBBS, PhD, FRCPsych. Professor and
Chairman Emeritus, Department of Psychiatry and
Behavioral Sciences, Duke University Medical Center,
Durham, NC, is soliciting signatures for a petition to
the U.S. Congress addressing at least one part of the
FDA-NIH interface problem that you identify. He writes:
</p>
<p>Colleagues,</p>
<p>
I am distributing a petition to the US Congress that I
have helped to write over the summer. It is called
“Truth in Research Labeling.” Here is the link for you
to read it:
<a href="https://tinyurl.com/hja4ccy" rel="nofollow"
>https://tinyurl.com/hja4ccy</a
>. Feel free to sign it after reading the Executive
Summary if you are too busy to read the whole thing.
Thanks to the Lown Institute in Boston for sponsoring
the on-line presence of this petition.
</p>
<p>
This petition aims to clean up the reporting of clinical
trials by getting the FDA on the same page as NIH
(ClinicalTrials.gov). The graphic below says it well – a
picture is worth a thousand words. Right now, FDA and
NIH don’t talk to each other, so a lot of dubious claims
– or worse – go unregulated into the medical journals.
</p>
<p>
<a
href="https://assets.change.org/photos/3/tg/xl/CBtgxliSeblIOgV-800x450-noPad.jpg?1475085058"
rel="nofollow"
>https://assets.change.org/photos/3/tg/xl/CBtgxliSeblIOgV-800×450-noPad.jpg?1475085058</a
>
</p>
<p>
This petition is unlike most petitions to the Congress.
It goes beyond simply making claims. It cites as
evidence for these claims the best available
scholarship. The petition also provides suggested
language for amending Section 801 of the Public Health
Service Act to bring about the desired change.
</p>
<p>
The issues we address affect the integrity of biomedical
science and, ultimately, the quality of the medical care
that we all receive. If the Congress responds to the
petition by adopting the changes of law that we propose,
all of us will benefit . . . most of all our patients.
</p>
<p>
If you agree with the thrust of the petition, please
sign on to lend your support . . . and pass it around
through your networks. We are hoping that Senator
Elizabeth Warren will at some point embrace and sponsor
this initiative as part of her consumer protections
advocacy agenda. Those of you who are based outside the
USA may still sign it – and perhaps it can serve as a
template for similar efforts in your own countries.
</p>
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