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holding.html
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<html>
<head>
<link rel="stylesheet" href="https://unpkg.com/[email protected]/build/pure-min.css" integrity="sha384-nn4HPE8lTHyVtfCBi5yW9d20FjT8BJwUXyWZT9InLYax14RDjBj46LmSztkmNP9w" crossorigin="anonymous">
<meta name="viewport" content="width=device-width, initial-scale=1">
<style>
body {
color: #333;
}
/*
The content `<div>` is where all your content goes.
*/
.content {
margin: 0 auto;
padding: 0 2em;
max-width: 800px;
margin-bottom: 50px;
line-height: 1.6em;
}
.header {
margin: 0;
color: #333;
text-align: center;
padding: 2.5em 2em 0;
border-bottom: 1px solid #eee;
}
.header h1 {
margin: 0.2em 0;
font-size: 3em;
font-weight: 300;
}
.header h2 {
font-weight: 300;
color: #ccc;
padding: 0;
margin-top: 0;
}
.footer {
margin: 0;
color: #333;
text-align: center;
padding: 2.5em 2em 0;
border-top: 1px solid #eee;
font-style: italic;
font-size: smaller;
}
</style>
</head>
<body>
<div id="main">
<div class="header">
<h1>FDAAA Compliance Tracker</h1>
</div>
<div class="content">
<p>
The best currently available evidence shows that the results
of clinical trials are routinely withheld from doctors,
researchers, and patients. This is
a <a href="http://alltrials.net/">global public health
scandal</a>.
</p>
<p>
The <a href="https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FoodandDrugAdministrationAmendmentsActof2007/default.htm">FDA
Amendment Act of 2007 (FDAAA)</a> requires certain clinical
trials to report their results on
<a href="https://clinicaltrials.gov/">ClinicalTrials.gov</a>. Despite
extensive evidence of breaches, no fines have ever been
issued.
</p>
<p>
The <a href="https://www.federalregister.gov/documents/2016/09/21/2016-22129/clinical-trials-registration-and-results-information-submission">Final
Rule</a> to properly implement this law has now finally come
into force. The first trials required to report results
under the new FDAAA rules will begin to come due on January
18, 2018. There is then a one month delay to results being
posted.
</p>
<p>
On February 16, 2018 this website will go live, showing
which individual sponsors and trials have breached their
legal requirement to report results.
</p>
</div>
<div class="footer">
<p>
The FDAAA Compliance Tracker is built by
<a href="https://www.phc.ox.ac.uk/team/sebastian-bacon">Seb Bacon</a>,
<a href="https://www.phc.ox.ac.uk/team/nicholas-devito">Nick DeVito</a>,
and
<a href="https://www.phc.ox.ac.uk/team/ben-goldacre">Ben Goldacre</a>
at the
<a href="https://www.bennett.ox.ac.uk/">Bennett Institute for Applied Data Science</a>
in the University of Oxford.
</p>
</div>
</div>
</body>
</html>