This is a post taken from the acor list by Gary Takata

Date:    Wed, 24 Oct 2007 20:18:34 EDT
From:    Gary Takata <GTTakata@AOL.COM>
Subject: OFF TOPIC: OPEN CLINICAL TRIALS

 A decade ago a clinical trial could be conducted in secret. The trial's=20
sponsor, claiming proprietary rights, could keep all information about it,=20
including its very existence, private. Thus, if a drug had important adverse=
 effects,=20
this information might never be made public. Legislators believed that such=20=
a=20
possibility was not in the best interests of the American people. Once a=20
clinical trial is mounted, the sponsor has an ethical obligation to publicly=
=20
acknowledge the contribution of the participants and the risk they have take=
n by=20
ensuring that information about the conduct of the trial and its principal=20
results are in the public domain.4 With the FDA Revitalization Act, the Unit=
ed=20
States joins other countries in recognizing that the human volunteers needed=
 to=20
complete a trial are more precious than the money required to mount it. Betw=
een=20
study subjects and financial sponsors, it is easy to see who is taking the=20
greater risk.
 It is time for participants in clinical trials to take the initiative.=20
People interested in participating in trials should consider only studies wh=
ose=20
sponsors have fully registered them in an appropriate public database and ag=
reed=20
to publish their results. All of the required fields in a trial registry mus=
t=20
be completed. Entries that obscure a trial's intent subvert a fundamental=20
purpose of trial registration. We trust that database managers will not allo=
w this=20
to occur.
 The FDA Revitalization Act sets a precedent in mandating the reporting of=20
trial results in a public database. The table format it mandates =E2=80=94 c=
omprising=20
information on trial participants and primary and principal secondary outcom=
es =E2=80=94=20
is a reasonable approach to results reporting. In the upcoming rulemaking,=20
the secretary of Health and Human Services should consider this format for t=
he=20
reporting of serious adverse events. The format confines itself to simple=20
facts, intentionally omitting any place for interpretation of the trial's re=
sults.=20
It encourages sponsors to prespecify and to register their key secondary=20
outcomes, because those would then become part of the results database.
 With this legislation, clinical trials in the United States will be played=20
out in the public arena. Research volunteers will know that their participat=
ion=20
is part of an unbiased public record. We think that fully open clinical=20
trials will lead to more effective and safer treatments for patients. With s=
everal=20
recent blockbuster drugs, including rofecoxib, telithromycin, and=20
rosiglitazone, serious breakdowns in the communication of trial results kept=
 safety=20
concerns from doctors and patients. Open for all to see, future clinical tri=
als can=20
lead to new treatments that will make a difference in safely combating=20
disease.