TITLE III—CLINICAL TRIALS 
SEC. 301. CLINICAL TRIAL REGISTRY DATABASE AND CLIN-
ICAL TRIAL RESULTS DATABASE. 
(a) IN GENERAL.—Subsection (i) of section 402 of 
the Public Health Service Act (42 U.S.C. 282), as amend-
ed by Public Law 109–482, is amended to read as follows: 
‘‘(i) CLINICAL TRIAL REGISTRY DATABASE; CLIN-
ICAL TRIAL RESULTS DATABASE.— 
‘‘(1) DEFINITIONS.—In this subsection: 
‘‘(A) APPLICABLE CLINICAL TRIAL.—The 
term ‘applicable clinical trial’— 
‘‘(i) means a clinical trial that is con-
ducted to test the safety or effectiveness 
(including comparative effectiveness) of a 
drug or device (irrespective of whether the 
clinical trial is federally or privately fund-
ed, and whether the clinical trial involves 
an approved or unapproved drug or de-
vice); 
‘‘(ii) includes such a clinical trial that 
is conducted outside of the United States 
if— 
‘‘(I) there is an application or 
premarket notification pending before 
the Food and Drug Administration 
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for approval or clearance of the drug 
or device involved under section 505, 
510(k), or 515 of the Federal Food, 
Drug, and Cosmetic Act or section 
351 of this Act; or 
‘‘(II) the drug or device involved 
is so approved or cleared; and 
‘‘(iii) notwithstanding subclauses (I) 
and (II), excludes— 
‘‘(I) a clinical trial to determine 
the safety of a use of a drug that is 
designed 
solely 
to 
detect 
major 
toxicities in the drug or to investigate 
pharmacokinetics, unless the clinical 
trial is designed to investigate phar-
macokinetics in a special population 
or populations; and 
‘‘(II) a small clinical trial to de-
termine the feasibility of a device, or 
a clinical trial to test prototype de-
vices where the primary focus is feasi-
bility. 
‘‘(B) CLINICAL TRIAL INFORMATION.—The 
term ‘clinical trial information’ means those 
data elements that are necessary to complete an 
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entry in the clinical trial registry database 
under paragraph (2) or the clinical trial results 
database under paragraph (3), as applicable. 
‘‘(C) COMPLETION DATE.—The term ‘com-
pletion date’ means the date of the final collec-
tion of data from subjects in the clinical trial 
for the primary and secondary outcomes to be 
examined in the trial. 
‘‘(D) DEVICE.—The term ‘device’ has the 
meaning given to that term in section 201(h) of 
the Federal Food, Drug, and Cosmetic Act. 
‘‘(E) DRUG.—The term ‘drug’ means a 
drug as defined in section 201(g) of the Federal 
Food, Drug, and Cosmetic Act or a biological 
product as defined in section 351 of this Act. 
‘‘(F) RESPONSIBLE PARTY.—The term ‘re-
sponsible party’, with respect to an applicable 
clinical trial, means— 
‘‘(i) the primary sponsor (as defined 
in the International Clinical Trials Reg-
istry Platform trial registration data set of 
the World Health Organization) of the 
clinical trial; or 
‘‘(ii) the principal investigator of such 
clinical trial if so designated by such spon-
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sor, so long as the principal investigator is 
responsible for conducting the trial, has ac-
cess to and control over the data, has the 
right to publish the results of the trial, and 
has the responsibility to meet all of the re-
quirements under this section that are ap-
plicable to responsible parties. 
‘‘(2) CLINICAL TRIALS REGISTRY DATABASE.— 
‘‘(A) ESTABLISHMENT.—To enhance pa-
tient enrollment and provide a mechanism to 
track subsequent progress of clinical trials, the 
Secretary, acting through the Director of NIH, 
shall establish and administer a clinical trial 
registry database in accordance with this sub-
section (referred to in this subsection as the 
‘registry database’). The Director of NIH shall 
ensure that the registry database is made pub-
licly available through the Internet. 
‘‘(B) CONTENT.—The Secretary shall pro-
mulgate regulations for the submission to the 
registry database of clinical trial information 
that— 
‘‘(i) conforms to the International 
Clinical Trials Registry Platform trial reg-
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istration data set of the World Health Or-
ganization; 
‘‘(ii) includes the city, State, and zip 
code for each clinical trial location; 
‘‘(iii) includes a statement of the esti-
mated completion date for the clinical trial; 
‘‘(iv) includes the identity and contact 
information of the responsible party; 
‘‘(v) if the drug is not approved under 
section 505 of the Federal Food, Drug, 
and Cosmetic Act or licensed under section 
351 of this Act, or the device is not cleared 
under section 510(k) or approved under 
section 515 of the Federal Food, Drug, 
and Cosmetic Act, specifies whether or not 
there is expanded access to the drug or de-
vice under section 561 of the Federal 
Food, Drug, and Cosmetic Act for those 
who do not qualify for enrollment in the 
clinical trial and how to obtain information 
about such access; 
‘‘(vi) includes, with respect to any in-
dividual who is not an employee of the re-
sponsible party for the clinical trial or of 
the manufacturer of the drug or device in-
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volved, information on any agreement that 
the responsible party or manufacturer has 
entered into with such individual that re-
stricts in any manner the ability of the in-
dividual— 
‘‘(I) to discuss the results of the 
trial at a scientific meeting or any 
other public or private forum; or 
‘‘(II) to publish the results of the 
trial, or a description or discussion of 
the results of the trial, in a scientific 
or academic journal; and 
‘‘(vii) requires the inclusion of such 
other data elements to the registry data-
base as appropriate. 
‘‘(C) FORMAT AND STRUCTURE.— 
‘‘(i) SEARCHABLE CATEGORIES.—The 
Director of NIH shall ensure that the pub-
lic may search the entries in the registry 
database by 1 or more of the following cri-
teria: 
‘‘(I) The indication being studied 
in the clinical trial, using Medical 
Subject Headers (MeSH) descriptors. 
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‘‘(II) The safety issue being stud-
ied in the clinical trial. 
‘‘(III) The enrollment status of 
the clinical trial. 
‘‘(IV) The sponsor of the clinical 
trial. 
‘‘(ii) FORMAT.—The Director of the 
NIH shall ensure that the registry data-
base is easily used by patients, and that 
entries are easily compared. 
‘‘(D) DATA SUBMISSION.—The responsible 
party for an applicable clinical trial shall submit 
to the Director of NIH for inclusion in the reg-
istry database the clinical trial information de-
scribed in subparagraph (B). 
‘‘(E) TRUTHFUL CLINICAL TRIAL INFOR-
MATION.— 
‘‘(i) IN GENERAL.—The clinical trial 
information submitted by a responsible 
party under this paragraph shall not be 
false or misleading in any particular. 
‘‘(ii) EFFECT.—Clause (i) shall not 
have the effect of requiring clinical trial in-
formation to include information from any 
source other than the clinical trial involved. 
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‘‘(F) TIMING OF SUBMISSION.—Except as 
provided in subparagraph (G), the clinical trial 
information for a clinical trial required to be 
submitted under this paragraph shall be sub-
mitted not later than 14 days after the first pa-
tient is enrolled in such clinical trial. 
‘‘(G) UPDATES.—The responsible party for 
an applicable clinical trial shall submit to the 
Director of NIH for inclusion in the registry 
database periodic updates to reflect changes to 
the clinical trial information submitted under 
this paragraph. Such updates— 
‘‘(i) shall be provided not less than 
once every six months until information on 
the results of the trial is submitted under 
paragraph (3); 
‘‘(ii) shall include identification of the 
dates of any such changes; 
‘‘(iii) not later than 30 days after the 
enrollment status of such clinical trial 
changes, shall include an update of the en-
rollment status; and 
‘‘(iv) not later than 30 days after the 
completion date of the clinical trial, shall 
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include a report to the Director that such 
clinical trial is complete. 
‘‘(3) CLINICAL TRIALS RESULTS DATABASE.— 
‘‘(A) ESTABLISHMENT.—To ensure that 
results of clinical trials are made public and 
that patients and providers have current infor-
mation regarding the results of clinical trials, 
the Secretary, acting through the Director of 
NIH, shall establish and administer a clinical 
trial results database in accordance with this 
subsection (referred to in this subsection as the 
‘results database’). 
‘‘(B) SEARCHABLE CATEGORIES.—The Di-
rector of NIH shall ensure that the public may 
search the entries in the results database by 1 
or more of the following: 
‘‘(i) The indication studied in the clin-
ical trial, using Medical Subject Headers 
(MeSH) descriptors. 
‘‘(ii) The safety issue studied in the 
clinical trial. 
‘‘(iii) Whether an application for the 
tested indication is approved, pending ap-
proval, withdrawn, or not submitted. 
‘‘(iv) The phase of the clinical trial. 
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‘‘(v) The name of the drug or device 
that is the subject of the clinical trial. 
‘‘(vi) Within the documents described 
in subclauses (II) and (III) of subpara-
graph (C)(ii), the following information, as 
applicable: 
‘‘(I) The sponsor of the clinical 
trial. 
‘‘(II) Each financial sponsor of 
the clinical trial. 
‘‘(C) CONTENTS.— 
‘‘(i) IN
GENERAL.—The responsible 
party for an applicable clinical trial shall 
submit to the Director of NIH for inclu-
sion in the results database the clinical 
trial information described in clause (ii). 
‘‘(ii) REQUIRED ELEMENTS.—In sub-
mitting clinical trial information for a clin-
ical trial to the Director of NIH for inclu-
sion in the results database, the respon-
sible party shall include, with respect to 
such clinical trial, the following informa-
tion: 
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‘‘(I) The information described in 
clauses (i) through (v) of subpara-
graph (B). 
‘‘(II) A non-promotional sum-
mary document that is written in non- 
technical, understandable language for 
patients that includes the following: 
‘‘(aa) The purpose of the 
clinical trial. 
‘‘(bb) The sponsor of the 
clinical trial. 
‘‘(cc) A point of contact for 
information about the clinical 
trial. 
‘‘(dd) A description of the 
patient population tested in the 
clinical trial. 
‘‘(ee) A general description 
of the clinical trial and results, 
including a description of and the 
reasons for any changes in the 
clinical trial design that occurred 
since the date of submission of 
clinical trial information for in-
clusion in the registry database 
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established under paragraph (2) 
and a description of any signifi-
cant safety information. 
‘‘(III) A non-promotional sum-
mary document that is technical in 
nature that includes the following: 
‘‘(aa) The purpose of the 
clinical trial. 
‘‘(bb) The sponsor of the 
clinical trial. 
‘‘(cc) Each financial sponsor 
of the clinical trial. 
‘‘(dd) A point of contact for 
scientific information about the 
clinical trial. 
‘‘(ee) A description of the 
patient population tested in the 
clinical trial. 
‘‘(ff) A general description 
of the clinical trial and results, 
including a description of and the 
reasons for any changes in the 
clinical trial design that occurred 
since the date of submission of 
clinical trial information for the 
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clinical trial in the registry data-
base established under paragraph 
(2). 
‘‘(gg) Summary data de-
scribing the results, including— 
‘‘(AA) whether the pri-
mary endpoint was achieved, 
including relevant statistics; 
‘‘(BB) an assessment of 
any secondary endpoints, if 
applicable, including relevant 
statistics; and 
‘‘(CC) any significant 
safety information, including 
a summary of the incidence 
of serious adverse events ob-
served in the clinical trial 
and a summary of the most 
common adverse events ob-
served in the clinical trial 
and the frequencies of such 
events. 
‘‘(IV) With respect to the group 
of subjects receiving the drug or de-
vice involved, and each comparison 
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group of subjects, the percentage of 
individuals who ceased participation 
as subjects and their reasons for ceas-
ing participation. 
‘‘(V) With respect to an indi-
vidual who is not an employee of the 
responsible party for the clinical trial 
or of the manufacturer of the drug or 
device involved, information (to the 
extent not submitted under paragraph 
(2)(B)(vi)) on any agreement that the 
responsible party or manufacturer has 
entered into with such individual that 
restricts in any manner the ability of 
the individual— 
‘‘(aa) to discuss the results 
of the trial at a scientific meeting 
or any other public or private 
forum; or 
‘‘(bb) to publish the results 
of the trial, or a description or 
discussion of the results of the 
trial, in a scientific or academic 
journal. 
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‘‘(VI) A link to available peer-re-
viewed publications based on the re-
sults of the clinical trial. 
‘‘(VII) The completion date of 
the clinical trial. 
‘‘(VIII) A link to the Internet 
web posting of any adverse regulatory 
actions taken by the Food and Drug 
Administration, such as a warning let-
ter, that was substantively based on 
the clinical trial design, outcome, or 
representation made by the applicant 
about the design or outcome of the 
clinical trial. 
‘‘(D) TIMING.— 
‘‘(i) IN
GENERAL.—Except as pro-
vided in clauses (ii) and (iii), a responsible 
party shall submit to the Director of NIH 
for inclusion in the results database clin-
ical trial information for an applicable clin-
ical trial not later than 1 year after the 
earlier of— 
‘‘(I) the estimated completion 
date of the trial, as submitted under 
paragraph (2)(B); or 
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‘‘(II) the actual date of the com-
pletion, or termination before comple-
tion, of the trial, as applicable. 
‘‘(ii) EXTENSIONS.—The Director of 
NIH may provide an extension of the 
deadline for submission of clinical trial in-
formation under clause (i) if the respon-
sible party for the trial submits to the Di-
rector a written request that demonstrates 
good cause for the extension and provides 
an estimate of the date on which the infor-
mation will be submitted. The Director of 
NIH may grant more than one such exten-
sion for the clinical trial involved. 
‘‘(iii) 
UPDATES.—The 
responsible 
party for an applicable clinical trial shall 
submit to the Director of NIH for inclu-
sion in the results database periodic up-
dates to reflect changes in the clinical trial 
information submitted under this para-
graph. Such updates— 
‘‘(I) shall be provided not less 
frequently than once every six months 
during the 10-year period beginning 
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