201 
‘‘(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 
‘‘(G) requires the inclusion of such other 
data elements to the registry database as ap-
propriate. 
‘‘(3) FORMAT AND STRUCTURE.— 
‘‘(A) SEARCHABLE CATEGORIES.—The Di-
rector of NIH shall ensure that the public may 
search the entries in the registry database by 1 
or more of the following criteria: 
‘‘(i) The indication being studied in 
the clinical trial, using Medical Subject 
Headers (MeSH) descriptors. 
‘‘(ii) The safety issue being studied in 
the clinical trial. 
‘‘(iii) The enrollment status of the 
clinical trial. 
‘‘(iv) The sponsor of the clinical trial. 
‘‘(B) FORMAT.—The Director of the NIH 
shall ensure that the registry database is easily
202 
used by patients, and that entries are easily 
compared. 
‘‘(4) DATA SUBMISSION.—The responsible party 
for an applicable clinical trial shall submit to the Di-
rector of NIH for inclusion in the registry database 
the clinical trial information described in paragraph 
(2). 
‘‘(5) TRUTHFUL
CLINICAL
TRIAL
INFORMA-
TION.— 
‘‘(A) IN GENERAL.—The clinical trial in-
formation submitted by a responsible party 
under this subsection shall not be false or mis-
leading. 
‘‘(B) EFFECT.—Subparagraph (A) shall 
not have the effect of requiring clinical trial in-
formation to include information from any 
source other than the clinical trial involved. 
‘‘(6) TIMING OF SUBMISSION.—Except as pro-
vided in paragraph (7), the clinical trial information 
for a clinical trial required to be submitted under 
this subsection shall be submitted not later than 14 
days after the first patient is enrolled in such clin-
ical trial. 
‘‘(7) UPDATES.—The responsible party for an 
applicable clinical trial shall submit to the Director
203 
of NIH for inclusion in the registry database peri-
odic updates to reflect changes to the clinical trial 
information submitted under this subsection. Such 
updates— 
‘‘(A) shall be provided not less than once 
every 6 months until information on the results 
of the trial is submitted under subsection (c); 
‘‘(B) shall include identification of the 
dates of any such changes; 
‘‘(C) not later than 30 days after the en-
rollment status of such clinical trial changes, 
shall include an update of the enrollment sta-
tus; and 
‘‘(D) not later than 30 days after the com-
pletion date of the clinical trial, shall include a 
report to the Director that such clinical trial is 
complete. 
‘‘(8) APPLICABILITY
OF
DEVICE
TRIALS.—In 
the case of an applicable clinical trial regarding a 
device, the responsible person for the trial shall sub-
mit to the Director of NIH the clinical trial informa-
tion as required in paragraph (4), but the Director 
may not make the information publicly available 
through the registry database until the device is ap-
proved or cleared (as the case may be).
204 
‘‘(c) CLINICAL TRIALS RESULTS DATABASE.— 
‘‘(1) ESTABLISHMENT.—To ensure that results 
of clinical trials are made public and that patients 
and providers have current information regarding 
the results of clinical trials, the Secretary, acting 
through the Director of NIH, shall establish and ad-
minister a clinical trial results database in accord-
ance with this section (referred to in this section as 
the ‘results database’). The Director of NIH shall 
ensure that the results database is made publicly 
available through the Internet. 
‘‘(2) SEARCHABLE CATEGORIES.—The Director 
of NIH shall ensure that the public may search the 
entries in the results database by 1 or more of the 
following: 
‘‘(A) The indication studied in the clinical 
trial, using Medical Subject Headers (MeSH) 
descriptors. 
‘‘(B) The safety issue studied in the clin-
ical trial. 
‘‘(C) Whether an application for the tested 
indication is approved, pending approval, with-
drawn, or not submitted. 
‘‘(D) The phase of the clinical trial.
205 
‘‘(E) The name of the drug or device that 
is the subject of the clinical trial. 
‘‘(F) Within the documents described in 
clauses (i) and (ii) of paragraph (3)(B), the fol-
lowing information, as applicable: 
‘‘(i) The sponsor of the clinical trial. 
‘‘(ii) Each financial sponsor of the 
clinical trial. 
‘‘(3) CONTENTS.— 
‘‘(A) IN GENERAL.—The responsible party 
for an applicable clinical trial shall submit to 
the Director of NIH for inclusion in the results 
database the clinical trial information described 
in subparagraph (B). 
‘‘(B) REQUIRED
ELEMENTS.—In submit-
ting clinical trial information for a clinical trial 
to the Director of NIH for inclusion in the re-
sults database, the responsible party shall in-
clude, with respect to such clinical trial, the fol-
lowing information: 
‘‘(i) The information described in sub-
paragraphs (A) through (E) of subsection 
(b)(2).
206 
‘‘(ii) A summary that is written in 
non-technical, understandable language for 
patients that includes the following: 
‘‘(I) The purpose of the clinical 
trial. 
‘‘(II) The sponsor of the clinical 
trial. 
‘‘(III) A point of contact for in-
formation about the clinical trial. 
‘‘(IV) A description of the patient 
population tested in the clinical trial. 
‘‘(V) 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 sub-
mission of clinical trial information 
for inclusion in the registry database 
established under subsection (b) and a 
description of any significant safety 
information. 
‘‘(iii) A summary that is technical in 
nature that includes the following: 
‘‘(I) The purpose of the clinical 
trial.
207 
‘‘(II) The sponsor of the clinical 
trial. 
‘‘(III) Each financial sponsor of 
the clinical trial. 
‘‘(IV) A point of contact for sci-
entific information about the clinical 
trial. 
‘‘(V) A description of the patient 
population tested in the clinical trial. 
‘‘(VI) 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 sub-
mission of clinical trial information 
for the clinical trial in the registry 
database established under subsection 
(b). 
‘‘(VII) Summary data describing 
the results, including— 
‘‘(aa) whether the primary 
endpoint was achieved, including 
relevant statistics; 
‘‘(bb) an assessment of any 
secondary endpoints, if applica-
208 
ble, including relevant statistics; 
and 
‘‘(cc) any significant safety 
information, including a sum-
mary of the incidence of serious 
adverse events observed in the 
clinical trial and a summary of 
the most common adverse events 
observed in the clinical trial and 
the frequencies of such events. 
‘‘(iv) With respect to the group of 
subjects receiving the drug or device in-
volved, and each comparison group of sub-
jects, the percentage of individuals who 
ceased participation as subjects and the 
reasons for ceasing participation. 
‘‘(v) With respect to an individual 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 sub-
section (b)(2)(F)) on any agreement that 
the responsible party or manufacturer has 
entered into with such individual that re-
209 
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. 
‘‘(vi) The completion date of the clin-
ical trial. 
‘‘(vii) A link to the Internet web post-
ing of any adverse regulatory actions taken 
by the Food and Drug Administration, 
such as a warning letter, that was sub-
stantively based on the clinical trial design, 
outcome, or representation made by the 
applicant about the design or outcome of 
the clinical trial. 
‘‘(C) LINKS IN DATABASE.—The Director 
of NIH shall ensure that the results database 
includes the following: 
‘‘(i) Links to Medline citations to pub-
lications reporting results from each appli-
210 
cable drug clinical trial and applicable de-
vice clinical trial. 
‘‘(ii) Links to the entry for the prod-
uct that is the subject of an applicable 
drug clinical trial in the National Library 
of Medicine database of structured product 
labels, if available. 
‘‘(iii) Links described in clauses (i) 
and (ii) for data bank entries for clinical 
trials submitted to the data bank prior to 
enactment of this section, as available. 
‘‘(4) TIMING.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraphs (B) and (C), a responsible party 
shall submit to the Director of NIH for inclu-
sion in the results database clinical trial infor-
mation for an applicable clinical trial not later 
than 1 year after the earlier of— 
‘‘(i) the estimated completion date of 
the trial, as submitted under subsection 
(b)(2); or 
‘‘(ii) the actual date of the completion, 
or termination before completion, of the 
trial, as applicable.
211 
‘‘(B) EXTENSIONS.—The Director of NIH 
may provide an extension of the deadline for 
submission of clinical trial information under 
subparagraph (A) if the responsible party for 
the trial submits to the Director a written re-
quest that demonstrates good cause for the ex-
tension and provides an estimate of the date on 
which the information will be submitted. The 
Director of NIH may grant more than one such 
extension for the clinical trial involved. 
‘‘(C) UPDATES.—The responsible party for 
an applicable clinical trial shall submit to the 
Director of NIH for inclusion in the results 
database periodic updates to reflect changes in 
the clinical trial information submitted under 
this subsection. Such updates— 
‘‘(i) shall be provided not less fre-
quently than once every 6 months during 
the 10-year period beginning on the date 
on which information is due under sub-
paragraph (A); 
‘‘(ii) shall identify the dates on which 
the changes were made; and 
‘‘(iii) shall include, not later than 30 
days after any change in the regulatory
212 
status of the drug or device involved, an 
update informing the Director of NIH of 
such change. 
‘‘(5) TRUTHFUL
CLINICAL
TRIAL
INFORMA-
TION.— 
‘‘(A) IN GENERAL.—The clinical trial in-
formation submitted by a responsible party 
under this subsection shall not be false or mis-
leading in any particular. 
‘‘(B) EFFECT.—Subparagraph (A) shall 
not have the effect of requiring clinical trial in-
formation with respect to a clinical trial to in-
clude information from any source other than 
such clinical trial. 
‘‘(6) PUBLIC AVAILABILITY OF RESULTS.— 
‘‘(A) PRE-APPROVAL STUDIES.—Except as 
provided in subparagraph (E), with respect to 
an applicable clinical trial that is completed be-
fore the drug is initially approved under section 
505 of the Federal Food, Drug, and Cosmetic 
Act or initially licensed under section 351 of 
this Act, or the device is initially cleared under 
section 510(k) or approved under section 515 of 
the Federal Food, Drug, and Cosmetic Act, the 
Director of NIH shall make publicly available
213 
on the results database the clinical trial infor-
mation submitted for such clinical trial not 
later than 30 days after— 
‘‘(i) the drug or device is approved 
under such section 505, licensed under 
such section 351, cleared under such sec-
tion 510(k), or approved under such sec-
tion 515, as applicable; or 
‘‘(ii) the Secretary issues a not ap-
provable letter or a not substantially equiv-
alent letter for the drug or device under 
such section 505, 351, 510(k), or 515, as 
applicable. 
‘‘(B) MEDICAL
AND
CLINICAL
PHARMA-
COLOGY
REVIEWS
OF
PRE-APPROVAL
STUD-
IES.—Not later than 90 days after the date ap-
plicable under clause (i) or (ii) of subparagraph 
(A) with respect to an applicable clinical trial, 
the Director of NIH shall make publicly avail-
able on the results database a summary of the 
available medical and clinical pharmacology re-
views conducted by the Food and Drug Admin-
istration for such trial. 
‘‘(C) POST-APPROVAL
STUDIES.—Except 
as provided in subparagraphs (D) and (E), with
214 
respect to an applicable clinical trial that is 
completed after the drug is initially approved 
under such section 505 or licensed under such 
section 351, or the device is initially cleared 
under such section 510(k) or approved under 
such section 515, the Director of NIH shall 
make publicly available on the results database 
the clinical trial information submitted for such 
clinical trial not later than 30 days after the 
date of such submission. 
‘‘(D) SEEKING APPROVAL OF A NEW USE 
FOR THE DRUG OR DEVICE.— 
‘‘(i) IN
GENERAL.—If the manufac-
turer of the drug or device is the sponsor 
or a financial sponsor of an applicable clin-
ical trial, and such manufacturer certifies 
to the Director of NIH that such manufac-
turer has filed, or will file within 1 year, 
an application seeking approval under such 
section 505, licensing under such section 
351, clearance under such section 510(k), 
or approval under such section 515 for the 
use studied in such clinical trial (which use 
is not included in the labeling of the ap-
proved drug or device), then the Director