registry and results data bank
(3) (A) (i)Beginning not later than 90 days after, for those clinical trials that form the primary basis of an efficacy claim or are conducted after the drug involved is approved or after the device involved is cleared or approved, the Secretary shall ensure that the registry data bank includes links to results information as described in clause (ii) for such clinical trial— (I)not earlier than 30 days after the date of the approval of the drug involved or clearance or approval of the device involved; or (II)not later than 30 days after the results information described in clause (ii) becomes publicly available. (ii) (I)The Secretary shall ensure that the registry data bank includes links to the following information: (II)The Secretary shall ensure that the registry data bank includes links to the following information: (iii)The Secretary may include the links described in clause (ii) for data bank entries for clinical trials submitted to the data bank prior to, as available. (B)The Secretary, acting through the Director of NIH, shall— (i)expand the registry data bank to include the results of applicable clinical trials (referred to in this subsection as the “registry and results data bank”); (ii)ensure that such results are made publicly available through the Internet; (iii)post publicly a glossary for the lay public explaining technical terms related to the results of clinical trials; and (iv)in consultation with experts on risk communication, provide information with the information included under subparagraph (C) in the registry and results data bank to help ensure that such information does not mislead the patients or the public. (C)Not later than 1 year after, the Secretary shall include in the registry and results data bank for each applicable clinical trial for a drug that is approved underor licensed underor a device that is cleared underor approved under section 360e or 360j(m) of title 21, the following elements: (i)A table of the demographic and baseline data collected overall and for each arm of the clinical trial to describe the patients who participated in the clinical trial, including the number of patients who dropped out of the clinical trial and the number of patients excluded from the analysis, if any. (ii)The primary and secondary outcome measures as submitted under paragraph (2)(A)(ii)(I)(ll), and a table of values for each of the primary and secondary outcome measures for each arm of the clinical trial, including the results of scientifically appropriate tests of the statistical significance of such outcome measures. (iii)A point of contact for scientific information about the clinical trial results. (iv)Whether there exists an agreement (other than an agreement solely to comply with applicable provisions of law protecting the privacy of participants) between the sponsor or its agent and the principal investigator (unless the sponsor is an employer of the principal investigator) that restricts in any manner the ability of the principal investigator, after the completion date of the trial, to discuss the results of the trial at a scientific meeting or any other public or private forum, or to publish in a scientific or academic journal information concerning the results of the trial. (D) (i)To provide more complete results information and to enhance patient access to and understanding of the results of clinical trials, not later than 3 years after, the Secretary shall by regulation expand the registry and results data bank as provided under this subparagraph. (ii) (I)The regulations under this subparagraph shall require the inclusion of the results information described in clause (iii) for— (II)The regulations under this subparagraph shall establish whether or not the results information described in clause (iii) shall be required for— (iii)The regulations under this subparagraph shall require, in addition to the elements described in subparagraph (C), information within each of the following categories: (I)A summary of the clinical trial and its results that is written in non-technical, understandable language for patients, if the Secretary determines that such types of summary can be included without being misleading or promotional. (II)A summary of the clinical trial and its results that is technical in nature, if the Secretary determines that such types of summary can be included without being misleading or promotional. (III)The full protocol or such information on the protocol for the trial as may be necessary to help to evaluate the results of the trial. (IV)Such other categories as the Secretary determines appropriate. (iv)The results information described in clause (iii) shall be submitted to the Director of NIH for inclusion in the registry and results data bank as provided by subparagraph (E), except that the Secretary shall by regulation determine— (I)whether the 1-year period for submission of clinical trial information described in subparagraph (E)(i) should be increased from 1 year to a period not to exceed 18 months; (II)whether the clinical trial information described in clause (iii) should be required to be submitted for an applicable clinical trial for which the clinical trial information described in subparagraph (C) is submitted to the registry and results data bank before the effective date of the regulations issued under this subparagraph; and (III)in the case when the clinical trial information described in clause (iii) is required to be submitted for the applicable clinical trials described in clause (ii)(II), the date by which such clinical trial information shall be required to be submitted, taking into account— (v)The regulations under this subparagraph shall also establish— (I)a standard format for the submission of clinical trial information under this paragraph to the registry and results data bank; (II)additional information on clinical trials and results that is written in nontechnical, understandable language for patients; (III)considering the experience under the pilot quality control project described in paragraph (5)(C), procedures for quality control, including using representative samples, with respect to completeness and content of clinical trial information under this subsection, to help ensure that data elements are not false or misleading and are non-promotional; (IV)the appropriate timing and requirements for updates of clinical trial information, and whether and, if so, how such updates should be tracked; (V)a statement to accompany the entry for an applicable clinical trial when the primary and secondary outcome measures for such clinical trial are submitted under paragraph (4)(A) after the date specified for the submission of such information in paragraph (2)(C); and (VI)additions or modifications to the manner of reporting of the data elements established under subparagraph (C). (vi)The Secretary shall consider the status of the consensus data elements set for reporting clinical trial results of the World Health Organization when issuing the regulations under this subparagraph. (vii)The Secretary shall hold a public meeting no later than 18 months after, to provide an opportunity for input from interested parties with regard to the regulations to be issued under this subparagraph. (E) (i)Except as provided in clauses (iii), (iv), (v), and (vi) the responsible party for an applicable clinical trial that is described in clause (ii) shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraph (C) not later than 1 year, or such other period as may be provided by regulation under subparagraph (D), after the earlier of— (I)the estimated completion date of the trial as described in paragraph (2)(A)(ii)(I)(jj)); 2or (II)the actual date of completion. (ii)An applicable clinical trial described in this clause is an applicable clinical trial subject to— (I)paragraph (2)(C); and (iii)If the responsible party for an applicable clinical trial submits a certification that clause (iv) or (v) applies to such clinical trial, the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) as required under the applicable clause. (iv)With respect to an applicable clinical trial that is completed before the drug is initially approved underor initially licensed under, or the device is initially cleared under section 360(k) or initially approved under section 360e or 360j(m) of title 21, the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) not later than 30 days after the drug or device is approved under such section 355, licensed under such section 262, cleared under such section 360(k), or approved under such section 360e or 360j(m), as applicable. (v) (I)With respect to an applicable clinical trial where the manufacturer of the drug or device is the sponsor of an applicable clinical trial, and such manufacturer has filed, or will file within 1 year, an application seeking approval under, licensing under, or clearance under section 360(k), or approval under section 360e or 360j(m) of title 21 for the use studied in such clinical trial (which use is not included in the labeling of the approved drug or device), then the responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information described in subparagraphs (C) and (D) on the earlier of the date that is 30 days after the date— (II)If a manufacturer makes a certification under clause (iii) that this clause applies with respect to a clinical trial, the manufacturer shall make such a certification with respect to each applicable clinical trial that is required to be submitted in an application or report for licensure, approval, or clearance (underor section 355, 360(k), 360e, or 360j(m) of title 21, as applicable) of the use studied in the clinical trial. (III)The responsible party shall submit to the Director of NIH for inclusion in the registry and results data bank the clinical trial information subject to subclause (I) on the date that is 2 years after the date a certification under clause (iii) was made to the Director of NIH, if an action referred to in item (aa), (bb), or (cc) of subclause (I) has not occurred by such date. (vi)The Director of NIH may provide an extension of the deadline for submission of clinical trial information under clause (i) if the responsible party for the trial submits to the Director a written request that demonstrates good cause for the extension 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 a clinical trial. (F)The Commissioner of Food and Drugs shall notify the Director of NIH when there is an action described in subparagraph (E)(iv) or item (aa), (bb), or (cc) of subparagraph (E)(v)(I) with respect to an application or a report that includes a certification required under paragraph (5)(B) of such action not later than 30 days after such action. (G)The Director of NIH shall ensure that the clinical trial information described in subparagraphs (C) and (D) for an applicable clinical trial submitted in accordance with this paragraph is posted publicly in the registry and results database not later than 30 days after such submission. (H)The Secretary may waive any applicable requirements of this paragraph for an applicable clinical trial, upon a written request from the responsible party, if the Secretary determines that extraordinary circumstances justify the waiver and that providing the waiver is consistent with the protection of public health, or in the interest of national security. Not later than 30 days after any part of a waiver is granted, the Secretary shall notify, in writing, the appropriate committees of Congress of the waiver and provide an explanation for why the waiver was granted. (I) (i)Not later than 18 months after, the Secretary shall by regulation determine the best method for including in the registry and results data bank appropriate results information on serious adverse and frequent adverse events for applicable clinical trials described in subparagraph (C) in a manner and form that is useful and not misleading to patients, physicians, and scientists. (ii)If the Secretary fails to issue the regulation required by clause (i) by the date that is 24 months after, clause (iii) shall take effect. (iii)Upon the application of clause (ii), the Secretary shall include in the registry and results data bank for applicable clinical trials described in subparagraph (C), in addition to the clinical trial information described in subparagraph (C), the following elements: (I)A table of anticipated and unanticipated serious adverse events grouped by organ system, with number and frequency of such event in each arm of the clinical trial. (II)A table of anticipated and unanticipated adverse events that are not included in the table described in subclause (I) that exceed a frequency of 5 percent within any arm of the clinical trial, grouped by organ system, with number and frequency of such event in each arm of the clinical trial. (iv)In carrying out clause (iii), the Secretary shall, in consultation with experts in risk communication, post with the tables information to enhance patient understanding and to ensure such tables do not mislead patients or the lay public. (v)Clinical trial information included in the registry and results data bank pursuant to this subparagraph is deemed to be clinical trial information included in such data bank pursuant to subparagraph (C).