ClinicalTrials.gov Background - ClinicalTrials.gov
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`ClinicalTrials.gov Background
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`ClinicalTrials.gov Background
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`Contents
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`What Is ClinicalTrials.gov?
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`What Information Can I Find on ClinicalTrials.gov?
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`What Can I Do on This Site?
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`What Is ClinicalTrials.gov?
`ClinicalTrials.gov is a Web-based resource that provides patients, their family
`members, health care professionals, researchers, and the public with easy access
`to information on publicly and privately supported clinical studies on a wide range of
`diseases and conditions. The Web site is maintained by the National Library of
`Medicine (NLM) at the National Institutes of Health (NIH). Information on
`ClinicalTrials.gov is provided and updated by the sponsor or principal investigator
`of the clinical study. Studies are generally submitted to the Web site (that is,
`registered) when they begin, and the information on the site is updated throughout
`the study. In some cases, results of the study are submitted after the study ends.
`This Web site and database of clinical studies is commonly referred to as a
`"registry and results database."
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`ClinicalTrials.gov contains information about medical studies in human volunteers.
`Most of the records on ClinicalTrials.gov describe clinical trials (also called
`interventional studies). A clinical trial is a research study in which human volunteers
`are assigned to interventions (for example, a medical product, behavior, or
`procedure) based on a protocol (or plan) and are then evaluated for effects on
`biomedical or health outcomes. ClinicalTrials.gov also contains records describing
`observational studies and programs providing access to investigational drugs
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`https://clinicaltrials.gov/ct2/about-site/background
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`MPI EXHIBIT 1076 PAGE 1
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1076-0001
`
`

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`ClinicalTrials.gov Background - ClinicalTrials.gov
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`outside of clinical trials (expanded access). Studies listed in the database are
`conducted in all 50 States and in 221 countries.
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`ClinicalTrials.gov does not contain information about all the clinical studies
`conducted in the United States because not all studies are required by law to be
`registered (for example, observational studies and trials that do not study a drug,
`biologic, or device). See FDAAA 801 and the Final Rule for more information.
`However, the rate of study registration has increased over time as more policies
`and laws requiring registration have been enacted and as more sponsors and
`investigators have voluntarily registered their studies.
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`ClinicalTrials.gov was created as a result of the Food and Drug Administration
`Modernization Act of 1997 (FDAMA). FDAMA required the U.S. Department of
`Health and Human Services (HHS), through NIH, to establish a registry of clinical
`trials information for both federally and privately funded trials conducted under
`investigational new drug applications to test the effectiveness of experimental drugs
`for serious or life-threatening diseases or conditions. NIH and the Food and Drug
`Administration (FDA) worked together to develop the site, which was made
`available to the public in February 2000.
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`The ClinicalTrials.gov registration requirements were expanded after Congress
`passed the FDA Amendments Act of 2007 (FDAAA). Section 801 of FDAAA
`(FDAAA 801) requires more types of trials to be registered and additional trial
`registration information to be submitted. The law also requires the submission of
`results for certain trials. This led to the development of the ClinicalTrials.gov results
`database, which contains summary information on study participants and study
`outcomes, including adverse events. The results database was made available to
`the public in September 2008. FDAAA 801 also established penalties for failing to
`register or submit the results of trials. In September 2016, HHS issued the Final
`Rule for Clinical Trials Registration and Results Information Submission (42 CFR
`Part 11) clarifying and expanding the registration and results information
`submission requirements of FDAAA 801. This regulation takes effect in January
`2017.
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`An account of the development and expansion of ClinicalTrials.gov in response to
`changes in policies and laws is provided on the History, Policies, and Laws page.
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`Searching ClinicalTrials.gov does not require registration or personal identification.
`Because ClinicalTrials.gov is a Government Web site, it does not host or receive
`funding or advertising from commercial entities or display commercial content.
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`https://clinicaltrials.gov/ct2/about-site/background
`
`MPI EXHIBIT 1076 PAGE 2
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1076-0002
`
`

`

`ClinicalTrials.gov Background - ClinicalTrials.gov
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`What Information Can I Find on ClinicalTrials.gov?
`Each ClinicalTrials.gov record presents summary information about a study
`protocol and includes the following:
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`Disease or condition
`Intervention (for example, the medical product, behavior, or procedure being
`studied)
`Title, description, and design of the study
`Requirements for participation (eligibility criteria)
`Locations where the study is being conducted
`Contact information for the study locations
`Links to relevant information on other health Web sites, such as NLM's
`MedlinePlus® for patient health information and PubMed® for citations and
`abstracts of scholarly articles in the field of medicine
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`Some records also include information on the results of the study, such as:
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`Description of study participants (the number of participants starting and
`completing the study and their demographic data)
`Outcomes of the study
`Summary of adverse events experienced by study participants
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`ClinicalTrials.gov was made available to the public on February 29, 2000, and the
`results database was released in September 2008. Once a study is registered on
`the site, it is not removed. The full history of the changes made to a record can be
`accessed by clicking on the History of Changes link near the bottom of the full text
`view of each record.
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`What Can I Do on This Site?
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`Find and view clinical studies. Conduct basic and advanced searches of
`clinical study records; browse studies; and search studies by topic, country, or
`region. See the Find Studies section of the site.
`Learn more about clinical research. Find out how clinical studies are
`conducted and who can participate. See Learn About Studies.
`Manage study records. Find out how to submit and maintain study records,
`access the Protocol Registration and Results System, and enter summary
`information about study protocols and results. See the Submit Studies section
`of the site.
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`https://clinicaltrials.gov/ct2/about-site/background
`
`MPI EXHIBIT 1076 PAGE 3
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1076-0003
`
`

`

`ClinicalTrials.gov Background - ClinicalTrials.gov
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`Use site tools and data. View statistics on registered studies or download
`study records for analysis. See the Resources section of the site.
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`This page last reviewed in May 2021
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`https://clinicaltrials.gov/ct2/about-site/background
`
`MPI EXHIBIT 1076 PAGE 4
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1076-0004
`
`