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`
`Mylan Exhibit 1069
`Mylan v. Regeneron, IPR2021-00880
`Page 1
`
`

`

`1/20/2021
`
`ClinicalTrials.gov Background- ClinicalTrials.gov
`
`registered and additional trial registration information to be submitted. The law also requires the submission
`of results for certain trials. This led to the developmentof theClinicalTrials.gov results database, which
`contains summary information on study participants and study outcomes, including adverse events. The
`
`results database was madeavailable to the public in September 2008. FDAAA 801 also established
`
`in January 2017.
`
`An accountof the development and expansionof ClinicalTrials.gov in response to changesin policies and
`
`lawsis provided on the History, Policies, and Laws page.
`
`Searching ClinicalTrials.gov does not require registration or personal identification. Because
`
`ClinicalTrials.gov is a Government Website, it does not hostor receive funding or advertising from
`
`commercial entities or display commercial content.
`
`TO TOP
`
`WhatInformation Can | Find on ClinicalTrials.gov?
`
`EachClinicalTrials.gov record presents summary information about a study protocol and includes the
`
`following:
`
`e Disease or condition
`
`e
`
`Intervention (for example, the medical product, behavior, or procedure being studied)
`
`e Title, description, and design of the study
`
`e Requirementsfor participation (eligibility criteria)
`
`e Locations where the study is being conducted
`
`¢ Contact information for the study locations
`
`e Links to relevant information on other health Web sites, such as NLM's MedlinePlus® for patient health
`
`information and PubMed®@forcitations and abstracts of scholarly articles in the field of medicine
`
`Somerecordsalso include information on the results of the study, such as:
`
`e Description of study participants (the numberof participants starting and completing the study and their
`
`demographic data)
`
`e Outcomesof the study
`
`e Summary of adverse events experienced by study participants
`
`Thefull history of the changes madeto a record can be accessed by viewing the archival version of the
`record on the ClinicalTrials.gov archive. Once a studyis registered on the site, the information aboutit is not
`removed.
`
`penaltiesfor 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
`
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`
`TO TOP
`
`2/3
`
`Mylan Exhibit 1069
`Mylan v. Regeneron, IPR2021-00880
`Page 2
`Joining Petitioner: Apotex
`
`Mylan Exhibit 1069
`Mylan v. Regeneron, IPR2021-00880
`Page 2
`
`

`

`1/20/2021
`
`ClinicalTrials.gov Background- ClinicalTrials.gov
`
`What Can | Do onThis Site?
`
`e Find and viewclinical studies. Conduct basic and advanced searchesofclinical study records; browse
`
`studies; and search studies by topic, country, or region. See the Find Studiessection of thesite.
`
`e Learn more aboutclinical research. Find out howclinical studies are conducted and who can
`
`participate. See Learn About Studies.
`
`e Managestudy records. Find out how to submit and maintain study records, access the Protocol
`
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`
`e Usesite tools and data. Viewstatistics on registered studies or download study recordsfor analysis.
`See the Resourcessection ofthe site.
`
`This page last reviewed in January 2018
`
`https://www.clinicaltrials.gov/ct2/about-site/background
`
`

    

  

  
`
`3/3
`
` 
`
`Mylan Exhibit 1069
`Mylan v. Regeneron, IPR2021-00880
`Page 3
`Joining Petitioner: Apotex
`
`Mylan Exhibit 1069
`Mylan v. Regeneron, IPR2021-00880
`Page 3
`
`