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

`

`1/20/2021
`
`CIinicaITriaIs.gov Background - CIinicaITriaIs.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 development of theClinicalTrials.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.
`
`An account of the development and expansion of CIinicaITriaIs.gov in response to changes in policies and
`
`laws is provided on the History, Policies, and Laws page.
`
`Searching CIinicaITriaIs.gov does not require registration or personal identification. Because
`
`CIinicaITriaIs.gov is a Government Web site, it does not host or receive funding or advertising from
`
`commercial entities or display commercial content.
`
`TO TOP
`
`What Information Can I Find on CIinicaITriaIs.gov?
`
`Each CIinicaITriaIs.gov record presents summary information about a study protocol and includes the
`
`following:
`
`a 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
`
`0 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
`
`Some records also include information on the results of the study, such as:
`
`. Description of study participants (the number of participants starting and completing the study and their
`
`demographic data)
`
`0 Outcomes of the study
`
`0 Summary of adverse events experienced by study participants
`
`The full history of the changes made to a record can be accessed by viewing the archival version of the
`
`

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`record on the CIinicaITriaIs.gov archive. Once a study is registered on the site, the information about it is not
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`
`https://www.c|inicaltrials.gov/ct2/about-site/background
`
`TO TOP
`
`2/3
`
`Mylan Exhibit 1069
`Mylan v. Regeneron, IPR2021-00880
`Page 2
`
`Mylan Exhibit 1069
`Mylan v. Regeneron, IPR2021-00880
`Page 2
`
`

`

`1/20/2021
`
`CIinicaITriaIs.gov Background - CIinicaITriaIs.gov
`
`What Can I Do on This Site?
`
`studies; and search studies by topic, country, or region. See the Find Studiessection of the site.
`
`Learn more about clinical research. Find out how clinical studies are conducted and who can
`
`participate. See Learn About Studies.
`
`Find and view clinical studies. Conduct basic and advanced searches of clinical study records; browse
`
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`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.
`
`Use site tools and data. View statistics on registered studies or download study records for analysis.
`
`See the Resources section of the site.
`
`This page last reviewed in January 2018
`
`https://www.clinicaltrials.gov/ct2/about-site/background
`
`

    

  

  
`
`3/3
`
` 
`
`Mylan Exhibit 1069
`Mylan v. Regeneron, |PR2021-00880
`Page 3
`
`Mylan Exhibit 1069
`Mylan v. Regeneron, IPR2021-00880
`Page 3
`
`