Award: ClinicalTrials.gov | Ash Center
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`Award: ClinicalTrials.gov
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`NEWS & EVENTS
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`January 1, 2004
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`INNOVATIONS IN AMERICAN GOVERNMENT
`AWARDS
`
`• AWARD WON: 2004 Winner
`• AWARDEE: ClinicalTrials.gov
`• DESIGNEE: U.S. Department of Health and Human Services
`• JURISDICTION: Federal
`
`Despite ever-advancing technology, providing up-to-date and widely accessible
`medical information presents a serious challenge. The rate of publication of new
`medical data and research is astounding: some estimate that nearly 20,000
`articles are released each week. The number of publications and databases that
`present medical information is likewise huge. Furthermore, this information is
`often conveyed in arcane medical language. As a result, thosewishing to fnd
`information on diseases and treatment options often fnd themselves sifting
`through too many websites with too much information and too little plain
`language.
`
`Until 2000, this problem was particularly pressing for those who wished to fnd
`information on clinical trials of medical treatments. Not only were medical care
`providers unable to access information on clinical trials in an efcient manner, but
`patients were often unable to access it at all, depriving them of both information
`and the opportunity to seek experimental treatment through trial participation. In
`response, Congress passed the Food and Drug Modernization Act of 1997,
`mandating the creation of a centralized, publicly accessible registry for federally
`
`https://ash.harvard.edu/news/clinicaltrialsgov
`
`MPI EXHIBIT 1077 PAGE 1
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1077-0001
`
`

`

`Award: ClinicalTrials.gov | Ash Center
`
`https://ash.harvard.edu/news/clinicaltrialsgov
`
`and privately funded trials "of experimental interventions for serious or life-
`threatening diseases and conditions."
`
`In 1998, the National Institutes of Health (NIH) designated the National Library
`of Medicine as the organization in charge of creating this registry. In less than two
`years, after careful consultation with care providers, patient advocates, and
`numerous government agencies, the project team was able to develop an efcient
`and efective data management and retrieval system. In February 2000,
`ClinicalTrials.gov was ofcially launched, allowing users to access information on
`the goals, design, and participation requirements of approximately 4,400 clinical
`trials.
`
`ClinicalTrials.gov was designed to be a centralized, standardized, and current
`resource for those seeking information on clinical studies. The database presently
`contains over 9,400 records for both privately and publicly funded studies.
`Included are over 1,110 records from more than 200 pharmaceutical
`companies, many of whom participate despite potential commercial risk in order
`to gain access to a larger recruiting pool. A single, web-based data entry form
`ensures the uniformity of information from diverse sources, while an automated
`data-validation system allows for continuous and timely updates and additions.
`For those users interested in researching treatment options, each trial page also
`features links to relevant online medical reference sites, including MEDLINEplus,
`the National Library of Health's consumer health website.
`
`The site was also designed to be as widely accessible and comprehensible as
`possible, in keeping with the goals of the 1997 legislation. The data for each trial
`are standardized and presented in a clear, easy-to-read format. Users can run
`specifc key-word searches or browse by condition, sponsor, or geographical
`location, making it easy to navigate the site's vast amount of information.
`Furthermore, knowledge of medical terminology is not presumed; the database
`indexes lay terms so that a search for "heart attack" will retrieve the same
`information as a search for "myocardial infarction." The site also contains a
`glossary of terms and answers to frequently asked questions about clinical trials.
`
`ClinicalTrials.gov has developed a successful model for the creation and
`maintenance of a system that processes and presents large amounts of specialized
`information to a wide range of users. The site now contains records from trials in
`all 50 states and more than 90 countries and it has logged over 75 million hits
`since its launch. In April 2002, Time magazine named ClinicalTrials.gov as the
`country's best overall online health resource. The technology and processes
`developed by the ClinicalTrials team have proven to be efective and promise to
`play an important role in the future management and dissemination of critical
`medical information.
`
`MPI EXHIBIT 1077 PAGE 2
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1077-0002
`
`

`

`Award: ClinicalTrials.gov | Ash Center
`
`ClinicalTrials.gov, a program of the U.S. Department of Health and Human Services and an
`Innovations in American Government Finalis, presented before the National Selection Committee
`in 2004.
`
`ClinicalTrials.gov, an initiative of the U.S. Department of Health and
`Human Services, provides
`patients, family members, health professionals,
`and members of the public easy access to
`information on federally and
`privately supported clinical trials for a wide range of diseases and
`conditions. The program was a 2004 Innovations in American Government
`Award winner.
`
`https://ash.harvard.edu/news/clinicaltrialsgov
`
`MPI EXHIBIT 1077 PAGE 3
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1077-0003
`
`

`

`Award: ClinicalTrials.gov | Ash Center
`
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`https://ash.harvard.edu/news/clinicaltrialsgov
`
`MPI EXHIBIT 1077 PAGE 4
`
`Apotex v. Novo - IPR2024-00631
`Petitioner Apotex Exhibit 1077-0004
`
`