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`How to Read a Study Record | ClinicalTrials.gov
`Go to the classic website
`
`How to Read a Study Record
`
`Learn how to read and understand a study record on ClinicalTrials.gov (https://clinicaltrials.gov/).
`
`Quick Guide to Finding Information
`
`The study record includes these main parts:
`Study introduction area – Found at the top of the page when you rst open a
`study record. Information found here:
`The study title – describes what the study is about
`Study status – tells if this study is accepting participants, is completed,
`or has results
`Other administrative information – study identication numbers, the
`study sponsor, the responsible party who entered the information, and
`the date the study was last updated.
`
`Study details – This is the tab already open below the introduction. It
`contains important study details organized into sections by the type of
`information. Some of the information found here:
`Study contacts and locations – who to call with questions and where
`the study is taking place
`Eligibility (Participation Criteria) – the criteria for participating in the
`study
`Study design – describes how the study will work
`Other people involved with the study
`
`Researcher View – Provides information of interest to data researchers and
`journal editors organized in a way that works best for them
`
`Results – The study results will be found here if they are available.
`“Results Posted” means the study results are available.
`“No Results Posted” means the study results are not available.
`“Results Submitted” means the study results are under review before
`being posted.
`
`Record History – A table that documents changes to the study record over
`time. Each version is listed according to the date the version was posted.
`
`On a desktop or laptop computer, several of the tabs include a left-sided menu
`that allows users to navigate to a specic section.
`
`https://clinicaltrials.gov/study-basics/how-to-read-study-record#record-history-tab
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`How to Read a Study Record | ClinicalTrials.gov
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`As you scroll through a study record on a mobile device, the title of the next
`section will appear at the bottom on the screen. As you move down the record,
`the title of the previous section will appear at the top of the screen.
`
`Helpful features:
`
`Feature
`
`Function
`
`Click on this to see the glossary
`denition for the term
`
`Click on this to see more
`information in part of the study
`record
`
`Click on this to close part of the
`study record
`
`Click on Expand all content to
`view all information in the study
`record
`Click on Collapse all content to
`view less information in the study
`record
`
`Click on this to view more
`information
`
`Click on this to view less
`information
`
`Finding Information in the Study Record
`
`The Study Introduction area
`
`In this area you’ll nd information important to the entire study record:
`Study status – whether the study is currently looking for participants, is
`completed, or has results
`Brief title of the study – a short title that describes what the study is about
`ClinicalTrials.gov ID (NCT number) – the ID number assigned to this study
`when it was registered on ClinicalTrials.gov
`
`https://clinicaltrials.gov/study-basics/how-to-read-study-record#record-history-tab
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`How to Read a Study Record | ClinicalTrials.gov
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`Study sponsor – the organization or person who has control over the study
`Information provided by – the person or organization responsible for entering
`the study information, also called the Responsible Party
`Last update posted – the last time changes were made to the study record
`
`The Study Details tab
`
`The Study Details tab is the default view. It opens when you rst look at a study
`record. This tab contains information about the people involved in the study, how
`it will be conducted, and information about participation.
`
`There are 8 parts:
`Study Overview
`Contacts and Locations
`Participation Criteria
`Study Plan
`Collaborators and Investigators
`Publications
`Study Record Dates
`More Information
`
`To jump to a section, click on the title in the menu to the left.
`
`Study Overview
`
`This section tells you what the study is about, how it will work, the dates that
`study will likely start and stop, and the number of participants.
`
`On the left side of this section, you’ll nd:
`Brief Summary and Detailed Description: Tells you the purpose of the study
`and how it will work.
`Ocial Title: The title given to the study by the researchers, often written in
`scientic language.
`Conditions: The focus of the study, usually a disease, illness, or condition, but
`may also be another health-related issue.
`Intervention/Treatment: The treatment, device, or procedure that’s being
`studied.
`
`On the right side of this section, you’ll nd:
`Study Dates: The study start dates and completion dates. Some of these
`may be estimated dates.
`
`https://clinicaltrials.gov/study-basics/how-to-read-study-record#record-history-tab
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`How to Read a Study Record | ClinicalTrials.gov
`2/12/24, 9:04 AM
`Enrollment: The number of participants who joined a study or who the
`researchers hope will join the study.
`Study Type – A study may be one of three basic types:
`Interventional (also called clinical trials) – Participants are assigned to
`receive an intervention so that researchers can study the effects.
`Observational (including patient registries) – Participants do not
`receive an assigned intervention. They are observed over time for
`health-related outcomes.
`Expanded access – A way for patients with serious conditions to
`receive a drug or treatment outside of a clinical trial.
`
`Note: The study records for each type of study will have different types
`of information available.
`Phase: The stage of the study, based on denitions from the U.S. FDA.
`Other Study ID Numbers: other identifying numbers for the study
`Expanded Access: This will appear if expanded access is available.
`
`At the bottom of the Study Overview, the National Library of Medicine provides
`resource links to learn more about topics related to the study.
`
`Contacts and Locations
`
`This section provides information on who to contact for questions about the
`study and where the study is taking place.
`Study Contact: The name and contact information for someone who can
`answer questions about the study.
`Study Contact Backup: This may be available as an option if you can’t reach
`the main study contact.
`
`Note: These elds are only available if the study status is “Not yet recruiting”
`or “Recruiting” and may not be available if there are individual contacts listed
`for each study location.
`Study Locations and Map: A map and list of locations in alphabetical order
`(by state then city within the United States) where the study is taking place. A
`location-specic study contact may be listed if the study status is “Not yet
`recruiting” or “Recruiting”.
`
`Features of the map:
`
`Red pins: Show specic study locations, also called clinical sites.
`Click on a red pin to zoom to that location information in the list.
`Blue circles: Show areas with many study locations.
`
`https://clinicaltrials.gov/study-basics/how-to-read-study-record#record-history-tab
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`How to Read a Study Record | ClinicalTrials.gov
`Click on a blue circle to zoom the map in to show red pins for
`each of the study locations in that area or more blue circles with
`more clusters of clinical sites.
`If you click on a location in the list, the map will zoom in to show that
`location.
`If you searched for a study using the location lter (entering an address
`or place), the map will already be zoomed in to that address or place,
`showing a circle representing the search distance and the study
`locations within it.
`You can zoom in on the map by double clicking, or using your cursor.
`Hold down the ‘Ctrl’ button on your keyboard and use your mouse wheel
`to scroll up to zoom in and scroll down to zoom out.
`
`Participation Criteria
`
`This section gives details about the types of participants that the study
`researchers need for the study, also known as eligibility criteria.
`
`Most records will show the participation criteria as:
`Inclusion Criteria: The characteristics of people who might be able to join the
`study.
`Exclusion Criteria: The characteristics of people who cannot join the study.
`
`On the right side of the participation criteria:
`Ages Eligible for Study: The ages of people who can join the study.
`Sexes Eligible for Study: The biological sex of people who can join the study.
`Accepts Healthy Volunteers: This tells if the study accepts participants who
`are healthy.
`
`Study Plan
`
`This gives details about how the study is set up and what the study is measuring.
`Click the + to view each of these sections:
`How is the study designed?
`What is the study measuring?
`
`How is the study designed?
`
`This section provides details on how the study will be run. This information may
`be different depending on the type of study.
`Interventional studies (clinical trials):
`Design Details
`
`https://clinicaltrials.gov/study-basics/how-to-read-study-record#record-history-tab
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`2/12/24, 9:04 AM
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`How to Read a Study Record | ClinicalTrials.gov
`Primary Purpose: What is being studied, such as a test
`(diagnostic) or a treatment.
`Allocation: How participants are assigned to a treatment or
`control, also called a placebo.
`Interventional Model and Interventional Model Description: The
`strategy for assigning participants to interventions in a clinical
`study.
`Masking: If the participants will know what group (and treatment)
`they are in.
`Arms and Interventions table: Shows what intervention each arm of the
`study will receive.
`
`Observational studies:
`Design Details or Intervention/Treatment section
`Observational Model: The strategy for identifying and following
`up with participants during an observational study.
`Time Perspective: The time period during which researchers will
`collect data from participants.
`Biospecimen Retention and Biospecimen Description: This does
`not always apply to a study. When it does, it is the type of sample
`that will be collected and stored from study participants, such as
`a blood sample or skin sample.
`Cohorts and Interventions table: Describes the characteristics of the
`group or groups in the study.
`
`Expanded access studies: These studies do not usually have a study plan.
`
`The lists above may not include all the different types of data that you will see in
`the study design.
`
`What is the study measuring?
`
`This part often has a table format to explain:
`Primary Outcome Measures: The most important measures to learn the
`effects of the drug, device, or intervention, including how and when
`researchers will measure it.
`Secondary Outcome Measures: These are still of interest, but less important
`than the primary measures.
`
`Collaborators and Investigators
`
`The names of people and organizations carrying out the study.
`
`https://clinicaltrials.gov/study-basics/how-to-read-study-record#record-history-tab
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`2/12/24, 9:04 AM
`Publications
`
`How to Read a Study Record | ClinicalTrials.gov
`
`Papers in scientic journals that are related to the study, if any are available.
`
`Study Record Dates
`
`Administrative dates for the study, such as when the study investigator
`submitted the study to ClinicalTrials.gov (https://clinicaltrials.gov/).
`
`More Information
`
`Additional information about the study, which may include:
`Terms Related to this Study: Key words related to the health conditions and
`interventions in the study.
`Plan for Individual participant data (IPD): A description of whether individual
`participant data will be shared, when it will be shared, and how it will be
`protected.
`Drug and Device Information, Study Documents, and Helpful Links: Whether
`the intervention studies a U.S. FDA-regulated drug or device, links to open
`study les, and links to websites with more information about the study.
`
`There is also a link to the Record History.
`
`The Researcher tab
`
`This section contains a more detailed description of the study details tab,
`organized in a way that is useful to data researchers and journal editors.
`
`The Results tab
`
`This section contains the results of the study. If the results are available, the tab
`will read, “Results Posted”. If the results are not available, the tab will read, “No
`Results Posted”. If the tab reads, "Results Submitted”, the study results are under
`review and are not posted yet.
`
`Note: Results are only available for Interventional and Observational studies.
`
`When results are available, there are 10 parts:
`Results Overview
`Study Record Dates
`Participant Flow
`Baseline Characteristics
`Outcome Measures
`Adverse Events
`
`https://clinicaltrials.gov/study-basics/how-to-read-study-record#record-history-tab
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`How to Read a Study Record | ClinicalTrials.gov
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`2/12/24, 9:04 AM
`Limitations and Caveats
`Collaborators and Investigators
`Publications
`More Information
`
`Results Overview
`
`This section gives you the basic information about how the study was set-up, the
`conditions being studied, how many people participated in the study, and the
`intervention or treatment used in the study.
`Study Type:
`Interventional (also called clinical trials) – Participants were assigned
`to receive an intervention so that researchers could study the effects of
`the intervention.
`Observational (including patient registries) – Participants did not
`receive an assigned intervention. They were observed over time for
`health-related outcomes.
`Conditions: The focus of the study, usually a disease, illness, or condition, but
`may also be another health-related issue.
`Enrollment: The number of participants who joined the study.
`Intervention/Treatment: The treatment, device, or procedure that was
`studied.
`Other Study ID Numbers: Other identifying numbers for the study.
`Study Design: Describes the study methods and is dependent on the study
`type.
`Results Point of Contact: The person or organization to contact if there are
`questions about the results.
`
`At the bottom, there is a link to important dates related to submitting and posting
`the study results.
`
`Study Record Dates
`
`These dates show the progress of the study record and results submissions to
`ClinicalTrial.gov. Study records and results submissions are reviewed by the
`National Library of Medicine to make sure they meet certain quality control
`standards before they are posted on ClinicalTrial.gov.
`
`Participant Flow
`
`A summary of the progress of participants through each stage of the clinical
`study, by study arm for interventional studies or by group/cohort for
`
`https://clinicaltrials.gov/study-basics/how-to-read-study-record#record-history-tab
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`How to Read a Study Record | ClinicalTrials.gov
`2/12/24, 9:04 AM
`observational studies. This includes the number of participants who started,
`completed, and dropped out of the study.
`
`Baseline Characteristics
`
`Data collected at the beginning of a clinical study for all participants and for each
`arm or comparison group. Examples of data include demographics, age, sex,
`race and ethnicity, and study-specic measures.
`
`Outcome Measures
`
`These are tables that show the results for each of the planned measurements
`used in the clinical study. For interventional studies, the results of each
`measurement are used to understand the effects of the intervention. For
`observational studies, the results of each measurement are used to see how a
`disease changes over time or to understand the effects of an exposure.
`
`Adverse Events
`
`These tables show the number of study participants who experienced a problem
`or unwanted health change during the clinical study or within a certain length of
`time after the study. These may include any abnormal physical exam or
`laboratory nding. Adverse events may or may not be caused by the intervention
`being studied.
`
`Limitations and Caveats
`
`Any barriers or limits that may affect the results of the study. These could be
`things like not enrolling enough participants or the length of time allowed for the
`study.
`
`Collaborators and Investigators
`
`The names of people and organizations who carried out the study.
`
`Publications
`
`Papers in scientic journals that are related to the study, if any are available.
`Publications that include the study results may be included here.
`
`More Information
`
`This section may include certain agreements that affect how the study results
`are reported. This information is required by law.
`
`https://clinicaltrials.gov/study-basics/how-to-read-study-record#record-history-tab
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`Regeneron Pharmaceuticals, Inc. Exhibit 2133 Page 9
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`2/12/24, 9:04 AM
`The Record History tab
`
`How to Read a Study Record | ClinicalTrials.gov
`
`This section shows the history of changes to the study record. You can use this
`tab to see different versions of the study record and compare the changes made
`to the study record over time. This tab is most often used by data researchers.
`Last updated on January 09, 2024
`
`https://clinicaltrials.gov/study-basics/how-to-read-study-record#record-history-tab
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`10/10
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2133 Page 10
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