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`Step 3: Clinical Research | FDA
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`Step 3: Clinical Research
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`While preclinical research answers basic questions about a drug’s safety, it is not a substitute for
`studies of ways the drug will interact with the human body. “Clinical research” refers to studies,
`or trials, that are done in people. As the developers design the clinical study, they will consider
`what they want to accomplish for each of the different Clinical Research Phases and begin the
`Investigational New Drug Process (IND), a process they must go through before clinical
`research begins.
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`On this page you will find information on:
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`Designing Clinical Trials
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`Clinical Research Phase Studies
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`The Investigational New Drug Process
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`Designing Clinical Trials
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`Asking for FDA Assistance
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`FDA IND Review Team
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`Approval
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`Researchers design clinical trials to answer specific research questions related to a medical
`product. These trials follow a specific study plan, called a protocol, that is developed by the
`researcher or manufacturer. Before a clinical trial begins, researchers review prior information
`about the drug to develop research questions and objectives. Then, they decide:
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`Who qualifies to participate (selection criteria)
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`How many people will be part of the study
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`How long the study will last
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`Whether there will be a control group and other ways to limit research bias
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`How the drug will be given to patients and at what dosage
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`Clinical trials follow a typical series from early, small-scale, Phase 1 studies to late-stage, large
`scale, Phase 3 studies.
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`What assessments will be conducted, when, and what data will be collected
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`How the data will be reviewed and analyzed
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`https://www.fda.gov/patients/drug-development-process/step-3-clinical-research
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2128 Page 1
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2128 Page 2
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2128 Page 3
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2128 Page 4
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2128 Page 5
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`8/23/23, 8:38 AM
`Asking for FDA Assistance
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`Step 3: Clinical Research | FDA
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`Drug developers are free to ask for help from FDA at any point in the drug development process,
`including:
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`Pre-IND application, to review FDA guidance documents and get answers to questions
`that may help enhance their research
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`After Phase 2, to obtain guidance on the design of large Phase 3 studies
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`Any time during the process, to obtain an assessment of the IND application
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`Even though FDA offers extensive technical assistance, drug developers are not required to take
`FDA’s suggestions. As long as clinical trials are thoughtfully designed, reflect what developers
`know about a product, safeguard participants, and otherwise meet Federal standards, FDA
`allows wide latitude in clinical trial design.
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`FDA IND Review Team
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`The review team consists of a group of specialists in different scientific fields. Each member has
`different responsibilities.
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`Project Manager: Coordinates the team’s activities throughout the review process, and
`is the primary contact for the sponsor.
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`Medical Officer: Reviews all clinical study information and data before, during, and
`after the trial is complete.
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`Statistician: Interprets clinical trial designs and data, and works closely with the
`medical officer to evaluate protocols and safety and efficacy data.
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`Pharmacologist: Reviews preclinical studies.
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`Pharmakineticist: Focuses on the drug’s absorption, distribution, metabolism, and
`excretion processes.Interprets blood-level data at different time intervals from clinical
`trials, as a way to assess drug dosages and administration schedules.
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`Chemist: Evaluates a drug’s chemical compounds. Analyzes how a drug was made and its
`stability, quality control, continuity, the presence of impurities, etc.
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`Microbiologist: Reviews the data submitted, if the product is an antimicrobial product,
`to assess response across different classes of microbes.
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`Approval
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`The FDA review team has 30 days to review the original IND submission. The process protects
`volunteers who participate in clinical trials from unreasonable and significant risk in clinical
`trials. FDA responds to IND applications in one of two ways:
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`https://www.fda.gov/patients/drug-development-process/step-3-clinical-research
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`6/7
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2128 Page 6
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`8/23/23, 8:38 AM
`Approval to begin clinical trials.
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`Clinical hold to delay or stop the investigation. FDA can place a clinical hold for specific
`reasons, including:
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`Step 3: Clinical Research | FDA
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`Participants are exposed to unreasonable or significant risk.
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`Investigators are not qualified.
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`Materials for the volunteer participants are misleading.
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`The IND application does not include enough information about the trial’s risks.
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`A clinical hold is rare; instead, FDA often provides comments intended to improve the quality of
`a clinical trial. In most cases, if FDA is satisfied that the trial meets Federal standards, the
`applicant is allowed to proceed with the proposed study.
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`The developer is responsible for informing the review team about new protocols, as well as
`serious side effects seen during the trial. This information ensures that the team can monitor the
`trials carefully for signs of any problems. After the trial ends, researchers must submit study
`reports.
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`This process continues until the developer decides to end clinical trials or files a marketing
`application. Before filing a marketing application, a developer must have adequate data from
`two large, controlled clinical trials.
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`https://www.fda.gov/patients/drug-development-process/step-3-clinical-research
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`7/7
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`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2128 Page 7
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