Terms & Definitions
The language of clinical trials can be dense, technical, and hard to navigate—especially for those outside the research world. We believe patients deserve plain-language explanations.
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Keeping participants and/or researchers unaware of which treatment is being given to prevent bias.
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Neither the patient nor the doctor knows who’s getting the treatment vs. the placebo, which helps reduce bias.
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A substance with no therapeutic effect, used to compare against the active treatment. Essentially a “lookalike” treatment with no active ingredient, used to compare real effects.
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Assigning participants to different groups (i.e. placebo vs. drug) by chance, to reduce bias.
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The specific outcomes a trial is measuring (e.g., symptom improvement, survival rate).
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A shortcut measurement (like lab results) used to predict long-term benefit.
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A faster FDA pathway for serious conditions—based on early data, with follow-up required.
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Pathways for patients to access investigational treatments outside of trials. A way to get a treatment outside of a trial, if you’re not eligible but have no other options.
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Data collected from actual patient experiences outside of controlled trials—like from electronic health records or patient registries.
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A process—not just a form—that ensures participants understand the risks, benefits, and purpose of a trial before joining. Your signature means you understand your rights.
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The official plan outlining how a clinical trial is conducted, including objectives, design, and eligibility criteria.
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The medical, demographic, or situational requirements that determine who can or cannot participate.
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Trials that use technology or local providers to reduce travel and increase access.
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Data directly from patients about how they feel or function, without interpretation by clinicians.
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A measurable indicator (like a protein or gene) used to assess disease or treatment response.
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A committee that reviews and approves trial protocols to protect participants.