Clinical Trial
A clinical trial is a research study that evaluates the safety and efficacy of new medical interventions, such as drugs, treatments, or behavioral modifications, on human subjects[1][2]. These studies are crucial for advancing medical knowledge and developing new therapies. Here's a glossary of key terms related to clinical trials:
Phases of Clinical Trials
Phase I: Initial studies conducted on a small group of people (20-80) to evaluate safety, determine safe dosage ranges, and identify side effects[1].
Phase II: Trials involving several hundred participants to assess efficacy and further evaluate safety[1].
Phase III: Large-scale trials involving 1,000 to 3,000 patients to confirm effectiveness, monitor side effects, and compare with standard treatments[2].
Phase IV: Post-marketing studies to gather additional information about the treatment's safety, efficacy, and optimal use[2].
Key Concepts and Terminology
Adverse Event (AE): Any unfavorable medical occurrence in a study participant, whether or not it's related to the research intervention[1].
Baseline: The initial time point in a clinical trial that serves as a reference for assessing changes in subsequent observations[1].
Bias: A point of view or preference that prevents impartial judgment in conducting or reporting research[1].
Placebo Controlled Study: A method where an inactive substance (placebo) is given to one group of participants, while the test article is given to another group for comparison[1].
Protocol: A document that outlines the objective(s), design, methodology, statistical considerations, and organization of a trial[1].
Pharmacokinetics: The process of how a drug or vaccine is absorbed, distributed, metabolized, and excreted in a living organism[1].
Principal Investigator (PI): The doctor responsible for conducting the clinical trial[3].
Serious Adverse Experience: An adverse event that is fatal, life-threatening, disabling, or results in hospitalization[2].
Source Documents: Original documents and records used in clinical trials, such as hospital records, laboratory notes, and evaluation checklists[2].
By understanding these terms, patients, researchers, and healthcare professionals can better navigate the complex world of clinical trials and contribute to the advancement of medical science.
Citations:
[1] https://www.nia.nih.gov/research/dgcg/nia-glossary-clinical-research-terms
[2] https://www.uab.edu/ccts/images/k_data_coord/Clinical_Trial_Glossary.pdf
[3] https://cancer.dartmouth.edu/patients-families/clinical-trials-glossary
[4] https://www.abbvieclinicaltrials.com/clinical-trials-glossary/
[5] https://www.michaeljfox.org/sites/default/files/media/document/A2_ClinicalTrialGlossary.pdf
