A research study that investigates the safety and effectiveness of medical treatments, interventions, or procedures in humans.
The process of assigning participants to different groups in a clinical trial randomly. This helps reduce bias and ensures each participant has an equal chance of receiving different treatments.
A harmless substance with no therapeutic effect given to participants in the control group of a clinical trial. It helps researchers assess the true effects of the treatment being studied.
A clinical trial design where neither the participants nor the researchers know who is receiving the treatment and who is receiving the placebo. This helps minimize bias in the study.
The process by which participants are fully informed about the risks and benefits of participating in a clinical trial before deciding whether to enroll.
A detailed plan that outlines the objectives, design, methodology, and statistical considerations of a clinical trial. It serves as a roadmap for conducting the study.
Clinical trials are typically conducted in phases:
Phase 0: Exploratory trials to test a small dose of a drug in a few participants.
Phase I: Initial testing in a small group of participants to evaluate safety, dosage, and side effects.
Phase II: Further testing in a larger group to assess effectiveness and side effects.
Phase III: Large-scale testing to confirm effectiveness, monitor side effects, and compare to standard treatments.
Phase IV: Post-marketing surveillance to monitor the long-term safety and effectiveness of a treatment after it’s approved and marketed.
Any undesirable experience or side effect associated with the use of a medical product in a clinical trial, whether or not considered related to the product.
Specific characteristics or conditions that must be met for a person to be eligible to participate in a clinical trial.
Specific characteristics or conditions that disqualify a person from participating in a clinical trial.
The practice of keeping certain information (such as treatment assignment) concealed from participants, researchers, or both, to prevent bias.
An independent group of experts responsible for reviewing and evaluating the accumulating data from a clinical trial to ensure participant safety and study integrity.
An analysis of trial data conducted before the study is complete to assess safety, efficacy, or futility. It may inform decisions to modify, continue, or terminate the trial.
A specific outcome used to measure the effectiveness or success of a clinical trial. It could be a clinical outcome, a laboratory measurement, or a patient-reported outcome.
An independent ethics committee that reviews and approves the initiation and conduct of clinical trials to ensure participant rights, safety, and well-being are protected.
Any medication taken by a participant in addition to the investigational treatment being studied in a clinical trial.
A study design where participants receive multiple interventions in a sequential order, often including a period of washout between treatments.
The lead researcher responsible for the overall conduct of a clinical trial at a particular site.
The degree to which participants adhere to the study protocol, including medication regimens, follow-up visits, and lifestyle changes.
The tendency for positive or statistically significant results to be published more frequently than negative or inconclusive results, which can skew the overall understanding of a treatment’s effectiveness.