A branch of medical science that investigates the safety and efficacy of medications, devices, diagnostic products, and treatment regimens intended for human use. It encompasses a variety of study designs, including observational studies, clinical trials, and experimental research.
The process by which individuals are provided with information about a clinical trial or research study, including its purpose, risks, benefits, and alternatives, and are given the opportunity to ask questions before deciding whether to participate.
A harmless substance or treatment with no therapeutic effect, often used as a control in clinical trials to evaluate the effectiveness of a new intervention.
A research design in which neither the participants nor the investigators know who is receiving the experimental treatment and who is receiving a placebo or standard treatment until the study is completed. This helps to minimize bias and ensure the validity of the results.
A type of clinical trial in which participants are randomly assigned to different treatment groups, allowing researchers to compare the outcomes of the groups and evaluate the effectiveness of the interventions being studied.
Any undesirable or unintended medical occurrence in a participant of a clinical trial, regardless of whether it is considered to be related to the investigational product. Adverse events are closely monitored and reported throughout the course of the study.
A detailed plan outlining the objectives, methodology, study population, and statistical analysis of a clinical trial. The protocol serves as a blueprint for conducting the research and ensures that all participants are treated consistently and ethically.
A measurable outcome used to evaluate the effectiveness of a treatment or intervention in a clinical trial. Clinical endpoints may include symptoms, laboratory values, or other physiological or functional parameters relevant to the disease or condition being studied.
A set of international ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials involving human participants. Compliance with GCP guidelines helps to ensure the integrity and credibility of clinical research data.
An independent group of experts responsible for reviewing the progress and safety of a clinical trial at regular intervals. The DMC may recommend modifications to the study protocol or early termination of the trial if significant safety concerns arise.
An independent ethics committee responsible for reviewing and approving the initiation of clinical research studies involving human participants. The IRB ensures that the rights, safety, and well-being of study participants are protected and that the research is conducted in accordance with ethical principles and regulatory requirements.
A type of clinical trial in which participants receive multiple treatments or interventions in a sequential order, with each participant serving as their own control. Crossover studies are often used to compare the effects of different interventions within the same group of participants.
The period of time after the completion of a clinical trial during which participants are monitored for any long-term effects or outcomes related to the intervention. Follow-up assessments are essential for evaluating the durability and safety of treatment effects over time.
The completeness, accuracy, and reliability of clinical research data, ensuring that the data accurately reflect the conduct and results of the study. Data integrity is essential for drawing valid conclusions and making informed decisions in clinical practice.
The process of identifying and enrolling eligible individuals into a clinical trial. Effective recruitment strategies are crucial for maintaining the integrity and timeliness of the study and ensuring that an adequate sample size is achieved.