A scientific investigation involving human subjects to evaluate the safety and efficacy of medical interventions, treatments, or procedures. Clinical studies aim to advance medical knowledge, develop new therapies, or improve existing ones.
A type of clinical study where participants are randomly assigned to different groups to receive either the treatment being tested or a control group receiving a placebo or standard treatment. RCTs are considered the gold standard for assessing the effectiveness of medical interventions.
An inactive substance or treatment given to participants in a clinical study to mimic the experience of receiving the active treatment. Placebos are used to compare the effects of the active treatment against a baseline, helping researchers to determine the true effects of the treatment being tested.
A type of clinical trial where neither the participants nor the researchers involved know who is receiving the active treatment and who is receiving the placebo until the study is completed. Double-blind studies help minimize bias and ensure the validity of study results.
The process by which participants in a clinical study are fully informed about the study’s purpose, procedures, potential risks, and benefits before agreeing to participate. Informed consent is essential to protect participants’ autonomy and ensure ethical conduct in research.
A detailed plan or set of guidelines outlining the objectives, methodology, participant eligibility criteria, and procedures for conducting a clinical study. The protocol serves as a blueprint for researchers to follow and ensures the study is conducted in a systematic and standardized manner.
Any undesirable or unintended occurrence experienced by a participant during a clinical study, regardless of whether it is related to the treatment being investigated. Adverse events are closely monitored and reported to assess the safety profile of the intervention under study.
A specific outcome or event used to measure the effectiveness or success of a clinical study. Endpoints can include clinical symptoms, laboratory results, or patient-reported outcomes and are predefined in the study protocol to guide data analysis and interpretation.
A type of clinical research that follows participants over an extended period to observe changes in health outcomes, disease progression, or treatment effectiveness over time. Longitudinal studies provide valuable insights into the long-term effects of interventions and disease trajectories.
A statistical technique used to combine and analyze data from multiple independent studies on a particular topic or intervention. Meta-analyses enable researchers to synthesize findings from various studies, increase statistical power, and draw more robust conclusions about the overall effect size of an intervention.
A type of clinical trial where participants receive multiple treatments or interventions in a predetermined sequence, with each participant acting as their control. Crossover studies help minimize variability between participants and increase the efficiency of comparing treatments within the same group of individuals.
An independent committee responsible for reviewing, approving, and monitoring the conduct of clinical studies to ensure the rights, safety, and well-being of participants are protected. Ethics committees evaluate study protocols, informed consent procedures, and potential risks and benefits before granting approval for research to proceed.
The treatment, procedure, or action being tested or evaluated in a clinical study. Interventions can include medications, medical devices, surgical techniques, behavioral therapies, or lifestyle modifications aimed at preventing, managing, or treating health conditions.
The period of time after the completion of a clinical study during which researchers continue to monitor participants to assess long-term outcomes, safety, and efficacy of the intervention. Follow-up allows researchers to track any delayed effects or changes in participants’ health status beyond the study period.
The process of identifying, screening, and enrolling eligible individuals into a clinical study. Participant recruitment strategies may include advertising, outreach to healthcare providers, or collaboration with patient advocacy groups to ensure a diverse and representative study population.
A measure used in clinical studies to evaluate the impact of a disease, treatment, or intervention on a person’s physical, psychological, and social well-being. Quality of life assessments provide valuable insights into the holistic effects of medical interventions beyond traditional clinical endpoints.
The probability that a clinical study will detect a true effect or difference between treatment groups if it exists. Statistical power depends on factors such as sample size, effect size, and variability and is essential for ensuring the reliability and validity of study findings.
A method used in clinical trials to prevent bias by keeping participants, researchers, or outcome assessors unaware of which treatment group participants belong to. Blinding helps minimize the influence of expectations or preconceptions on study outcomes and enhances the objectivity of data collection and analysis.
The tendency for positive or statistically significant results from clinical studies to be published more frequently than negative or non-significant results. Publication bias can distort the overall body of evidence and lead to misleading conclusions about the effectiveness or safety of interventions.