A specialized facility dedicated to conducting clinical trials and research studies to evaluate new medical treatments, interventions, and therapies. CRCs play a vital role in advancing medical knowledge and improving patient care.
The lead researcher responsible for designing, implementing, and overseeing clinical trials conducted at the CRC. The PI ensures that the study adheres to ethical guidelines, regulatory requirements, and scientific standards.
A process through which participants in a clinical trial are provided with comprehensive information about the study, including its purpose, procedures, potential risks, and benefits. Participants must voluntarily agree to participate after understanding this information.
A detailed plan outlining the objectives, methodology, study design, and procedures of a clinical trial. The protocol serves as a blueprint for conducting the research and ensures consistency across different study sites.
A substance or treatment with no therapeutic effect, used in clinical trials as a control to compare the effectiveness of the investigational treatment. Placebos are essential for assessing the true effects of a new intervention.
The process of assigning participants to different treatment groups in a clinical trial randomly. Randomization helps minimize bias and ensures that each participant has an equal chance of receiving either the experimental treatment or the control.
A type of clinical trial in which neither the participants nor the researchers know who is receiving the experimental treatment and who is receiving the placebo or standard treatment. Double-blinding helps reduce bias and ensures the validity of study results.
Any unfavorable or unintended medical occurrence that happens to a participant during the course of a clinical trial, regardless of whether it is related to the investigational treatment. Adverse events are closely monitored and reported to ensure participant safety.
An independent group of experts responsible for monitoring the safety and efficacy of a clinical trial. The DMC reviews interim data at predefined intervals and may recommend modifications to the study protocol or early termination if necessary.
The adherence to laws, regulations, and guidelines governing the conduct of clinical research, including those set forth by government agencies such as the Food and Drug Administration (FDA) and institutional review boards (IRBs). Compliance ensures the protection of participants’ rights and welfare.
A specific event or outcome used to measure the effectiveness or safety of the investigational treatment in a clinical trial. Endpoints can include clinical symptoms, laboratory results, or patient-reported outcomes.
The process of collecting, storing, and analyzing data generated during a clinical trial. Data management ensures the accuracy, integrity, and confidentiality of study data and facilitates the generation of reliable results.
The tendency of researchers and journals to publish only positive or statistically significant results, while omitting negative or inconclusive findings. Publication bias can distort the overall body of evidence and lead to erroneous conclusions.
The involvement of local communities, patient advocacy groups, and stakeholders in the planning, implementation, and dissemination of clinical research. Community engagement fosters trust, transparency, and collaboration, ultimately enhancing the relevance and impact of research outcomes.
Ongoing monitoring of the safety and effectiveness of a medical product after it has been approved and marketed for public use. Post-marketing surveillance helps identify rare or long-term adverse effects that may not have been apparent during clinical trials.