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A method used to prevent bias in clinical trials by randomly assigning participants to different treatment groups, ensuring that the results are statistically valid.

Any undesirable experience associated with the use of a medical product in a patient. Tracking these is essential for assessing drug safety during a trial.

Studies that determine how a patient's well-being is affected by the disease and its treatment. These are important for understanding the impact of the treatment beyond its effectiveness.

The analysis of specific molecules, genes, or characteristics that can predict a disease's progress, treatment response, or the presence of specific types of cancer cells, guiding personalized treatment.

These trials test the safety, dosage, and side effects of a new treatment. They are crucial as the first step in determining the effects of a new cancer drug in humans.

After safety is assessed, Phase II trials evaluate the efficacy of the drug and further monitor its safety. This phase helps to determine if the drug works in people who have the specific cancer.

These trials compare the new treatment with the current standard treatment. They are large-scale studies that determine the overall risk-benefit ratio of the intervention.

A detailed plan that outlines the study objectives, design, methodology, statistical considerations, and organization of a clinical trial, ensuring consistency and safety for participants.

A study that starts with a low dose of a drug and increases doses cautiously to find the highest dose that does not cause unacceptable side effects.

The group in a clinical trial that receives a standard treatment or placebo, providing a comparison for evaluating the effectiveness and safety of the new treatment.

The status a new drug must have to be legally administered in a clinical trial, it includes approval from regulatory bodies based on safety and efficacy data.

Conducted after drug approval, Phase IV trials collect information on the drug's long-term effectiveness, impact on quality of life, and any rare side effects.

Outcomes measured to determine a trial's effectiveness, such as overall survival, progression-free survival, or response rate, which are critical in deciding if a treatment should move to the next phase.

A way to provide experimental drugs to seriously ill patients who do not qualify for clinical trials. This approach can provide access to potentially life-saving therapies that are not yet available to the public.

An approach to data analysis where all participants who were randomized are included in the statistical analysis, which reflects real-world treatment scenarios.

A process by which patients are fully informed about the trials they are considering, including potential risks and benefits, helping them make an educated decision on their participation.

A trial design where participants do not know which treatment they are receiving to prevent bias. Single-blind involves participant unawareness, while double-blind means neither participants nor researchers know.

A trial that includes a group receiving a placebo to compare against the group receiving the experimental treatment, evaluating the treatment's real effect.

Standards that determine who is eligible to participate in a clinical trial, based on factors like age, gender, the type and stage of cancer, previous treatment history, and other medical conditions.