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Clinical trial

aka clinical trials, clinical study, clinical studies, enrolled, enrolment, enrollment, enrolling, recruiting, trial participants, trial arm, experimental arm, control arm, comparator arm, single-arm, single arm, investigational

A research study that tests a treatment in volunteers under strict rules, to find out whether it is safe and whether it works. Every approved cancer drug went through several.

Trials have a written protocol specifying who may join, what they receive, what is measured and how the results will be analysed, and are overseen by ethics committees and regulators; participants give informed consent and are usually monitored more closely than in routine care. Cancer trials progress through phases, from small safety studies to large randomised comparisons against the standard of care, and their results, reported at congresses such as ASCO and ESMO and in journals, are what change practice and win approvals. Fewer than one in ten adult cancer patients take part, participation is skewed towards younger, wealthier and white patients, and the cost and duration of trials is one of the field's main bottlenecks.

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Clinic basics

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