Cycle groups
A cycle refers to the planned sequence of treatments and recovery periods that participants undergo during the study. In Study Designer, the cycles can be added only within the dedicated cycle group that needs to be created first.
Throughout the clinical trial, data is collected during various visits to assess the drug's efficacy and safety. The researchers analyze the data to determine if the treatment achieves the required outcomes. Cycles provide a structured framework for administering interventions, monitoring participants, and evaluating treatment effects. They help ensure consistency in treatment delivery and allow researchers to assess the long-term impact of the intervention on patient health.
The implementation of cycles may be required or optional depending on the study design. The duration and number of cycles can vary depending on the nature of the study and the specific treatment that is investigated. Typically, a cycle consists of several phases, including the administration of the treatment, observation of its effects, and a period of recovery. Let us consider the following example to illustrate the implementation of cycles in a clinical trial.
Suppose there is a study investigating a new drug for lung cancer. According to the trial protocol, each subject undergoes six treatment cycles added to the cycle group within a year, and every cycle involves the following steps:
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Treatment administration: at the beginning of each cycle, the subject receives the chemotherapy drug according to a predetermined dosage and schedule.
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Monitoring and evaluation: after the drug administration, the subject's response to treatment is closely monitored with regular check-ups, blood tests, and so on.
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Recovery period: the participant enters a recovery period to recuperate from the treatment's side effects and regain strength before the next cycle begins.
After the recovery period, the subject proceeds to the next cycle, where steps 1-3 are repeated. This process continues until all of the six planned cycles are completed or until the participant experiences adverse effects that require discontinuation from the study.
In this section, you can learn how to do the following: