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Protocol Title phase II randomized controlled trial of a parent/carer targeted intervention to improve quality of life in families of young cancer survivors. Version Number: 12 Date of Protocol: 3rd
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To fill out a phase II randomised trial, follow these steps:
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Determine the objective of the trial and define the primary outcome measure.
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Design the study protocol, including inclusion and exclusion criteria for participants.
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Randomly assign eligible participants into two or more study groups.
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Develop an intervention or treatment plan for each group, ensuring blinding if necessary.
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Collect data on the outcomes of interest at predetermined time points.
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Prepare a comprehensive report summarizing the trial design, methodology, results, and conclusions.
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Publish or disseminate the findings to contribute to scientific knowledge.

Who needs a phase ii randomised?

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Phase II randomised trials are typically needed by researchers and pharmaceutical companies who want to evaluate the efficacy and safety of a new intervention or treatment in a controlled setting. These trials are essential in the development of new drugs, therapies, or medical interventions before they can be tested in larger populations during phase III trials. Regulatory agencies often require phase II data to ensure that the benefits outweigh the risks before granting approval for further testing or marketing.

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A Phase II randomized trial is a type of clinical study that evaluates the effectiveness and safety of a drug or treatment in a larger group of participants after initial safety has been established in Phase I trials. It randomly assigns participants to different treatment groups to compare outcomes.
Researchers and pharmaceutical companies conducting clinical trials are required to file Phase II randomized studies with regulatory authorities to ensure compliance with safety and efficacy standards.
To fill out a Phase II randomized trial submission, one must provide a detailed study protocol including objectives, methodology, statistical analysis plan, informed consent documents, and any preclinical data supporting the study.
The purpose of a Phase II randomized trial is to assess the effectiveness of a treatment, further evaluate its safety, determine optimal dosages, and compare it to standard treatments or placebo in a controlled trial setting.
Essential information to report includes trial design, participant demographics, inclusion/exclusion criteria, treatment regimen, primary and secondary endpoints, adverse events, and statistical analyses conducted.
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