Question

Research a website that contains a Clinical trial protocol and read through the protocol and choose the parameters which you feel need to be closely followed throughout the trial. Think of the outcomes measures that would be required for safety and efficacy. Write a list (no more than a page) of these.

Answer 1

The protocol is a document that describes the objectives, design, methodology, statistical considerations and organisation of a clinical trial . High quality protocols facilitate proper conduct, reporting and external review of clinical trials. It also ensures the safety of the trial subjects and integrity of the data collected.

Clinical trials are experiments or observations done in clinical research. They generate data on safety and efficacy and are conducted only after the approval of the health authority.

The parameters to be followed throughout the trial are: rational for the conduct of the trial, hypothesis being evaluated, trial design, selection and withdrawal of the subjects and their exposure to investigational products, safety and efficacy assessment, statistical analysis and data management, record keeping and quality control.

Measures required for safety and efficacy are ensuring optimal efficacy, anticipation, prevention and assessment of any event that can have an unfavourable impact on the enrolled subjects.