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Hello, I am Mallorie Mitchell-Dellac!
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How can we reduce the amount of protocol deviations that matter to data integrity and patient safety?
23-Jun-2020
One efficient way to limit them is to consider potential protocol deviations at the time the protocol is developed. Ask the following questions: Is the protocol operationally feasible? Is it too complex (for example does it include a multitude of objectives)? Is all the data to be collected necessary?
Too many complex assessments can discourage patients from participating and they may discontinue their participation or refuse to comply with study assessments (for example, questionnaires and multiple lab samples).
A protocol that is too complex and different from the sites’ standard practice can confuse and add to the site personnel’s workload, resulting in missed or inaccurate evaluations.
How can we make this better? It is a good idea for the sponsor to ask for input from site personnel, such as Investigators but also Study Coordinators and other experts, who treat and evaluate patients regularly, when a new study is designed. They can provide useful information on how the study procedures are routinely performed within their hospital/practice or country.
How do ICH E6 and E8 guidelines work together to ensure the quality of a clinical trial?
07-Jun-2020
While ICH E6 focuses on the conduct of clinical trials, E8 focuses on the design of those trials. The most important message of E8 is that the quality of a clinical trial is closely linked to how carefully the elements critical to the success of the study were considered. For example, were the endpoints carefully chosen, were the right experts involved in the protocol design, are the eligibility criteria representative of the population being studied? This concept is called "Quality by Design".
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Have you heard of ICH E8 guideline?
07-Jun-2020
It is the umbrella for all ICH efficacy guidelines.
The ICH efficacy guidelines are a set of guidance covering the design, conduct, analysis and reporting of clinical studies. They are meant to be used in a holistic way, with ICH E8 (General Considerations for Clinical Studies) giving an overall introduction to clinical development.
The ICH Expert Working Group is currently revising ICH E8 as part of a good clinical practice renovation project that will also see a new revision to ICH E6 in the near future.
What is a Clinical Quality Management System?
09-May-2020
This is the structure (or framework, like for a house) upon which clinical trials are built. It should be in place before the trial starts. The more robust the Clinical QMS is, the easier it will be to ensure and demonstrate the high quality of a clinical trial.
