Your Easy Guide to Clinical Studies

In studies, a “Quality by Design” (QbyD) approach involves focusing on “Critical to Quality” (CtoQ) factors of the study to:

• Ensure the rights and safety of study participants
• Maximise the ability to answer the research question by generating reliable, interpretable, and meaningful study results

 

A QbyD approach requires that researchers prospectively integrate quality aspects into the study protocol, by addressing quality considerations in the design, planning, conduct, analysis, and reporting of the study (e.g. study report(s) include a description of the study`s CtoQ factors).

 

The QD approach requires for researchers to prospectively:

• Select a study design that is fit for purpose. Note: Study objective(s) impact the choice of study design and the scope/source of collected study data, which in turn impacts the strength of the study
• Identify the study`s CtoQ factors
• Identify risks threatening the integrity of CtoQ factors
• Define risk control-measures proportionate to the importance of the data being collected, and safety risks to study participant

As a SP-INV, use a QbyD approach to your study, which includes to:

• Predefine study objective and study outcome(s)/endpoint(s), with outcome(s)/endpoint(s) being well defined, measurable, clinically meaningful, and relevant to the study population
• Select a study design that is fit for purpose, operationally feasible, and void of unnecessary complexity
• Select a fit for purpose population (e.g. disease, treatment, gender/age, genetic profile)
• Define measures to minimize bias (e.g. randomization, blinding, control of confounders)
• Establish a QMS with a risk-based approach. Include a framework for the identification, management, and review of CtoQ factors. The framework should be established at the time of study design and planning, and used throughout study conduct, analysis, and reporting

 

The study protocol

• Adherence to the study protocol and other relevant documents is essential. Aspects of adherence should be considered among the study’s CtoQ factors
• Successful application of the QbyD principles may minimize the need for protocol modifications, facilitating study adherence

References

ICH GCP E6(R3) – see in particular ICH GCP principles and guidelines

• Main principle: Quality by design should be implemented to identify factors critical to trial quality
• Principle 6. Quality should be built into the scientific, operational design, and conduct of the trial
• 3.11.4.3 Monitoring plan and CtoQ
• 6.2 Factors critical to quality
• 7.3 Management of CtyQ factors

ICH E8(R1) – see in particular guidelines

• 2.2 Scientific approach in clinical study design
• 3. Designing quality into clinical studies
• 3.1 Quality by design of clinical studies
• 5. Design elements and data sources for clinical studies
• 6.1 Study conduct
• 6.1.1 Protocol adherence
• 6.3 Study reporting