According to the definition provided by CTTI “Quality” is characterized by the ability to effectively and efficiently addressing the intended question about the benefits and the risks of a medical product (therapeutic or diagnostic) or procedure while safeguarding the protection of the human subjects. The Clinical Trials Transformation Initiative (CTTI) is a public-private partnership formed in 2008 between the US FDA and Duke University. CTTI advocates for the integration of Quality by Design (QbD) and Quality Risk Management (QRM) principles into the design of clinical studies.

As drug and device developing companies, most sponsors will agree that a good study design is the key to a successful clinical study. A well designed, scientifically and statistically robust study leads to definite conclusions. Developing a design that aligns with the sponsor’s research and commercial objectives necessitates extensive planning and careful consideration from the outset. A good design requires a lot of time commitment from sponsor’s clinical team members and practicing clinicians and statisticians to validate it. Therefore, this becomes the most challenging and daunting task to take the input from all concerned and come up with an efficient and proper design. Multiparty involvement, collaborative approach, attention is essential and vital for this exercise. The design process demands effective communication and well-defined procedures, as this step is crucial to the clinical trial. It is crucial to finalize the majority, if not the entire, design promptly by incorporating input from all stakeholders to optimize overall time efficiency.

If the design is robust and firm to start with, has built in quality, a reliable risk mitigation plan and has concurrence of all the parties, it will eventually contribute towards maintaining high quality during the trial conduct. It will also aid in speedy compilation of essential regulatory documents like clinical study protocol, informed consent documents, case report forms and other related documents.

After several decades of collaborating with sponsors and clinicians on numerous studies for various therapeutic areas and various clinical phases, we have noted that mostly the design aspects are handled very hurriedly due to pressing timelines and this approach does not help in the long term. So, it is essential that all stakeholders should deliberate together to develop a strategy for study design that is quality driven, efficient, practical, robust, scientific, statistically sound, ethical and fulfils regulatory requirement while protecting the trial participant. Hence, it is required to be a focussed and dedicated exercise.

The next question is how the design can be converted into an efficient and high-quality study. Quality aspects integrated into the study design must be maintained throughout the execution of the studies. Our practical experience has shown that traditional monitoring methods and conventional audits provide only limited effectiveness.

During CQA audits we still identify issues that could have been rectified along the way instead of being identified at the time of the audit. Sometimes issues identified during audits are not rectifiable and effects study objective and impacts quality. We feel that there should be a continuous, focussed and collaborative approach between the CRO (if CRO exists), site and sponsor to maintain real-time control over issues that arise during the implementation of the study. A close, consistent and systematic watch to have a check on quality so that issues can be rectified, and prevention plan executed across all participating sites in a timely manner to avoid costly deviation