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Quality by Design for Clinical Trials

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Anushree Reddy

Abstract: Quality by design for clinical trials comprises an independent entity responsible for quality standards and an integrated system where each person is accountable for quality. This article explores myths about quality and provides a general overview of the principles and philosophy of quality by design. Quality issues normally encountered at clinical research sites and contract research organizations as well as practical ways to build quality into a research program in order to prevent issues are highlighted.

The Plan-Do-Check-Act cycle and its tie-in with risk-based monitoring are described. Clinical Research Training studies are always in need of volunteers. Without these volunteers, medications and treatments cannot be approved by the concerned authorities and thus cannot reach the patients.  Apart from gaining access to a potential treatment for a particular disease, other perks include receiving care at the topmost facilities, helping science, and making a potential impact on all those living in that particular condition. These studies generally offer generous compensation for your participation.

 

Covid-19 and clinical trials

The pandemic COVID-19 has created havoc all over the world. It has caused us to rethink everything, including how clinical research is conducted. Clinical research institutes have completely changed their way of working and processing data and results. The best clinical research course of action has changed drastically and has resulted in new trends in the research world. Clinical trial recruitment has become a challenge due to the global pandemic as people are socially distanced from one another. However, they have stayed connected through social media platforms. The benefit of reaching patients online or digitally is that they can be reached from any part of the world. Digital platforms make it easier to reach out to people, and it also encourages active participation in clinical trials. The latest trends in clinical trial recruitments include increased use of digital advertising to find the most suited patients for a trial.

 

Myths about Quality

There are many myths about quality in clinical trials, which will be unmasked in this article.

Quality Myth #1:
Auditors are the only ones qualified to implement quality systems and processes.

Quality Myth #2:
Maintaining a quality system is impossible with so many variables in clinical research.

Quality Myth #3:
The cost of establishing, maintaining, and re-evaluating quality is usually very high.

Quality Myth #4:
Quality is a department, a function, a specific role, or someone else’s job.

 

Conclusion

Clinical research trainings are given to every professional involved in the trial. Clinical research trainings are continuously updated based on the disease and development of technology to ensure the complete safety of the participants of the trial.

 

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Anushree Reddy
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