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The scientific method is the bedrock of clinical research but the gap between theory and practice can be significant. A recent development to bridge this gap has been the development of the estimand framework which looks to link the study objective, design and estimates together while accounting for real-world challenges such as inter-current events like patient dropout.
ICH E9 (R1) was a major step forward for the adoption of the estimand framework but significant research and debate continues on how best to utilise the framework.
We are delighted to host the first episode in this webinar series, presented by Dr Luis Rojas, CEO & President & Luis Rojas-Graterol, Vice President, Biometrics, InCSD.
In this webinar, you will learn more about the scientific method, how this can be applied to clinical research and how it intersects with the estimand framework as described in ICH E9 (R1).
For more information on InCSD and their webinar series, please visit www.incsd.com or watch their YouTube channel.
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The scientific method has been the bedrock of medical and scientific advancement for over a century. However, mapping the ideals of the scientific method onto clinical research practice can be challenging and thus there continues to be significant interest in methodological approaches which can bridge this gap between theory and practice.
A recent initiative in this area has been the development of the estimand framework. The estimand is a concept which seeks to link the study objective, study design, patient measurements and statistical estimates while including the realities of research such as inter-current events like dropout or study delays - such as those seen during the Covid-19 pandemic.
In 2022, the publication of ICH E9 (R1) was a major step forward for the wider adoption of the estimand framework and has sparked much ongoing research, work and debate on how best to implement this approach in clinical research. However, to maximise the benefits of this new paradigm a better understanding of how and why this approach links to fundamental objectives of clinical research is vital.
To provide an insight into the estimand framework, our partners at Innovative Clinical Study Designs (InCSD) are starting a new webinar series on the estimand framework and how they tie into the theory and practice of clinical research.
nQuery is delighted to host the first webinar in this series. This webinar will provide a summary of the scientific method, how it maps onto the practical questions of clinical research design and how the estimand framework fits into this process.
Speakers:
Dr. Luis Rojas, CEO & President, InCSD
Luis Rojas-Graterol, Vice President, Biometrics, InCSD
Duration: 60 minutes
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InCSD is a team of clinical trial professionals with the education, training, experience, and expertise in the pharmaceutical and medical device industry. Led by Dr Luis Rojas, a Senior Research Scientist Statistician with over 35 years of clinical trial experience, InCSD is ready to provide you with our high-quality Innovative Clinical Trial Design, Statistics, and Statistical Programming services.
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