Innovative Strategies For Successful Trial Design - Webinar SlidesnQuery
Full webinar available here: https://www.statsols.com/webinar/innovative-strategies-for-successful-trial-design
[Webinar] Innovative Strategies For Successful Trial Design- In this free webinar, you will learn about:
- The challenges facing your trials
- How to calculate the correct sample size
- Worked examples including Mixed/Hierarchical Models
- Posterior Error
- Adaptive Designs For Survival
www.statsols.com
Presentation at Harvard Medical School and CIMIT (Center for Integration of Medicine & Innovative Technology) on Techniques for Inventing, Funding, Developing & Commercializing High Impact Clinical Innovations
SIMPLE STRATEGIES TO PUBLISH IN A BETTER JOURNALpadmapriya priya
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Intradermal drug delivery: human, medical and design factorsNovosanis
The skin is a barrier between our inner body and the outside
environment. Due to its specific pharmacokinetic and immunogenic properties, the dermal layer of the skin is of particular interest, both to re-consider existing drug delivery techniques and target radically new drugs and therapies. It is challenging to develop new intradermal drug delivery systems (IDDSs) because there are many factors that can have an influence on the quality of the end result in terms of e.g. accuracy, reliability
and usability. However, the interest in IDDSs has induced a realm of research and development in several domains. All these developments are, at first sight, only partially related.
Advances in Clinical Trial Design: Adaptive and Platform TrialsClinosolIndia
Advances in clinical trial design have led to the emergence of two innovative approaches: adaptive trials and platform trials. These designs offer flexibility, efficiency, and the potential to accelerate the development of new therapies.
Adaptive Trials:
Adaptive trials are designed to make real-time modifications to key aspects of the study, such as the sample size, treatment arms, or patient population, based on accumulating data during the trial. This adaptive approach allows researchers to make informed decisions and optimize the trial design as new information becomes available. Adaptive trials can be particularly beneficial when studying complex diseases or evaluating treatments with varying responses.
Advances in Clincal Trial Design- Adaptive and Platform TrialsClinosolIndia
Adaptive designs can make clinical trials more flexible by utilising results accumulating in the trial to modify the trial’s course in accordance with pre-specified rules. Trials with an adaptive design are often more efficient, informative and ethical than trials with a traditional fixed design since they often make better use of resources such as time and money, and might require fewer participants. Adaptive designs can be applied across all phases of clinical research, from early-phase dose escalation to confirmatory trials. The pace of the uptake of adaptive designs in clinical research, however, has remained well behind that of the statistical literature introducing new methods and highlighting their potential advantages.
This talk will provide a means to discuss the capture, integration and dissemination of data across large enterprises. We will show how data variety is continuing to grow, meaning new data sources are steadily becoming available for use in analysis. Data veracity is also of importance since a large amount of data is fuzzy (uncertain) in nature. The ability to integrate these various data sources and provide improved capabilities to understand and use it is of increasing importance in today’s pharma climate. We call this Reference Master Data Management (RMDM).
This talk will span an arc of data lifecycle management, beginning with instrument data, moving across to clinical studies, production, regulatory affairs and finally e-archiving (see Fig. 1). I will show how these systems can use a common semantics for modeling of important metadata, which can apply the FAIR principles of Findability, Accessibility, Interoperability and Reusability to a common “semantic hub” that can connect data sources of different varieties across the enterprise. ADF files, for example, use their Data Description layer to provide semantic metadata about file contents. Similarly, semantics can be used to describe clinical trials data, regulatory data, etc., through to archiving, for improved storage and search over long periods of time.
1. A novel approach to modelling
of tablet film-coating
Michael Lu, Joy Phophichitra
Dr Axel Zeitler
2. Motivation
Coated tablets are the dominant drug dosage form
Benefits: protect drug, mask taste, uniformity,
appearance, release profile
Batch process: Tablets are sprayed in a rotating drum
Complex multi-parameter system
4. Motivation
Better process understanding – basis for future process
improvement
Benefits of improved modelling:
Manufacturer - reduce expensive and time-consuming
trials
Regulator - compliance with FDA’s recent “quality by
design” initiative
5. Weaknesses of
Current approaches
Thermodynamic
models
Empirical
studies
Discrete element
model (DEM)
simulations
Limited
predictive power
No description of
film-forming
phenomena
Semi-empirical
Cannot translate
between coating
units
Many trials required
Most papers
concentrate on
isolated aspects
Large
computational
expense
Ray-tracing
spray coating
algorithm
7. Entire process had never been combined before:
Demonstrates holistic approach is possible
Links macroscale parameters to microstructural
processes
Large scope for further work and collaboration
