Clinical Trials

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The discovery of the unicist ontological structure of complex systems developed at The Unicist Research Institute provided the final input to develop a methodology for adaptive clinical trials. The unicist ontology of health that was discovered provided the basic background for this methodology:

Clinical TrialsThis approach is based on the integration of aspects of traditional clinical trials, the concept of the “learn and confirm” standard and the unicist approach to complexity sciences.

This approach is based on the use of destructive tests, which are a special kind of falsification test (Karl Popper), to sustain the Phase I and Phase II clinical trials.

The objective of destructive tests is to confirm the limits of the functionality that is being tested.

They are necessary in the previous research work but their application in these phases allows providing a safe input to develop the following phases. Destructive tests are based on universal experimenting and on the knowledge of the conceptual foundations of what is being researched.

Clinical TrialsPhase III and IV are approaches that use non destructive tests that are analogous to the traditional clinical trials but with the inclusion of a quality assurance process that triggers a “learning” process when predefined limits are exceeded.

The “learn & confirm” methodology introduced at Wyeth changed the paradigms of clinical trials and introduced a conceptual simplification in the R&D processes that could not expand massively because of the non-evident economic benefits of this technology.

The unicist approach to adaptive clinical trials is an approach based on the complexity science research methodology developed at The Unicist Research Institute that simplified the discovery-learn-confirm method introduced by Wyeth and provides a secure approach to life-sciences.

A research consortium, coordinated by Peter Belohlavek, is being organized to develop this solution in real application fields. It is expected that this methodology becomes a standard within the next two years based on the shortening of the R&D processes and the saving of up to 50% of the costs.

Medicine is a paradigmatic case of complexity sciences

The objective of applicative sciences is to study and research aspects of reality to find the foundations of their functionality in order to use the information to be able to do something.

There are aspects of reality that are complex and cannot be approached using a cause-effect systemic method, because their integrating elements have interdependent relationships and the boundaries are open.

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Systemic sciences approach reality based on a dualistic cause-effect approach which is functional in all the cases where the isolation of variables is possible without generating unmanageable side-effects.

But when a complex adaptive system cannot be managed using cause-effect influences it needs to be managed in its oneness. The management of complex adaptive systems in their oneness is the field of complexity sciences.

It is self-evident that if variables cannot be isolated there is no possibility to make artificial experimentation or simulation to research the field of complex adaptive systems.

Complexity cannot be analytically apprehended. It needs to be conceptually apprehended as a unified field. The extension of the unified field needs to include all the aspects that influence significantly a complex system.

Significance requires using pilot tests to be confirmed. A reality is perceived chaotic when the amplitude of a unified field of an actual reality exceeds the possibility of a mind to apprehend it.

Only individuals who are able to work with open boundaries can deal with the open boundaries of a complex adaptive system.

It requires a high level of inner freedom which implies being willing to assume the responsibility to produce results, and being able to extend the boundaries of the mind as far as it is needed to apprehend the unified field of the system.

About Health

Health can be defined as the integration of organic functionality, psychic functionality and the functionality of the inner energy flow.

The organic functionality is defined by the functionality of organs which, working as complex adaptive systems, can only be measured based on the consequences of their function. Organic functionality also includes the functionality of inner systems, although they cannot be considered as organs (e.g: the immune system). The fallacy of organs functionality is a proof of the limits of the possibilities of organic functionality.

The psychic functionality is defined by the functionality of the instinctive, spiritual and psychological processes whether they are conscious or unconscious that allow individuals to adapt to the environment. The psychic functionality deals with the interpersonal and intrapersonal adaptive processes and with the meaning of life.

The energy-flow functionality can only be measured by the consequences of its lack of functionality. It implies that the human being considered as a system flows internally in a harmonic way. This allows individuals to live and adapt to the environment.

Fostering health requires ensuring that the psychic functionality, which is the active function of health, maintains and does not hinder the energy flow that sustains the functionality of organs. Fostering health requires stimulating a meaningful life where the interpersonal and intrapersonal adaptation conflicts can be managed.