Science continuously gives us new means and methodologies to further exploring drivers that may be behind unwanted or deleterious developments of an individual’s health or the progression of an already established disease.
The universe has always fascinated us. When we looked out in space to distant stars and asked, where does it end, we used the parallax angle method to measure the distance to stars. The further we reached out the less accurate became our measures. The invention of the spectrograph led to many more new insights when we decoded the complexity in the messages from the spectral lines. The Doppler shift in the color spectra and shift in spectral lines let us measure the distance to far away objects. More so, we also revealed the speed in which the stars and planets moved in space. We could measure the temperature of stars, weigh them, size them, and get a measure of the magnetism at the surface of the stars. Our knowledge took a huge leap forward as science developed and brought us new methodologies. So, where takes us this metaphor?
It’s all about the knowledge of the individual’s specifics and characteristics, and the individual’s whereabouts in groups or in the environment as a whole.
Today, we can do more to meet the individual’s need, in a bigger context. We have the methodologies and technologies to resolve the complexity, understand patterns and derive new relationships in a multifaceted data environment. From medical, physiological, psychological or sociological perspectives, we have typically used limited group of variables or parameters to help us understand what’s behind a change in a person’s health, what leads us to a diagnose, emerging drug misuse, drop out from the expected norm, and so on.
Let’s take an example: the product-centric approach. Pharmaceutical drug research and development has generally been focused on the product and in what way the product should be developed for use in large groups of patients, all based on a limited sample of subjects not at all necessarily representative for all subjects the product is aimed for. The clinical studies look at a limited group of very well defined variables measured at intervals and stringent statistical models are used to evaluate the results. The result is an answer to a cut off hypothesis and provides a response with only few answers. While randomized controlled clinical trials remain the gold standard for assessing the safety and efficacy of pharmaceutical medicines, there is a growing need to generate real-world evidence data, adding value and differentiation to the product profile. This can be accomplished in various types of observational research.
So let’s turn it around and start to look at what serves each individual best and what has to be done to meet specific individual needs: ie, go individual-centric. We know we can reach so much further ‘out in the unknown space’ if we include many more of the characteristics in our viewer of what dictates an individual’s life and way forward. That’s why our ‘systemic approach’ (systemic in its physiological sense) includes many more measures. We record our measures much more frequently, we use more sophisticated algorithms to understand what we record, we continuously monitor what we see to learn and acquire new knowledge that in turn is fed back to each individual and in parallel reused to improve the methodology or refine the applied hypothesis. We believe this open and evolving circuit is a key to better understand needs and apply approaches that prevent bad things to happen and deliver ‘online’ response to identified individual requirements and needs.
We acquire data continuously and report events and triggers real-time. Our multifactorial assessment methodology integrates and closes the gaps between three key information areas: fit for purpose investigational methodology; flexibly designed use of real-time technology and systems; and methodology for analyses for prediction [and recommendation] adapted for the individual.
We have in place methodology and technology for data acquisition to expand analyses and to create new insights and knowledge about the individual’s complex state of life that enable the individual to predict, become aware and understand what may maintain sustained health. In addition, it positions the individual and its relationship to professional medical services at a new frontier where an unwanted development may be prevented.
Furthermore, the acceleration of new insights and knowledge will in turn guide the generation of new hypotheses for advanced research and clinical investigations.
Engagement is a keyword we want to use. The quality of the acquired data in numerous research projects and clinical investigations can be questioned, or should be, regardless of if the assessments are made by the individual/patient self or if performed at a research center. The response to many uncertainties is lack of motivation on all sides, the gap between the investigator and subject, not being enough involved, not knowing enough of the study progress and the context, and not seeing readouts of now-and-then. Technology is the solution to improved engagement. New and better technology has enabled us to develop our methodology to address some of the critical engagement criteria.
The individual owns her/his information. The individual responds to dynamic questions, ie questions generated based on previous answers (interpreted manually and/or by machine learned algorithms), or use additive tools that they control and see progress through. The feedback to investigators and subjects is designed to respond to events and triggers that immediately show up onscreen as reminders or developments in investigational process.