Systems Thinker: Evaluates the complex external forces, interactions, and relationships impacting the development of medical interventions, including patient needs and preferences, regulatory requirements, current standards of care, and market and business demands.

The Systems Thinker is another quality of a translational scientist that sets them apart from other biomedical and health researchers. The ideal translational scientist, at whatever phase of the translational spectrum they work in, must consider the complex forces and influences that enable, as well as stagnate, the efficient and effective flow of therapeutic innovation.

Far too often, preclinical discoveries made in academic laboratories do not account for the rigorous regulatory requirements for an investigational new drug (IND) application, leading to a false perception of how quickly and easily one can advance a promising new compound into the clinic for human testing. Additionally, failure to factor in the requirements of health technology assessment agencies into the design of one’s research can also hinder the results from being successfully handed off to practitioners in the next phase of translation. In other words, if one does not design their research to meet the needs and requirements of the next player on the translational team, then it is unlikely to advance toward impacting human health.

The same can also be said for integrating the patient perspective and current standard of care when formulating a research question and designing an experimental protocol. Do patients want an entirely novel therapy that could take decades to bring to market, or is the current therapeutic regimen sufficient if only the side effects could be mitigated? For patients with the disease under study, is it more important to slow its progression or go all out to find a cure? What level of risk is this particular patient population willing to tolerate in a clinical trial? All of these questions and many more require direct patient engagement at the earliest stages of translational research and continued seeking of the patient perspective throughout.

 

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EATRIS

NCATS

Therapeutic Innovations Australia