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Authors
Advisor(s)
Abstract(s)
Randomized, controlled clinical trials, although important for ensuring safety and efficacy,
are criticized for being an inadequate validation process for certain medical innovation
modalities and conditions. The main limitations and causes for critique are high costs, long
duration, low patient recruitment, design rigidity and ethical issues.
At the same time, there is growing evidence that patients and their family members
innovate in treatments, therapies, and medical devices. These patient innovators are
increasingly recognized as an important source of innovation. Although there is a fairly
complex structure developed to formally validate healthcare products, little is known about
the paths patient innovators take to validate their solutions before involving health regulators.
In this context, we attempt to answer the following research questions: What are the
patterns of the validation processes undertaken by patient innovators for their innovations?
How can current practices of patient innovation validation be improved from its comparison
with observational studies and clinical trials?
To address these questions, we study cases of patient innovators who attempted to share
their innovations with other patients. More specifically, we structure the observed processes
of patient innovation diffusion as a process model for an iterative observational trial process
in which incremental validation of the innovation is performed by diffusing it to other patients.
We contrast this process with a general streamlined process of randomized clinical trials.
We argue learning from the patient innovators practices is important for discussing viable
frameworks and structures for improving the safety and efficacy of these processes. We
discuss related implications to innovation research, management and policy.
Description
Keywords
User innovation Patient innovation Diffusion Validation of health-care innovations Observational trials