According to the National Center for Advancing Translational Sciences (NCATS), "approximately 80 percent of candidate drugs fail in human clinical trials" due to the lack of safety and effectiveness and "more than 30 percent of promising medications have failed [due to toxicity] in human clinical trials," all in spite of the promising results from animal trails. It is difficult to determine whether or not a medication is toxic to/effective in humans through animal testing and even more difficult to obtain approval. The Food and Drug Administration (FDA) aims to approve drugs in ten months for "Standard Review' drugs that offer minor improvement for existing therapies and six months for "Priority Review' drugs that are major advances to both existing and non existing treatment. These however are just ideal times, the approval process can be extended to over five years and are followed by the four phases of clinical trials that add several more years (FDA, 2015). This process is not only time consuming but also cost ineffective. The current human on a chip/tissue research aspires to model the structure and function of human organs and systems on a chip, creating a "newer human cell based approach" (NCATS). With this approach, pharmaceuticals can be efficiently tested for effectiveness without any animal or human test subjects. The chip allows for a faster drug screen process which will ultimately benefit pharmaceutical and biomedical research companies as well as the general public. However, the current chips are limiting in that they contain a lot of attachments which make the chip large and also the chips do not have integrated sensors which would extract information for the improvement of gastrointestinal cancer countermeasures.
The objectives of this research focuses specifically on the gastro-intestinal tract to create a better gut-on-a-chip model through the integration of various types of sensors. The sensors will serve to better replicate the conditions of the human gut. Each sensor will have a quantitative effect that can be measured to analyze the effects of a drug treatment on a disease. The disease and treatment chosen for testing the improved gut-on-a-chip model are Clostridium difficile Infection (CDI) and vancomycin, respectively. If sensors can be successfully integrated into the gut-on-a-chip model, then treatments such as vancomycin can be more accurately tested and modeled for diseases such as CDI.