Usage history
The term has been in use since 1967. In a 1969 hearing of the Committee on Science and Astronautics, Subcommittee on Advanced Research and Technology, ''proof of concept'' was defined as following: One definition of the term "proof of concept" was by Bruce Carsten in the context of a "proof-of-concept prototype" in his magazine column "Carsten's Corner" (1989): The column also provided definitions for the related but distinct terms ' breadboard' (a term used since 1940), ' prototype', 'engineering prototype', and ' brassboard'.Examples
Filmmaking
'' Sky Captain and the World of Tomorrow'', '' 300'', and '' Sin City'' were all shot in front of a greenscreen with almost all backgrounds and props computer-generated. All three used proof-of-concept short films. In the case of ''Sin City'', the short film became the prologue of the final film. Pixar sometimes creates short animated films that use a difficult or untested technique. Their short film '' Geri's Game'' used techniques for animation of cloth and of human facial expressions later used in '' Toy Story 2''. Similarly, Pixar created several short films as proofs of concept for new techniques for water motion, sea anemone tentacles, and a slowly appearing whale in preparation for the production of '' Finding Nemo''.Engineering
In engineering and technology, a rough prototype of a new idea is often constructed as a "proof of concept". For example, a working concept of an electrical device may be constructed using a breadboard. ABusiness development
In the field of business development andSecurity
In both computer security and encryption, ''proof of concept'' refers to a demonstration that in principle shows how a system may be protected or compromised, without the necessity of building a complete working vehicle for that purpose. Winzapper was a proof of concept which possessed the bare minimum of capabilities needed to selectively remove an item from the Windows Security Log, but it was not optimized in any way.Software development
InDrug development
Although not suggested by natural language, and in contrast to usage in other areas, ''proof of principle'' and ''proof of concept'' are not synonymous in drug development. A third term, ''proof of mechanism'', is closely related and is also described here. All of these terms lack rigorous definitions and exact usage varies between authors, between institutions and over time. The descriptions given below are intended to be informative and practically useful. The underlying principle is related to the use of biomarkers as surrogate endpoints in early clinical trials. In early development it is not practical to directly measure that a drug is effective in treating the desired disease, and a surrogate endpoint is used to guide whether or not it is appropriate to proceed with further testing. For example, although it cannot be determined early that a new antibiotic cures patients with pneumonia, early indicators would include that the drug is effective in killing bacteria in laboratory tests, or that it reduces temperature in infected patients—such a drug would merit further testing to determine the appropriate dose and duration of treatment. A new anti-hypertension drug could be shown to reduce blood pressure, indicating that it would be useful to conduct more extensive testing of long-term treatment in the expectation of showing reductions in stroke (cerebrovascular accident) or heart attack (myocardial infarction). Surrogate endpoints are often based on laboratory blood tests or imaging investigations like X-ray or CT scan. * ''Proof of mechanism'' or PoM relates to the earliest stages of drug development, often pre-clinical (i.e., before trialling the drug on humans, or before trialling with research animals). It could be based on showing that the drug interacts with the intended molecular receptor or enzyme, and/or affects cell biochemistry in the desired manner and direction. * ''Proof of principle'' or PoP relates to early clinical development and typically refers to an evaluation of the effect of a new treatment on disease biomarkers, but not the clinical endpoints of the condition. Early stage clinical trials may aim to demonstrate Proof of Mechanism, or Proof of Principle, or both. A decision is made at this point as to whether to progress the drug into later development, or if it should be dropped. * ''Proof of concept'' or PoC refers to early clinical drug development, conventionally divided into the phases of clinical research Phase I ("first-in-humans") and Phase IIA. Phase I is typically conducted with a small number of healthy volunteers who are given single doses or short courses of treatment (e.g., up to 2 weeks). Studies in this phase aim to show that the new drug has some of the desired clinical activity (e.g., that an experimental anti-hypertensive drug actually has some effect on reducing blood pressure), that it can be tolerated when given to humans, and to give guidance as to dose levels that are worthy of further study. Other Phase I studies aim to investigate how the new drug is absorbed, distributed, metabolised and excreted (ADME studies). Phase IIA is typically conducted in up to 100 patients with the disease of interest. Studies in this Phase aim to show that the new drug has a useful amount of the desired clinical activity (e.g., that an experimental anti-hypertensive drug reduces blood pressure by a useful amount), that it can be tolerated when given to humans in the longer term, and to investigate which dose levels might be most suitable for eventual marketing. A decision is made at this point as to whether to progress the drug into later development, or if it should be dropped. If the drug continues, it will progress into later stage clinical studies, termed Phase IIB and Phase III. Phase III studies involve larger numbers of patients—commonly multicenter trials—treated at doses and durations representative of marketed use, and in randomised comparison to placebo and/or existing active drugs. They aim to show convincing, statistically significant evidence of efficacy and to give a better assessment of safety than is possible in smaller, short-term studies. A decision is made at this point as to whether the drug is effective and safe, and if so an application is made to regulatory authorities (such as the US Food and Drug Administration FDA and the European Medicines Agency) for the drug to receive permission to be marketed for use outside of clinical trials. Clinical trials can continue after marketing authorization has been received, for example, to better delineate safety, to determine appropriate use alongside other drugs or to investigate additional uses.See also
*References
External links
* * {{Authority control Evaluation methods