Proof of concept
Encyclopedia
A proof of concept or a proof of principle is a realization of a certain method or idea(s) to demonstrate its feasibility
, or a demonstration in principle, whose purpose is to verify that some concept or theory that has the potential of being used. A proof-of-concept is usually small and may or may not be complete.
One of the early definitions of the term "proof of concept" was by Bruce Carsten in the context of a "proof of concept prototype" in the column "Carsten's Corner":
The column also provided definitions for the related but distinct terms 'breadboard
', 'prototype
', 'engineering prototype', and 'brassboard
'.
, 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.
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
.
. A patent
application often requires a demonstration of functionality prior to being filed. Some universities have proof of concept centers to "fill the 'funding gap'" for "seed-stage investing" and "accelerate the commercialization of university innovations". Proof of concept centers provide "seed funding to novel, early stage research that most often would not be funded by any other conventional source".
and sales
, a vendor may allow a prospect customer to trial the software product. This use of proof of concept helps establish viability, technical issues, and overall direction, as well as providing feedback for budgeting and other forms of internal decision making processes.
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.
The underlying principle is related to the use of biomarkers as surrogate endpoints in early clinical trials. See for example the introductory discussion on pages 3 to 9 of Downing's Biomarkers and surrogate endpoints: clinical research and applications. In early development it is not practical to directly measure that a drug is effective in treating the desired disease, and a surrogate endopoint 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 antihypertension drug could be shown to reduce blood presssure, 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 (ie, before the drug is given to humans, or before given to 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.
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 Phase I and Phase IIa.
Phase I is typically conducted in 10-20 healthy volunteers who are given single doses or short courses of treatment (eg, up to 2 weeks). Studies in this Phase aim to show that the new drug has some of the desired clinical activity (eg, that an experimental antihypertensive 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 (so-called 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 (eg, that an experimental antihypertensive 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.
Proof of Principle or PoP relates to later clinical development, Phase III, typically invoilving larger numbers of patients 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 authorisation has been received, for example to better delineate safety, to determine appropriate use alongside other drugs or to investigate additional uses.
Feasibility study
Feasibility studies aim to objectively and rationally uncover the strengths and weaknesses of the existing business or proposed venture, opportunities and threats as presented by the environment, the resources required to carry through, and ultimately the prospects for success. In its simplest...
, or a demonstration in principle, whose purpose is to verify that some concept or theory that has the potential of being used. A proof-of-concept is usually small and may or may not be complete.
Usage history
The appearance of the terms in news archives suggests it might have been in common use as long ago as 1973.One of the early definitions of the term "proof of concept" was by Bruce Carsten in the context of a "proof of concept prototype" in the column "Carsten's Corner":
The column also provided definitions for the related but distinct terms 'breadboard
Breadboard
A breadboard is a construction base for prototyping of electronics. The term is commonly used to refer to solderless breadboard ....
', 'prototype
Prototype
A prototype is an early sample or model built to test a concept or process or to act as a thing to be replicated or learned from.The word prototype derives from the Greek πρωτότυπον , "primitive form", neutral of πρωτότυπος , "original, primitive", from πρῶτος , "first" and τύπος ,...
', 'engineering prototype', and 'brassboard
Brassboard
A brassboard or brass board is an experimental or demonstration test model, intended for field testing outside the laboratory environment. A brassboard follows an earlier prototyping stage called a breadboard. A brassboard contains both the functionality and approximate physical configuration of...
'.
In filmmaking
Sky Captain and the World of TomorrowSky Captain and the World of Tomorrow
Sky Captain and the World of Tomorrow is a 2004 American pulp adventure science-fiction film written and directed by Kerry Conran in his directorial debut. The film is set in an alternative 1939 and follows the adventures of Polly Perkins , a newspaper reporter, and Harry Joseph "Joe" Sullivan ,...
, 300
300 (film)
300 is a 2007 American fantasy action film based on the 1998 comic series of the same name by Frank Miller. It is a fictionalized retelling of the Battle of Thermopylae. The film was directed by Zack Snyder, while Miller served as executive producer and consultant...
, and Sin City
Sin City (film)
Sin City, also known as Frank Miller's Sin City, is a 2005 crime thriller film written, produced and directed by Frank Miller and Robert Rodriguez...
were all shot in front of a greenscreen with almost all backgrounds and props computer generated
Computer-generated imagery
Computer-generated imagery is the application of the field of computer graphics or, more specifically, 3D computer graphics to special effects in art, video games, films, television programs, commercials, simulators and simulation generally, and printed media...
. All three used proof of concept short films.
Pixar sometimes creates short animated films that use a difficult or untested technique. Their short film Geri's Game
Geri's Game
Geri's Game is a five-minute animated short film made by Pixar in 1997, written and directed by Jan Pinkava. It was the first Pixar Short created after Toy Story, the previous short being Knick Knack in 1989....
used techniques for animation of cloth and of human facial expressions later used in Toy Story 2
Toy Story 2
Toy Story 2 is a 1999 American computer animated film directed by John Lasseter and co-directed by Lee Unkrich and Ash Brannon. It is the sequel to the 1995 film Toy Story, released by Walt Disney Pictures and the third film to be produced by Pixar...
. Similarly, Pixar
Pixar
Pixar Animation Studios, pronounced , is an American computer animation film studio based in Emeryville, California. The studio has earned 26 Academy Awards, seven Golden Globes, and three Grammy Awards, among many other awards and acknowledgments. Its films have made over $6.3 billion worldwide...
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
Finding Nemo
Finding Nemo is a 2003 American comi-drama animated film written by Andrew Stanton, directed by Andrew Stanton and Lee Unkrich and produced by Pixar. It tells the story of the overly protective clownfish Marlin who, along with a regal tang called Dory , searches for his abducted son Nemo...
.
In 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 breadboardBreadboard
A breadboard is a construction base for prototyping of electronics. The term is commonly used to refer to solderless breadboard ....
. A patent
Patent
A patent is a form of intellectual property. It consists of a set of exclusive rights granted by a sovereign state to an inventor or their assignee for a limited period of time in exchange for the public disclosure of an invention....
application often requires a demonstration of functionality prior to being filed. Some universities have proof of concept centers to "fill the 'funding gap'" for "seed-stage investing" and "accelerate the commercialization of university innovations". Proof of concept centers provide "seed funding to novel, early stage research that most often would not be funded by any other conventional source".
In Business Development
In the field of business developmentBusiness development
A subset of the field of commerce, business development comprises a number of techniques and responsibilities which aim at:1. Researching new types of business/products/services with an emphasis on identifying gaps in the mitigation of needs of potential clients .2. Attracting new customers3...
and sales
Sales
A sale is the act of selling a product or service in return for money or other compensation. It is an act of completion of a commercial activity....
, a vendor may allow a prospect customer to trial the software product. This use of proof of concept helps establish viability, technical issues, and overall direction, as well as providing feedback for budgeting and other forms of internal decision making processes.
In security
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. WinzapperWinzapper
Winzapper is a freeware utility / hacking tool used to delete events from the Microsoft Windows NT 4.0 and Windows 2000 Security Log. It was developed by Arne Vidstrom as a proof-of-concept tool, demonstrating that once the Administrator account has been compromised, event logs are no longer reliable...
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.
In software development
In software development, proof of concept (abbreviated POC) is often used to describe several distinct processes with different objectives and participant roles:- A proof of concept can refer to a partial solution that involves a relatively small number of users acting in business roles to establish whether the system satisfies some aspect of the requirements.
- A steel thread is a technical proof of concept that touches all of the technologies in a solution.
- By contrast, the objective of a proof of technology is to determine the solution to some technical problem, such as how two systems might be integrated or that a certain throughput can be achieved with a given configuration. No business users need be involved in a proof of technology.
- A pilotSoftware prototyping*Software prototyping, refers to the activity of creating prototypes of software applications, i.e., incomplete versions of the software program being developed...
project refers to an initial roll out of a system into production, targeting a limited scope of the intended final solution. The scope may be limited by the number of users who can access the system, the business processes affected, the business partners involved, or other restrictions as appropriate to the domain. The purpose of a pilot project is to test, often in a production environment, whether the system is working as it was designed while limiting business exposure.
In drug 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. See for example the introductory discussion on pages 3 to 9 of Downing's Biomarkers and surrogate endpoints: clinical research and applications. In early development it is not practical to directly measure that a drug is effective in treating the desired disease, and a surrogate endopoint 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 antihypertension drug could be shown to reduce blood presssure, 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 (ie, before the drug is given to humans, or before given to 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.
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 Phase I and Phase IIa.
Phase I is typically conducted in 10-20 healthy volunteers who are given single doses or short courses of treatment (eg, up to 2 weeks). Studies in this Phase aim to show that the new drug has some of the desired clinical activity (eg, that an experimental antihypertensive 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 (so-called 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 (eg, that an experimental antihypertensive 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.
Proof of Principle or PoP relates to later clinical development, Phase III, typically invoilving larger numbers of patients 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 authorisation has been received, for example to better delineate safety, to determine appropriate use alongside other drugs or to investigate additional uses.
See also
- Case studyCase studyA case study is an intensive analysis of an individual unit stressing developmental factors in relation to context. The case study is common in social sciences and life sciences. Case studies may be descriptive or explanatory. The latter type is used to explore causation in order to find...
- Concept vehicle
- Feasibility studyFeasibility studyFeasibility studies aim to objectively and rationally uncover the strengths and weaknesses of the existing business or proposed venture, opportunities and threats as presented by the environment, the resources required to carry through, and ultimately the prospects for success. In its simplest...
- PrototypePrototypeA prototype is an early sample or model built to test a concept or process or to act as a thing to be replicated or learned from.The word prototype derives from the Greek πρωτότυπον , "primitive form", neutral of πρωτότυπος , "original, primitive", from πρῶτος , "first" and τύπος ,...
- Sanity testing
- Technology readiness levelTechnology Readiness LevelTechnology Readiness Level is a measure used by some United States government agencies and many of the world's major companies to assess the maturity of evolving technologies prior to incorporating that technology into a system or subsystem...
- An example: