Author Topic: Proof of concept studies?  (Read 10112 times)

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Offline srikanth

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Proof of concept studies?
« on: Tue, 4 May 2010 »
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Hi Folks,

Can any one explain what exactly a "Proof of Concept Study" means?

When are they conducted and the rationale for conducting such studies?

Regards
Srikanth

Offline chitaranjan

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Re: Proof of concept studies?
« Reply #1 on: Wed, 5 May 2010 »
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Dear Srikanth,

Definition as per Wikipedia; Proof of concept is a short and/or incomplete realization (or synopsis) 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 is probably capable of being useful. A related (somewhat synonymous) term is "proof of principle".

The proof of concept is usually considered a milestone on the way to a fully functioning prototype.

They offer the advantage of investigating the efficacy of a product using a very simplified study design and a lower number of subjects, thus reducing the amount of control and references substance required and time.

Hope this helps you out

Thanks & Regards
Chittaranjan

Offline srikanth

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Re: Proof of concept studies?
« Reply #2 on: Wed, 5 May 2010 »
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Hi Chitaranjan,

Thanks a lot for providing the definition :)

But i have few more queries:

   1) Can you elaborate the term(Proof of concept) in clinical trials perspective?

   2) During which phase (I/II/III) are such studies conducted?

   3) Is it a regulatory  requirement?


Looking forward for your responses  :)  :)

Regards,
Srikanth

Offline chitaranjan

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Re: Proof of concept studies?
« Reply #3 on: Thu, 6 May 2010 »
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Dear Shrikanth,

As per my knowledge proof of concept studies can be done mainly between phase II and phase III  stage of the trial. could be between phaseIIa and phase IIb studies too, the regulatory requirements remains the same.

Such type of trials have more chances of getting regulatory approval as it is always done over a very small number of subjects and it is more ethical to conduct on a smaller number of population rather jumping directly to a huge subject number.

It is done mainly to assess the preliminary safety and efficacy data on a smaller number of population.

Thanks
Regards
Chittaranjan

Offline Mr Mitchum

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Re: Proof of concept studies?
« Reply #4 on: Mon, 20 Sep 2010 »
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Chittaranjan, as per your knowledge, you don't seem to know what you are talking about.  This is a clinical research forum.  Your wikipedia definition isn't helpful.

A proof of principle study is done before a proof of concept study.  Typically, it is a Phase I study that is primarily looking at safety in healthy volunteers but also examines the intended pharmacological effect. Eg, an intended  diabetes drug might look at the effect on blood sugar in healthy volunteers. It might also look at an expected change in a relevant biomarker. Proof of principle therefore provides the first measurable evidence that an investigational product might work in humans, but in this case healthy volunteers.

Proof of concept studies are typically Phase II studies and are performed in a larger number of subjects, and in this case the subjects are patients with the disease.  Proof of concept often include several doses and are used to establish the dose and patient population to be used in the subsequent confirmatory Phase III studies.

These are are the classic definitions, and different disease may are may not be amenable to this approach.  Are they regulatory requirements?  In most cases health authorities and ethics committees would require such trials, such a step wise development, to insure patients safety in subsequent trials.  Also, it is in  the pharmaceutical company's best interest to get this information before going on to bigger and more expensive trials.

Offline chitaranjan

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Re: Proof of concept studies?
« Reply #5 on: Mon, 20 Sep 2010 »
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Mr Mitchum,

Thank you very much for this wonderful information. Can you share few more details about POC studies with us. It will be very helpful for the forum members.

Regards
Chittaranjan

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