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A Methodology for Predicting Clinical Trial Protocol Feasibility

IP.com Disclosure Number: IPCOM000229422D
Publication Date: 2013-Jul-29
Document File: 2 page(s) / 58K

Publishing Venue

The IP.com Prior Art Database


Disclosed is a method to predict the feasibility of a new clinical trial protocol based on data from past protocols.

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A Methodology for Predicting Clinical Trial Protocol Feasibility

A clinical trial is a very expensive undertaking and as such, any analyses that can point out the potential setbacks and expose the risks offer a great value to the pharmaceutical companies who carry out such trials.

The solution is to provide a new protocol and a defined success vector and assess the probability of success based on the performance of earlier protocols before embarking on an expensive clinical trial.

The invention comprises:

• Index Protocol: a new protocol

• Reference Pool of Protocols: an existing body of completed protocols

• Protocol "Success" vector: to assess the chances of success for the Index Protocol: United States Food and Drug Administration (FDA) approval after trial completion, on-time completion, on-budget completion, complications during the trial, etc.

Similarity Analysis

1. Identify the key features representing a protocol, Protocol Feature Vector. This requires a Subject Matter Expert (SME) to identify the most relevant features.

2. Optionally identify the set of features most likely indicative of similarity among protocols. Again, an SME is needed. This set may be empty.

3. Identify the set of Protocols in the Reference Pool that are similar to the Index Protocol (e.g., leverage an existing Similarity platform).

Feasibility Analysis

Compute the value of the Success Vector of the Index Protocol based on the values observed in the set of similar Protocols (e...