COMPUTER SYSTEMS AND METHODS FOR SELECTING SUBJECTS FOR CLINICAL TRIALS
2 Assignments
0 Petitions
Accused Products
Abstract
Computers, computer program products, and methods for identifying a plurality of subjects for a clinical trial are provided. A candidate set of molecular profiles in a stored plurality of molecular profiles are identified. Each such profile has measurements for a discriminating set of cellular constituents that match the measurements of corresponding cellular constituents in a responder set of biological samples, thereby identifying the plurality of subjects for the trial from those subjects from which the candidate set of molecular profiles were derived. Each respective molecular profile in the stored plurality of profiles has measurements of a plurality of cellular constituents from a respective biological sample in a plurality of samples obtained from a first plurality of subjects. The discriminating set of cellular constituents is identified from those cellular constituents in the plurality of cellular constituents whose measurement values discriminates between the responder and nonresponder sets of biological samples.
20 Citations
96 Claims
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1-68. -68. (canceled)
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69. A method of identifying a plurality of subjects for a clinical trial for a therapy of interest, the method comprising:
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providing and storing a plurality of pre-treatment molecular profiles where each pre-treatment molecular profile is associated with a subject having a particular condition and is developed from a biological sample taken prior to treatment of any of the subjects using a therapy of interest; providing and storing results of treating one or more of the subjects using the therapy of interest; determining, after treatment of the one or more subjects, one or more responders of the one or more subjects to the therapy of interest where a responder is a subject that has a change in progression of the particular condition; providing and storing post-treatment molecular profiles for the responders, where each post-treatment molecular profile is associated with a subject having a particular condition and is developed from a biological sample taken after treatment using the therapy of interest; evaluating the pre-treatment and post-treatment molecular profiles of the one or more responders to determine a discriminating set of cellular constituents from among the cellular constituents in respective molecular profiles, wherein the discriminating set of cellular constituents distinguishes the molecular profiles of responders from the molecular profiles of subjects who were non-responders to the therapy of interest; and determining, by one or more processors, a candidate set of molecular profiles from the plurality of pre-treatment molecular profiles including matching the discriminating set of cellular constituents against the pre-treatment molecular profiles of one or more non-treated subjects; and identifying a candidate set of subjects for a clinical trial whose molecular profiles match the discriminating set of cellular constituents based on the determining. - View Dependent Claims (70, 71, 72, 73, 74, 75)
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76. A computer-implemented method of identifying a plurality of subjects for a clinical trial for a therapy of interest, the method comprising:
identifying a candidate set of molecular profiles in a stored first plurality of molecular profiles, wherein each molecular profile in said candidate set of molecular profiles has measurements for a discriminating set of cellular constituents that match the measurements of said discriminating set of cellular constituents in a responder set of biological samples, said responder set being responsive to said therapy of interest, thereby identifying said plurality of subjects for said clinical trial from those subjects from which said candidate set of molecular profiles were derived;
whereineach respective molecular profile in said stored first plurality of molecular profiles comprises measurements of a first plurality of cellular constituents from a respective biological sample in a first plurality of biological samples obtained from a first plurality of subjects; and said discriminating set of cellular constituents is identified from those cellular constituents in said first plurality of cellular constituents whose measurement values taken prior to exposure to said therapy of interest discriminates between said responder set of biological samples and a nonresponder set of biological samples, said nonresponder set being nonresponsive to said therapy of interest, wherein the method further comprising, prior to said identifying step, a step of measuring a molecular profile for each biological sample in said first plurality of biological samples thereby obtaining said first plurality of molecular profiles, and wherein the method further comprising, prior to said identifying step, a step of determining; said responder set of biological samples that are responders to said therapy of interest for said disease of interest in said first plurality of biological samples, and said nonresponder set of biological samples that are nonresponders to said therapy of interest for said disease of interest in said first plurality of biological samples. - View Dependent Claims (77, 78, 79, 80, 81, 82, 83, 84, 85, 86, 87, 88)
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89. A computer-implemented method of identifying a plurality of subjects for a clinical trial for a therapy of interest, the method comprising:
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(a) measuring a molecular profile for each biological sample in a first plurality of biological samples thereby obtaining a first plurality of molecular profiles, wherein said first plurality of biological samples are obtained from a first plurality of subjects and each respective molecular profile in said first plurality of molecular profiles comprises measurements of a first plurality of cellular constituents from a respective biological sample in said first plurality of biological samples; (b) storing said first plurality of molecular profiles; (c) measuring a molecular profile for each biological sample in a second plurality of biological samples prior to exposure to said therapy of interest, thereby obtaining a second plurality of molecular profiles, wherein each biological sample in said second plurality of biological samples is from a subject having a disease of interest or is a model for said disease of interest and each respective molecular profile in said second plurality of molecular profiles comprises measurements of two or more of said first plurality of cellular constituents from a respective biological sample in said second plurality of biological samples; (d) determining a responder set of biological samples that are responders to said therapy of interest for said disease of interest in said second plurality of biological samples and a nonresponder set of biological samples that are nonresponders to said therapy of interest for said disease of interest in said second plurality of biological samples; (e) identifying a discriminating set of cellular constituents in said first plurality of cellular constituents, wherein the measurements in said second plurality of molecular profiles for each respective cellular constituent in said discriminating set of cellular constituents discriminates between the responder set of biological samples and the nonresponder set of biological samples; and (f) identifying a candidate set of molecular profiles in said stored first plurality of molecular profiles that have measurements for the discriminating set of cellular constituents that match the measurements of said discriminating set of cellular constituents in the responder set of biological samples, thereby identifying said plurality of subjects for said clinical trial from those subjects from which said candidate set of molecular profiles were derived. - View Dependent Claims (90, 91, 92, 93, 94)
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95. A method of identifying a plurality of subjects for a clinical trial for a therapy of interest, the method comprising:
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providing and storing a plurality of molecular profiles where each molecular profile is associated with a subject having a particular condition and is developed from a biological sample taken prior to treatment of any of the subjects using a therapy of interest; providing and storing results of treating one or more of the subjects using the therapy of interest; determining, after treatment of the one or more subjects, one or more responders of the one or more subjects to the therapy of interest where a responder is a subject that has a change in progression of the particular condition; evaluating the molecular profiles of the one or more responders to determine a discriminating set of cellular constituents from among the cellular constituents in a respective molecular profile, wherein the discriminating set of cellular constituents is determined based on a presence of a mutation in DNA associated with the biological sample; and determining, by one or more processors, a candidate set of molecular profiles from the plurality of molecular profiles that were previously stored and not including the one or more subjects that were treated with the therapy of interest comprising, matching the discriminating set of cellular constituents against the molecular profiles of one or more non-treated subjects; and identifying a candidate set of subjects for a clinical trial whose molecular profiles match the discriminating set of cellular constituents without ex-vivo testing of each of the molecular profiles of respective subjects with the therapy of interest. - View Dependent Claims (96)
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Specification