Method and system for collection, validation, and reporting of data and meta-data in conducting adaptive clinical trials
First Claim
1. A method for centrally managing data in an adaptive clinical trial or other adaptive process that is conducted at a plurality of geographically remote sites according to a set of procedures or parameters, said method comprising the steps of:
- (a) collecting data from patients or participants in the course of conducting said clinical trial or other process at a remote site;
(b) electronically transmitting the data from said remote site to a processing location;
(c) checking the transmitted data at said processing location for validity, in automated fashion against one or more pre-determined rules;
(d) electronically reporting the data to an entity capable of determining whether the data require correction or whether procedures or parameters utilized in conducting said clinical trial or other process require modification; and
(e) providing instructions, based on the reported data, to(i) correct the data, or(ii) follow or modify the procedures or parameters utilized in conducting said clinical trial or other process.
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Accused Products
Abstract
A method and system are described for centrally managing data in an adaptive clinical trial or other adaptive process that is conducted at a plurality of geographically remote sites. The invention includes (1) flexible means for collecting data from remote sites; (2) processing, tracking, and validating such data and meta-data at a processing location; (3) interacting between central and remote sites to manage and resolve data discrepancies (4) reporting data to managers and remote sites; and (5) facilitation of special services to clinical research such as flexible randomization of patients, patient participation eligibility verification and double-blind trials. The invention is of particular relevance to adaptive clinical trials and other applications that demand the ability to quickly collect, process, and respond to various forms of data in order to adjust actions such as randomization schedules, interim analyses, treatment arm pruning, editing subpopulations, and other adaptive measures.
43 Citations
36 Claims
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1. A method for centrally managing data in an adaptive clinical trial or other adaptive process that is conducted at a plurality of geographically remote sites according to a set of procedures or parameters, said method comprising the steps of:
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(a) collecting data from patients or participants in the course of conducting said clinical trial or other process at a remote site; (b) electronically transmitting the data from said remote site to a processing location; (c) checking the transmitted data at said processing location for validity, in automated fashion against one or more pre-determined rules; (d) electronically reporting the data to an entity capable of determining whether the data require correction or whether procedures or parameters utilized in conducting said clinical trial or other process require modification; and (e) providing instructions, based on the reported data, to (i) correct the data, or (ii) follow or modify the procedures or parameters utilized in conducting said clinical trial or other process. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. A system for centrally managing data in an adaptive clinical trial or other adaptive process that is conducted at a plurality of geographically remote sites according to a set of procedures or parameters, said system comprising:
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(a) means for collecting data from patients or participants in the course of conducting said clinical trial or other process at a remote site; (b) means for electronically transmitting the data from said remote site to a processing location; (c) means for checking the transmitted data at said processing location for validity, in automated fashion against one or more pre-determined rules; (d) means for electronically reporting the data to an entity capable of determining whether the data require correction or whether procedures or parameters utilized in conducting said clinical trial or other process require modification; and (e) means for providing instructions, based on the reported data, to (i) correct the data, or (ii) follow or modify the procedures or parameters utilized in conducting said clinical trial or other process. - View Dependent Claims (20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36)
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Specification