Method for conducting clinical trials over the internet
First Claim
1. A method of conducting a clinical trial of a test substance over the internet from a primary site, comprising the following steps:
- assigning, at the primary site, a unique identifier and a unique log-in password to at least one clinical trial participant located at a remote internet site distinct from the primary site, the unique identifier and the unique log-in password for accessing protected information from the primary site;
providing to the participant, responsive to receipt by the primary site of the unique identifier and the unique login password, instructions on;
using the test substance;
accessing and completing at least one evaluation form from a website maintained at the primary site; and
returning electronically said at least one evaluation form to the primary site;
providing, responsive to receipt by the primary site of the unique identifier and the unique log-in password, said at least one evaluation form in electronic format for use by the participant, said at least one evaluation form having a question and answer section, presenting at least one question, that when completed by a participant using the test substance, provides information regarding one or more effects of the test substance on the participant completing the evaluation form;
modifying, while the participant completes said at least one evaluation form in electronic format, said presentation of at least one question presented in said at least one evaluation form based at least in part upon one or more responses provided by the participant on at least one said evaluation form currently being completed by the participant and an evaluation form previously completed by the participant;
completing, by the participant, said at least one evaluation form; and
compiling in an investigator accessible form data regarding at least one of said one or more effects of the test substance on the participant from information from at least one received and completed evaluation form returned by the participant to at least one investigator conducting the clinical trial.
1 Assignment
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Accused Products
Abstract
The invention encompasses a method of conducting a clinical trial of a test substance from a primary site, via the internet. The internet is used in various phases of a clinical trial, including: recruiting and screening for candidates who are eligible to participate in a clinical trial of a test substance using the internet; obtaining, directly from a participant at a remote site, personal information as well as information allowing a determination of any effect(s) of the test substance on the participant after use (e.g., by evaluation forms completed and transmitted over the internet); compiling data from multiple participants.
176 Citations
35 Claims
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1. A method of conducting a clinical trial of a test substance over the internet from a primary site, comprising the following steps:
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assigning, at the primary site, a unique identifier and a unique log-in password to at least one clinical trial participant located at a remote internet site distinct from the primary site, the unique identifier and the unique log-in password for accessing protected information from the primary site; providing to the participant, responsive to receipt by the primary site of the unique identifier and the unique login password, instructions on;
using the test substance;
accessing and completing at least one evaluation form from a website maintained at the primary site; and
returning electronically said at least one evaluation form to the primary site;providing, responsive to receipt by the primary site of the unique identifier and the unique log-in password, said at least one evaluation form in electronic format for use by the participant, said at least one evaluation form having a question and answer section, presenting at least one question, that when completed by a participant using the test substance, provides information regarding one or more effects of the test substance on the participant completing the evaluation form; modifying, while the participant completes said at least one evaluation form in electronic format, said presentation of at least one question presented in said at least one evaluation form based at least in part upon one or more responses provided by the participant on at least one said evaluation form currently being completed by the participant and an evaluation form previously completed by the participant; completing, by the participant, said at least one evaluation form; and compiling in an investigator accessible form data regarding at least one of said one or more effects of the test substance on the participant from information from at least one received and completed evaluation form returned by the participant to at least one investigator conducting the clinical trial. - View Dependent Claims (2, 3, 4, 5, 6, 7, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25)
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8. A method of conducting a clinical trial of a test substance over the internet, comprising the following steps:
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maintaining, at a primary site, a website that is accessible from remote sites via the internet and that provides information about the clinical trial and minimum eligibility criteria for participants in the clinical trial; causing a screening questionnaire to appear over the internet at a remote site, after receipt, at the primary site from the remote site, of a request to display the questionnaire, wherein the questionnaire has portions for receiving information that enables a determination of whether a candidate, upon whose behalf the questionnaire is completed, is eligible to be a participant in the clinical trial; obtaining the candidate'"'"'s informed consent to participate in the clinical trial; receiving the candidate'"'"'s completed questionnaire at the primary site via the internet; reviewing the received questionnaire and making a determination of whether the candidate is eligible to be a participant in the clinical trial according to a set of predetermined criteria; after receipt of the candidate'"'"'s informed consent by at least one investigator, causing information transfer between the primary site and the remote site for the purpose of confirming the existence, identity, and eligibility of the candidate to participate; assigning, at the primary site, a unique identifier and a unique log-in password to at least one clinical trial participant, the unique identifier and the unique log-in password for accessing protected information from the primary site; providing, responsive to receipt by the primary site of the unique identifier and the unique log-in password, to the participant, instructions on;
using the test substance;
accessing and completing at least one evaluation form from a website maintained at the primary site; and
returning electronically said at least one evaluation form to the primary site;providing, responsive to receipt by the primary site of the unique identifier and the unique log-in password, said at least one evaluation form in electronic format for use by the participant, said at least one evaluation form having a question and answer section, presenting at least one question, that when completed by a participant using the test substance, provides information regarding one or more effects of the test substance on the participant completing the evaluation form; modifying, while the participant completes said at least one evaluation form in electronic format, said presentation of at least one question presented in said at least one evaluation form based at least in part upon one or more responses provided by the participant on at least one said evaluation form currently being completed by the participant and an evaluation form previously completed by the participant; completing, by the participant, said at least one evaluation form; and compiling in an investigator accessible form data regarding at least one of said one or more effects of the test substance on the participant from information from at least one received and completed evaluation form returned by the participant to at least one investigator conducting the clinical trial.
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26. A computer executable program code embodied on a computer readable medium, for conducting, with a processor and memory for said code, a clinical trial of a test substance over the internet from a primary site, comprising:
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program code for assigning, at the primary site, a unique identifier and a unique log-in password to at least one clinical trial participant located at a remote internet site distinct from the primary site, the unique identifier and the unique log-in password for accessing protected information from the primary site; program code for providing, via the internet, responsive to receipt by the primary site of the unique identifier and the unique log-in password, to at least one clinical trial participant located at a remote site distinct from the primary site, instructions on;
using the test substance;
accessing and completing at least one evaluation form from a website maintained at the primary site; and
returning electronically said at least one evaluation form to the primary site;program code for providing, responsive to receipt by the primary site of the unique identifier and the unique log-in password, said at least one evaluation form in electronic format for use by the participant at the remote site, said at least one evaluation form having a question and answer section including at least one question that, when completed by a participant using the test substance, provides information regarding one or more effects of the test substance on the participant completing the evaluation form; and program code for modifying, while the participant completes said at least one evaluation form in electronic format, at least a portion of the question and answer section included in said at least one evaluation form based at least in part upon one or more responses provided by the participant on at least one of said evaluation form currently being completed by the participant and an evaluation form previously completed by the participant; and program code for compiling into a central database at the primary site, investigator accessible data regarding at least one of said one or more effects of the test substance on the participant from information from at least one received and completed evaluation form returned by the participant to at least one investigator conducting the clinical trial. - View Dependent Claims (27, 28, 29, 30, 31, 32, 33, 34, 35)
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Specification