Systems and methods for selecting and recruiting investigators and subjects for clinical studies

A method for identifying subjects eligible to participate in a clinical study, comprising the steps of:

• (a) accessing a computer database that stores information about a plurality of persons;
• wherein for each of said plurality listed in the database, the database includes a geographic location of the person, an age and a gender of the person, and disease conditions of interest to the person;
• (b) submitting a query to the database, wherein the query includes criteria that reflect eligibility characteristics for persons suitable for participation as subjects in the clinical study;
• and
• (c) identifying de-identified data records of persons likely to be subjects eligible for the clinical study based on the query.

An integrated on-line interactive forum that promotes exchange of information among clinical study sponsors, clinical study investigators, and potential clinical study subjects, comprising:

• (a) an investigator database that contains information suitable for identification of qualified investigators for clinical studies sponsored by the sponsors;
• (b) a subject database that contains information suitable for identification of eligible subjects for clinical studies sponsored by the sponsors;
• and
• (c) an extranet coupled to the investigator database and the subject database that allows sponsors and investigators to securely exchange documents required to launch a clinical study.

A method for identifying a qualified investigator to perform a clinical study, comprising the steps of:

• (a) accessing a computer database that stores a geographic location of each of a plurality of investigators;
• wherein the database also stores an incidence or a prevalence of each of a plurality of disease conditions in each of a plurality of different geographic locations;
• (b) submitting a query to the database, wherein the query includes information representing a selected disease condition associated with the clinical study;
• and
• wherein the qualified investigator is identified from the database based on the query and in accordance with the incidence or prevalence of the selected disease condition in the geographic location of the qualified investigator.

A method for identifying a qualified investigator to perform a clinical study, comprising the steps of:

• (a) accessing a computer database that stores a geographic location of each of a plurality of investigators;
• wherein the database also stores a geographic location of subjects for the study;
• (b) submitting a query to the database, wherein the query includes information representing a selected disease condition associated with the clinical study;
• and wherein the qualified investigator is identified from the database based on the query and in accordance with the geographic location of subjects for the study.

A method for identifying investigators qualified to perform a clinical study, comprising the steps of:

• (a) accessing a computer database that stores information on a plurality of investigators;
• wherein a data record is stored for each investigator listed in the database and includes information corresponding to the prescription writing history of the investigator with respect to a plurality of medications;
• and
• wherein the database also stores information that associates each of the medications with one or more disease conditions;
• (b) submitting a query to the database, wherein the query includes information representing a selected disease condition associated with the study;
• and
• wherein a given investigator is identified from the database based on the query and in accordance with the given investigator's prescription writing history.

A method for identifying investigators qualified to perform a clinical study, comprising the steps of:

• (a) accessing a computer database that stores information on a plurality of investigators;
• wherein a data record is stored for each investigator listed in the database and includes information corresponding to a history of laboratory procedure requests made by the investigator;
• and
• wherein the database also stores information that associates each of the historical laboratory procedure requests with one or more disease conditions;
• (b) submitting a query to the database, wherein the query includes information representing a selected disease condition associated with the study;
• and wherein a given investigator is identified from the database based on the query and in accordance with the given investigator's historical laboratory request information.

A method for identifying investigators qualified to perform a clinical study, comprising the steps of:

• (a) accessing a computer database that stores information on a plurality of investigators;
• wherein a data record is stored for each investigator listed in the database and includes information corresponding to past participation of the investigator in clinical studies;
• (b) submitting a query to the database, wherein the query includes criteria corresponding to past clinical study experience suitable to qualify investigators for participating in a clinical study;
• and
• (c) identifying qualified investigators from the database based on the query.

A method for identifying investigators qualified to perform a clinical study, comprising the steps of.

• (a) accessing a computer database that stores information on a plurality of investigators;
• wherein a data record is stored for each investigator listed in the database and includes information corresponding to a medical specialty of the investigator;
• and
• wherein the database also stores information that associates the medical specialty with one or more disease conditions;
• (b) submitting a query to the database, wherein the query includes information representing a selected disease condition associated with the study;
• and
• wherein a qualified investigator is identified from the database based on the query and in accordance with the given investigator's medical specialty.

A method for identifying investigators qualified to perform a clinical study, comprising the steps of:

• (a) accessing a computer database that stores information on a plurality of investigators;
• wherein a data record is stored for each investigator listed in the database and includes information corresponding to experience of a medical staff of the investigator;
• and
• (b) submitting a query to the database, wherein the query includes information representing a selected disease condition associated with the study;
• and
• wherein a qualified investigator is identified from the database based on the query and in accordance with the experience of the medical staff of the qualified investigator's medical specialty.

A method for identifying investigators qualified to perform a clinical study, comprising the steps of:

• (a) accessing a computer database that stores information on a plurality of investigators;
• wherein a data record is stored for each investigator listed in the database and includes information corresponding to how many clinical studies have been performed by the investigator;
• (b) submitting a query to the database, wherein the query includes information representing a selected disease condition associated with the study;
• and
• wherein a qualified investigator is identified from the database based on the query and in accordance with how many clinical studies have been performed by the qualified investigator.

A method for identifying investigators qualified to perform a clinical study, comprising the steps of:

• (a) accessing a computer database that stores information on a plurality of investigators;
• wherein a data record is stored for each investigator listed in the database and includes information corresponding to hospital affiliations of the investigator;
• and
• (b) submitting a query to the database, wherein the query includes information representing a selected disease condition associated with the study;
• and
• wherein a qualified investigator is identified from the database based on the query and in accordance with the qualified investigator's hospital affiliations.

A method for identifying investigators qualified to perform a clinical study, comprising the steps of:

• (a) accessing a computer database that stores information on a plurality of investigators;
• wherein a data record is stored for each investigator listed in the database and includes information corresponding to a number of beds in hospital affiliations of the investigator;
• and
• (b) submitting a query to the database, wherein the query includes information representing a selected disease condition associated with the study;
• and
• wherein a qualified investigator is identified from the database based on the query and in accordance with the number of beds in hospital affiliation of the qualified investigator.

A method for identifying investigators qualified to perform a clinical study, comprising the steps of:

• (a) accessing a computer database that stores information on a plurality of investigators;
• wherein a data record is stored for each investigator listed in the database and includes information corresponding to insurance provider affiliations of the investigator;
• and
• (b) submitting a query to the database, wherein the query includes information representing a selected disease condition associated with the study;
• and
• wherein a qualified investigator is identified from the database based on the query and in accordance with the insurance provider affiliations of the qualified investigator.

A method for identifying investigators qualified to perform a clinical study, comprising the steps of:

• (a) accessing a computer database that stores information on a plurality of investigators;
• wherein a data record is stored for each investigator listed in the database and includes information corresponding to mandated IRB relationships of the investigator;
• and
• wherein the database also stores information that associates the mandated IRB relationships with one or more disease conditions;
• (b) submitting a query to the database, wherein the query includes information representing a selected disease condition associated with the study;
• and
• wherein a qualified investigator is identified from the database based on the query and in accordance with the mandated IRB relationships of qualified investigator.

A method for identifying investigators qualified to perform a clinical study, comprising the steps of:

• (a) accessing a computer database that stores information on a plurality of investigators;
• wherein a data record is stored for each investigator listed in the database and includes information corresponding to regulatory agency audits of the investigator;
• and
• (b) submitting a query to the database, wherein the query includes information representing a selected disease condition associated with the study;
• and wherein a qualified investigator is identified from the database based on the query and in accordance with the regulatory agency audits information of the qualified investigator.

A method for identifying investigators qualified to perform a clinical study, comprising the steps of:

• (a) accessing a computer database that stores information on a plurality of investigators;
• wherein a data record is stored for each investigator listed in the database and includes information corresponding to PRF affiliations of the investigator;
• and
• wherein the database also stores information that associates the PRF affiliations with one or more disease conditions;
• (b) submitting a query to the database, wherein the query includes information representing a selected disease condition associated with the study;
• and
• wherein a qualified investigator is identified from the database based on the query and in accordance with the qualified investigator's PRF affiliations.

A method for identifying investigators qualified to perform a clinical study, comprising the steps of:

• (a) accessing a computer database that stores information on a plurality of investigators;
• wherein a data record is stored for each investigator listed in the database and includes information corresponding to equipment of the investigator;
• and
• wherein the database also stores information that associates the equipment of the investigator with one or more disease conditions;
• (b) submitting a query to the database, wherein the query includes information representing a selected disease condition associated with the study;
• and
• wherein a qualified investigator is identified from the database based on the query and in accordance with the equipment of the qualified investigator.

A method for identifying investigators qualified to perform a clinical study, comprising the steps of:

• (a) accessing a computer database that stores information on a plurality of investigators;
• wherein a data record is stored for each investigator listed in the database and includes information corresponding to the investigator's practice setting;
• and
• (b) submitting a query to the database, wherein the query includes information representing a selected disease condition associated with the study;
• and
• wherein a qualified investigator is identified from the database based on the query and in accordance with the qualified investigator's practice setting.

A method for identifying investigators qualified to perform a clinical study, comprising the steps of:

• (a) accessing a computer database that stores information on a plurality of investigators;
• wherein a data record is stored for each investigator listed in the database and includes information corresponding to the investigator's city and state of practice;
• and
• wherein the database also stores information that associates the investigator's city and state of practice information with one or more disease conditions;
• (b) submitting a query to the database, wherein the query includes information representing a selected disease condition associated with the study;
• and
• wherein a qualified investigator is identified from the database based on the query and in accordance with the qualified investigator's city and state of practice information.

A method for identifying investigators qualified to perform a clinical study, comprising the steps of:

• (a) accessing a computer database that stores information on a plurality of investigators;
• wherein a data record is stored for each investigator listed in the database and includes information corresponding to the investigator's name;
• (b) submitting a query to the database, wherein the query includes information representing a selected disease condition associated with the study;
• and
• wherein a qualified investigator is identified from the database based on the query and in accordance with the qualified investigator's name.

A method for developing a permission based online database, comprising the steps of:

• (a) presenting one or more web pages that allow a person to register with a database by submitting registration information to the database, wherein the registration information includes name information and contact information and permission information indicating whether the person wishes to receive notice of one or more clinical studies;
• (b) automatically registering the person with the database upon receipt of the registration and permission information;
• (c) obtaining permission from the person to send information regarding drugs, medical devices or medical therapies;
• (d) building the database by repeating steps (a) through (c);
• and
• (e) generating a list for use in marketing drugs, medical devices and medical therapies to persons by querying the database using criteria associated with the drugs, medical devices or medical therapies.

A method of maintaining the confidentiality of clinical study information associated with each of a plurality of clinical study sponsors, comprising the steps of:

• (a) receiving said clinical study information from said plurality of clinical study sponsors;
• and
• (b) storing said clinical study information in a database;
• wherein each sponsor is permitted full access to said clinical study information submitted by that sponsor and only aggregated access to information submitted by other sponsors.

A method for identifying investigators qualified to perform a clinical study, comprising the steps of:

• (a) accessing a computer database that stores information on a plurality of investigators;
• wherein a data record is stored for each investigator listed in the database and includes information corresponding to a history of laboratory results of the investigator;
• and
• wherein the database also stores information that associates each of the laboratory results with one or more disease conditions;
• (b) submitting a query to the database, wherein the query includes information representing a selected disease condition associated with the study;
• and wherein a given investigator is identified from the database based on the query and in accordance with the given investigator's historical laboratory results information.

A method for identifying investigators qualified to perform a clinical study, comprising the steps of:

• (a) accessing a computer database that stores information on a plurality of investigators;
• wherein a data record is stored for each investigator listed in the database and includes information corresponding to services performed in hospital affiliations of the investigator;
• and
• wherein the database also stores information that associates the services performed in hospital affiliations with one or more disease conditions;
• (b) submitting a query to the database, wherein the query includes information representing a selected disease condition associated with the study;
• and
• wherein a qualified investigator is identified from the database based on the query and in accordance with the services performed in hospital affiliations of the qualified investigator.

A method for identifying investigators qualified to perform a clinical study, comprising the steps of:

• (a) accessing a computer database that stores information on a plurality of investigators;
• wherein a data record is stored for each investigator listed in the database and includes information corresponding to claims information of the investigator;
• and
• wherein the database also stores information that associates the claims information with one or more disease conditions;
• (b) submitting a query to the database, wherein the query includes information representing a selected disease condition associated with the study;
• and
• wherein a qualified investigator is identified from the database based on the query and in accordance with the claims information.