Inspire strives to find better ways to connect patients to relevant clinical trials. The goals of our clinical trial program are to:
Inspire works with our partner organizations and clinical trial sponsors. We require that clinical trial sponsors meet the following criteria:
The company or organization sponsoring the trial must agree to:
Inspire recommends that all patients considering participation in a clinical trial discuss the information with their doctor. Your physician will be familiar with your medical history and can best evaluate the study criteria to determine if the clinical trial is appropriate for you. Inspire recognizes that the decision to participate in a clinical trial is a personal one and should be made only after careful consideration of the potential risks and benefits.
Inspire encourages patients to explore clinical trials as a treatment option and provides links to comprehensive resources that attempt to offer opportunities for patients to learn about all of the clinical trials being conducted for which they might be eligible.
Through its partners, Inspire provides general education about clinical trials, including what clinical trials are, how they are conducted, the types of trials available to individuals and common barriers to participation people experience in clinical trials. We encourage our members to visit our partners' sites for more information.
Once Inspire agrees to work with a clinical trial sponsor, we attempt to connect members who are interested in and qualified for the trial with the trial investigators. The process is completely opt-in for Inspire members. No personally identifiable member information is shared with anyone outside of Inspire without the member's express permission. The process of connecting members with trial investigators involves three steps:
The process starts with the clinical trial sponsor providing Inspire with inclusion and exclusion criteria for the trial. We use the basic inclusion and exclusion criteria to determine which members to contact about the trial. Basic inclusion and exclusion criteria include the condition being studied, the desired age range and gender of patients, and location of study sites.
Using the basic inclusion and exclusion criteria, we send a message to members who we believe may be interested in the trial, subject to their preferences regarding such communication. We do not contact members who have, by setting their message preferences accordingly, opted out of clinical trial notifications. The message we send provides a link to a qualification questionnaire which gives complete information about the trial along with questions the member can answer to determine if she may qualify. For some clinical trials we may also publish information about the trial and a link to the qualification questionnaire in public areas of Inspire.
Members who are not interested in the trial can simply ignore these communications. No personally identifiable member information is shared with anyone outside of Inspire without the member's express permission.
Members who are interested in the trial can visit the qualification questionnaire to learn more about the trial and see if they may qualify for it. The qualification questionnaire provides information and links for learning about the trial in depth, and a set of questions based on the trial's inclusion and exclusion criteria. Members who are not interested in the trial can simply ignore the questionnaire. Members who are interested can complete the questionnaire to see if they may qualify. In the questionnaire we ask for contact information (name, phone number) and require that the member agree that if her answers suggest she may qualify for the trial, we may share her responses with the physicians and nurses conducting the trial (also known as Principal Investigators or PIs). Anyone who does not wish to share their responses with the PIs investigating the trial can simply opt not to fill out the questionnaire.
Connecting qualified members with trial investigators
Upon completing the questionnaire, if a member's responses indicate that she may qualify for the trial, we provide the member with contact information for the PI nearest to her. At the same time we notify that PI that a member who may qualify for the trial has completed the questionnaire. The PI can then access a secure, password-protected, encrypted site on Inspire's servers to retrieve the member's contact information and questionnaire responses. In most cases we expect the PI to contact the member, but the member may contact the PI herself. We provide both the member and the PI with contact information to facilitate their getting in touch with each other. Once the PI and member are in touch, the PI will discuss the trial in depth with the member, inquire about additional inclusion and exclusion criteria, schedule an appointment for in-person screening, and perform any other steps necessary to ensure that the patient is fully informed about the trial and qualified to participate.