Inspire's policy on clinical trials

Inspire strives to find better ways to connect patients to relevant clinical trials. The goals of our clinical trial program are to:

• Raise awareness of clinical trials
• Increase the number of patients who identify clinical trials as part of their review of care and treatment options
• Reduce the number of patients who get lost or overwhelmed by the search process
• Help our partners by providing a resource for clinical trials for their constituents
• Increase participation in clinical trials and help expedite the availability of better ways to prevent, diagnose and treat disease

How we select clinical trials and studies

Inspire works with our partner organizations and clinical trial sponsors. We require that clinical trial sponsors meet the following criteria:

• The clinical trial or study must be scientifically rigorous and employ appropriate and meaningful outcomes
• The clinical trial or study must be approved by an Institutional Review Board (IRB). The trial must employ mechanisms to provide adequate protection for participant privacy and the confidentiality of participant information
• The clinical trial must meet all the requirements to be listed in the U.S. National Institutes of Health clinical trial database at www.clinicaltrials.gov

The company or organization sponsoring the trial must agree to:

• Provide comprehensive background on the study design and an opportunity to meet with Inspire to address any questions or concerns Inspire may have
• Ensure the trial is listed in the U.S. National Institutes of Health database at www.clinicaltrials.gov
• Provide periodic updates to Inspire on the status of the trial

What should you know before participating in a clinical trial

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.

The clinical trial process for Inspire members

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:

• Inspire contacts members we believe may be interested in the trial
• Interested members complete a qualification questionnaire
• Inspire introduces qualified questionnaire respondents to the trial investigators

Contacting members

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.

Qualification questionnaires

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.