The CADTH Scientific Advice Program includes patient input as part of the process for developing Scientific Advice. There are two main sources of patient information that are used in the development of CADTH Scientific Advice:
1. Information Submitted by the Applicant in the Briefing Book (If Available)
Applicants to the CADTH Scientific Advice Program are asked to describe the patient engagement activities they have conducted to date. As part of the Briefing Book submitted, applicants indicate any consultations or interactions they have had with patients or patient groups related to their drug development program regarding input on the design of clinical trials. If this information is available, CADTH takes it into account when preparing Scientific Advice for the applicant.
2. Patient Interview
For each application, CADTH contacts at least one relevant patient group to arrange for a patient representative to speak with CADTH staff on current therapies and needs unmet by current therapies. When a patient group does not exist for a given disease or condition, CADTH will attempt to engage an individual with the disease or condition. No written submissions are required of the patient representative(s), and the patient representatives do not attend the face-to-face meeting between CADTH and the applicant for the Standard CADTH Scientific Advice process. For the parallel Scientific Advice process with CADTH and NICE, patient representatives engaged by each organization may attend and participate in the Scientific Advice meeting. Patient representatives are financially compensated for their involvement.
The interview between CADTH and the patient representative(s) occurs at a time between application approval and the Scientific Advice meeting between CADTH and the applicant. A summary of the patient interview will be shared with the Scientific Advice team and the patientâs perspective will be considered in the development of the Scientific Advice. If permission is granted by the patient representative(s), CADTH will provide the summary of the patient interview to the applicant as an appendix of the CADTH Record of Scientific Advice. Relevant patient group input from past submissions to CADTH may also be included in the appendix, when available.
As background information for the patient representative(s), applicants to the CADTH Scientific Advice Program are asked to complete and submit a Patient Drug Information Form. This form requests information about the drug and the planned phase III clinical trials that will allow for a relevant conversation about the application between CADTH and the patient representative(s). Completion of the form is optional for applicants and the form may be completed in whole or in part (i.e., all fields are optional except drug name and applicant name, as these are needed for identification). Applicants are encouraged to complete the form to allow for input of highest relevance from patient representatives.
Confidentiality and Patient Input Process
Patient representatives are required to sign the Non-Disclosure Agreement and to comply with the Confidentiality Guidelines for Scientific Advice and the CADTH Conflict of Interest Guideline for Contractors.
To protect the identity of the drug name and the applicantâs name, there is no public call for patient input. Instead, CADTH staff liaises directly with patient groups to solicit patient representatives. The drug name, applicant name, and the Patient Drug Information Form (if applicable) are shared with the selected patient representatives only after the Non-Disclosure Agreement has been signed. This information is not shared with other members of the patient group.
Although patient input is part of the process for every application to the CADTH Scientific Advice Program, confidential information from the applicant and information produced as part of the Scientific Advice Program is shared with patient representatives only with the express permission of the applicant. Applicants indicate permission to share information in the online application form for Scientific Advice.
Note that submission of the Patient Drug Information Form constitutes the applicantâs agreement to share the completed form with patient representatives involved in the application.
Evolution of Patient Involvement in Early Scientific Advice
At this point in time, best practices for involving patients in early Scientific Advice programs are not established. The CADTH process may evolve as more experience is gained.