News

Pilot Process for Receiving Patient Group Input Submissions for Therapeutic Reviews

The Canadian Agency for Drugs and Technologies in Health (CADTH) has implemented a pilot process for receiving patient input submissions for therapeutic reviews from patient groups. Patient groups are invited to provide experiences and perspectives about living with the condition for which the drugs included in the therapeutic review are indicated and about the impact of therapy on the lives of patients with the condition. This opportunity to provide patient group input is in addition to the available opportunities for all stakeholders, including patient groups, to provide feedback during different phases of the therapeutic review in response to a request for feedback.

The pilot will continue until July 31, 2014 when it will be assessed. This pilot was initiated with receipt of patient input for the therapeutic review Management of Relapsing-Remitting Multiple Sclerosis.

CADTH will invite patient group input by issuing an E-Alert to CADTH E-Alert subscribers for future therapeutic reviews.

Therapeutic reviews are reviews of publicly available evidence about a class or group of drugs used in the treatment of a condition. More information about therapeutic reviews can be found in the Therapeutic Review Framework.

Stakeholders, including patient groups, have had opportunity to provide comments on the list of studies included in the therapeutic review, draft science reports that make up the therapeutic review, and draft Canadian Drug Expert Committee (CDEC) recommendations, and beginning in the fall of 2013 they will be invited to comment on the scope of the therapeutic review project. This pilot project allows patient groups to provide patient input that will be systematically incorporated into the therapeutic review process, in a manner similar to that which is currently used for reviews of single drug submissions to the Common Drug Review at CADTH. The process for patient groups to provide input is as follows:

  • The patient group will download and complete the Template for Submitting Patient Group Input to the Therapeutic Review.
  • The identity of the author, the submitting patient group, and conflict of interest information, including whether any assistance was provided in preparing the submission, are required. Note: the name of the submitting patient group and conflict of interest information will be included in the posted original (i.e., in its entirety) patient group submission; however, the name of the author will not be posted.
  • No private information that can identify patients (e.g., names and also cities and ages if their inclusion can identify patients) is to be included in the patient input submission.
  • Patient groups will have 15 business days to provide input. Depending on timeframes for the therapeutic review, CADTH will endeavour to give advance notice of the therapeutic review. In order to be used in the therapeutic review, the patient group input for that therapeutic review must be submitted by the deadline date posted on the specific project page in the Therapeutic Reviews section on the CADTH website.
  • Patient group input should be provided, succinctly and clearly, in English, and in a form that is ready to be posted on the CADTH website.
  • Submissions should be in Microsoft Word using a minimum of an 11-point font. They should not exceed six typed pages (approximately 3,500 words). Additional or supplemental information, such as a description of a survey, may be included as an appendix; however, such additional information will not be included in the summary of all submitted patient input. The instructions and examples under each heading in the template may be deleted.
  • Completed patient group submissions should be emailed to [email protected].
  • All patient group input that is received will be collated and summarized by CADTH staff.
  • All patient groups that have submitted patient input will be invited to comment on whether the summary created reflects their main issues and concerns and to ensure that all personal information that could identify any patient is removed. They will not be able to add new information to the summary. They will be invited to comment only on the approximately two-page summary.
  • Patient groups will have up to five business days to comment on the summary.
  • The summary will be incorporated into the Therapeutic Review Science Report, which will be posted on the CADTH website.
  • All patient group input submissions in their entirety will be posted on the CADTH website at the same time as the related Therapeutic Review Science Reports.
  • CADTH will use reasonable care to prevent the disclosure of individual's identities or private information in publicly available documents, and will format the submission for posting if necessary. CADTH will not edit or copy-edit the patient input submissions filed by patient groups, but will remove any information that can identify patients.