261 - A company is considering a patient support program. Before proceeding, they wish to conduct a pilot program that has been designed by an expert steering committee of specialists in the therapeutic area. Informed consent would be required from patients and the treating physician would give the information to the patient. During the course of treatment, the patient consent would include an agreement to be contacted by a PIPEDA-compliant CRO to collect information regarding the relative utility of the patient materials. The data would then be used to create the final program. The question is do the materials provided during the pilot stage need to be cleared by PAAB? It is understood that the final materials would be submitted to PAAB. Thank you for the opportunity to present this via the site. Excellent feature.
-
I'll assume that the a pilot is intended simply to evaluate the program's impact, benefits and weaknesses before implementation. I'll also assume that good market research practices will be followed. A pilot should not be intended to promote the sale or disposal of medication. In that vein, it must have a small controlled scale (e.g. short term & low number of test cases). Provided the size and duration are the minimum required to contemplate the program, the pilot does not require review. Long duration or large scale may render the pilot promotional (thus disqualifying it from preclearance exemption). Note that the program will require review if the decision is made to implement it. Even when the pilot does not require review, it is advisable to submit it for pre-clearance if you are concerned about consistency of message between the pilot and implemented program. The pilot may have little value in predicting impact/benefits/weaknesses if it is significantly different from the eventual approved/implemented program.
