Dear ISPOR colleagues,

Earlier this year the FDA indicated that they would be circulating 4 draft guidances related to Patient-Focused Drug Development. With your help, ISPOR responded to first one in October 2018. The second one, focusing on “Approaches to identify what is most important to patients with respect to their experience as it relates to burden of disease and burden of treatment,” is now available for comment. Their announcement, the draft guidance, and related documents can be found here.

To help ISPOR formulate its response, we would welcome your comments on the guidance. Please note the specific line numbers in your comments whenever appropriate.

Question Title

* I. Introduction (lines 14 - 73)

Question Title

* II. Methods to Identify and Understand What is Important to Patients (lines 76 - 116)

Question Title

* III. Qualitative Research Methods (lines 121 - 243)

Question Title

* IV. Quantitative Research Methods lines (248 - 366)

Question Title

* V. Mixed Methods (lines 367 - 413)

Question Title

* VI. Specific Populations and (Children, Cognitively Impaired, Rare Diseases) and Culturally Diverse Populations (lines 414 - 469)

Question Title

* VII. Considerations for Use of Social Media (lines 471 - 496)

Question Title

* Appendices (lines  593 - 1163)

T