In a 33-page report titled Assessment of the Use of Patient Experience Data in Regulatory Decision-Making prepared by Eastern Research Group (here), the views of the FDA and its stakeholders (patients, industry, and physicians) are either leaning towards “we are just figuring it out” (FDA) or “we have no real idea how the Agency utilizes patient experience data in its regulatory decision-making process”(stakeholders).
While the more frequent inclusion of this data in NDA reviews points towards the FDA beginning to consider such data, the reviewers themselves appear unsure exactly how to factor the data collected into the gold-standard safety and efficacy determination. FDAers report that they make their decisions primarily on clinical outcome data and rely heavily rely on the FDA team’s clinical outcomes and safety assessments in reaching approval decisions. The FDA stakeholders would like to see more emphasis placed on this data but are not certain how ready the FDA is to rely more heavily on it or under which circumstances such data would provide additional support for the impacting clinical outcome assessments made by FDA reviewers and supervisors.
The report has several recommendations for both the FDA and its stakeholders but, in general, these support the Agency’s movement towards adopting the collection of the data, and the authors of the report appear to believe that the Agency needs to keep the process moving forward so that greater consideration for this type of data can better inform the FDA’s decision-making. From my perspective, there is still much room for understanding how and when such patient experience can be useful for consideration or better incorporated into the FDA’s review and approval process. The report is very interesting but leaves one to think that there is still some road to be traveled before it will be clear how the Agency will use this type of data, and that this road is, perhaps, longer then some might like.
In a 33-page report titled Assessment of the Use of Patient Experience Data in Regulatory Decision-Making prepared by Eastern Research Group (here), the views of the FDA and its stakeholders (patients, industry, and physicians) are either leaning towards “we are just figuring it out” (FDA) or “we have no real idea how the Agency utilizes patient experience data in its regulatory decision-making process”(stakeholders).
While the more frequent inclusion of this data in NDA reviews points towards the FDA beginning to consider such data, the reviewers themselves appear unsure exactly how to factor the data collected into the gold-standard safety and efficacy determination. FDAers report that they make their decisions primarily on clinical outcome data and rely heavily rely on the FDA team’s clinical outcomes and safety assessments in reaching approval decisions. The FDA stakeholders would like to see more emphasis placed on this data but are not certain how ready the FDA is to rely more heavily on it or under which circumstances such data would provide additional support for the impacting clinical outcome assessments made by FDA reviewers and supervisors.
The report has several recommendations for both the FDA and its stakeholders but, in general, these support the Agency’s movement towards adopting the collection of the data, and the authors of the report appear to believe that the Agency needs to keep the process moving forward so that greater consideration for this type of data can better inform the FDA’s decision-making. From my perspective, there is still much room for understanding how and when such patient experience can be useful for consideration or better incorporated into the FDA’s review and approval process. The report is very interesting but leaves one to think that there is still some road to be traveled before it will be clear how the Agency will use this type of data, and that this road is, perhaps, longer then some might like.
