Prostate ablation using HIFU — the role of patient preference information


A newly published review by staff of the Center for Devices and Radiological Health (CDRH at the U.S. Food & Drug Administration (FD) addresses the potential role for patient preference information (PPI) in determining patient perceptions of the “value” of high-intensity focused ultrasound (HIFU) and similar techniques in the management of prostate cancer.

The new article by Babalola et al. provides a detailed assessment of the data used to consider the clinical value of the two approved types of HIFU technology currently available for the ablation of prostate tissue but also looks in more detail at the relevance of and degree to which patient preference information may be helpful and could be used as a key factor in the evaluation of HIFU and similar techniques in the treatment of prostate cancer and other comparable categories of disease.

The full text of this article is available on line for interested readers.

The methods that the FDA uses to make decisions about new forms of treatment — for prostate cancer and for other disorders — are important, for all sorts of reasons.

It was never going to be easy for the developers of HIFU technology to designs and implement randomized clinical trials to support the approval of HIFU in the treatment of prostate cancer (which is not to suggest that they tried very hard to do this well). It is also a truism that there was a subsection of the prostate cancer patient population believed from Day 1 that HIFU “had to be” a better option for treatment of localized prostate cancer than the other forms of therapy available back in the early 2000s. (Whether such a belief was or is justified is a very different question.)

What this article does, and why it is therefore interesting, is to explore how patient perspectives on the benefit-risk trade-offs associated with HIFU may provide useful information to prostate cancer stakeholders in relation to the approval of HIFU for the treatment of prostate cancer (and how patient preference information could therefore be used in analogous situations yet to be well defined).

The article’s conclusions are informative:

The CDRH … at the FDA has recognized the value of PPI to its mission. Partnering with Patients was one of the Strategic Priorities for 2016 to 2017. The goals of this initiative are to “promote a culture of meaningful patient engagement by facilitating CDRH interaction with patients” and “increase use and transparency of patient input as evidence of our decision making.” Patient preference information from future studies might provide additional information to patients, clinicians, and current and prospective device developers. In addition, it might be used by regulators in the benefit-risk evaluation of prostate tissue ablation devices. With this in mind the FDA recently issued final guidance on how it may consider PPI in its evaluation of medical devices. Ultimately the incorporation of PPI into all stages of device development and regulation may enhance the safety and effectiveness of medical devices.

Patient advocates please take note!

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