ICH will start to develop patient-centered drug development guidelines

ICH is seeking feedback on the development of a globally uniform method guide for collecting patient opinions and incorporating them into the drug development and regulatory process, including the development of a new uniform guideline for collecting patient opinions in a reasonable and sustainable method for industry and regulatory agencies.

ICH first initiated this proposed initiative by identifying key areas. ICH believes that collecting patient opinions can improve the quality, relevance, safety and effectiveness of drug development, and provide a basis for regulatory decision-making. ICH discussed this proposal in a draft patient-centered drug development (PFDD) thinking document, and the call for comments on the draft will close in March 2021.

ICH pointed out that although the needs of patients have been sought and considered in many cases, “the methods used to identify, collect, and analyze content that is meaningful to patients are not standard or uniform.” Similarly, in terms of patient preference research, ICH It was pointed out that although these studies may not be necessary in many clear cases, when needed, "it would be beneficial to let these methods follow agreed standards." "Patient preference research can help discover which aspects of medical products are important to patients, and why patients choose specific drugs over others."

ICH believes that "in the entire drug development process" there are opportunities to improve the quality of drug development plans by effectively incorporating patient perspectives. These include the development of endpoints that reflect the most important benefit to the patient, the patient's acceptability of the benefit, and the relationship between risk and tolerance.

The thinking document points out a series of related issues that may arise when patient feedback is included in the drug development process or regulatory decision-making. ICH recommends the development of two new guidelines outlining the methods and standards that should be used when collecting and merging patient opinions to address these issues.

Specifically, ICH proposes to develop new guidelines on:

· What to measure in clinical trials. Given that not everything that patients, caregivers, and clinicians consider important is measurable or can be proven to be changed in a specific treatment trial, the new guidelines will address how sponsors should choose what to measure for drug development plans The purpose is to show clinical benefit. The guidelines will also explain how the sponsor can identify, modify, or develop clinical outcome assessments suitable for the purpose, which may include patient-reported outcome tools to assess outcomes that are important to the patient.

· How to reliably obtain information about the value of patients for treatment, which can help explain patients' different views on benefits, risks, and tolerability issues. The guidelines can clarify the methodological requirements for designing and conducting patient preference studies. These requirements include "sufficient rigor and quality" to provide a basis for drug development and regulatory decisions.

As certain jurisdictions (for example, the European Union and the United States) are already undertaking plans related to these proposed guidelines, considering that there are limited personnel with the necessary expertise in psychology, related statistics and decision sciences in regulatory agencies and enterprises, the ICH It is recommended that the work on these new documents should be started after the relevant plans are basically completed.

In the European Union, a public-private partnership project (IMI-PREFER) is seeking regulatory agencies and health technology assessment agencies to verify its proposed best practice methods for conducting patient preference studies. In the United States, the FDA is formulating a series of patient-oriented drug development guidelines in accordance with the requirements of the "21st Century Medicine Act" and organizing patient-centered drug development conferences. [FDA's first patient-centered drug development guidelines are finalized 2020/12/08], [How can patient participation affect regulatory decisions? 2020/12/08】

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