Table 2 –

Steps to consider in benefit and risk assessments in clinical trials of chronic pain treatments

1. Specify

Specify the chronic pain condition(s) under study and the currently available treatments for the condition(s). Unmet clinical needs associated with the condition and contextual information such as common comorbidities associated with the condition should also be addressed.

2. Identify

Identify the key outcomes that will be utilized to assess the benefits (e.g., reductions in pain intensity or severity) and risks (adverse events, reduced quality of life). Patient preference on meaningful benefit and risk outcomes should be incorporated at this level and patient-reported outcomes should be used to gather data.

3. Evaluate

Collect and combine data related to the benefits and risks of an intervention(s) in a way that allows for the ranking or weighting of data. In general, two approaches to benefit-risk analyses can be performed: compare and combine at the level of the intervention or combine and compare at the level of the individual patient.

4. Interpret

The interpretation of data should incorporate value judgments, or trade-offs between the relative importance of benefits and risks in a particular situation, which can vary depending on the type of stakeholder (patient, clinician, regulatory agency). This step should also address the uncertainty associated with the analysis given that benefit-risk assessments are dynamic and evolve as information changes over time.

5. Communicate

Communicate the results of the analysis, including sharing the processes and rationale leading to the final conclusions. Messaging of the findings might need to be tailored depending on the audience and information should be summarized in succinct, transparent, and user-friendly ways (e.g., graphical representations).