Q（Question）

When a physician or pharmacist requests a comparative table of efficacy information (from head-to-head trials or individual trials) between one's own and competing products, is it permissible to provide it?

A（MHLW answer）

Same as A3.

So what (meaning): Providing a comparative table is handled identically to A3: source disclosure, clear labeling of primary and secondary endpoints, and scientific fairness are all required, with explicit distinction between direct and indirect comparisons.

So why (rationale): The table format does not change the scientific fairness requirements that apply to efficacy comparisons, so A3 applies in full.

Commentary — background, application, practical notes

A comparative table places numerical values side by side visually, which tends to emphasise the impression of comparison more strongly than an individual verbal explanation. Q5 simply applies A3 and neither relaxes nor adds to the rules on the basis that the format is tabular. All information required by scientific fairness principles — source disclosure, trial design, explicit labelling of primary and secondary endpoints, and identification of whether the comparison is direct or indirect — must be included in the table just as it would be in any other format.

A typical scenario is a prescribing physician requesting a table to compare the efficacy rates and adverse event rates of several drugs in the same class at a glance. When preparing a table that lists individual trial results for the manufacturer's own product and competing products, presenting only the numbers without footnotes or annotations showing each trial's patient background (disease stage, study duration, control group design) is considered to lack scientific fairness.

A particularly common error is mixing results from head-to-head trials and results from separate individual trials in the same table without clearly distinguishing them. The question itself in Q5 specifically contemplates information from 'head-to-head trials or individual trials,' implying that the source of each data point must be identified in the table. A table that omits this distinction risks leading physicians to misread indirect comparison data as head-to-head results, and therefore fails to meet the Guideline's requirement to 'promote accurate understanding.'