RTI International, 3040 E, Cornwallis Road, P.O. Box 12194, Research Triangle Park, NC, 27709, USA.
U.S. Food and Drug Administration, Office of Prescription Drug Promotion, Silver Spring, MD, USA.
Ther Innov Regul Sci. 2023 Jul;57(4):712-716. doi: 10.1007/s43441-023-00523-3. Epub 2023 Apr 15.
Healthcare providers (HCPs) often encounter clinical trial results in the form of data displays in prescription drug promotions. Information conveyed in data displays vary in their presentation and complexity. This study describes characteristics of data displays in prescription drug advertising targeted to HCPs.
This study characterized the content of 140 data displays in 98 unique print advertisements from 2009 to present and identified in AdPharm, an online database of pharmaceutical advertisements. Two reviewers independently coded the advertisements for characteristics (κ = 0.85) including complexity, format, and quality.
About one-third (32%) of the advertisements contained multiple data displays (range 2 to 6) and 44% showed clinical data from oncology trials; other disease domains were mental and behavioral health (14%), rheumatology and autoimmune disorders (8%), endocrinology (7%), cardiology (6%), infectious disease (6%), pulmonology and allergy (4%), and others (< 2% each). About one-half (51%) of displays were classified as "simple" which included "pseudographs" and basic tables or charts. "Complex" displays appeared as survival curves, line graphs, or bar graphs with complex features. Most complex displays included a comparator drug (90%), plain language restatement of the key finding (93%) and disclosure statements (91%) with additional study details, although their placement varied. Complex displays were of high quality, according to our selected indicators; our analysis found no data distortion or errors.
Data displays in prescription drug advertising are often highly complex. Future research assessing understanding of data displays and the potentially beneficial effect of disclosures and other features is warranted.
医疗保健提供者(HCPs)经常在处方药促销中以数据展示的形式遇到临床试验结果。数据展示中传达的信息在呈现和复杂程度上有所不同。本研究描述了针对 HCPs 的处方药广告中数据展示的特征。
本研究对 2009 年至今 AdPharm 在线药物广告数据库中识别出的 98 个独特印刷广告中的 140 个数据展示的内容进行了特征描述。两名审查员对广告的特征进行了独立编码(κ=0.85),包括复杂性、格式和质量。
约三分之一(32%)的广告包含多个数据展示(范围 2 至 6),44%展示了肿瘤学试验的临床数据;其他疾病领域包括精神和行为健康(14%)、风湿病和自身免疫性疾病(8%)、内分泌学(7%)、心脏病学(6%)、传染病(6%)、肺病和过敏(4%)以及其他(<2%)。约一半(51%)的展示被归类为“简单”,包括“伪图”和基本表格或图表。“复杂”展示则以生存曲线、线图或带有复杂特征的条形图出现。大多数复杂展示都包含了对照药物(90%)、关键发现的通俗语言重述(93%)和披露声明(91%)以及其他研究细节,尽管它们的位置有所不同。根据我们选择的指标,复杂展示具有较高的质量;我们的分析没有发现数据扭曲或错误。
处方药广告中的数据展示通常非常复杂。未来的研究评估对数据展示的理解以及披露和其他特征的潜在有益效果是有必要的。