Krumholz Samuel D, Egilman David S, Ross Joseph S
Never Again Consulting LLC, Providence, Rhode Island, USA.
Arch Intern Med. 2011 Jun 27;171(12):1100-7. doi: 10.1001/archinternmed.2011.241.
Seeding trials, clinical studies conducted by pharmaceutical companies for marketing purposes, have rarely been described in detail.
We examined all documents relating to the clinical trial Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) produced during the Neurontin marketing, sales practices, and product liability litigation, including company internal and external correspondence, reports, and presentations, as well as depositions elicited in legal proceedings of Harden Manufacturing vs Pfizer and Franklin vs Warner-Lambert, most which were created between 1990 and 2009. Using a systematic search strategy, we identified and reviewed all documents related to the STEPS trial in order to identify key themes related to the trial's conduct and determine the extent of marketing involvement in its planning and implementation.
Documents demonstrated that STEPS was a seeding trial posing as a legitimate scientific study. Documents consistently described the trial itself, not trial results, to be a marketing tactic in the company's marketing plans. Documents demonstrated that at least 2 external sources questioned the validity of the study before execution, and that data quality during the study was often compromised. Furthermore, documents described company analyses examining the impact of participating as a STEPS investigator on rates and dosages of gabapentin prescribing, finding a positive association. None of these findings were reported in 2 published articles.
The STEPS trial was a seeding trial, used to promote gabapentin and increase prescribing among investigators, and marketing was extensively involved in its planning and implementation.
制药公司为营销目的开展的植入性试验（seeding trials），这类临床试验鲜有详细描述。
我们查阅了与加巴喷丁（Neurontin）市场营销、销售行为及产品责任诉讼期间所开展的“加巴喷丁滴定至有效剂量及安全性概况研究（STEPS）”相关的所有文件，包括公司内部和外部通信、报告、演示文稿，以及在哈登制造公司诉辉瑞公司和富兰克林诉华纳-兰伯特公司法律诉讼中获取的证词，其中大部分文件形成于1990年至2009年期间。我们采用系统检索策略，识别并审查了与STEPS试验相关的所有文件，以确定与该试验开展相关的关键主题，并确定市场营销在其规划和实施过程中的参与程度。
文件显示，STEPS是一项伪装成合法科学研究的植入性试验。文件一致将该试验本身而非试验结果描述为公司营销计划中的一种营销策略。文件显示，至少有两个外部来源在试验执行前就对该研究的有效性提出质疑，且研究期间的数据质量常常受到影响。此外，文件描述了公司的分析，该分析考察了作为STEPS研究者参与试验对加巴喷丁处方率和剂量的影响，发现存在正相关关系。但在两篇已发表的文章中均未报告这些发现。
STEPS试验是一项植入性试验，用于推广加巴喷丁并增加研究者的处方量，市场营销广泛参与了其规划和实施过程。
