Paper mills produce fraudulent research manuscripts built on recycled tables and figures, or on entirely fabricated data. A more recent pattern has emerged: apparently genuine trials with real patients, but with manipulated statistical analyses engineered to support regulatory approval while remaining plausible to peer reviewers. This analysis applies the INSPECT-SR trustworthiness framework to 23 randomised controlled trials and post-marketing studies linked to CinnaGen Co., Iran's largest biosimilar manufacturer, and its clinical operations subsidiary Orchid Pharmed. Papers were retrieved from PubMed and assessed against the original study records. A total of 180 problems were identified across nine categories. The five most frequent issues were reporting failures (n=37), arithmetic violations (n=28), design flaws (n=26), registration irregularities (n=25), and statistical errors (n=25). Analysis of the co authorship network shows that trial design, data management, and manuscript preparation were concentrated within the sponsoring organisation. The underlying structural drivers appear to be a convergence of domestic publication incentives, commercial pressure from international sanctions that created demand for domestically produced drugs, and regulatory pathways that require this body of trial evidence. Because this pattern differs fundamentally from classical paper mills, we propose the term clinical trial engineering to describe it. Regulatory bodies, including the European Medicines Agency (EMA), should treat published clinical evidence from this cluster as unverified until independent access to individual participant data is granted

翻译：论文工厂通过重复使用表格和图片或完全捏造数据产出欺诈性研究手稿。近期出现了一种新模式：看似真实的试验包含真实患者，但经过操纵的统计分析被设计成既能支持监管审批，又能通过同行评审的审查。本研究应用INSPECT-SR可信度评估框架，对伊朗最大生物仿制药制造商CinnaGen公司及其临床运营子公司Orchid Pharmed相关的23项随机对照试验和上市后研究进行分析。论文从PubMed数据库检索，并与原始研究记录进行比对。共识别出九大类180个问题，其中最常见的五项问题为：报告缺陷（37项）、算术违规（28项）、设计缺陷（26项）、注册不规范（25项）和统计错误（25项）。合作网络分析表明，试验设计、数据管理和手稿撰写均集中于赞助机构内部。其潜在结构性驱动因素包括：国内发表激励机制、国际制裁导致的商业压力催生了对国产药物的需求，以及要求此类试验证据的监管审批路径。由于该模式与经典论文工厂存在本质差异，我们提出"临床试验工程"这一术语进行描述。监管机构（包括欧洲药品管理局EMA）应将此类集群中的已发表临床证据视为未经验证，直至获得独立访问个体参与者数据的权限。