A clinical trial engineering firm
For regulatory agencies like the EMA, this reveals a systematic manipulation of clinical trial evidence that undermines trust in published drug approval data.
The study identifies a new pattern of research fraud, termed 'clinical trial engineering,' in 23 trials from CinnaGen Co., finding 180 problems including reporting failures, arithmetic violations, and statistical errors, with trial design and analysis concentrated within the sponsor.
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