A clinical trial engineering firm

TL;DR

This paper identifies a new form of research misconduct termed clinical trial engineering, involving manipulated statistical analyses in genuine trials to support regulatory approval, especially in the context of domestic pharmaceutical pressures.

Contribution

It introduces the concept of clinical trial engineering, distinguishes it from traditional paper mills, and provides an analysis framework for assessing trustworthiness of such trials.

Findings

Identified 180 problems across 23 trials, including reporting failures and statistical errors.

Most issues concentrated within the sponsoring organization, indicating internal systemic problems.

Regulatory bodies should treat evidence from this pattern as unverified until independent data access is granted.

Abstract

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