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首页> 外文期刊>International journal of pharmaceutical medicine >Clinical Trials and the Independence of Investigators A Novel Method for the Conduct of Pharmaceutical Company-Funded Clinical Drug Trials Which Ensures Investigator Independence
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Clinical Trials and the Independence of Investigators A Novel Method for the Conduct of Pharmaceutical Company-Funded Clinical Drug Trials Which Ensures Investigator Independence

机译：临床试验和研究者的独立性进行制药公司资助的临床药物试验的新方法可确保研究者的独立性

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Industry-funded research has long been criticised for its ability to allow bias through the manipulation of the reporting of results. This paper describes an approach that addresses some of these concerns by implementing a process for the conduct of clinical trials, especially trials conducted in private practice.The approach involves the use of a private practice clinician to act as chief investigator to design a study, recruit fellow investigators, employ a contract research organisation (CRO), organise insurance and to act as the designated sponsor of the project, thereby relegating ownership of the study data to the investigators, as sponsors, rather than the pharmaceutical company funding the trial. All parties involved must adhere to Good Clinical Practice (GCP) standards.In an ongoing trial using this model, the chief investigators adopted the role of sponsor but separated the management and finances of the trial from the other accounting procedures within the clinical practice by using the vehicle of a pre-existing, limited liability, registered private company which already undertook such activities with regards to clinical research conducted within the private practice setting. The study was a multicentre, placebo-controlled, double-blind, randomised, crossover design. Operating procedures were designed to overcome any potential areas of conflict of interest. A CRO was contracted to manage the day-to-day conduct of the trial. The sponsoring company, representing the investigators, was completely independent of the funding pharmaceutical company thereby ensuring unencumbered potential to publish findings, irrespective of their positive or negative results.The concept in which a pharmaceutical company funds, but does not sponsor, a trial ensures that the execution, ownership and reporting of the study findings remain the precinct of the sponsor, which is independent of commercial influences relevant to the pharmaceutical industry. Such autonomy, granted to the chief investigators, may provide a significant advance in the realisation of clinical drug trials, especially those conducted within community based private practice, and respects scientific integrity without sacrificing mandatory rigour.
机译：长期以来，一直受到行业资助的研究的批评，因为该研究能够通过操纵结果报告而产生偏见。本文介绍了一种通过实施临床试验过程（特别是在私人诊所进行的试验）来解决其中一些问题的方法，该方法涉及使用私人诊所的临床医生担任首席研究员来设计研究，研究员，雇用合同研究组织（CRO），组织保险并担任项目的指定赞助商，从而将研究数据的所有权委托给研究者，作为赞助者，而不是制药公司为试验提供资金。所有相关方都必须遵守良好临床规范（GCP）标准。在使用该模型进行的正在进行的试验中，首席调查员采用保荐人的角色，但通过使用以下方法将试验的管理和财务与临床实践中的其他会计程序分开既有的有限责任注册私人公司的载体，该公司已经在私人执业环境中进行了有关临床研究的此类活动。该研究是一个多中心，安慰剂对照，双盲，随机，交叉设计。设计操作程序是为了克服任何潜在的利益冲突领域。与CRO签订了合同，以管理审判的日常进行。代表研究者的保荐公司完全独立于出资的制药公司，从而确保了发表研究结果的潜能，无论其结果是阳性还是阴性。制药公司资助但不提供资助的试验概念确保：研究结果的执行，所有权和报告仍然是发起者的职责范围，而该发起者不受与制药行业相关的商业影响。授予首席研究人员的这种自主权可以在实现临床药物试验方面取得重大进展，尤其是在基于社区的私人实践中进行的临床试验，并且在不牺牲强制性的前提下尊重科学完整性。

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