Academic medical centers' standards for clinical-trial agreements with industry
Academic medical centers' standards for clinical-trial agreements with industry
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DOI：
10.1056/nejmsa044115
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发表时间：
2005-05-26
影响因子：
158.5
通讯作者：
Studdert, DM
中科院分区：
文献类型：
--
作者：
Mello, MM;Clarridge, BR;Studdert, DM
尽管在美国，制药企业为临床药物试验提供了大约70%的资金，但人们对制药企业和学术研究者之间存在的法律协议知之甚少。我们研究了限制研究者控制试验的合同条款的制度标准。方法：我们采用结构化的横断面邮件调查，调查对象是负责与行业发起人谈判临床试验协议的医学院研究管理人员。结果122所院校中，有107所参与。管理人员对若干与出版物有关的合同条款的可接受性有高度的一致意见。例如，超过85%的人报告说，他们的办公室不会批准给予行业发起人修改手稿或决定是否发表结果的权力的规定。对于允许主办者在手稿中插入自己的统计分析（24%的人允许，47%的人不允许，29%的人不确定是否应该允许）、起草手稿（50%的人允许，40%的人不允许，11%的人不确定是否应该允许）、并禁止调查人员在试验结束后与第三方共享数据（41%的人允许，34%的人不允许，24%的人不确定是否应该允许）。协议签署后，纠纷很常见，最常见的纠纷集中在支付（75%的管理人员报告在前一年至少发生过一次此类纠纷）、知识产权（30%）和对数据的控制或访问（17%）。在不同的学术医疗中心，与行业赞助商签订的临床试验协议中某些限制性条款的标准差异很大。为了就适当的标准达成共识，需要与行业发起人更多地分享有关法律关系的信息。
BackgroundAlthough industry sponsors provide approximately 70 percent of the funding for clinical drug trials in the United States, little is known about the legal agreements that exist between industry sponsors and academic investigators. We studied institutional standards regarding contractual provisions that restrict investigators' control over trials.MethodsWe used a structured, cross-sectional mail survey of medical-school research administrators responsible for negotiating clinical-trial agreements with industry sponsors.ResultsOf 122 institutions approached, 107 participated. There was a high degree of consensus among administrators about the acceptability of several contractual provisions relating to publications. For example, more than 85 percent reported that their office would not approve provisions giving industry sponsors the authority to revise manuscripts or decide whether results should be published. There was considerable disagreement about the acceptability of provisions allowing the sponsor to insert its own statistical analyses in manuscripts (24 percent allowed them, 47 percent disallowed them, and 29 percent were not sure whether they should allow them), draft the manuscript (50 percent allowed it, 40 percent disallowed it, and 11 percent were not sure whether they should allow it), and prohibit investigators from sharing data with third parties after the trial is over (41 percent allowed it, 34 percent disallowed it, and 24 percent were not sure whether they should allow it). Disputes were common after the agreements had been signed and most frequently centered on payment (75 percent of administrators reported at least one such dispute in the previous year), intellectual property (30 percent), and control of or access to data (17 percent).ConclusionsStandards for certain restrictive provisions in clinical-trial agreements with industry sponsors vary considerably among academic medical centers. Greater sharing of information about legal relationships with industry sponsors is desirable in order to build consensus about appropriate standards.