Examination of Clinical Trial Costs and Barriers for Drug Development. 4.6.1 Administrative

07/25/2014

Contract negotiation and internal review are two major administrative areas where drug companies suffer from inefficiencies of their own creation. The IOM and the National Cancer Institute (NCI) have tried to generate standard contract terms so that the trickiest parts of contracts between sponsors and contractors and clinical sites would not need to be renegotiated from scratch every time; however, these have gone largely unused by drug companies. Contract negotiation delays can be exacerbated when pharmaceutical companies outsource the execution of standard contracts to subcontractors, who cannot make decisions without approval (Kramer, Smith, & Califf, 2012; Institute of Medicine Forum on Drug Discovery, Development, and Translation, Undated).

Internal review processes for organizations conducting or sponsoring clinical trials can also delay a trial’s start. For example, in the past, Bristol-Myers Squibb needed 8 months and 34 internal review cycles to develop and activate a new protocol. The company has recently made an effort to streamline this process and shorten it to about five months (English, Lebovitz, & Giffin, 2010).

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