Managing clinical trials

Several organizations, for example, offer trained study coordinators through a central corporate enterprise. These companies typically secure the grants and use their network of study coordinators to conduct the studies. Some of these organizations own their facilities and hire the principal investigators. Others contract with area physicians to manage clinical trials within the physician s practice. 

Subject Information Systems Data Management Clinical Trials Supplies Production Protocol Management... 

There are several other key components to trial execution that will require special attention subject recruitment, the informed consent, IRBs/IEC review product accountability, adverse experience and adverse reaction reporting, financial disclosure, and record retention. Each is critical in the overall success of a clinical trial. If one of these is not handled or processed appropriately, the clinical trial will not be used in support of a new product application. Many of these components have been discussed previously in the context of monitoring. Adverse experience and adverse reaction reporting, informed consent, and IRB/IEC are detailed in Chaps. 11 and 20. The remaining key components relative to managing clinical trials will now be addressed. 

Risk-management System I Information relating to Clinical Trials... 

Carroll KM, Sinha R, Nich C, er al Conringency management to enhance naltrexone treatment of opioid dependence a randomized clinical trial of reinforcement magnitude. Exp Clin Psychopharmacol 10 5d—63, 2002 Carroll KM, Fenron LR, Ball SA, er al Efficacy of disulfiram and cognitive behavior rherapy in cocaine-dependenr ourparienrs. Arch Gen Psychiatry 61 264—272, 2004... 

Electronic-based data collection and management systems use various computer hardware and software technologies. Although some organizations design and develop their own systems, others purchase well-established e-clinical trials software from a wide range of vendors. 

With the increased acceptance of the Internet and the huge innovations in web development tools, web-based data collection and management systems have become the choice of many CROs because of their capability for collecting clinical trial data in real time and disseminating critical clinical trial information to the participating sites and various oversight committees [27]. 

Web-based data collection and management systems provide a mechanism for remote data entry, where entered data are added to a centralized database once the submit button is pressed. They can be designed to automate the various aspects of clinical trials such as eligibility evaluation, data collection, and tracking specimens. They also serve as a resource site for participating sites to access trial-specific information, facilitate communication, track data queries and their resolutions, and allow administrative management of trials [28, 29]. For these reasons, they play an important role in facilitating the conduct of international clinical trials. 

Computer-controlled systems [54] are commonly used in clinical trials to control dispensing and manage site inventories of trial supplies. Such systems are implemented with telephone voice-based or Internet web-based systems. 

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