We propose a set of requirements for designing handheld computer systems for electronic collection of patient diary and questionnaire data in clinical trials: (1) the system should be suitable for use by all types of patient to be included in the clinical trial programme; (2) patients must be capable of using the system and be comfortable with it after a short period of training; (3) responses should always result from an action by the user--defaults should not be taken as data; (4) all information necessary to a given question should be simultaneously available on the screen. This applies to both the questions and the response options. We present guidelines as to how these requirements may be met in practice, so that bias may be avoided both in patient selection and in the responses made; so that electronic data collection may be as effective as possible, and so that study procedures are convenient and unobtrusive for the patients.

Internet solution for online communication of clinical research data between the investigator, the clinical study monitor, a central laboratory for blood and urine analysis, and Astra Hassle AB was evaluated in two international multicenter studies involving 894 patients from 78 centers in 9 countries across Europe and Canada. For access to the common information space, a security system combining a unique user name and one-time passwords was used. The Internet application allowed investigators to create patient records and enter data for existing patients into the electronic case report form (eCRF). Certain data were checked immediately at data entry, resulting in automaticallygenerated questions. Additional data checks were also performed on data each night, the results of which were made available for the monitors using the Web application. Thanks to the immediate availability of clinical study data and the data checks, the study monitors were able to monitor the eCRFs and generate questions on unclear or inconsistent data, both immediately after they had been entered at the study site, and within 24 hours after data entry using the data checks.Measures of lead times clearly showed positive effects. The time from last data available to clean file was, on average, six days. The additional workload was considered reasonable, despite the use of a paper workbook as a back-up in these studies. This is the first time this concept and technology has been reported, and it suggests a shiji in paradigm. From a scientific, time, resource, and logistic point of view, an approach based on use of the World Wide Web offers advantages to paper-based systems.

This paper presents the study of multi-objective optimization of a pharmaceutical portfolio when both cost and return values are uncertain. Decision makers in the pharmaceutical industry encounter several challenges in deciding the optimal selection of drug projects for their portfolio since they have to consider several key aspects such as a long product-development process split into multiple phases, high cost and low probability of success. Additionally, the optimization often involves more than a single objective (goal) with a non-deterministic nature. The aim of the study is to develop a stochastic multi-objective approach in the frame of chance-constrained goal programming. The application of the results of this study allows pharmaceutical decision makers to handle two goals simultaneously, where one objective is to achieve a target return and another is to keep the cost within a finite annual budget. Finally, the numerical results for portfolio optimization are presented and discussed.

No abstract