Definition of clinical research and clinical trial
In World Health Organization’s definition, “for the purpose of registration, a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcome” (WHO, 2014). National Institute of Health specified the differences between clinical research and clinical trials. “Clinical research is research that directly involves a particular person or group of people, or that uses materials from humans, such as their behavior or samples of their tissue. A clinical trial is one type of clinical research that follows a pre-defined plan or protocol. By taking part in clinical trials, participants can not only play a more active role in their own health care, but they can also access new treatments and help others by contributing to medical research” (National Institute of Health, 2012).
Discipline-specific information requirements
The nature of a clinical trial is to prove or refute a hypothesis by generating, collecting, and analyzing data (Krishanankutty, Bellary, Kumar & Moodahadu, 2012). Acquiring data is the first step and it is a difficult and time-consuming progress. After the data are obtained, they should be appropriately integrated and stored for the purpose of retrieving, comparing, manipulating, and investigating. To maximum the deployment of information technologies in clinical research, the discipline-specific requirements for different types of clinical research should be addressed.
Population-Based research, such as public health research and health services research, can be more productive because of the large numbers of subjects. Using the electronic medical record (EMR) is the best choice to enable the observation for a large volume data over time. Nevertheless, significant regulation restrictions as well as technical limitations are existed that obstruct the processes of providing and operating electronic data. The Association of American Medical Colleges (AAMC) has indicated the technical limitations and barriers in using the electronic data in five primary aspects, “1), lack of standardization in coding, vocabulary and nomenclature; 2), lack of standardized messaging for transmitting data; 3), lack of infrastructure capacity for inputting, storing, and retrieving data; 4), lack of a ‘gold standard’ for the validity of data contained in electronic systems; and 5), lack of use of algorithms to enhance the validity of data” (Association of American Medical Colleges, 2002). Hence, the requirements for population-base research in information technology are summarized by AAMC as the following:
• The need in coding and vocabulary standardization P11
• The need in developing and employing standards for information transmitting
• The need in building and enhancing information technology infrastructure – to set up the information system infrastructure is the most expensive...