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Clinical Trials: General Information
Industry is one of the major stakeholders in Clinical Trials with interests and contributions spanning from the supply of products and services to researches to the use of the results of clinical trials in a variety of applications.
Clinical trials help everybody involved gain new knowledge for improving health care. For pharmaceutical companies there is a huge interest to receive faster results on larger cohorts to assure the safety and efficacy of their newly developed drugs and to minimize risks and costs. At the same time there is a lack of interoperability and access to clinical and genetic data. Information in a trial are collected with a special questionnaire. Because of lacking an Ontology in trials today these data can not be analyzed for additional research in most cases. Most of pharmaceutical companies run their trials in small regions on a national level. This makes it nearly impossible to enroll patients with different genetic preconditions and different metabolic pathways to discover rare (side-)effects of new drugs. It is critical that people from all races participate in clinical trials, because different ethnic groups often respond differently to drug therapies. To run such trials is difficult, because there is still a lack of:
- access to international patient cohorts and multi-centered trials
- standardized trial design and data Management systems
- interoperability of IT systems
- easy enrollment of patients on an international level
- usability of different data formats in management, research and imaging studies
- fulfilling international ethical and legal requirements and guidelines
- Resources that allow the integration of multilevel and heterogenous data
The ACGT project provides a Virtual environment for clinical trials and tools for researchers, clinical professionals and vendors to make data comparable and provide a platform where
- data can easily be exchanged using a Grid-architecture
- patients can be enrolled internationally including minorities
- advanced tools for research and imaging analysis are provided
- a Master Ontology is used to allow the use of data for further research
Commercial organizations and institutions and pharmaceutical companies will have the opportunity to run their trials on the ACGT platform using all available tools and functionalities. Conditions have to be set up with ACGT. Software development companies are also able to contribute their own ACGT compliant services.