- medical professionals
- Main menu
Clinical trials
Clinical Trials: General Information
Information arising from post-genomics research, and combined genetic and clinical trials on one hand, and advances from high-performance computing and informatics on the other is rapidly providing the medical and scientific community with new insights, answers and capabilities. The breadth and depth of information already available in the research community at large, present an enormous opportunity for improving our ability to reduce mortality from cancer, improve therapies and meet the demanding individualization of care needs.
The aforementioned needs, and the posted scientific and technological challenges push for trans-disciplinary team science and translational research. Up to now, the lack of a common infrastructure has prevented clinical research institutions from being able to mine and analyze disparate data sources. This inability to share technologies and data developed by different cancer research institutions can therefore severely hamper the research process. Most critically researchers have difficulty integrating data from different technologies because of a lack of common standards and other technological and medico-legal and ethical issues. Today the legal and ethical guidelines for running a clinical trial build a high threshold. Nevertheless this threshold is needed to increase the safety for patients enrolled in clinical trials. For clinicians it is difficult to set up such trials without getting support regarding these requirements also including issues like data management, data processing, data security, data integration, etc.. All these problems are still not solved. Especially the integration of heterogeneous data (molecular genetic data, clinical data and data from Web databases) in clinicogenomic trials is of utmost importance for developing a more personalised medicine.
ACGT aims to help clinicians in setting up new clinicogenomic trials by providing an integrated Clinico-Genomic ICT environment enabled by a powerful GRID infrastructure. Within this infrastructure a Trial Builder will be integrated, guiding a clinician or any other principal investigator to write a new treatment protocol by the use of a Master protocol and enabling him to be in compliance with all ethical and legal requirements. The Trial Builder is a fully-developed data-management system called Ontology based Trial management system (ObTiMa) that will be based on the ACGT Master Ontology. The seamless integration of heterogeneous data and the use of a Master Ontology allows to query throughout different trials within the ACGT platform. This will create new knowledge leading to a more individualized treatment of patients with cancer.
One objective of ACGT is to increase the number of clinicogenomic trials. To achieve this goal ACGT invites clinicians and study groups to participate in ACGT by using available tools to set up new clinicogenomic trials.
If you are a medical professional and are interested in using ACGT resources or creating a new clinical trial please contact us directly by sending an email here.
Masterprotocol
The Master protocol provides the "skeleton" for the trial protocol. The main topics are shown below.
- Introduction
- Background
- Study objectives
- Investigational agent
- Study design
- Statistical plan
- Data handling and record keeping
- Study monitoring, Auditing and Inspecting
- Study Administration
- Publication Plan
- Attachments
- References
The full version will be available via ObTiMA.
There is a lot of information given in the Web. With the following links ACGT lists pages in the Web regarding Clinical Trials including Legal and Ethical issues.