A strategy for in-silico clinical trials
Avicenna is a support action co-funded by the European commission which kicked off its activities on Oct 1st, 2013 with the goal of creating a Roadmap for in silico Clinical Trials.
The beginning of the 21st century saw the birth of a completely new way to investigate living organisms through computer simulations, called in silico medicine. In the span of 24 months, the project will explore how computer simulations can be used to improve clinical trials of drugs, devices and biotechnology products.
Avicenna is a Persian physician and philosopher (980-1037) who first gave a formal structure to the process of evaluating the effect of a treatment on a disease. This concept was elaborated in one of his most famous books, the Canon of Medicine, that presents a clear and organized summary of all the medical knowledge of the time:
- The drug must be free from any extraneous accidental quality.
- It must be used on a simple, not a composite, disease.
- The drug must be tested with two contrary types of diseases, because sometimes a drug cures one disease by its essential qualities and another by its accidental ones.
- The quality of the drug must correspond to the strength of the disease. For example, there are some drugs whose heat is less than the coldness of certain diseases, so that they would have no effect on them.
- The time of action must be observed, so that essence and accident are not confused.
- The effect of the drug must be seen to occur constantly or in many cases, for if this did not happen, it was an accidental effect.
- The experimentation must be done with the human body, for testing a drug on a lion or a horse might not prove anything about its effect on man.
Surprisingly since then, the fundamental nature of clinical trials has changed very little!
Avicenna does not only aim to develop a Roadmap for in silico Clinical Trials, but it will also put the bases to establish a precompetitive alliance between biomedical industries and European research organisations, with the purpose of developing the technology, methods, protocols and standards required in order to make possible the use of computer simulations before real clinical trials.
"Avicenna will reduce the costs and the risks (both clinical and financial) involved in clinical trials"
Avicenna will be designed around four or five large consultation meetings. Each meeting will be designed to open a dialogue with key experts and stakeholders in the field, so to collectively define the grand challenges that need to be addressed to make in silico clinical trials a reality.
During the process the consortium will use an innovative crowd-sourcing knowledge discovery and consensus building system, based on alignment cycles: Schelling Point.
This approach involves systems thinking - the recognition that many factors may combine in complex ways to create sometimes surprising futures (due to non-linear feedback loops), allowing the inclusion of factors that are difficult to formalise, such as novel insights about the future, deep shifts in technology, unprecedented regulations or inventions.
WHO AVICENNA WANTS TO HEAR FROM?
- Biomedical industry
- IT industry
- Engineering firms
- Clinical research organizations (CRO)
- Research hospital
- Regulatory bodies
- Computer aided engineering (CAE) tools producers
- Patient organisations
If you are interested to get involved drop us an email: email@example.com